Evidence Report/Technology Assessment 

Number 112 

The Use of Episiotomy in Obstetrical Care: 

A Systematic Review 

Prepared for: 

Agency for Healthcare Research and Quality 

U.S. Department of Health and Human Services 

540 Gaither Road 

Rockville, MD 20850 

www.ahrq.gov 

Contract No. 290-02-0016 

Prepared by: 

RTI-UNC Evidence-based Practice Center 

Research Triangle Park, North Carolina 

Investigators 

Meera Viswanathan, PhD 

Katherine Hartmann, MD, PhD 

Rachel Palmieri, BS 

Linda Lux, MPA 

Tammeka Swinson, BA 

Kathleen N. Lohr, PhD 

Gerald Gartlehner, MD, MPH 

John Thorp, Jr., MD 

AHRQ Publication No. 05-E009-2 

May 2005 
This report may be used, in whole or in part, as the basis for development of clinical practice 

guidelines and other quality enhancement tools, or a basis for reimbursement and coverage 

policies. AHRQ or U.S. Department of Health and Human Services endorsement of such 

derivative products may not be stated or implied. 

AHRQ is the lead Federal agency charged with supporting research designed to improve the 

quality of health care, reduce its cost, address patient safety and medical errors, and broaden access 

to essential services. AHRQ sponsors and conducts research that provides evidence-based 

information on health care outcomes; quality; and cost, use, and access. The information helps 

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make more informed decisions and improve the quality of health care services. 
This document is in the public domain and may be used and reprinted without permission except 

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specific permission of copyright holders. 

Suggested Citation: 

Viswanathan M, Hartmann K, Palmieri R, Lux L, Swinson T, Lohr KN, Gartlehner G, Thorp J 

Jr. The Use of Episiotomy in Obstetrical Care: A Systematic Review. Evidence Report/ 

Technology Assessment No. 112. (Prepared by the RTI-UNC Evidence-based Practice Center, 

under Contract No. 290-02-0016.) AHRQ Publication No. 05-E009-2. Rockville, MD: Agency 

for Healthcare Research and Quality. May 2005. 

ii 
Preface 

The Agency for Healthcare Research and Quality (AHRQ), through its Evidence-Based 

Practice Centers (EPCs), sponsors the development of evidence reports and technology 

assessments to assist public- and private-sector organizations in their efforts to improve the 

quality of health care in the United States. The reports and assessments provide organizations 

with comprehensive, science-based information on common, costly medical conditions and new 

health care technologies. The EPCs systematically review the relevant scientific literature on 

topics assigned to them by AHRQ and conduct additional analyses when appropriate prior to 

developing their reports and assessments. 

To bring the broadest range of experts into the development of evidence reports and health 

technology assessments, AHRQ encourages the EPCs to form partnerships and enter into 

collaborations with other medical and research organizations. The EPCs work with these partner 

organizations to ensure that the evidence reports and technology assessments they produce will 

become building blocks for health care quality improvement projects throughout the Nation. The 

reports undergo peer review prior to their release. 

AHRQ expects that the EPC evidence reports and technology assessments will inform 

individual health plans, providers, and purchasers as well as the health care system as a whole by 

providing important information to help improve health care quality. 

We welcome comments on this evidence report. They may be sent by mail to the Task Order 

Officer named below at: Agency for Healthcare Research and Quality, 540 Gaither Road, 

Rockville, MD 20850, or by email to epc@ahrq.gov. 

Carolyn M. Clancy, M.D. Jean Slutsky, P.A., M.S.P.H. 

Director Director, Center for Outcomes and Evidence 

Agency for Healthcare Research and Quality Agency for Healthcare Research and Quality 

Marian D. James, M.A., Ph.D. 

EPC Program Task Order Officer 

Agency for Healthcare Research and Quality 

Kenneth S. Fink, M.D., M.G.A., M.P.H. 

Director, EPC Program

Agency for Healthcare Research and Quality 

The authors of this report are responsible for its content. Statements in the report should 

not be construed as endorsement by the Agency for Healthcare Research and Quality or the 

U.S. Department of Health and Human Services of a particular drug, device, test, treatment, 

or other clinical service.

iii 
Structured Abstract 

Context: In the United States, use of episiotomy varies from less than 10 percent to more than 

75 percent of vaginal births. Overall, 30 to 35 percent of vaginal births include episiotomy. 

Routine episiotomy may not yield maternal benefits traditionally ascribed to it. 

Objectives: We addressed five key questions (KQs):

1. Does the practice of liberal or routine episiotomy, compared to more selective use of

episiotomy, influence maternal postpartum outcomes?

2. Does episiotomy incision type (i.e., midline or mediolateral), influence maternal 

postpartum outcomes?

3. Does the repair of the perineal defect (i.e., suture type and repair approach) influence 

maternal postpartum outcomes?

4. Does episiotomy have a long-term influence on urinary incontinence, fecal incontinence, 

or pelvic floor defects? 

5. Does episiotomy or incision type, or both, influence future sexual function?

Data Sources: We searched MEDLINE®, Cochrane Library, and CINAHL® and did hand–

searches, and consulted with experts. 

Study Selection: We excluded studies (1) not about outcomes of vaginal birth; (2) in 

languages other than English; (3) not pertinent to the key questions; (4) with < 40 subjects; and 

(5) not representing original research. KQs1, 2, and 3 were limited to randomized controlled 

trials. KQs4 and 5 included nonrandomized prospective cohorts. 

Data Extraction: We entered data into pretested abstraction forms; did a second review for 

accuracy, completeness, and consistency; and graded quality of studies. 

Data Synthesis: Literature searches yielded 986 articles; 659 were excluded after abstract 

review. Of the remaining 327, we included 45 articles. 

Conclusions: Fair to good evidence suggests immediate maternal outcomes from routine 

episiotomy are not better than those from restrictive use; instead, outcomes are worse because 

some proportion of women who would have had lesser injury instead had a surgical incision. 

Evidence is insufficient to provide guidance on choice of midline or mediolateral episiotomy

when indicated. For perineal injury requiring suturing, fair to good evidence suggests leaving 

superficial vaginal and perineal skin unsutured is potentially preferable. If used for skin 

approximation, a continuous, subcuticular repair is superior to an interrupted, transcutaneous 

method. Evidence is consistent and clear that absorbable suture is preferred and that 

polyglycolic acid suture is associated with less morbidity than gut and chromic gut suture. 

Evidence is insufficient to determine whether novel materials, such as tissue adhesive, offer 

benefits. Evidence regarding long-term sequelae is fair to poor; assessment of pelvic floor 

dysfunction was not conducted in the age groups of greatest relevance. Limited data show that 

episiotomy does not prevent fecal and urinary incontinence, pelvic floor relaxation, or impaired 

sexual function, within months to years from childbirth.

v 
Contents 

Chapter 1. Introduction ................................................................................................................... 1 

Background................................................................................................................................. 1 

Key Questions and Conceptual Framework ............................................................................... 3 

Key Questions......................................................................................................................... 3 

Conceptual Framework for Analysis of the Use of Episiotomy in Obstetric Care................. 4 

Production of This Evidence Report........................................................................................... 5 

Organization of This Evidence Report ................................................................................... 5 

Technical Expert Advisory Group (TEAG)............................................................................ 5 

Uses of This Report ................................................................................................................ 6 

Chapter 2. Methods......................................................................................................................... 7 

Literature Review Methods......................................................................................................... 7 

Inclusion and Exclusion Criteria............................................................................................. 7 

Literature Search and Retrieval Process................................................................................. 8 

Literature Synthesis .................................................................................................................. 11 

Development of Evidence Tables and Data Abstraction Process......................................... 11 

Quality and Strength of Evidence Evaluation....................................................................... 11 

External Peer Review................................................................................................................ 15 

Chapter 3. Results......................................................................................................................... 17 

Key Question 1: Episiotomy and Maternal Postpartum Outcomes......................................... 17 

Literature Search and Included Studies ................................................................................ 17 

Results................................................................................................................................... 20 

Key Question 2: Episiotomy Incision Type and Maternal Morbidity ..................................... 28 

Literature Search and Included Studies ................................................................................ 28 

Results................................................................................................................................... 29 

Key Question 3: Repair of Perineal Defect and Maternal Morbidity ...................................... 30 

Literature Search and Included Studies ................................................................................ 30 

Results for Methods of Repair.............................................................................................. 33 

Results for Materials for Repair............................................................................................ 36 

Results on Combined Approaches to Repair: Methods and Materials................................ 42 

Key Question 4: Episiotomy and Urinary Incontinence, Fecal Incontinence, and 

Pelvic Floor Defects.................................................................................................................. 43 

Literature Search and Included Studies ................................................................................ 43 

Results................................................................................................................................... 45 

Key Question 5: Episiotomy and Future Sexual Function........................................................ 57 

Literature Search and Included Studies ................................................................................ 57 

Results................................................................................................................................... 59 

vii 
Chapter 4. Discussion ................................................................................................................... 67 

Principal Findings..................................................................................................................... 69 

Key Question 1: Episiotomy and Maternal Postpartum Outcomes...................................... 69 

Key Question 2: Episiotomy Incision Type and Maternal Morbidity .................................. 69 

Key Question 3: Repair of Perineal Defect and Maternal Morbidity ................................... 69 

Key Question 4: Episiotomy and Urinary Incontinence, Fecal Incontinence, and Pelvic 

Floor Defects......................................................................................................................... 73 

Key Question 5: Episiotomy and Future Sexual Function.................................................... 74 

Limitations of This Review and the Literature ......................................................................... 74 

Deficiencies in The Literature .............................................................................................. 74 

Limitations to Our Review Procedures................................................................................. 75 

Future Research .................................................................................................................... 75 

Conclusion ................................................................................................................................ 77 

References and Included Studies.................................................................................................. 79 

Listing of Excluded Studies.......................................................................................................... 85 

Tables 

Table 1. Inclusion/exclusion criteria......................................................................................... 7

Table 2. Focused search terms and results from MEDLINE® .................................................. 8 

Table 3. Additional search terms and results from MEDLINE® .............................................. 9 

Table 4. Results of randomized controlled trials of liberal versus restrictive use of 

episiotomy: Perineal trauma ..................................................................................... 21 

Table 5. Results of randomized controlled trials of liberal versus restrictive use of 

episiotomy: Pain outcomes....................................................................................... 24 

Table 6. Description of trials of episiotomy repair relating to methods, materials, or both ... 31 

Table 7. Trial results for polyglycolic-acid and chromic-catgut sutures ................................ 39 

Table 8. Episiotomy and urinary incontinence, fecal incontinence, and pelvic floor 

defects....................................................................................................................... 46 

Table 9. Episiotomy and future sexual function ..................................................................... 60 

Table 10. Episiotomy and dyspareunia ..................................................................................... 64 

Table 11. Overall strength of the evidence for this body of literature ...................................... 68 

Figures 

Figure 1. Conceptual framework for routine use of episiotomy in obstetric care...................... 4 

Figure 2. Episiotomy article disposition................................................................................... 10 

viii 
Appendixes 

Appendix A: Exact Search Strings 

Appendix B: Sample Abstraction Forms/Quality Rating Forms 

Appendix C: Evidence Tables 

Appendix D: Acknowledgments 

Note: Appendixes are provided electronically at http://www.ahrq.gov/clinic/tp/epistp.htm

ix 
Introduction 

Episiotomy, incision of the perineum at the

time of vaginal childbirth, is a common surgical

procedure experienced by women in the United

States.1 Based on national hospital discharge data

for 1999, just over 35 percent of women who

gave birth vaginally had an episiotomy

performed; the figure was approximately 33

percent in 2000.2,3

Despite several decades of research, which

many interpret as definitive evidence against

routine (or “liberal”) use of episiotomy, little

professional consensus has developed about the

appropriateness of routine use. Lack of consensus

is illustrated by variation in rates of use, ranging

from 13.3 percent to 84.6 percent in one study

with a prospectively enrolled low-risk population,

with an average of 51 percent among spontaneous

term births.4 Variation has been reported by type

of clinician,4 time of day,

5 and facility type, size,

and location.6 Wide practice variations suggest

that episiotomy use is heavily driven by local

professional norms, experiences in training, and

individual provider preference rather than

variation in the physiology of vaginal birth. The

goal of this synthesis is to inform care providers,

professional organizations, advocates, and

individual women about the current state of the

evidence on routine use of episiotomy.

Key Questions

The RTI–UNC EPC addressed the following

Key Questions (KQs):

KQ 1. Does the practice of liberal or routine

episiotomy, compared to more selective

use of episiotomy, influence maternal

postpartum outcomes?

KQ 2. Does episiotomy incision type (i.e.,

midline or mediolateral) influence the

risk of maternal morbidity?

KQ 3. Does the repair of the perineal defect (i.e.,

suture type and repair approach)

influence the risk of maternal morbidity?

KQ 4. Does episiotomy have a long-term impact

on urinary incontinence, fecal

incontinence, or pelvic floor defects? 

KQ 5. Does episiotomy or incision type, or

both, influence future sexual function? 

Methods

Inclusion and Exclusion Criteria

We excluded studies that (1) did not report on

women of reproductive age, (2) were published in

languages other than English, (3) did not report

information pertinent to the key clinical

questions, (4) had fewer than 40 subjects, and (5)

were not original studies. Criteria for study

design were based on sufficiency and quality of

evidence. KQs 1 and 3 have been more

commonly examined in randomized controlled

trials (RCTs); thus, we elected to limit searches to

RCTs. KQs 2, 4, and 5 have been studied less

extensively in trials; therefore, we included both

RCTs and prospective cohort studies. 

Literature Search and Retrieval

Process

We used standard electronic databases:

MEDLINE®, Cochrane Collaboration resources,

and the Cumulative Index to Nursing and Allied

Health Literature (CINAHL®). We reviewed

Evidence Report/Technology Assessment

Number 112

The Use of Episiotomy in Obstetrical Care: A

Systematic Review

Summary

Authors: Viswanathan M, Hartmann K, Palmieri R, Lux L, Swinson T, 

Lohr KN, Gartlehner G, Thorp J Jr 

Agency for Healthcare Research and Quality

Advancing Excellence in Health Care • www.ahrq.gov

Agency for Healthcare Research and Quality Evidence-Based

Practice
2

reference lists of relevant articles and consulted with the

Technical Expert Advisory Group (TEAG) to obtain additional

relevant articles. We conducted a dual review for abstracts and a

single review for full articles to decide inclusion according to

preset criteria.

Development of Evidence Tables and Data

Abstraction Process

Abstractors trained themselves on entering data into evidence

tables by abstracting several articles and then reconvening as a

group to discuss the utility of the table design. After several

iterations and TEAG review, the final table design had all

needed, appropriate categories for systematically recording

information on the articles. 

All team members did initial entry of information onto data

abstraction forms. Another team member reviewed articles and

edited all initial table entries for accuracy, completeness, and

consistency. The two abstractors reconciled all disagreements

concerning information in the abstraction tables. We then

entered data from the abstraction forms into evidence tables

and again checked for consistency and accuracy.

Quality and Strength of Evidence Evaluation

Rating the Quality of Individual Articles 

Two article abstractors independently rated each article on

each of the categories on our quality assessment form. A third

reviewer reviewed the scores and flagged studies with differences

in scoring on individual components. We reconciled these

differences by consensus. 

Grading the Strength of Available Evidence 

Our scheme follows the criteria utilized by Berkman et al.7

That system included three domains: quality of the research,

quantity of studies (including number of studies and adequacy

of the sample size), and consistency of findings. Grades were

assigned by consensus of the four senior staff members. 

External Peer Review 

As is customary for all evidence reports and systematic

reviews done for AHRQ, the RTI–UNC EPC requested review

of this report from a wide array of outside experts in the field

and from relevant professional societies and public

organizations. We compiled comments from 18 respondents

and addressed each one individually, revising the text as

appropriate.

Results

Literature Search Yield

The literature search yielded 986 articles. Of these, we

excluded 659 articles after reviewing the abstracts. Of the

remaining 327 articles, we included 45 in our evidence report.

Of these, 7 address KQ 1, 1 addresses KQ 2, 20 address KQ 3,

15 address KQ 4, and 10 address KQ 5. 

Key Question 1: Episiotomy and Maternal

Postpartum Outcomes

Seven primary publications of RCTs addressed liberal versus

restrictive use of episiotomy.8-14 Each trial compared two study

arms or groups: (1) an intention to restrict routine use of

episiotomy and (2) a liberal-use policy that endorsed routine

use. Use of episiotomy in the restrictive groups ranged from

lows of 7.6 percent9 and 10.2 percent8 to highs of 44 percent11

and 53 percent.13 We emphasize that these trials compared

policies of episiotomy use, not episiotomy to no episiotomy; six

of the seven studies used mediolateral episiotomy. 

This literature has high internal consistency with respect to

the postpartum effects of differing strategies for episiotomy use.

Compared to women in liberal-use groups, women in the

restrictive-use groups had less severe posterior perineal trauma,

less need for suturing, higher probability of having an intact

perineum, no greater or lesser risk of wound healing

complications, and higher likelihood of resuming intercourse

earlier. 

Key Question 2: Episiotomy Incision Type and

Maternal Morbidity

Only one RCT compared outcomes of midline episiotomy

to those of mediolateral episiotomy.15 An additional focused

literature search did not reveal any prospective cohort studies

on this issue. Women in the midline group began sexual

intercourse significantly earlier and had a significantly better

cosmetic appearance of the scar than women in the

mediolateral group. The groups did not differ significantly on

pain or satisfaction from sexual intercourse. Women receiving

midline episiotomy also had a significantly greater probability

of anal sphincter injuries than women in the mediolateral

episiotomy group. This study did not assess fecal incontinence

as a long-term health outcome. Because of considerable

methodologic flaws, any conclusions must be drawn cautiously. 

Key Question 3: Repair of Perineal Defect and

Maternal Morbidity

We included 17 RCTs (in 21 articles) examining various

methods and materials for repairing perineal defects; virtually

all episiotomies in these trials were mediolateral.16,17,17-35

Four trials investigated techniques of repair.17,27,29,32,35 Two

compared a two-layer approach (leaving the perineal skin

unsutured) with a three-layer approach (suturing the perineal

skin); two others compared a continuous (subcutaneous)

technique with an interrupted (transcutaneous) technique. 

Fourteen trials investigated materials for repair;19 16,17,20-23,25-28,30-

34 eight compared polyglycolic-acid sutures with chromic-catgut

sutures, both absorbable; two compared absorbable sutures (one

polyglycolic acid and one chromic catgut) with an enbucrilate

tissue adhesive (Histoacryl®); two compared standard

absorbable suture material with its rapidly absorbed
counterpart; and one compared untreated chromic catgut with

a glycerol-treated “softgut” chromic catgut. In addition, two

trials compared nonabsorbable and absorbable sutures: one

compared silk sutures with polyglycolic-acid sutures and one

compared silk sutures with both polyglycolic-acid and chromiccatgut sutures.

Finally, two trials combined comparison of both techniques

and materials in their design.18,24

Most of these trials randomly allocated participants to one of

two groups. However, three trials incorporated a factorial

design of randomization. Using a 2x2 design, both the socalled Ipswich Childbirth Study29,30,32 and the Kettle et al. trial36

randomized to methods of repair and type of sutures. The

Mahomed et al. perineal suture study used a 2x3x2 design and

randomized to suture type for deep tissue repair (two groups),

suture type for the perineal skin (three groups), and method of

repair (two groups).27

Methods 

Two-layer vs. three-layer repair. The trials provided

consistent evidence that favored the two-layer approach;

differences between the two approaches were not always

statistically significant.29,32,35

Despite some limitations, collectively these trials suggest that

less overall perineal morbidity is associated with the two-layer

repair approach than with the traditional three-layer approach.

The reduction in pain, need for analgesia, wound healing

problems, and sexual morbidity as well as a decrease in the time

and cost required for initial suturing of the perineal skin,

removal, and possible resuturing, may make the two-layer

approach more beneficial than the three-layer approach.

Continuous vs. interrupted sutures. Two good-quality

trials produced inconsistent evidence that the continuous

method of repair has less perineal morbidity and more patient

satisfaction associated with it than the interrupted method.17,27

In both trials, the authors describe greater familiarity with the

interrupted method of repair. One clinical group even suggests

that their inconsistencies with other trials might be attributable

to lack of practice with the method and subsequent

unpopularity with the operators that performed the repair.27

Whether such differences in outcome arise for clinicians and

women outside the United Kingdom, where methods of repair

and training of those performing the repair could be different

than in other countries, remains to be seen. 

Materials 

Absorbable vs. tissue adhesive. These two trials were small

(n < 65 in both trials) and of poor quality because of poor

randomization,16,33 but they defined and measured perineal pain

well and achieved good followup. They contribute possible

evidence that repair with tissue adhesive may decrease perineal

pain in the immediate postpartum. 

Absorbable sutures: standard vs. rapidly absorbed.

Mixed results from a good trial36 and lack of significant

differences between groups in a poor trial31 yielded insufficient

evidence, pointing to a difference in perineal pain between

standard and rapidly absorbed sutures. Stronger evidence

indicated that women who had rapidly absorbed sutures

required less removal of the material, presumably because it was

absorbed into the skin quickly in the postpartum period.

Although the two trials evaluated sexual functioning at different

times, rapidly absorbed sutures may decrease the amount and

severity of dyspareunia in the puerperium. 

Untreated catgut vs. treated catgut. Only one trial

addressed treated and untreated chromic catgut.25 It produced

no evidence that treated catgut is superior to untreated catgut

with regard to perineal morbidity; in fact, treated catgut may be

associated with higher morbidity (more perineal pain in the

immediate postpartum period; painful sexual intercourse in the

longer term). 

Nonabsorbable vs. absorbable suture. Because of the

study design of the fair-quality trial23 and lack of control for

possible confounding by method of repair, we cannot draw

conclusions about the role of silk sutures in perineal morbidity

from this trial. The authors concluded that the subcuticular

method lent itself to short-term advantages but did not present

supporting data. Thus, although this trial may contribute to a

body of evidence about combinations of materials and

methods, it does not contribute to the overall understanding of

the role of suture materials in perineal morbidity, separate from

methods of repair. The Mahomed et al. trial27 found no

differences between the two groups in the short-term

postpartum period, but did find differences at 3 months,

indicating a possible delayed effect of the suture material. 

Polyglycolic acid vs. chromic catgut. In 2004, the

Cochrane Library published a systematic review and metaanalysis of information on polyglycolic-acid versus catgut suture

material for repair of perineal trauma.37 The authors reported

that polyglycolic-acid sutures were associated with less pain in

the short-term postpartum period (odds ratio [OR] = 0.62;

95% confidence interval [CI], 0.54-0.71) and with less need

for analgesia (OR = 0.63; 95% CI, 0.52-0.77), but groups did

not differ in long-term pain outcomes or reports of

dyspareunia. 

Our systematic review includes six of the eight trials that

appeared in the Cochrane review and two additional trials.

Overall, the evidence is from a combination of poor, fair, and

good trials; it is consistent with the previous Cochrane review.

Polyglycolic-acid sutures are associated with less perineal pain,

less need for analgesia use, and fewer healing problems in the

short term. Long-term outcomes do not differ substantially

between polyglycolic-acid sutures and chromic catgut. One

trial not in the Cochrane review reported more perineal pain

and dyspareunia in the polyglycolic-acid group at 6 months,34

3
4

an outcome the authors attributed to the slower absorption rate

of polyglycolic-acid sutures; however, these results were neither

statistically significant nor precise. Overall, the body of

evidence about polyglycolic-acid versus chromic-catgut sutures

suggests that polyglycolic-acid sutures offer many short-term

advantages.

Combined methods and materials. Two trials compared

entire approaches, combining both materials and methods in a

single randomization design.18,24 The poor trial18 found no

differences between the groups; the fair-quality trial24 found

that women repaired with polyglycolic-acid sutures using a

continuous, subcuticular approach suffered less perineal

morbidity. This result is consistent with other trials that

investigated subcuticular suturing and polyglycolic-acid sutures

separately, perhaps reinforcing the notion that this method and

suture type are superior to other options available to obstetric

clinicians. 

Key Question 4: Episiotomy and Urinary

Incontinence, Fecal Incontinence, and Pelvic

Floor Defects

Sixteen publications prospectively collected data about some

aspect of continence or pelvic floor muscle function with good

documentation of perineal status and episiotomy use at the

time of the index birth. Outcomes of interest included

physiologic measures of muscle strength, clinical urodynamic

testing, or self-report by interview or questionnaire. 

The 16 publications include four reports from two RCTs of

liberal versus restrictive use of episiotomy and 11 prospective

studies of representative cohorts of women delivering at

particular facilities or with a particular practice group

(including two publications from a cohort of women who

participated in an RCT of perineal massage versus none in the

third trimester). One study of a cohort of all women in a

region who had third-degree lacerations at the time of the index

birth followed them to assess risk of fecal incontinence at 3

months. 

All studies reflect the dominant practice patterns in the

countries in which the studies were conducted. No study

directly compared the influence of mediolateral versus midline

(also called median) episiotomy on pelvic floor function or

continence. For this reason, long-term differences in

continence and pelvic floor muscle outcomes that would be

anticipated secondary to differences in episiotomy type are

unknown. 

Randomized Controlled Trials

Both RCTs (Sleep and colleagues in the United Kingdom8

and Klein and colleagues in Canada11) required providers to

alter their use of episiotomy. These trials randomized women

to “liberal use” or “restricted use” of episiotomy; the latter

category intended to restrict use to circumstances such as fetal

distress or maternal exhaustion with an “unyielding perineum.”

Both trials enrolled singleton, vertex presentation pregnancies at

term and randomized in the delivery suite close to the time of

birth. 

Neither trial showed meaningful differences in varied

measures of urinary incontinence such as subjective sensation of

perineal bulging, perineometry readings, involuntary loss of

urine, use of a pad, loss of urine with coughing, sneezing,

laughing, and loss with urgent need to void. Neither trial

collected data about continence of flatus or stool, descriptive

data from physical examination, or urodynamic studies. Both

research teams concluded that they did not observe any benefits

associated with episiotomy. Klein and colleagues, using

perineometry measures, also concluded that episiotomy fails to

prevent pelvic floor relaxation.11

Prospective Studies

The most global assessment of continence and pelvic floor

function concluded that episiotomy is associated with lower

pelvic floor muscle strength than spontaneous tears.38 The

clinical significance of this finding is unclear because all selfreported symptoms of urinary and anal incontinence and

degree of prolapse on physical examination were equivalent

across groups. Overall, episiotomy apparently did not protect

against incontinence, prolapse, or decrements in pelvic floor

muscle function by 3 months postpartum. 

Studies focused on self-reported urinary continence.

Excluding the clinical trial populations and the Sartore et al.

study above, five studies (in four study populations) evaluated

self-reports of urinary continence.39-43 Overall, episiotomy and

spontaneous-tear groups had the same frequency of

incontinence symptoms; no evidence emerged that episiotomy

prevents pelvic floor damage.

Studies focused on self-reported incontinence of stool or

flatus. Three cohort studies asked women about rectal

incontinence symptoms; one also conducted physical 

examinations.44-46 These authors focused on the high prevalence

of anorectal dysfunction at 3 months with episiotomy as a key

risk factor. None of these research teams found episiotomy to

be statistically associated with reduced risk.

Studies focused on physiologic measures of pelvic floor

function. Overall, none of these research teams concluded that

episiotomy had advantages,29,47,48 and one identified a decrease

in functional muscle strength. As intermediate measures, these

findings concur with the self-report and clinical examination

findings of other studies: essentially, episiotomy confers no

benefits with respect to preserving continence or pelvic floor

muscle function.

Key Question 5: Episiotomy and Future

Sexual Function 

Nine studies (in 10 publications) prospectively collected

outcome data about sexual function among women who did or
did not have a routine episiotomy. One study compared

incision type and assessed sexual function;15 three RCTs

examined restrictive versus liberal use of episiotomy;8,11,49 one

trial studied mediolateral versus median episiotomy;15 and five

were prospective cohort studies.38,42,50-52 One study (the only

study conducted in the United States), described by the authors

as “retrospective,” included a single followup time point (6

months) with prospective data collection about sexual

function.53 Two publications reflect a primary analysis from an

RCT with 3 months of followup8 and a secondary analysis after

3 years49 in the same UK study population. In two

publications with analyses of the same study population, a

Canadian research team reported analyses of 3-month followup

data: one on randomization to liberal or restrictive episiotomy

groups, and the other on perineal trauma at the time of delivery

by exposure group.11,52

Apart from the one study directly comparing mediolateral to

median episiotomy, all studies reflect the dominant practice

patterns of the countries in which they were conducted. Thus,

the literature reflects two distinct types of procedures, the

effects of which need to be addressed separately. 

Randomized Controlled Trials

Two publications from RCTs of restrictive compared to

liberal use of episiotomy reported intention-to-treat analyses of

long-term effects on the sexual outcomes of populations of

women. In one study,8 by 1 month after delivery, 37 percent of

the restrictive group and 27 percent in the liberal group had

resumed sexual intercourse (P < 0.01). The proportion of

women with resumption of intercourse by 3 months, current

dyspareunia at 3 months, or any dyspareunia within the 3

months of followup did not differ significantly by group. By

the third year of followup, the likelihood of “ever suffering

painful intercourse” remained comparable across groups.49

Klein and colleagues found less episiotomy use in the

restrictive group with higher rates of spontaneous lacerations.11

Women in the restrictive group resumed intercourse an average

of 1 week earlier that those in the liberal group; however, all

other measures of sexual function were equivalent by 3

months.11 This team conducted a separate analysis of the

relationship between degree of perineal trauma and sexual

function using 3-month interview data. They regrouped

participants by perineal status that had been systematically

documented at the time of the index birth, creating a

prospective cohort. Women with episiotomy had the slowest

return to intercourse. Pain with the first intercourse followed a

similar pattern.

Prospective Cohorts 

These cohort studies did not find large or statistically

significant differences in sexual function. Only one study

identified lasting differences in dyspareunia at 3 months.

Current dyspareunia at 3 months can be estimated from three

of the cohort studies using 818 women with episiotomy and

938 women without episiotomy.38,50,51 A meta-estimate from

the combined cohorts suggests that women with episiotomy are

54 percent more likely to have pain with intercourse 3 months

after delivery, with an absolute increase in risk of dyspareunia of

5 percent among women who had episiotomy. The two studies

that assessed any dyspareunia during the 3 months after

childbirth revealed no difference in the overall probability of

having had painful intercourse. 

Discussion

Findings by Key Question

Key Question 1: Episiotomy and Maternal Postpartum

Outcomes

Trials of fair to poor quality provide consistent findings that

clearly support limited use of episiotomy. Routine episiotomy

achieves no short-term goals that it has been hypothesized to

achieve. Indeed, routine use is harmful to the degree that it

creates a surgical incision of greater extent than many women

might have experienced had episiotomy not been performed. 

Key Question 2: Episiotomy Incision Type and Maternal

Morbidity

A single study found that women with midline episiotomy

had a significantly greater rate of anal sphincter injuries than

women with mediolateral episiotomy.15 Treatment groups did

not report differences in pain or satisfaction with intercourse at

3 months. Because of considerable methodological flaws in this

trial (poor internal validity), any conclusions must be drawn

cautiously. However, because differences in sphincter injury

rates are clinically important, we consider the finding of

increased risk of severe injury with midline episiotomy

compared to mediolateral episiotomy to be relevant

observational evidence. 

Key Question 3: Repair of Perineal Defect and Maternal

Morbidity

Limited but consistent evidence favored two-layer repair over

three-layer repair; limited and inconsistent evidence favored

continuous over interrupted sutures. Evidence was insufficient

to comment on comparisons between standard and rapidly

absorbed sutures, tissue adhesive and absorbable sutures, or

nonabsorbable and absorbable sutures. We found no evidence

that treated catgut is superior to untreated catgut with regard to

perineal morbidity; the former may in fact be associated with

higher morbidity. The evidence suggests short-term advantages

for perineal repeat associated with the use of polyglycolic-acid

sutures compared to chromic-catgut sutures. 

Three major classes of suture material (nonabsorbable,

absorbable, and tissue adhesive) and two subtypes of sutures

(treated versus untreated and standard versus rapidly absorbed)

were studied, all in the presence of different approaches to the

method of suturing; thus, individual effects of the materials

themselves cannot be examined. Likewise, methods of repair

5
were examined in the context of different materials both among

and within studies for different stages of repair. We are unable

to assess the true effects of a certain method of repair because

we cannot tell whether outcomes are confounded or modified

by suture material. 

Key Question 4: Episiotomy and Urinary Incontinence,

Fecal Incontinence, and Pelvic Floor Defects

These prospective studies did not identify improvements in

continence for urine or stool or in pelvic floor muscle function

among women who had had episiotomy compared to those

who had not. This finding includes comparison to women

who had spontaneous lacerations of similar severity. Several

authors reported decrements in pelvic floor function among

women who had had episiotomy. Only a single study, using

multivariable models, found that episiotomy was an

independent predictor of urinary continence.41 In the majority

of other studies using multivariate models, adjusting for factors

such as parity, neonatal weight, and length of second-stage

labor, episiotomy was not an independent risk factor for

incontinence. Taken in total, this literature, predominantly of

fair to poor quality, does not support use of episiotomy for the

purpose of preventing pelvic floor defects, urinary

incontinence, or incontinence of stool or flatus. 

These studies are limited because they do not follow women

long enough to detect disease occurrence. At present, the

assumption that intermediate variables, such as pelvic muscle

strength measured by perineometry, urodynamic test results, or

early reports of symptoms, can predict later disease has not

been validated. Prospective evaluation only during the months

after birth when the pelvic floor is still in a recovery and

stabilization period may be misleading. Conclusions about

whether episiotomy prevents or increases risk for incontinence

and prolapse later in adult life cannot be reached from currently

available randomized and cohort studies.

Key Question 5. Episiotomy and Future Sexual Function 

The studies addressing this question need to be considered in

two groups: mediolateral episiotomy and median episiotomy.

From the clinical trials of episiotomy strategy—liberal versus

restrictive—one trial addressed each type of incision and one

directly compared the two incision types. None found

substantive differences in sexual function. The preponderance

of the studies, however, supported a conclusion that degree of

perineal trauma is associated with probability of pain with

intercourse, in a dose-response fashion such that greater

perineal injury is associated with greater probability of pain. 

Measures that are more complex than those typically used in

this literature are needed to understand properly the

relationships between perineal trauma and future sexual

function. Specific factors such as prior sexual function and

current libido, in addition to factors such as duration of

second-stage labor, size of infant, and lactation status, need to

be incorporated into multivariable models to derive more

informative and less biased estimates of the long-term effects of

episiotomy or to determine that they do not exist.

Limitations

Deficiencies in the Literature

The available studies that met our inclusion criteria for this

systematic review contained numerous (and commonly

encountered) deficiencies. These included variations in

episiotomy rate, violations of protocol, inconsistent reporting of

the definitions of measures, inadequate reporting of statistics,

infrequent a priori designation of primary and secondary

outcomes, infrequent masking of the assessor, infrequent use of

multivariate modeling, and infrequent use of validated outcome

measures. In all, much of this literature could be regarded as

fair in quality, with some studies of good quality and a few of

poor quality. 

Limitations to Our Review Procedures

Our review process also had some limitations. Because of

time and resource constraints, we did not conduct dual,

independent, blinded review of articles for inclusion or

abstraction of information into evidence tables. Instead, one

reviewer performed the initial review, and a second reviewer

examined that input and recommended changes. Differences

were reconciled between the two reviewers. We used dual

review for grading the quality of individual articles, allowing us

to evaluate rigorously systematic bias in these assessments. 

Future Research

Currently, the evidence suggests that the putative benefits of

episiotomy do not outweigh its harms. Instead, outcomes from

episiotomy are worse because some proportion of women who

would have had lesser injury instead had a surgical incision. 

If episiotomy were restricted to indicated uses, an important

question remains for women and their care providers: Which,

if any, of the prevailing indications for episiotomy are

supported by an adequate research base? A two-stage research

agenda could address this need. First, a systematic review may

clarify current knowledge about outcomes of episiotomy for the

leading presumed indications. Second, primary data collection

may be needed to fill in research gaps identified by such a

review and to improve understanding of whether these are

indeed indications for episiotomy. 

Work relating to this latter part of such a research agenda is

under way on several topics. This work includes a recent

publication of a retrospective cohort study that suggests that

episiotomy conferred no benefit in averting neonatal injury at

the time of births that had been complicated by shoulder

dystocia.54 Additional evidence will be required to investigate

fully what circumstances should be considered indications for

episiotomy.

6
Furthermore, if the professional community accepts that

routine episiotomy is not an effective means to reduce perineal

injury, then that attitude should enable them to redouble

efforts to understand fully various other approaches to

attending the second stage of labor that can promote maternal

and infant safety, minimize perineal trauma, and maximize

maternal comfort. These steps might include giving attention

to maternal position, avoiding fundal pressure, reducing

coached pushing, providing perineal support, and employing

“hands poised” versus “hands on” techniques to support the

perineum. The role for lubrication and types of lubrication for

use during crowning of the infant head are other important

research topics that warrant more rigorous investigation. 

To understand pelvic floor defects and childbirth experiences

properly, including history of episiotomy, studies need to be

designed to identify populations of women who have a known

episiotomy history. In this way, researchers can evaluate

continence and pelvic organ prolapse status in the age groups

between 40 and 70 years. 

Conclusion

Our systematic review finds no health benefits from

episiotomy. We found fair to good evidence suggesting that the

immediate outcomes for routine (liberal-use policies)

episiotomy are no better than those for indicated use of

episiotomy under more restrictive-use policies. Indeed, routine

use is harmful to the degree that it creates a surgical incision of

greater extent than many women might have experienced had

episiotomy not been performed. Weak trial evidence,

consistent with observational data, suggests that the harms of

midline episiotomy are greater than the harms of mediolateral

episiotomy. 

For episiotomy repair, fair to good evidence, albeit across

different comparisons of methods and materials, suggests that

leaving the perineal skin unsutured may confer some benefit; if

suturing is indicated, then a continuous, subcuticular method is

better than an interrupted, transcutaneous method. Regarding

suture material, the evidence is consistent and clear that

absorbable sutures are preferred and that polyglycolic-acid

sutures have significantly less perineal morbidity associated with

them. Newer materials, such as tissue adhesive, may offer

further benefits, but the data are at present wholly inadequate

to inform care practices.

The level of evidence for long-term sequelae, specifically fecal

and urinary incontinence, pelvic floor function, and future

sexual function, is fair to poor. Nonetheless, it is consistent in

demonstrating the lack of benefit of the procedure in a

comparatively early timeframe. For women in later adult life,

when morbidity is most likely to occur in the form of severe

and persistent incontinence or pelvic organ prolapse, the

expected results of routine episiotomy are unknown. 

Availability of the Full Report

The full evidence report from which this summary was taken

was prepared for the Agency for Healthcare Research and

Quality (AHRQ) by the RTI-UNC Evidence-based Practice

Center, under Contract No. 290-02-0016. It is expected to be

available in May 2005, The Use of Episiotomy in Obstetrical

Care: A Systematic Review. In addition, Internet users will be

able to access the report and this summary online through

AHRQ's Web site at www.ahrq.gov.

Suggested Citation

Viswanathan M, Hartmann K, Palmieri R, Lux L, Swinson

T, Lohr KN, Gartlehner G, Thorp J Jr. The Use of Episiotomy

in Obstetrical Care: A Systematic Review. Summary, Evidence

Report/Technology Assessment No. 112. (Prepared by the

RTI-UNC Evidence-based Practice Center, under Contract

No. 290-02-0016.) AHRQ Publication No. 05-E009-1.

Rockville, MD: Agency for Healthcare Research and Quality.

May 2005.

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10. House MJ, Cario G, Jones MH. Episiotomy and the perineum: A

random controlled trial. J Obstet Gynaecol 1986; 7(2):107-10.

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14. Dannecker C, Hillemanns P, Strauss A, et al. Episiotomy and perineal

tears presumed to be imminent: Randomized controlled trial. Acta

Obstet Gynecol Scand 2004; 83:364-8.

15. Coats PM, Chan KK, Wilkins M, et al. A comparison between

midline and mediolateral episiotomies. Br J Obstet Gynaecol 1980;

87(5):408-12.

16. Adoni A, Anteby E. The use of Histoacryl for episiotomy repair. Br J

Obstet Gynaecol 1991; 98(5):476-8.

17. Kettle C, Hills RK, Jones P, et al. Continuous versus interrupted

perineal repair with standard or rapidly absorbed sutures after

spontaneous vaginal birth: A randomised controlled trial. Lancet 2002;

359(9325):2217-23.

18. Doyle PM, Johanson R, Geetha T, et al. A prospective randomised

controlled trial of perineal repair after childbirth, comparing

interrupted chromic catgut to subcuticular prolene for skin closure. Br

J Obstet Gynaecol 1993; 100(1):93-4.

19. Beard R, Boyd I, Sims C. A trial of polyglycolic acid and chromic

catgut sutures in episiotomy repair. Br J Clin Pract 1974; 28(12):409-

10.

20. Livingstone E, Simpson D, Naismith WC. A comparison between

catgut and polyglycolic acid sutures in episiotomy repair. J Obstet

Gynaecol Br Commonw 1974; 81(3):245-7.

21. Rogers RE. Evaluation of post-episiorrhaphy pain: Polyglycolic acid vs

catgut sutures. Mil Med 1974; 139(2):102-4.

22. Ping WW, Kee TS. Episiotomy repair: A comparison of catgut and

polyglycolic acid sutures. Med J Malaysia 1975; 30(2):135-8.

23. Buchan PC, Nicholls JA. Pain after episiotomy--a comparison of two

methods of repair. J R Coll Gen Pract 1980; 30(214):297-300.

24. Isager-Sally L, Legarth J, Jacobsen B, et al. Episiotomy repair--

immediate and long-term sequelae. A prospective randomized study of

three different methods of repair. Br J Obstet Gynaecol 1986;

93(5):420-5.

25. Spencer JA, Grant A, Elbourne D, et al. A randomized comparison of

glycerol-impregnated chromic catgut with untreated chromic catgut for

the repair of perineal trauma. Br J Obstet Gynaecol 1986; 93(5):426-

30.

26. Grant A, Sleep J, Ashurst H, et al. Dyspareunia associated with the use

of glycerol-impregnated catgut to repair perineal trauma. Report of a

3-year follow-up study. Br J Obstet Gynaecol 1989; 96(6):741-3.

27. Mahomed K, Grant A, Ashurst H, et al. The Southmead perineal

suture study. A randomized comparison of suture materials and

suturing techniques for repair of perineal trauma. Br J Obstet

Gynaecol 1989; 96(11):1272-80.

28. Olah KS. Episiotomy repair-suture material and short term morbidity.

J Obstet Gynaecol 1990; 10:503-5.

29. Gordon B, Mackrodt C, Fern E, et al. The Ipswich Childbirth Study:

1. A randomised evaluation of two stage postpartum perineal repair

leaving the skin unsutured. Br J Obstet Gynaecol 1998; 105(4):435-

40.

30. Mackrodt C, Gordon B, Fern E, et al. The Ipswich Childbirth Study:

2. A randomised comparison of polyglactin 910 with chromic catgut

for postpartum perineal repair. Br J Obstet Gynaecol 1998; 105(

4):441-5.

31. McElhinney BR, Glenn DR, Dornan G, et al. Episiotomy repair:

Vicryl versus Vicryl rapide. Ulster Med J 2000; 69(1):27-9.

32. Grant A, Gordon B, Mackrodat C, et al. The Ipswich childbirth study:

One year follow up of alternative methods used in perineal repair. Br J

Obstet Gynaecol 2001; 108(1):34-40.

33. Bowen ML, Selinger M. Episiotomy closure comparing enbucrilate

tissue adhesive with conventional sutures. Int J Gynaecol Obstet 2002;

78(3):201-5.

34. Upton A, Roberts CL, Ryan M, et al. A randomised trial, conducted

by midwives, of perineal repairs comparing a polyglycolic suture

material and chromic catgut. Midwifery 2002; 18(3):223-9.

35. Oboro VO, Tabowei TO, Loto OM, et al. A multicentre evaluation of

the two-layered repair of postpartum perineal trauma. J Obstet

Gynaecol 2003; 23(1):5-8.

36. Kettle C. Perineal care. Clin Evid 2002; (7):1284-95.

37. Kettle C, Johanson RB. Absorbable synthetic versus catgut suture

material for perineal repair. Cochrane Database Syst Rev 2000;

(2):CD000006.

38. Sartore A, De Seta F, Maso G, et al. The effects of mediolateral

episiotomy on pelvic floor function after vaginal delivery. Obstet

Gynecol 2004; 103(4):669-73.

39. Rockner G. Urinary incontinence after perineal trauma at childbirth.

Scand J Caring Sci 1990; 4(4):169-72.

40. Viktrup L, Lose G, Rolff M, et al. The symptom of stress incontinence

caused by pregnancy or delivery in primiparas. Obstet Gynecol 1992;

79(6):945-9.

41. Viktrup L, Lose G. The risk of stress incontinence 5 years after first

delivery. Am J Obstet Gynecol 2001; 185(1):82-7.

42. Karacam Z, Eroglu K. Effects of episiotomy on bonding and mothers'

health. J Adv Nurs 2003; 43(4):384-94.

43. Eason E, Labrecque M, Marcoux S, et al. Effects of carrying a

pregnancy and of method of delivery on urinary incontinence: A

prospective cohort study. BMC Pregnancy Childbirth 2004; 4(1):4.

44. Eason E, Labrecque M, Marcoux S, et al. Anal incontinence after

childbirth. CMAJ 2002; 166(3):326-30.

45. Walsh CJ, Mooney EF, Upton GJ, et al. Incidence of third-degree

perineal tears in labour and outcome after primary repair. Br J Surg

1996; 83(2):218-21.

46. MacArthur C, Bick DE, Keighley MR. Faecal incontinence after

childbirth. Br J Obstet Gynaecol 1997; 104(1):46-50.

47. Rockner G, Jonasson A, Olund A. The effect of mediolateral

episiotomy at delivery on pelvic floor muscle strength evaluated with

vaginal cones. Acta Obstet Gynecol Scand 1991; 70(1):51-4.

48. Fleming N, Newton ER, Roberts J. Changes in postpartum perineal

muscle function in women with and without episiotomies. J

Midwifery Womens Health 2003; 48(1):53-9.

49. Sleep J, Grant A. West Berkshire perineal management trial: Three year

follow up. Br Med J (Clin Res Ed) 1987; 295(6601):749-51.

50. Rockner G, Henningsson A, Wahlberg V, et al. Evaluation of

episiotomy and spontaneous tears of perineum during childbirth.

Scand J Caring Sci 1988; 2(1):19-24.

51. Larsson PG, Platz-Christensen JJ, Bergman B, et al. Advantage or

disadvantage of episiotomy compared with spontaneous perineal

laceration. Gynecol Obstet Invest 1991; 31(4):213-6.

52. Klein MC, Gauthier RJ, Robbins JM, et al. Relationship of episiotomy

to perineal trauma and morbidity, sexual dysfunction, and pelvic floor

relaxation. Am J Obstet Gynecol 1994; 171(3):591-8.

53. Signorello LB, Harlow BL, Chekos AK, et al. Postpartum sexual

functioning and its relationship to perineal trauma: A retrospective

cohort study of primiparous women. Am J Obstet Gynecol 2001; 

184(5):881-8; discussion 888-90.

54. Gurewitsch ED, Donithan M, Stallings SP, et al. Episiotomy versus

fetal manipulation in managing severe shoulder dystocia: A comparison

of outcomes. Am J Obstet Gynecol 2004; 191(3):911-6.

8

www.ahrq.gov

AHRQ Pub. No. 05-E009-1

May 2005

ISSN 1530-440X
Chapter 1. Introduction

Background 

Episiotomy, incision of the perineum at the time of vaginal childbirth, is a common surgical 

procedure experienced by women in the United States.1

 Based on national hospital discharge 

data for 1999, just over 35 percent of women who gave birth vaginally had an episiotomy 

performed; the figure was approximately 33 percent in 2000.2,3 National rates reflect a steady 

decline over the prior two decades,1

 with 2001 data suggesting that approximately 30 percent of 

vaginal births include episiotomy.4

 

Actual rates are likely to be higher because administrative data sources are prone to capture 

fewer events than occur. A study of the validity of birth data for Washington state in 1989 found 

that hospital discharge data underestimated episiotomy incidence by 44 percent overall when 

compared with medical records; accuracy of discharge record reporting for individual facilities 

ranged from recording none of the episiotomies performed at worst, to 86.4 percent at best.5

 In 

their nationally representative survey of women’s childbearing experiences between 2000 and 

2002, the Maternity Center Association documented that 35 percent of women who had a vaginal 

birth reported having an episiotomy.6

 

Likelihood of episiotomy is known to vary based on whether a woman is having a first 

vaginal birth or a subsequent birth and whether the birth is assisted by use of vacuum or forceps. 

Both a first birth and assisted vaginal delivery are associated with greater use of episiotomy.1,7 

Likelihood of episiotomy also varies across obstetric care settings. A study of 49,692 vaginal 

births in 18 hospitals in Philadelphia between 1994 and 1998 examined use of episiotomy among 

women giving birth for the first time to infants who weighed 2500 to 4000 grams and whose 

records did not note a difficult labor or assisted delivery. Forty-two percent of women in the 

study had an episiotomy, with a range of hospital averages from 20 percent to 73 percent.8

The precise origins of episiotomy are lost. Descriptions appear in European texts by the 

1740s.9

 Taliaferro first described its use in the U.S. medical literature in 1852.10 While caring 

for a moribund primiparous woman with eclampsia, he describes “immense distension of the 

vulva” and proceeding to make “an incision at the vulva, believing that preferable to permitting it 

[the fetal head] to force its way through [the anus] below.” He further noted: “...surely a smooth 

incised wound would be less injurious and heal more readily than one by rough violence.”10 

These observations foreshadow early uses of episiotomy that became ingrained in hospital 

obstetric practice beginning in the 1920s: to hasten delivery for maternal or fetal indications; to 

resolve the “unyielding vulva”; and in cases thought to portend imminent severe laceration, to 

forestall an extensive spontaneous laceration and substitute a more readily repaired surgical 

incision. In this decade, Joseph DeLee, an opinion leader in the drive to establish obstetrics as a 

medical specialty, began to promote the concept that episiotomy should be “used routinely” for 

the maternal indications above as well as to prevent brain damage, epilepsy, and cerebral palsy 

that might result from the “battering” of the fetal head against a rigid perinuem.11,12

Most obstetric textbooks endorsed episiotomy by the 1930s: “This is a prophylactic 

procedure, its purpose being: (a) to prevent extensive damage of the posterior vaginal wall and 

pelvic floor; (b) to save from gross injury the sphincter ani muscle and wall of the anal canal; (c) 
to curtail long-drawn-out overdistension of the vaginal wall, and the damage resulting 

therefore...,” providing the advantages of preventing extensive laceration, preserving sphincter 

integrity, providing a clean-cut wound and making scar tissue less likely to form, and ultimately 

achieving a result that is more satisfactory from “anatomical, functional, and cosmetic 

standpoints.”13 (Chapter 22, p. 666) Authors of texts frequently note that the procedure is 

especially warranted for primiparous patients, observing, “inasmuch as some degree of laceration 

occurs in the majority of cases episiotomy is a conservative rather than a radical procedure”14

(Vol 2, Section 10, p. 330). 

In the 1940s and 1950s, routine episiotomy was little debated and increasingly used. During 

subsequent decades, the proposed benefits of episiotomy continued to take on broader scope. 

These benefits included goals of reducing postpartum perineal pain when compared to 

spontaneous lacerations, preventing future pelvic organ prolapse and urinary and rectal 

incontinence, and preserving sexual function both by reducing slackness of the vaginal introitus 

and by reducing the likelihood of pain with intercourse.15,16 By the 1980s, episiotomy

accompanied 64 percent of vaginal births in this country.17 

Episiotomy became a routine practice of physicians long before emphasis on using outcomes 

research to inform practice. In seeking to establish an evidence base to support or refute the use 

of episiotomy, randomized clinical trials in the mid and late 1980s revealed two key findings: (1) 

routine mediolateral episiotomy use compared to restricted use was associated with higher risk of 

anal sphincter and rectal injuries, and (2) such surgery precluded a woman’s possibility of giving 

birth with an intact or minimally damaged perineum.

18 Larger trials in more varied populations 

of women and providers followed in the 1990s, with similar results. Investigators also sought to 

assess longer-term effects of perineal management at the time of birth on outcomes such as 

persistent pain, pelvic floor defects, urinary and rectal continence, and sexual function and 

satisfaction. The latter topics entered the spotlight as these outcomes became more dominant 

among the prevention-oriented goals proposed to be achieved by episiotomy. 

Despite several decades of research, which many interpret as definitive evidence against 

routine use of episiotomy, little professional consensus has developed about the appropriateness 

of routine use. Lack of consensus is illustrated by variation in rates of use. From 1987 to 1992, 

Kane Low and her colleagues documented provider-level variation from 13.3 percent to 84.6 

percent, with an average of 51 percent among spontaneous term births in a prospectively enrolled 

low-risk population.19 Episiotomy use varied widely in the midwives and physicians studied. 

Variation has been reported by time of day20 and by facility type, size, and location.21 

Although restricted-use arms of trials have achieved episiotomy rates as low as 8 percent to 

10 percent,22,23

 use remains common in many locations. Current obstetric care providers who 

continue to view episiotomy favorably most strongly agree with survey items that indicate they 

employ episiotomy to “prevent perineal trauma and to prevent pelvic floor relaxation and the 

consequences of pelvic floor relaxation, such as bladder prolapse and urinary incontinence.” 

Furthermore, providers endorse the statement that they “prefer to employ episiotomy frequently, 

because it is easier to repair than the laceration that results when episiotomy is not used.”24

Five points summarize the long history of episiotomy: 

1. routine use of episiotomy evolved from more limited indications; 

2. a goal of preventing future problems is eclipsing goals for labor “management”; 

3. provider type is associated with acceptance or avoidance of its use; 

2 
4. among providers of the same type, use varies widely; and 

5. rates of use vary distinctively by institution and region. 

The last three of these characteristics—wide practice variation—suggest to health services 

researchers that episiotomy use is heavily driven by local professional norms, experiences in 

training, and individual provider preference. Variation in biology, in this case the physiology of 

vaginal birth, rarely explains discrepancies in practice as large as those seen for episiotomy use. 

When practice variation is prominent, accrual of evidence of benefits and risks should take on a 

key role in informing care. In this context, episiotomy has the hallmarks of a procedure that 

warrants repeated synthesis of the evidence of proposed benefits and potential risks. A 1968 

Lancet editorial aptly captures the issues: “Despite the apparent simplicity of episiotomy, 

argument continues about how often the operation should be undertaken, the choice of incision, 

and the method of repair. Moreover, little information is available about the incidence of later 

complications such as dyspareunia.”25 

This systematic evidence review revisits randomized trials of routine versus restricted use, 

identifies the sole trial of midline versus median episiotomy, presents evidence for choosing 

among options for repair methods, and extends prior reviews to encompass longer-term 

outcomes. Specifically, we have systematically assessed the evidence from trials and 

prospective cohorts related to the influence of episiotomy on measures of pelvic floor relaxation, 

continence, and sexual function and satisfaction. The goal of this synthesis is to inform care 

providers, professional organizations, advocates, and individual women about the current state of 

the evidence about the routine use of episiotomy. 

Key Questions and Conceptual Framework 

Key Questions 

The original Scope of Work for this review was developed by the American College of 

Obstetricians and Gynecologists (ACOG) and forwarded by the Agency for Healthcare Research 

and Quality (AHRQ) to the RTI International–University of North Carolina Evidence-based 

Practice Center (RTI–UNC EPC). The work assignment proposed four provisional questions for 

review. Those questions were the basis for a brief review completed by the EPC Coordinating 

Center (The Lewin Group). Brief reviews help prioritize the topics AHRQ assigns to the 10 

“generalist” EPCs. 

The RTI–UNC EPC further revised the proposed questions after discussions with internal 

technical staff, AHRQ staff, and our Technical Expert Advisory Group (TEAG). The final key 

questions (KQ s) are listed below. 

KQ 1. Does the practice of liberal or routine episiotomy compared to more selective use of

episiotomy influence maternal postpartum outcomes? 

KQ 2. Does episiotomy incision type (i.e., midline or mediolateral) influence maternal 

postpartum outcomes?

KQ 3. Does the repair of the perineal defect (i.e., suture type and repair approach) influence 

maternal postpartum outcomes?

3 
KQ 4. Does episiotomy have a long-term influence on urinary incontinence, fecal incontinence, 

or pelvic-floor defects? 

KQ 5. Does episiotomy or incision type, or both, influence future sexual function? 

Conceptual Framework for Analysis of the Use of Episiotomy in 

Obstetric Care 

The conceptual framework in Figure 1 (i.e., the causal pathway developed for this systematic 

review) summarizes the critical issues addressed here and their links to the key questions. 

Figure 1. Conceptual framework for routine use of episiotomy in obstetric care 

Anticipated

Spontaneous

Vaginal Birth

Episiotomy

Integrity of

Perineum

Incision/

laceration:

3⁄4 Location

3⁄4 Number

3⁄4 Severity

Postpartum

Outcomes

3⁄4 Pain

3⁄4 Need for suturing

3⁄4 Blood loss/transfusion

3⁄4 Infection

3⁄4 Wound breakdown

3⁄4 Satisfaction with birth

experie nce

3⁄4 Sexual concerns and/

or deficits in sexual

function

Later

Outcomes

3⁄4 Pelvic floor

defects

3⁄4 Urinary

incontinence

3⁄4 Fecal

incontinence

3⁄4 Deficits in sexual

function

Repair Perineal Defect

3⁄4 Suture type

3⁄4 Repair approach

KQ1 KQ2

KQ4 KQ5

KQ3

3⁄4 Routine

3⁄4 Indicated

3⁄4 None

3⁄4 Urinary

incontinence

3⁄4 Fecal

incontinence

The key questions for this review present several conceptual challenges. Although the 

conceptual framework (Figure 1) treats episiotomy as the exposure of interest, trial participants 

cannot feasibly be allocated to receive an episiotomy with 100 percent certainty under any 

circumstance versus no episiotomy under any circumstance. Relevant controlled clinical trials 

most often compare a policy of liberal or routine use to a policy of indicated use only (often with 

varied or unspecified indications). These studies appropriately conduct analyses that compare 

maternal outcomes by study group as allocated. As a result, authors report on the status of the 

integrity of the vagina and perineum, including whether episiotomy was performed, as an 

outcome. In contrast, nonrandomized prospective studies (included for KQ 4 and 5) most often 

report outcomes, such as pain with intercourse, stratified by actual perineal status after the birth. 

To address potential differences arising from these variations in exposure categorization as study 

group versus episiotomy status, we have analyzed outcomes such as type of perineal trauma by 

strata, including episiotomy versus none, spontaneous versus assisted vaginal birth, and by other 

potential modifiers such as parity whenever such a summary is possible. 

4 
Another issue is how to define “routine episiotomy.” Defining the term is a challenge 

because the category is described in studies by negatives such as “not for fetal distress” and “not 

for dystocia.” We captured the operational definitions provided by authors of included 

publications and attempted to isolate data that reflect use of episiotomy at the time of 

uncomplicated spontaneous vaginal births. The text of this review and the evidence tables 

specify how authors define the terms “indicated” and “routine” so that our readers may use this 

information as a filter through which to view study findings. 

A third concern is how to distinguish immediate versus long-term outcomes. To ensure a 

broad review of the available literature, we included all studies that report relevant outcomes 

without regard to the specific followup interval. We abstracted the intervals at which followup 

data are collected. Studies were later classified into those that report on postpartum versus those 

that include longer-term followup. If a study provides both types of information—immediate 

and long-term followup—study results appear in more than one portion of the review. 

Production of This Evidence Report 

Organization of This Evidence Report 

Chapter 2 describes our methods, including our search strategies and inclusion/exclusion 

criteria; we also document our approach to grading the quality of articles and rating the strength 

of evidence. In Chapter 3, we present the results of our literature search and synthesis of

retained articles by key question. Chapter 4 further discusses the findings, presents our 

conclusions, and offers recommendations for future research. Our references and included 

studies and a listing of excluded studies follow Chapter 4. Appendixes include a detailed 

description of our search strings (Appendix A), abstraction and quality-rating forms (Appendix 

B), detailed evidence tables (Appendix C), and acknowledgments (Appendix D). Appendixes 

and evidence tables cited in this report are provided electronically at http://www.ahrq.gov/clinic/ 

tp/epistp.htm. 

Technical Expert Advisory Group (TEAG) 

We identified technical experts in the field of episiotomy to provide assistance throughout 

the project. The TEAG (see Appendix D) was expected to contribute to AHRQ’s broader goals 

of (1) creating and maintaining science partnerships as well as public-private partnerships and 

(2) meeting the needs of an array of potential customers and users of its products. Thus, the 

TEAG was both an additional resource and a sounding board during the project. The TEAG 

included eight members: seven technical/clinical experts and one potential user of the final 

evidence report, an ACOG representative. 

To ensure robust, scientifically relevant work, we called on the TEAG to provide reactions to 

work in progress and advice on substantive issues or possibly overlooked areas of research. 

TEAG members participated in conference calls and discussions through e-mail to 

5 
• refine the analytic framework and key questions at the beginning of the project; 

• discuss the preliminary assessment of the literature, including inclusion/exclusion 

criteria; and 

• provide input on the information and categories included in evidence tables. 

Because of their extensive knowledge of the literature, including numerous articles authored 

by TEAG members themselves, and their active involvement in professional societies and as 

practitioners in the field, we also asked TEAG members to participate in the external peer review 

of the draft report. 

Uses of This Report 

This evidence report addresses the key questions outlined in Chapter 2 through systematic 

review of published literature. We anticipate that the report will be of value to ACOG and other 

professional societies for their various efforts to inform and educate obstetricians, family 

physicians, nurses, midwives, childbirth educators, doulas, and women in their reproductive 

years. This report can bring practitioners up to date about the current state of evidence, and it 

provides an assessment of the quality of studies that aim to determine the outcomes of the 

practice of episiotomy. Researchers can obtain a concise analysis of the current state of 

knowledge in this field and will be poised to pursue further investigations that are needed to 

improve health for obstetric populations. 

6 
Chapter 2. Methods 

In this chapter, we document the procedures that the RTI International–University of North 

Carolina Evidence-based Practice Center (RTI–UNC EPC) used to develop this comprehensive 

evidence report on episiotomy. We first describe our strategy for identifying articles relevant to 

our key questions, our inclusion/exclusion criteria, and the process we used to abstract relevant 

information from the eligible articles and generate our evidence tables. We also discuss our 

criteria for grading the quality of individual articles and the strength of the evidence as a whole. 

Finally, we explain the peer-review process. 

Literature Review Methods 

Inclusion and Exclusion Criteria 

Our inclusion and exclusion criteria, documented in Table 1, were relatively complex. The 

reason is largely that criteria for study design differed for each key question based on the 

sufficiency and quality of evidence. Key Questions 1 and 3 have been more commonly 

examined in randomized controlled trials (RCTs); thus, we elected to limit the searches to RCTs. 

Key Questions 2, 4, and 5 have been studied less extensively in trials; therefore, we searched for 

both RCTs and prospective cohort studies. 

Table 1. Inclusion/exclusion criteria 

Category Criteria

Study population Humans

Study settings and geography Inpatient, outpatient, home; all geographical locations subject to 

publication language and study design criteria 

Time period 1950 through 2004 

Publication languages English only 

Sample size N greater than or equal to 40 

Admissible evidence (study design 

and other criteria) 

Original research studies that provide sufficient detail regarding 

methods and results to enable use and adjustment of the data 

and results 

For studies on KQ 1 and KQ 3

RCTs: double-blinded and single-blinded designs 

For studies on KQ 2, KQ 4 and KQ 5

RCTs: double-blinded and single-blinded designs

Non-RCTs: prospective cohort studies 

Relevant outcomes must be able to be abstracted from data 

presented in the papers 

We excluded studies that (1) did not report on women of reproductive age; (2) were 

published in languages other than English; (3) did not report information pertinent to the key 

clinical questions; (4) had fewer than 40 subjects; and (5) were not original studies (although we 

did include systematic reviews and meta-analysis in our discussion). 

7
Literature Search and Retrieval Process 

Databases. We used multifaceted search strategies to include all the current valid research 

on the key questions. We used standard electronic databases: MEDLINE®, Cochrane 

Collaboration resources, and the Cumulative Index to Nursing and Allied Health Literature 

(CINAHL®). We also undertook hand-searches of the reference lists of relevant articles to make 

sure that we were not missing any relevant studies. We consulted with the Technical Expert 

Advisory Group (TEAG) about any studies or trials that are currently under way that may not be 

published yet. 

Search Terms. Based on the inclusion/exclusion criteria above, we generated a list of 

Medical Subject Heading (MeSH) search terms (Tables 2 and 3, also Appendix A∗

). Our TEAG 

also reviewed these terms to ensure that we were not missing any critical areas, and this list 

represents our collective decisions as to the MeSH terms used for all searches. MEDLINE®

searches for “Episiotomy” articles are fairly straightforward because the concept is well 

established and the MeSH indexing is standard. In addition to searching on the MeSH term

“Episiotomy,” we also searched for “Labor Stage, Second.” 

Table 2. Focused search terms and results from MEDLINE®

Search Terms Results 

"Episiotomy" [MeSH] Field: All Fields, Limits: English, 

Randomized Controlled Trial, Human 

75 

"Episiotomy" [MeSH], English, Review, Human 68 

Labor Stage, Second [mh], English, Review, Human 40 

Labor Stage, Second [mh], English, Randomized Controlled Trial, Human 58 

Figure 2 presents the yield and results from our search. We conducted our initial search in 

late 2003 and updated it in November 2004. Beginning with a yield of 992 articles, we retained 

45 articles that we determined were relevant to address our key questions and met our 

inclusion/exclusion criteria. 

Article Selection Process. Once we had identified articles through the electronic database 

search, review articles, and bibliographies, we examined abstracts of articles to determine 

whether studies did, in fact, meet our criteria. Two reviewers separately evaluated the abstracts 

for inclusion or exclusion, using an Abstract Review Form (see Appendix B). If one abstractor 

concluded that the article should be included in the review, we retained it. Abstracts initially 

excluded from the study by one reviewer received a second review. The group included three 

physician health-services researchers—Katherine Hartmann, MD, PhD (Scientific Director); 

John Thorp, Jr., MD (Co-Investigator); and Gerald Gartlehner, MD, MPH (Study Coordinator); 

one health-services researcher—Meera Viswanathan, PhD (Study Director); and one junior 

epidemiologist—Rachel Palmieri, B.S. 

 

∗

 Appendixes are provided electronically at http://www.ahrq.gov/clinic/tp/epistp.htm

8
Table 3. Additional search terms and results from MEDLINE®

Search 

Number Search Terms Results 

#1 "Episiotomy"[MeSH:NoExp] Field: All Fields, Limits: English, Human 676 

#2 "Episiotomy” English, Editorial, Human 14 

#3 "Episiotomy" English, Letter, Human 58 

#4 "Episiotomy" English, Review, Human 68 

#5 "Episiotomy" English, Meta-Analysis, Human 3 

#6 "Episiotomy" English, Practice Guideline, Human 0 

#7 #2 OR #3 OR #4 OR #5 OR #6 140 

#8 #1 NOT #7 536 

#9 Repair 138,222

#10 #1 AND #9 86 

#11 labor stage, second [mh] 638 

#12 #9 AND #11 6 

#13 (("Episiotomy" OR “pregnancy”) AND (“midline" AND "mediolateral")) 

[MeSH:NoExp] Field: All Fields, Limits: English, Human 

11 

#14 (("Episiotomy" OR “pregnancy”) AND (“sphincter")) [MeSH:NoExp] 

Field: All Fields, Limits: English, Human

3 

9
Figure 2. Episiotomy article disposition 

Citations excluded

n=659

Full text articles

reviewed

n= 323

Potentially eligible but

full text unavailable

n=4

Full text articles excluded for

one or more reason listed below n= 292

• 156 Not original research

including episiotomy

• 4 Wrong population

• 40 Small sample size

(n<40)

• 98 Wrong outcome and/or

study design

Pulled for

background

n=56

Hand -

searched

references

n=11

Marked as

background

n= 29

Hand -

searched

references

n=8

Full text articles

included in review

n= 45

RCT

n= 30

Prospective

cohort

n= 15

7 KQ1

1 KQ2

20 KQ3

3 KQ4

4 KQ5

12 KQ4

6 KQ5

Non -duplicate articles

identified in searches

n=986

10
Approximately 325 articles required review of the full article because of missing or 

uninformative abstracts. For the full article review, one reviewer read each article and decided 

whether it met our inclusion criteria, using a Full Text Inclusion/Exclusion Form (see Appendix 

B∗

). A list of articles excluded at the full-article review stage is provided at the end of this 

report, along with the reasons for their exclusion. 

Literature Synthesis 

Development of Evidence Tables and Data Abstraction Process 

The five staff members who conducted this systematic review jointly developed the data 

abstraction tables (see Appendix B) and evidence tables (Appendix C). These tables were 

designed to provide sufficient information to enable readers to understand the studies and to 

determine their quality; we gave particular emphasis to essential information related to our key 

questions. The format of the evidence tables, which was based on successful designs used for 

prior systematic reviews, varies somewhat by key questions. 

The abstractors trained themselves on entering data into the tables by abstracting several 

articles and then reconvening as a group to discuss the utility of the table design. The abstractors 

repeated this process through several iterations until they decided that the tables included the 

appropriate categories for gathering the information contained in the articles. The design was 

then reviewed by the TEAG through a teleconference. 

All team members shared the task of initially entering information into the data abstraction 

forms. Another member of the team also reviewed the articles and edited all initial table entries 

for accuracy, completeness, and consistency. The two abstractors reconciled all disagreements 

concerning the information reported in the abstraction forms. The full research team met 

regularly during the article abstraction period and discussed global issues related to the data 

abstraction process. 

We then entered the data from the abstraction forms into evidence tables and once again 

checked for consistency and accuracy. 

The final evidence tables are presented in their entirety in Appendix C. Entries in the tables 

are listed by publication date. A list of abbreviations used in the tables appears at the beginning 

of that appendix. 

Quality and Strength of Evidence Evaluation 

Rating the Quality of Individual Articles. The RTI–UNC EPC’s approach to assessing the 

quality of individual articles was developed based on the domains and elements recommended in 

the evidence report by West and colleagues, Systems to Rate the Strength of Scientific 

Evidence.26 We developed different rating schemes for RCTs and prospective cohort studies. 

For RCTs, we rated studies on the following criteria (see Appendix B for the RCT Quality 

Rating Form). 

 

∗

 Appendixes are provided electronically at http://www.ahrq.gov/clinic/tp/epistp.htm

11
1. Randomization Approach and Implementation: This item judged whether the approach 

described a valid method of randomization, whether allocation concealment was 

achieved, and whether balance was documented across study groups. 

Approach: Articles that assigned the groups in a manner inconsistent with true 

randomization methods automatically received a poor rating for this category and overall. 

Articles that merely stated that they “randomly assigned” the groups and had either no 

balance or did not report on balance received a poor rating. Articles with no 

documentation of concealment were rated poor. Those with potentially inadequate 

concealment methods were rated poor if the study had poor balance of allocation or if 

balance was not documented in the paper. Those with potentially poor concealment were 

rated fair if they documented good balance.

2. Masking: This item was relevant only to Key Question (KQ) 3. For KQ 1, masking of 

the birth attendant is not feasible and for KQ 2, masking the kind of episiotomy the 

women received was not possible. 

Approach: If the outcome assessors and participants were adequately masked within the 

possibilities of the study design, we rated the category as good. If there was a mix of 

masking among the outcomes, we rated the category as fair. If masking was not done at 

all and not attempted, we rated the category as poor. In the event that the article did not 

report on masking, we noted this point in the quality assessment table and counted it 

against the trial in the overall quality rating. 

3. Operational Definitions and Measurements: This item judged the quality of the 

operational definitions of the outcomes (i.e., were they adequately described) and 

whether they were adequately collected (i.e., was the method sufficient and appropriate). 

Approach: If a primary outcome was identified, we gave it more weight in its 

contribution to this category’s score. Otherwise, we rated this category on the basis of an 

average across all outcomes and the ability to define and measure them. Good definitions 

and measurement include the following: visual analog scale, detailed Likert scale, 

detailed time points in question, details about what was asked of the patient, medical 

chart abstractions, and clinical examination or assessment. If an article simply stated an 

outcome, such as “perineal pain,” and gave no further explanations about it, we rated the 

category in the fair-to-poor range, depending on how the study collected the information. 

4. Post-Randomization Exclusions: This item captured how many post-randomization 

exclusions were explicitly stated. 

Approach: In typical randomized trials, intention to treat analysis is expected. Some

investigators represented in this literature enrolled women during prenatal care rather 

than on labor and delivery in an effort to get a representative sample of prenatal patients. 

We note exclusions as appropriate when individual gave birth at a hospital not 

12
participating in the study, or when participants had outcomes that made them ineligible to 

participate in the trial such as preterm birth or cesarean birth. Any other exclusions after 

randomization were considered inappropriate. 

5. Loss to Followup: This item collected percentages of followup at every time point in the 

study at which data were collected; we used it to determine if followup was adequate. 

Approach: An average of followup percentages for short-term and long-term followup 

contributed to this category. In general, we considered followup greater than or equal to 

90 percent in the short term and 80 percent in the long term to be good. 

6. Statistical analysis: This factor included whether the investigators conducted the study in 

an appropriate manner and took the effect of multiple comparisons into account. This 

item also reviewed the study’s use of multivariate statistical techniques and/or participant 

restriction or stratification to control for confounding. 

Approach: This category is not included on the quality assessment form because of the 

nature of reporting in journals dating back to 1974. P-values were sufficient for reporting 

in the past, whereas point estimates, tests for homogeneity, stratification, and confidence 

intervals are more widely reported now. Although this category did not explicitly 

contribute to the overall quality rating, we used it for articles that were on the border 

between categories. 

For RCTs, the two article abstractors independently rated each article on each of the first five 

categories as indicated by the quality assessment form (Appendix B∗

). A third reviewer flagged 

studies with differences in scoring on individual components. We reconciled these differences 

by consensus. We then created a composite rating. If a study had poor randomization approach 

or implementation with a fatal flaw (e.g., lottery cards), we rated it as poor. For all other scores, 

we gave each item equal weight. Specifically, studies that received good ratings on all 

categories were rated as good studies overall. If a study received one or two fair or poor ratings, 

or the equivalent of a deficiency, it was rated as an overall fair-quality study. Studies with three 

or more fair ratings or a poor randomization design or implementation with a fatal flaw were 

rated poor-quality studies. 

For classifying the quality of prospective cohort studies included for KQs4 and 5, we 

assessed the following factors: 

1. Study population: We sought documentation in the publication of the degree to which 

the study population was representative of women with uncomplicated spontaneous 

vaginal births in the study facilities or broader population sampled. 

Approach: To receive a rating of good for this component of study design and conduct, 

we required a study to describe clearly (1) the base population from which cohort 

participants were sought, (2) the number of women in that base population (a 

 

∗

 Appendixes are provided electronically at http://www.ahrq.gov/clinic/tp/epistp.htm

13
denominator), (3) clear inclusion and exclusion criteria, and (4) the proportion of eligible 

women who were ultimately enrolled in the cohort. 

Studies lacking only items (2) and (4) were classified as fair, and studies lacking items

(1) or (3) with any combination of other missing documentation were rated as poor with 

respect to documentation of the study population. 

2. Measures: We sought documentation in the publication of four components of quality of 

measurements. The first was specification of whether the measure was a primary or 

secondary measure for the study as noted in any portion of the paper. The second was a 

clear description of the measures used that is sufficient to allow replication of the 

measure (e.g., visual analog scale, McGill Pain Score). We accepted references to 

methods described more fully in other publications as documentation if the reference in 

fact provided details. The third component was a clear description of how the measure 

was obtained and by whom if, applicable (e.g., telephone interview, face-to-face 

interview, mailed questionnaire). The fourth was a clear specification of the time interval 

in which the data were collected with respect to the index birth. 

Approach: We classified studies that achieved all four document requirements for the 

measurement of relevance to the key question as having good implementation of the 

measures component. We classified studies as fair for this component if item (1) was 

unclear or not noted and if this was the only limitation. If any other item was missing, we 

considered the quality of documentation of measures to be poor. Of note, a given study 

could be classified as good for one key question (e.g., the key question about sexual 

function), while getting a fair rating for another measure that related to a different key 

question. 

3. Loss to followup: If data from more than one time interval were reported, we sought 

documentation of the these followup measures: (1) the number of participants in the 

sample at the time of followup, (2) analysis of how respondents differed from

nonrespondents if loss exceeded 20 percent, and (3) absolute loss to followup by time

interval. 

Approach: We rated a study as good quality if the research team accomplished each of

the above measures and had ≤ 20 percent loss to followup at 3 months and beyond. A 

study was rated fair if the investigators accomplished items (1) and (2), had no apparent 

response bias as investigated by comparison of baseline characteristics, and had up to 30 

percent loss to followup; or if they had between 20 percent and 25 percent loss to 

followup without documentation of comparability. We rated a study as poor for this 

component if it had more than 30 percent loss to followup or more than 25 percent loss 

without comparison for response bias. 

4. Analysis: We sought four tiers of documentation: (1) thorough enumeration of the 

number of cohort participants, the characteristics of their birth experience and perineal 

status, and general descriptive characteristics such as parity and number of prior vaginal 

14
births in cohorts that included multiparous women; (2) assessment of confounding and

modifying factors by bivariate analysis, stratified analysis, or multivariable modeling; (3) 

reporting of adjusted estimates for main effects that took into account identified 

confounding or modifying factors (stratified or separate analyses were acceptable for 

simple constructs); and (4) presentation of adjusted results with a measure of statistical 

precision such as a confidence interval or P-value. 

Approach: We rated a study as having a good analysis implementation if all of these 

elements were present. Missing or limited detail for item (1) resulted in a fair rating if

this was the only deficit; similarly, we rated a study fair if it was missing or providing 

only limited detail for item (2) if subsequent multivariable modeling implied that the step 

had been completed and all other items were present. Missing items (3) or (4) or any 

other two or more items in combination resulted in a poor rating. 

Grading the Strength of Available Evidence. Our scheme follows the criteria applied by 

Berkman et al.27 That system included three domains: quality of the research, quantity of 

studies (including number of studies and adequacy of the sample size), and consistency of 

findings. The four senior staff members assigned grades by consensus. 

We graded the body of literature applicable to each of the four components of the two key 

questions separately and present our findings in Chapter 4. The possible grades in our scheme

are as follows: 

I. The evidence is from studies of strong design; results are both clinically important and 

consistent with minor exceptions at most; results are free from serious doubts about 

generalizability, bias, or flaws in research design. Studies with negative results have 

sufficiently large samples to have adequate statistical power. 

II. The evidence is from studies of strong design, but some uncertainty remains because of

inconsistencies or concern about generalizability, bias, research design flaws, or adequate 

sample size. Alternatively, the evidence is consistent but derives from studies of weaker 

design. 

III. The evidence is from a limited number of studies of weaker design. Studies with strong

design either have not been done or are inconclusive. 

IV. No published literature. 

External Peer Review 

As is customary for all evidence reports and systematic reviews done for the Agency for 

Healthcare Research and Quality (AHRQ), the RTI–UNC EPC requested review of this report 

from a wide array of outside experts in the field and from relevant professional societies and 

public organizations. AHRQ also requested review from its own staff and appropriate federal 

agencies. We received 18 responses; the 17 individuals listed in Appendix D∗

 gave us 

permission to acknowledge them. We compiled all comments and addressed each one 

individually, revising the text as appropriate. 

 

∗

 Appendixes are provided electronically at http://www.ahrq.gov/clinic/tp/epistp.htm

15
Chapter 3. Results 

This chapter presents results of our literature search and findings for each key question (KQ) 

introduced in Chapter 1. KQ 1 examines postpartum maternal outcomes related to liberal or 

restrictive use of episiotomy. KQ 2 compares postpartum outcomes of midline and mediolateral 

episiotomy. KQ 3 examines outcomes of methods for repair of perineal defects. KQ 4 

summarizes longer-term outcomes of episiotomy related to fecal and urinary incontinence and 

pelvic floor integrity and function, and KQ 5 examines longer-term sexual function. 

We report results in five main sections of this chapter corresponding to the core issues that 

this systematic review addressed. In each section, we report first on specific details about the 

yields of the literature searches, population, outcomes, and quality of the studies, and then on the 

findings for each key question. Summary tables present selected information on each study. 

Detailed evidence tables are in Appendix C∗

. 

Overall, our literature search yielded 992 articles (Figure 2). Of these, we excluded 662 

articles after reviewing the abstracts and obtained 326 articles for complete review (4 were 

unavailable for full article review). Of the 326 articles retained for full article review, we 

included 45 articles in this evidence report, some of which address multiple key questions. Of

the 45 articles, seven address KQ 1, one addresses KQ 2, 20 address KQ 3, 15 address KQ 4, and 

10 address KQ 5. 

Key Question 1: 

Episiotomy and Maternal Postpartum Outcomes 

Literature Search and Included Studies 

Overview of the Evidence. We identified seven primary publications of randomized 

controlled trials (RCTs) of liberal versus restrictive use of episiotomy.

22,23,28-32 Evidence Table 1 

in Appendix C provides details on each study. Three of these studies were conducted in the 

United Kingdom;

22,23,28 one at a British military hospital in Saudi Arabia;31 one in Germany;32

one in Argentina;30 and one in Canada.29 The first trial was performed in the United Kingdom

and published in 1984;23 the most recent, in Germany in 2004.32 The studies are not evenly 

distributed over time: three trials were conducted in the early to mid-1980s in the United 

Kingdom, three in the first half of the 1990s, and a decade passed before the publication by 

Danneker and colleagues in Germany in 2004. We also identified two secondary reports from

randomized clinical trials.33,34 One publication reports on 3-year followup of a trial cohort;33 the 

other is a re-analysis of 3-month followup data grouped by degree of perineal trauma after the 

birth, rather than by allocated trial group.34 Discussion of these publications is included in the 

results for Key Questions 4 and 5 because they focus on continence and sexual function 

outcomes. 

Each trial that we identified compared two study arms or groups: (1) one in which the 

intention was to restrict routine use of episiotomy and (2) one group in which a liberal-use policy 

 

∗

 Appendixes are provided electronically at http://www.ahrq.gov/clinic/tp/epistp.htm

17
endorsed routine use. Defining the distinctions between such groups in a manner that can be 

uniformly achieved is the central challenge for these trials. 

The strictest definition of “restrictive” was to avoid episiotomy unless indicated for fetal 

well-being.23,32 Other definitions pivoted on instructions to “avoid episiotomy,” use only when 

“medically necessary,” or not perform episiotomy for the sole purpose of avoiding a 

laceration.22,28,29,31 The largest trial defined restrictive use as only for fetal indications and/or to 

avoid severe lacerations.

30 

Liberal-use arms were defined in terms such as “routinely conducted,” “routine,” “usual 

care,” and “elective.”22,28-31

 Two studies describeed the liberal-use policy as encouraging routine 

use of episiotomy when “a tear is imminent”32 and “to prevent a tear.”23 

Regardless of how the randomization groups were defined for study implementation, neither 

definition may align with the usual practice of individual clinicians, especially with respect to 

how they would describe the goal they are trying to achieve when performing an episiotomy. 

Variation in norms and usual practice patterns are demonstrable in the variation of episiotomy

use observed in these trials. Use of episiotomy in the restrictive groups ranged from lows of 7.6 

percent22 and 10.2 percent23 to highs of 44 percent29 and 53 percent.31 We observed up to a 

seven-fold difference in the use of episiotomy within the restrictive groups across these trials. 

The routine-use/liberal-use arms had episiotomy use rates from a low of 44.9 percent22 to a high 

of 83 percent.30,31 Wide variation in patterns of use across trials introduces substantial 

heterogeneity in the “exposures” under study. A large degree of built-in “cross-over” occurred 

in the setting of higher rates of use in the restrictive groups. In synthesizing these data, we 

emphasize that these trials compare policies of episiotomy use, not episiotomy versus no 

episiotomy. 

An additional factor that influences generalizability of findings for practice in the United 

States is that six of the seven studies used mediolateral episiotomy. The only North American 

study, conducted in Canada, was also the only study in which median (midline) episiotomy was 

used. Because midline episiotomy is the most common technique used in the United States,9,35

this means that the majority of the literature reflects outcomes that would be expected with a 

distinctively different episiotomy approach with respect to anatomic location of the defect and 

potential complications. Key Question 2, focused on incision type, identified only one poorquality RCT directly comparing median and mediolateral episiotomy.

36 We review this study in 

detail in the next section; briefly, the study suggests increased risk of rectal injury and 

complicated or extended incision with midline episiotomy. This finding is comparable to those 

of observational studies that report that midline incisions are more likely to result in extensions 

that injure the anal sphincter and/or rectal mucosa.37,38

Study Populations. Six studies restricted participation to term births;22,23,28-31 the seventh, to 

births at longer than 34 weeks’ gestation.32 Five studies specified that they enrolled only 

singleton gestations. The two studies that did not specify singleton gestations were conducted in 

the 1980s before routine use of ultrasound; in that period, providers were unlikely to miss a 

multiple gestation clinically, excluding twin gestations before enrollment in a trial might have 

been difficult to do with complete confidence.22,23

 Two studies required vertex presentations.28,31

Regardless of stated inclusion criteria, multiple gestations and breech presentations do not seem

to be represented in these trials. To this extent the studies do represent episiotomy use in 

uncomplicated vaginal deliveries. 

Three studies enrolled only women having their first births.22,31,32 This approach eliminates 

any influence of prior perineal trauma and healing on the trial outcomes. The combined study 

18
populations of these three studies was 409 participants; this is smaller than the entire cohort of 

each of the other studies. Four studies enrolled multiparous women. In these studies, the 

proportion of women who were primiparous ranged from 40 percent to 68 percent, generally 

with good balance across study groups.23,28-30 The exception occurred in the publication by 

House and colleagues in which it appears that multiparous women were more likely to have been 

randomized to the restricted-use group.28 Within the studies that achieved balanced allocation by 

parity, analyses that stratify outcomes by parity help inform how outcomes may differ based on 

prior childbirth experiences. No trial data were identified that allow consideration of whether 

outcomes vary by race and ethnicity. 

Each study focused on normal spontaneous vaginal births. To reduce the number of women 

who subsequently had operative vaginal deliveries or cesarean births, the majority of studies 

allocated women to study groups as close to the anticipated time of birth as feasible. The 

proportion of assisted vaginal births (both forceps and vacuum) in these trials was 2 percent,30 3 

percent,29 4 percent to 5 percent,31 11 percent to 14 percent,28 or not specifically reported. The 

absence of reporting on instrumental and cesarean births raises the potential of unreported postrandomization exclusions. In two cases, authors noted the number of cesarean births and that 

those cases are described as part of the trial population and excluded from analyses.29,32 Both of 

these studies enrolled women during prenatal care, an approach that improved representativeness 

of the study population and explains the increased numbers of women with cesarean births who 

were logically excluded later. 

Outcomes. The most common primary outcome was perineal status after the birth. All 

seven studies reported incidence of episiotomy and of third- or fourth-degree lacerations or 

extensions. Five studies reported prevalence of intact perineum;

22,23,29,31,32

 one reported 

prevalence of intact perineum combined with first-degree lacerations.

28 One trial did not report 

data about intact perineum or minor lacerations, but the proportion can be inferred because firstdegree or intact should be the converse of the data they do report about “any perineal suturing” 

required.30 

A single study incorporated masked assessment of perineal trauma; Sleep and colleagues 

arranged to have a clinician who did not assist the delivery and was masked to the study group 

asesss perineal status and perform the repair.23 Although this design approach does not mask the 

obvious appearance of an episiotomy compared to a spontaneous tear or intact perineum, it 

prevents any bias in uniformly recording the extent and location of any perineal trauma. The 

other studies are at risk of this type of bias. 

The most common secondary outcome was pain in the days immediately after the birth. Five 

of the seven trials assessed pain. Two groups used visual analog scores and classified responses 

into categories of mild, moderate, or severe.28,32 One study used an unspecified “standardized 

questionnaire” and also reported pain severity as mild, moderate, or severe. 23 Another used the 

McGill Pain Questionnaire and reported the composite score of the 10-item scale.29 The largest 

study, conducted in Argentina, did not define how they collected data about “perineal pain.”30 

Additional measures include use of pain medications and reports of pain with specific physical 

activities. 

Three publications did not report masking of the assessors to study group.22,31,32 The 

remainder of the studies reported that the individual conducting the pain assessment was 

unaware of allocation of the participants. Two studies clearly noted that women were not aware 

of the group to which they were allocated.23,28

19
Additional outcomes assessed include resumption of sexual activity, estimated blood loss, 

and wound-healing appearance and complications, including infection, healing by secondary 

intention, and persistent granulation tissue. Few of these outcomes were measured uniformly in 

more than one study. 

Results 

Perineal Trauma Outcomes. Table 4 summarizes key elements of study design and the 

perineal outcomes observed in each of the RCTs. The table provides a summary and does not 

include all outcomes such as anterior tears. Based on quality of the conduct of the trials, the 

strongest of these studies (rated good quality) was the first RCT conducted; like the majority of 

these trials, it evaluated the use of mediolateral episiotomy. This first study, conducted in the 

early 1980s, enrolled 1,000 women, featured an appropriate randomization approach that 

achieved good balance, and had masked assessment of outcomes with clear definitions.23 The 

investigators did not make any post-randomization exclusions and specifically reported 

conducting an intention-to-treat analysis. The study methods achieved a wide gradient of 

episiotomy use between the liberal and restrictive groups — a 41 percentage point difference: 

51.4 percent in the liberal-use group and 10.2 percent in the restrictive-use group. Women in the 

restrictive group were more likely to have an intact perineum; 24.3 percent of those in the liberal 

group had intact perinea compared to 33.9 percent in the restrictive group. Third- and fourthdegree lacerations were rare (0.2 percent in the trial cohort) and did not differ by group. The 

effects of liberal versus restricted use with respect to any need for suturing were less marked 

among multiparous women who had similar outcomes: 69 percent of multiparous women in the 

liberal group and 66 percent in the restrictive group required any suturing for repair. Among 

nulliparous women, the difference in need for suturing was more pronounced (89 percent in the 

liberal-use group and 74 percent in the restrictive group). Sleep and colleagues concluded that 

restricting use of episiotomy neither increased nor decreased maternal morbidity.23 

The largest trial conducted was a multisite study in Argentina that enrolled 2,606 women and 

was of fair quality (see evidence tables in Appendix C for details).30 This study found a 2.4-fold 

increase in risk of anterior tears among women in the restrictive-use arm (95% confidence 

interval [CI], 1.9-2.9), and decreased risk of posterior perineal surgical repair (relative risk [RR] 

= 0.72; 95% CI, 0.68-0.75) when comparing restrictive to liberal use. Eighty-eight percent of 

women in the liberal group had a surgical repair, as did 63 percent in the restrictive group. Pain, 

healing complications, and dehiscence were all less frequent in the restrictive-use group. The 

authors concluded that episiotomy confers no apparent benefit and that high rates of use cannot 

be justified. 

These two studies, which are also the two largest trials, yield results compatible with the 

findings of the other trials with respect to perineal outcomes (see Table 4 for summary). Intact 

perineum was uniformly more common in the restrictive groups.28,29,31,32

 With two 

exceptions,

29,32 studies reported more third- and fourth-degree lacerations among women in the 

liberal-use group. However, each of these studies was underpowered to distinguish differences 

in risk across the groups because third- and fourth-degree lacerations were rare. In fact, one 

study of 200 women had no severe lacerations among participants in either arm.

31 Anterior 

lacerations, including anterior labial lacerations, were reported to be more common in three 

20
21

Table 4. Results of randomized controlled trials of liberal versus restrictive use of episiotomy: Perineal Citation Country Episiotomy Type Number 

Inclusion Parity 

Groups Episiotomy Use Outcome(s) 

Outcome among LiberalUse Group 

Outcome among RestrictiveUse Group 

Sleep et al., 198423

United Kingdom Mediolateral N = 1,000 

Term, singleton pregnancy Anticipated NSVD 40%-46% primiparous 

G1: Liberal = “try to prevent a tear” G2: Restrictive = “try to avoid episiotomy and restrict to fetal indications” G1: 51.4% G2: 10.2% 

Intact Third or fourth degree Any suturing 

24.3% n = 1 Primip: 89% Multip: 69% 

33.9% n = 4 Primip: 74% Multip: 66% 

Harrison et al., 198422

Ireland Mediolateral N = 181 

Term, primigravid, anticipated vaginal birth 

G1: Mediolateral episiotomy routinely conducted G2: No episiotomy unless “medically necessary” G1: 44.9% G2: 7.6% 

Intact Third or fourth degree 

Not reported 6% 

21% None 

House et al., 198628

United Kingdom Mediolateral N = 165 

Term, vertex, anticipated NSVD 53%-68% primiparous 

G1: Standard current management G2: Episiotomy not performed to prevent laceration G1: 69% G2: 18% 

Intact or first degree Second degree = Episiotomy or second degree Third degree 

Primip: 4% Multip: 26% Primip: 96% Multip: 70% Primip: 4% Multip: 4% 

Primip: 32% Multip: 54% Primip: 68% Multip: 45% Primip: None Multip: None 
22

Table 4. Results of randomized controlled trials of liberal versus restrictive use of episiotomy: Perineal Citation Country Episiotomy Type Number 

Inclusion Parity 

Groups Episiotomy Use Outcome(s) 

Outcome among Liberal-Use Group 

Outcome amonRestrictive-Use Group 

Klein et al., 199229

Canada Midline N = 730 

Term, singleton; anticipated NSVD 50%-52% primiparous 

G1: Liberal = avoid tear G2: Restrictive = attempt to avoid episiotomy G1: Primip: 81% Multip: 52% G2: Primip: 47% Multip: 31% 

Intact (no suturing) Episiotomy alone Third or fourth degree 

Primip: 6.6% Multip: 19.3% Primip: 67.2% Multip: 45.2% Primip: 7.9% Multip: 0% 

Primip: 7.5% Multip: 30.7% Primip: 42.2% Multip: 29.0% Primip: 13.9% Multip: 0% 

Argentine Episiotomy Trial Collaborative Group, 199330

Argentina Mediolateral N = 2,606 

Term, singleton first or second vaginal birth; no prior cesarean or severe perineal trauma 40%-41% primiparous 

G1: Routine G2: Selective G1: 82.6% G2: 30.1% 

Perineal suturing Third or fourth degree 

88.1% Primip: 1.8% Multip: 0.9% 

63.1% Primip: 1.4% Multip: 0.8% 
Table 4. Results of randomized controlled trials of liberal versus restrictive use of episiotomy: Perineal 

Citation CountryEpisiotomyTypeNumber 

Inclusion Parity

Groups Episiotomy Use Outcome(s) 

Outcome among Liberal-Use Group 

Outcome amonRestrictive-Use Group 

Eltorkey and Nuaim, 199431

Saudi Arabia(British staff) Mediolateral N = 200 

Term, singleton, vertex, primiparous; anticipated NSVD 

G1: Elective G2: Selective = essential G1: 83%* G2: 53%* 

IntactSecond degree or episiotomy without extension Third degree or episiotomy with extension 

7% 71%* None

28% 49%* None

Dannecker etal., 200432

Germany Mediolateral N = 109 

>34 weeks, singleton, primiparous; anticipated NSVD 

G1: Liberal = if tear imminent and/or fetal indicationsG2: Restrictive = fetal indicationsonly G1: 77% G2: 41% 

IntactThird degree 

10% 8% 

29% 4% 

23

G, group; primip, primiparous; multip, multiparous; NSVD, normal spontaneous vaginal delivery. *Text and tables in this publication are not concordant; overall incidence from text; second degree and episiotomy totals from table. 
Table 5. Results of randomized controlled trials of liberal versus restrictive use of episiotomy: Pain outc

Citation CountryEpisiotomyTypeNumber 

Inclusion Parity

Groups Episiotomy Use 

Outcome(s): How Measured? When? 

Outcome among Liberal-Use Group 

Outcome among RestrictiveUse Group 

Sleep, 198423

United Kingdom Mediolateral N =1000 

Term, singleton pregnancy, anticipated NSVD* 40%-46% primiparous 

G1: Liberal = “try to prevent a tear” G2: Restrictive = “try to avoid episiotomy and restrict to fetal indications” G1: 51.4% G2: 10.2% 

Pain severity in prior 24 hours; questionnaireadministered by midwife; 10 days postpartum Worst pain in past week; postal questionnaire; 3 months postpartum 

10 days Mild: 14.6% Mod: 7.8% Severe: 0.2%3 monthsMild: 5.7% Mod: 1.8% Severe: 0.2%

10 days Mild: 14.1% Mod: 7.5% Severe: 0.9%3 monthsMild: 4.6% Mod: 2.5% Severe: 0.5%

House et al., 198628

United Kingdom Mediolateral N = 165 

Term, vertex, anticipated NSVD* 53%-68% primiparous. 

G1: Standardcurrent management G2: Episiotomy not performed to prevent laceration G1: 69% G2: 18% 

Pain severity; interview by one of authors using VAS scale 1 to 10 with 1-3 grouped as minimal; 4-6 moderate; 7-10severe;3 days; 6 weeks; 3 months

3 days Mild: 55% Mod: 34% Severe: 11%No differencesat 6 weeks and 3 months

3 days Mild: 68% Mod: 22% Severe: 10%No women in either group with more than minimal pain at 3 months

24
Table 5. Results of randomized controlled trials of liberal versus restrictive use of episiotomy: Pain outc

Citation CountryEpisiotomyTypeNumber 

Inclusion Parity

Groups Episiotomy Use 

Outcome(s) How Measured? When? 

Outcome among Liberal-Use Group 

Outcome among RestrictiveUse Group 

Klein et al., 199229

Canada Midline N = 730 

Term, singleton; anticipated NSVD 50%-52% primiparous 

G1: Liberal = avoid tear G2: Restrictive = attempt to avoid episiotomy G1: Primip: 81% Multip: 52% G2: Primip: 47% Multip: 31% 

Perineal pain measured by 10 individually scored items using the McGill Pain Questionnaire at 1, 2, and 10 days postpartum 

First day Primip: 1.8±0.8

Multip:1.3±0.8 Second day Primip: 1.3±0.7

Multip:0.9±0.7 Tenth day Primip:0.5±0.5 Multip: 0.3±0.4 

First day Primip: 1.7±0.8

Multip:1.3±0.9 Second day Primip: 1.4±0.8

Multip: 0.9±0.8 Tenth day Primip: 0.5±0.5

Multip: 0.3±0.5 

Argentine Episiotomy Trial Collaborative Group, 199330

Argentina Mediolateral N = 2,606 

Term, singleton first or second vaginal birth; no prior cesareanor severeperineal trauma 40%-41% primiparous 

G1: Routine = do according to hospital’s policy before trial G2: Selective = try to avoid, do only for fetal indications or if severe tear isimminent G1: 82.6% G2: 30.1% 

Perineal pain (not clearly defined), assessment method not clearly delineated, physician masked to allocation evaluated on day of discharge 

42.5% 30.7% 

25

G, group; primip, primiparous; mod, moderate; multip, multiparous; NSVD, normal spontaneous vaginal delivery. 
Table 5. Results of randomized controlled trials of liberal versus restrictive use of episiotomy: Pain outc

Citation CountryEpisiotomyTypeNumber 

Inclusion Parity

Groups Episiotomy Use 

Outcome(s) How Measured? When? 

Outcome among Liberal-Use Group 

Outcome among RestrictiveUse Group 

Dannecker etal., 200432

Germany Mediolateral N = 109 

>34 weeks, singleton, primiparous; anticipated NSVD 

G1: Liberal = if tear imminent and/or fetal indicationsG2: Restrictive = fetal indicationsonly G1: 77% G2: 41% 

Perineal pain in postpartum period(days 1 to 5) on 100 mm visual analogscale anchored at “not at all” and “very much” for a range ofactivities; approach to measurement not clearly specified 

Bedrest: 39±28 

Sitting: 69±23Walking: 56±24 Defecation: 36±30 

Bedrest: 22±21 

Sitting: 51±25Walking: 37±24 Defecation: 21±21 

26
27 

studies23,30,32 and equivalent in one study.32 Anterior lacerations did not contribute to overall 

higher use of suturing, suggesting that these tears were less severe than posterior tears. 

The findings of these studies are fully compatible. None of the authors concluded that 

episiotomy provides any benefits with respect to perineal trauma. The majority concluded that 

intact or minimal perineal trauma is more common when episiotomy use is restricted. This 

synthesis of the data is compatible with the findings of prior systematic evidence reviews that are 

updated with this report. Although the authors of these research publications appear loath to 

ascribe harm to the use of episiotomy, in our judgment, concluding from their data that routine 

use is harmful is accurate, at least to the extent that it creates a surgical incision of greater extent 

than a woman might have experienced had the episiotomy not been performed. 

Pain Outcomes. Five studies assessed pain outcomes (Table 5).23,28-30,32 The two largest 

trials collected pain outcome data.23,30 Sleep and colleagues used midwives masked to study 

group to assess pain at 10 days postpartum. Participants were asked to assess pain severity in the 

prior 24 hours. Pain severity groupings were virtually identical by study group. Among those in 

the liberal-use group, 14.6 percent had mild pain; 7.8 percent, moderate; and 0.2 percent, severe; 

the comparable proportions for the restricted-use group were 14.1 percent, 7.5 percent, and 0.9 

percent, respectively. Use of oral analgesics by postpartum day 10 was rare in both groups — 2 

percent and 3 percent, respectively — and not different by group. The Argentine study did not 

adequately define how they measured pain; pain is reported as “pain on the day of discharge”; 

the liberal-use group is reported as 42.5 percent with pain, and the restricted-use group as 30.7 

percent with pain. 

The most recent study, although small, provided the most nuanced approach to pain 

assessment. The investigators used a visual analog scale to assess pain with four activities: 

bedrest, sitting, walking, and defecation. Scores were reported in millimeters of the 100 mmpain scale for each activity. Those in the liberal-use group had the following mean scores (±

standard deviation): 39 ± 28 mm with bedrest; 69 ± 23 mm with sitting; 56 ± 24 mm with 

walking; and 36 ± 30 mm with defecation. The comparable scores in the restrictive group were 

22 ± 21 mm; 51 ± 25 mm; 37 ± 24 mm; and 21 ± 21 mm. These differences indicate that the 

restrictive-use group experienced significantly lower perineal pain during all activities, at levels 

that are likely clinically significant. These findings could indicate a real difference in pain 

outcomes or some bias in assessment. The publication does not report masking of the assessors 

or how the assessments were conducted. 

House and colleagues report that pain was more severe on postpartum day 3 among those in 

the liberal-use group. They also assessed pain outcomes by visual analog scale during an 

interview conducted by an author; masking of the assessors is not specifically noted. On day 3 in 

the liberal-use group, 55 percent of women had mild pain; 34 percent, moderate pain; and 11 

percent, severe; the comparable categories for those in the restrictive-use group were 68 percent, 

22 percent, and 10 percent. They also report tenderness at the time of examination on 

postpartum day 3. The restricted-use group had less tenderness on examination: 79 percent had 

mild or minimal pain; 18 percent, moderate; 3 percent, severe; compared to 51 percent, 39 

percent, and 10 percent in the liberal-use group. These differences were statistically significant 

and likely to be clinically relevant.28 These differences in pain by group had resolved by 6 

weeks and 3 months, respectively.

Klein and colleagues, who conducted the only North American trial and the only trial using 

midline episiotomy, found no difference in McGill pain scores on days 1, 2, and 10 after the birth 
28 

for either perineal pain or pain with urination.29 They reported that they conducted analyses both 

with individual pain-scale items and composite scores. Across each of the five studies, no study 

found a pain measure that was improved by routine liberal use of episiotomy. 

Healing Outcomes. Two studies assessed healing outcomes by physical examination. The 

Argentine trial reported no difference in rates of the following adverse outcomes that were 

adequately defined: hematoma prior to discharge; and infection, healing complications, and 

dehiscence as assessed on day 7 postpartum. At discharge, they assessed 92 percent and 93 

percent of participants in the restricted-use and liberal-use groups, respectively; this dropped to 

43 percent of both groups by the evaluation on day 7 postpartum.30 House and colleagues 

examined participants on day 3 postpartum and at 6 weeks. Risk of infection was assessed for all 

participants on day 3; poor wound apposition and granulation tissue indicating secondary healing 

were assessed at the later visit at which 53 percent of the trial participants were assessed. Each 

adverse outcome was equivalent across groups.28

Other Outcomes. Two trials, both reflecting use of mediolateral episiotomy, reported on 

timing of resumption of intercourse. One study documented that women in the restricted 

episiotomy-use group resumed intercourse an average of a week earlier (5.5 ± 3.0 weeks 

compared to 6.5 ± 3.0 weeks).28 The other study found that 37 percent of the women in the 

restrictive group had resumed intercourse by 1 month postpartum compared to 27 percent in the 

liberal-use group (P < 0.01).23 Longer-term influences on sexual function — those assessed at 3 

months or later — are reviewed in the section on KQ 5. 

Two studies, also of mediolateral episiotomy use, assessed estimated maternal blood loss. 

One found no difference in the amount that maternal hemoglobin measures fell.32 The other 

found that estimated blood loss (method not defined) was 58 cc greater in the liberal-use group, a 

statistically significant but likely not clinically relevant mean difference.23

Key Question 2: 

Episiotomy Incision Type and Maternal Morbidity 

Literature Search and Included Studies 

We found only one RCT comparing outcomes of midline episiotomy to those of mediolateral 

episiotomy.36 Evidence Table 2 in Appendix C provides details. An additional focused literature 

search did not reveal any prospective cohort studies pertaining to this key question. 

Study Participants. The study included primigravidas who were admitted to the delivery 

unit of a university hospital in London. The mean age at delivery was 26 years; the mean 

gestational age was 40 weeks. 

Episiotomy Type. Midline episiotomy — “incisions divided 2 to 3 cm of the perineal tissue 

in the midline.” Mediolateral incisions “were made from the midline and were carried to the 

right of the anal sphincter for about 3 to 4 cm.”36 Method of repair was identical for both study 

groups. Standard repair technique for both types of incisions included subcuticular skin closure 

with polygycolic acid suture. 

Outcomes. Outcome measures included the proportion of extended or complicated 

incisions, recommencement of sexual intercourse, pain, pain during intercourse, satisfaction from 

intercourse, and the cosmetic appearance of the scar. Investigators did not report methods of 
29 

outcomes assessment or the use of objective scales for pain and sexual satisfaction. An exam 

was conducted and pain was queried before hospital discharge and again at a 3-month followup 

visit that included the sexual function data collection. The study did not assess differences in 

fecal incontinence. 

Quality. This study had serious methodological flaws; we gave it a poor rating for internal 

validity. In particular, we viewed an inadequate randomization method, lack of allocation 

concealment, and failure to blind the outcome assessors as potential sources of severe biases and 

as a rationale for a poor-quality rating. Consequently, the evidence is insufficient to draw any 

firm conclusions on differences in adverse outcomes of midline compared to mediolateral 

episiotomy. 

Results 

The trial included 407 primigravidas who were randomly assigned to midline or mediolateral 

episiotomy. Results revealed a significantly higher rate of complicated or extended incisions for 

the midline group than for the mediolateral group (P < 0.001). A total of 23.9 percent of women 

in the midline group experienced an extension of the episiotomy into or through the sphincter, 

compared to 9 percent of women in the mediolateral group. The midline group had significantly 

less bruising of the perineum than the mediolateral group (P < 0.001). The investigators did not 

note any differences in pain in the postpartum timeframe. Of all enrolled women, 76 percent 

attended a 3-month followup. Women in the midline group began sexual intercourse 

significantly earlier (P < 0.01) and had a significantly better cosmetic appearance of the scar 

(P < 0.02) than women in the mediolateral group. No significant differences in pain or 

satisfaction from sexual intercourse were detected. 

On the question of midline versus mediolateral episiotomy, the only study in our review that 

met our inclusion criteria found that women receiving midline episiotomy had a significantly 

greater probability of anal sphincter injuries than women in the mediolateral episiotomy group.36 

This study did not assess fecal incontinence as a long-term health outcome. Because of 

considerable methodologic flaws, any conclusions must be made cautiously. 

Differences in sphincter injury rates are clinically important. As an RCT, this study’s 

internal validity is poor. Nevertheless, considering that this is the only trial pertaining to this key 

question, the findings regarding sphincter injuries could be viewed as relevant observational 

evidence. Multiple retrospective cohort studies that did not meet eligibility criteria for this key 

question support findings regarding high sphincter injury rates and midline episiotomy.39-45 

These studies provide consistent evidence that midline episiotomy leads to significantly higher 

rates of third- and fourth-degree tears than mediolateral episiotomy. In another study, women 

with midline episiotomy had a significantly higher rate of fecal incontinence than did women 

with spontaneous second-degree tears.46
Key Question 3: 

Repair of Perineal Defect and Maternal Morbidity 

Literature Search and Included Studies 

Overview. We included 17 randomized controlled trials (RCTs) examining various 

methods and materials for repairing perineal defects.47,48,48-66 As shown in the three main 

sections of Table 6, four trials investigated techniques of repair;48,58,60,63,66 14 trials investigated 

materials for repair;50 47,48,51-54,56-59,61-65and two trials combined comparison of both techniques 

and materials in their design.49,55 Details on all 17 studies are provided in Evidence Tables 3-10 

in Appendix C. 

Of the four trials investigating techniques of repair, two compared a two-layer approach 

(leaving the perineal skin unsutured) with a three-layer approach (suturing the perineal skin) and 

two trials compared a continuous (subcutaneous) technique with an interrupted (transcutaneous) 

technique. 

Of the 14 trials investigating repair materials, eight compared polyglycolic-acid sutures 

with chromic-catgut sutures, both absorbable. Two trials compared absorbable sutures (one 

polyglycolic acid and one chromic catgut) with an enbucrilate tissue adhesive (Histoacryl®). 

Two trials compared standard absorbable suture material with its rapidly absorbed counterpart, 

and one trial compared untreated chromic-catgut with a glycerol-treated “softgut” chromic 

catgut. In addition, two trials compared nonabsorbable and absorbable sutures: one compared 

silk sutures with polyglycolic-acid sutures and one compared silk sutures with both polyglycolicacid and chromic-catgut sutures. 

Most of these trials randomly allocated participants to one of two groups. Three trials, 

however, incorporated a factorial design of randomization. Using a 2x2 design, both the Ipswich 

Childbirth Study60,61,63

 and the Kettle et al. trial67 randomized to methods of repair and type of 

sutures. The Mahomed et al. perineal suture study used a 2x3x2 design and randomized to suture 

type for deep tissue repair (two groups), suture type for the perineal skin (three groups), and 

method of repair (two groups).58 These studies contributed to more than one section of the 

results below. 

Country. Approximately 65 percent of the RCTs in this report were conducted in the United 

Kingdom, including Ireland and Scotland. Australia, Denmark, Israel, Malaysia, Nigeria, and 

the United States each contributed one trial to this report. 

30 
Table 6. Des

cription of trials of e

pisiotomy repair relating to metho

ds, materials, or both 

31

Trial Trial Groups Setting Trial Size 

Percentage Primiparous 

Percentage InstrumentalDeliver

y

T

ype of Repair 

Oboro et al., 200366 2 layer vs. 3 

layer 

Nigeria

N =1,0

7

7

5

3

%

2

3

%

Ipswich Childbirth Study, Gordon et al., 1998,60 Grant 

et al., 200163

2 layer vs. 3 layer 

United King

d

om N =1,780* 61% 17% 

Kettle, 200267

C

ontinuous vs.

interrupted 

United King

d

om N =1,542 56% 0% 

Mahomed et al., 198958

C

ontinuous vs.

interrupted 

United King

d

om N =1,574† 51% 23% 

Materials for Repair Bowen and S

elinger, 200264

A

bsorbable vs.

adhesive 

United King

d

om N = 62 100% NR 

Adoni and Anteby, 199147

A

bsorb

a

ble vs.

adhesive 

Israel N = 60 NR NR 

Kettle, 200267

A

bsorb

a

ble vs.

rapidly absorbable 

United King

d

om N = 1,542 56% 0% 

McElhinney et al., 200062

A

bsorb

a

ble vs.

rapidly absorbable 

Ireland N = 153 55% NR 

Spencer et al., 1986,56 Grant 

et al., 198957

Untreated vs.treated CC 

United King

d

om N = 737 47% 0% 

Buchan and Nicholls, 198

054

N

ona

bsorbable

vs. absorbable 

United King

d

om N = 140 100% 0% 

Mahomed et al., 198958 a. Absorbable vs. 

absorbable vs. nonabsorbable b. PGA vs. CC 

United King

d

om N = 1,574 52% 23% 

Upton et al., 200265 PGA vs. CC Australia N = 391 47% 0% 
‡900 women were randomized but 98 were excluded because they transferred to another hospital or left the hospital before the fifth day after delivery. T

age, parity, or frequency of previous episiotomy.†The trial used a 2x3x2 factorial design to investigate both methods and materials for repair. The methods for the repair arm of the trial investigated conmethods for absorbable sutures, a subset (N= 1,057) of the entire population (N = 1,574). Percentages of primiparous and instrumental deliveries were denominator of 1,057. 

*The Ipswich Childbirth Study61,63 reported a 1-year followup of results63 that included a subset (n= 793) of the original trial’s population. Percentages sh

population. 

Table 6. Description of trials of episiotomy repair relating to methods, materials, or both (continued) Trial Trial Groups Setting Trial Size 

Percentage Primiparous 

Percentage InstrumentalDelivery

Ipswich Childbirth Study, Mackrodt et al., 1998,61 Grant 

et al., 200163

PGA vs. CC United Kingdom N = 1,780* 61% 17% 

Olah, 199059 PGA vs. CC United Kingdom N = 120 46% 100% Ping and Kee, 197553 PGA vs. CC Malaysia N = 122 61% 38% Rogers, 197452 PGA vs. CC United States N = 600 NR NR Livingstone et al., 197451 PGA vs. CC Scotland N = 100 100% 62% Beard et al., 197450 PGA vs. CC United Kingdom N = 200 51% NR Repair Techniques and Materials Doyle et al., 199349 Absorbable

sutures (plaincatgut, PGA) and combination of methods 

United Kingdom N = 199 72% NR 

Isager-Sally et al., 198655 Combination of

absorbable and nonabsorbable sutures and combination of methods 

Denmark N = 900‡ 61% NR 

Note: CC, chromic catgut; NR, not reported; PGA, polyglycolic acid.

32
Episiotomy Type. These trials included women who had an episiotomy at the time of

vaginal childbirth, regardless of the number of previous pregnancies or births. The vast majority 

of episiotomies repaired in these studies were mediolateral. This reflects the fact that most of the 

studies were conducted in European countries, the majority contributed by the United Kingdom. 

Practitioners in North America generally perform midline episiotomy, whereas mediolateral is 

the rule elsewhere. 

Because this question addresses outcomes of repair, we reviewed trials that included women 

who had forcep- or vacuum-assisted births with an episiotomy. The rationale for inclusion is that 

the technique of repair and materials can be evaluated with respect to postpartum perineal 

healing and maternal morbidity, regardless of the mechanisms that led to the perineal trauma. Of 

these 17 trials, seven explicitly excluded women who had instrumental deliveries; four did not 

report whether instrumental deliveries were included; one trial included instrumental deliveries 

but did not report the proportion of women who had them; and five trials reported proportions of 

participants who had instrumental deliveries (see Table 6). The proportion of participants who 

had instrumental deliveries ranged from17 percent to 64 percent. 

Outcomes. Perineal pain and need for analgesia were assessed during the short-term

postpartum period in a majority of the trials and during the long-term postpartum period for 

some of the trials. Investigators used self-report through interviews administered by midwives or 

study staff and questionnaires to measure subjective levels of pain and use of analgesia. Trials 

also reported on specific aspects of healing and wound breakdown including inflammation, 

bruising, infection, wound gaping, need for removal of sutures, and need for resuturing. In each 

case, a clinician involved in the trial assessed these outcomes, often without masking to study 

allocation. Longer-term outcomes related to sexual function, such as dyspareunia, 

recommencement of sexual intercourse, and timing of resumption of intercourse, were typically 

measured at 3 months postpartum and up to 3 years by interview or questionnaire. Incontinence 

and other pelvic-floor-related outcomes were investigated by one trial.55 Few trials collected 

data on comfort with daily activities or satisfaction with repair. 

Quality. Of the 17 trials, we rated three as good quality, eight as fair quality, and six as poor 

quality; for the last group, four trials were rated poor because of inadequate randomization 

techniques and were most likely not truly randomized. We rated trials as fair or poor quality on 

the basis of inadequate randomization approach and implementation, failure to mask the outcome

assessors, and high loss to followup. Specific limitations of the trials are discussed elsewhere in 

this report. 

Results for Methods of Repair 

Two-layer vs. Three-layer Repair. One trial of good quality60,63 and one trial of fair 

quality66 compared a two-layer suturing approach with a three-layer suturing approach (Evidence 

Table 3, Appendix C). Both trials described the standard technique as three-layered, suturing the 

perineal skin closed after repair of the vagina and deeper tissues with interrupted transcutaneous 

or continuous subcuticular sutures. The two-layer approach leaves the perineal skin unsutured, a 

technique that is hypothesized to decrease perineal morbidity. 

Pain and analgesia use. Consistent evidence from these two trials suggests that the twolayer suturing technique decreases perineal pain in both the short- and long-term postpartum

33 
34 

periods and requires less analgesia use. When the evidence is limited to the trial of good quality, 

however, these differences were not statistically significant. 

Although both trials reported less perineal pain in the two-layer groups, only one trial66 found 

significant differences in the short-term postpartum period (0 to 3 months) and the long-term 

postpartum period (> 3 months). At 48 hours postpartum, fewer participants in the two-layer 

approach reported perineal pain than those in the three-layer approach (RR = 0.87; 95% CI, 0.78-

0.97). Over time, the differences persisted: two-layer was superior at 14 days (RR = 0.77; 95% 

CI, 0.61-0.98), at 6 weeks (RR = 0.64; 95% CI, 0.44-0.93), and at 3 months postpartum (RR = 

0.19; 95% CI, 0.06-0.54). The Ipswich Childbirth Study60,63 did not note differences between the 

two groups in self-report of any, mild, moderate, or severe perineal pain at 24 to 48 hours, 10 

days, 3 months, or 1 year. At each followup period, however, fewer women in the two-layer 

group reported perineal pain. 

Similar findings extended to analgesia use in the two groups but only in the short-term 

postpartum period. Participants in the two-layer group of the Oboro et al. trial reported 

significantly less use of analgesics at 48 hours (RR = 0.71; 95% CI, 0.60-0.83) and at 14 days 

(RR = 0.54; 95% CI, 0.32-0.90) but not at 6 weeks (RR = 0.56; 95% CI, 0.16-0.1.89) or at 3 

months postpartum (RR = 0.16; 95% CI, 0.02-1.34). The Ipswich trial found no differences in 

analgesia use at followup.60,63

Healing and wound breakdown. Despite inconsistent definition and measurement of healing 

outcomes, the evidence suggesting that the two-layer approach decreases healing complications 

and that wound gaping associated with leaving the perineal skin unsutured resolves shortly after 

repair. 

Significantly fewer participants in the two-layer group needed sutures removed for pain or 

infection in both trials at any time. Healing outcomes were assessed at 14 days, 6 weeks, and 3 

months in one trial66 and were generally significant ; these outcomes were also significant at 1 

year in the other trial (RR = 0.61, 95% CI, 0.45-0.83, P = 0.002).60,63 

Oboro et al. found that fewer women in the two-layer group reported “tight stitches” than in 

the three-layer group.66 Neither trial found a difference in the need for resuturing. 

In the Ipswich trials, more women in the two-layer group than the three-layer group had 

wound gaping, defined in one of the trials as having edges greater than 0.5 cm apart, in the 24- to 

48-hour postpartum period.60 Observing such a separation may be an artifact of the technique 

used to examine the incision, because only incisions without suture approximation of the skin 

can appear to “gape” when tension is applied to the posterior perineum to allow visual 

inspection. Only one trial looked at outcomes at 1 year postpartum; the authors reported that 

fewer women in the two-layer group reported that the area that had been cut or torn felt different 

(RR = 0.75; 95% CI, 0.61-0.91; P < 0.01).63

Incontinence and pelvic floor function. Neither trial investigated outcomes related to 

incontinence and pelvic floor function in terms of the difference in suturing methods. 

Sexual function. These two trials did not investigate the same sexual functioning outcomes. 

The trend in healing outcomes suggests that the two-layer approach to suturing is associated with 

less morbidity.

Women in the two-layer repair group were significantly less likely in the Oboro et al. trial to 

have superficial dyspareunia than women in the three-layer repair group at both 6 weeks and 3 

months (RR = 0.60; 95% CI, 0.42-0.85 and RR = 0.52; 95% CI, 0.33-0.81, respectively).66 

These results did not extend to deep dyspareunia, which was comparable between the two 
35 

groups. At 6 weeks, more women in the two-layer group had resumed pain-free intercourse (26 

percent vs. 10 percent, RR = 2.54; 95% CI, 1.82-3.55);66 in the Ipswich trial,60,63 this difference 

was noted but not statistically significant. 

Continuous vs. Interrupted Sutures. Two trials, both of good quality, investigated perineal 

outcomes in women whose repairs were made with a continuous, subcutaneous suturing method 

compared to an interrupted, transcutaneous method48,58 (Evidence Table 4, Appendix C). 

Pain and analgesia use. The evidence is inconsistent as to whether the continuous 

subcutaneous method of suturing decreases perineal pain and need for oral analgesia following 

repair. In the Mahomed et al. trial,58 the groups did not differ across the categories of any, mild, 

moderate, or severe perineal pain at day 2, day 10, and 3 months postpartum. By contrast, the 

trial by Kettle and colleagues documented significant differences.48 In this latter trial, at the 

same time points, women in the continuous-suture group reported less pain than women in the 

interrupted-suture group. On day 2, 69 percent of the continuous group and 79 percent of the 

interrupted group reported pain (P < 0.0001). The difference in pain outcomes continued at day 

10 (26.5 percent vs. 44 percent; P < 0.0001), 3 months (9 percent vs. 13 percent; P = 0.03) and 1 

year (4 percent vs. 7 percent; P = 0.05). At day 10, significant differences were also seen in 

perineal pain reported during walking, sitting, urination, and defecation; the difference in favor 

of less pain among those with subcutaneous repair ranged from 7 percent to 16 percent. 

The former study also did not find significant differences between the two groups in their 

need for oral analgesia at day 2 (52% vs. 48%) or day 10 (7% vs. 9%). By contrast, the latter 

trial found that women in the continuous group needed less analgesia at 10 days postpartum 

(8.5% vs. 13.5%; P = 0.002). 

Healing and wound breakdown. Evidence was inconsistent with respect to healing and 

wound breakdown. The Mahomed et al. trial found no significant differences in edema, bruising, 

or inflammation between the groups on day 2. The trial by Kettle and colleagues reported less 

morbidity in the continuous suture group on day 2 for uncomfortable stitches (OR = 0.78; 95% 

CI, 0.64-0.96) and tight stitches (OR = 0.40; 95% CI, 0.22-0.74), but they did not find a 

difference in wound gaping. They reported significant differences on day 10 for wound gaping 

(OR = 0.46; 95% CI, 0.29-0.74), uncomfortable stitches (OR = 0.58; 95% CI, 0.46-0.74), and 

tight stitches (OR = 0.43; 95% CI, 0.27-0.69). The need to remove sutures was significantly 

lower in the continuous method group on day 10 (OR = 0.17; 95% CI, 0.10-0.28). The 

Mahomed trial measured this variable only at 3 months; they reported a significant difference in 

favor of continuous subcutaneous closure (26% vs. 37%; P < 0.001). 

Incontinence and pelvic floor function. Neither trial investigated the difference in suturing 

methods regarding outcomes related to incontinence and pelvic floor function. 

Sexual function. Neither trial found significant differences between the groups regarding 

dyspareunia at 3 months postpartum. The trial that measured dyspareunia at 1 year also found 

equivalent outcomes across the groups. 

Other outcomes. Kettle et al. collected information from the women about their overall 

satisfaction with the repair.48 Significantly more women in the continuous method group 

reported being satisfied with the repair at both 3 months and 12 months postpartum (OR = 1.64; 

95% CI, 1.28-2.11 and OR = 1.68; 95% CI, 1.27-2.21, respectively). 
36 

Results for Materials for Repair 

Absorbable Suture vs. Tissue Adhesive. Two trials examined use of tissue adhesive in the 

repair of episiotomy as compared to polyglycolic-acid64or chromic-catgut sutures47 (Evidence 

Table 5, Appendix C) Both trials were poor quality because randomization methods were either 

broken64 or inadequate (odd and even registration numbers).47 As such, conclusions about 

perineal morbidity related to the use of tissue adhesive are speculative at best. 

Perineal pain and analgesia use. Both trials report less pain during several activities and at 

rest in women whose episiotomies were repaired with tissue adhesive. Bowen and colleagues64

used a 10-point visual analog scale (VAS) and Adoni and colleagues47 used a Likert pain scale of 

1 (minimum) to 5 (maximum). Because of the differences in the pain scales, the results are not 

directly comparable, but the overall differences do contribute to the consistent evidence in these 

two trials that adhesive may lead to less perineal pain in the immediate postpartum. Both trials 

reported less pain while walking (1.6 vs. 2.6, P < 0.00147 and 2.7 vs. 4.0, P = 0.0015)64 on day 2. 

One trial47 reported significantly less pain on day 3 (2.0 vs. 2.9, P = 0.029). Both trials reported 

less pain during micturition: in the Adoni and Anteby trial47 on days 1 and 3 (4.5 vs. 6.3, P = 

0.025 and 3.0 vs. 4.0, P = 0.025, respectively) and, in the Bowen and Selinger trial,64 on day 2 

(1.0 vs. 1.7, P < 0.031). Bowen and Selinger64 reported less pain in the adhesive group on day 2 

(1.95 vs. 3.3, P < 0.001), both while sitting (1.75 vs. 3.6, P < 0.0001) and while lying down (1.0 

vs. 2.35, P < 0.001). Adoni and colleagues reported less pain in the adhesive group during 

defecation on days 3 and 4 (2.2 vs. 4.3, P = 0.003 and 2.1 vs. 3.7, P = 0.015, respectively). 

Nonsignificant differences were reported on other days. Neither trial compared need for 

analgesia between the two repair groups. 

Healing and wound breakdown. Neither trial investigated differences in these outcomes by 

type of repair materials. One trial64 did report that they identified no cases of wound infection or 

dehiscence. 

Sexual function. Only one trial reported on sexual functioning postpartum.64 The group 

repaired with adhesive, in this case Enbucrilate® tissue adhesive, had a 35 percent reduction in 

the onset of pain-free sexual intercourse (P = 0.0009). Neither trial reported any other outcomes 

related to sexual functioning. 

Absorbable Sutures: Standard vs. Rapidly Absorbed. Two studies compared standard 

absorbable to rapidly absorbed sutures (Evidence Table 6, Appendix C). McElhinney and 

colleagues, in a poor-quality trial,62 compared standard absorbable sutures with rapidly 

absorbable suture material (Vicryl® polyglycolic acid). Kettle and colleagues, in a trial of good 

quality,48 also addressed the continuous versus interrupted methods of suturing in its 2x2 

factorial design while comparing standard polyglactin 910 with its rapidly absorbed counterpart. 

Perineal pain and analgesia use. The poor-quality trial, although it used good measurements 

of pain (VAS and Likert scale), found no significant differences in perineal pain between the two 

groups at 24 hours and 3 days. Analgesic use before discharge also did not differ by group. The 

good-quality Kettle trial reported mixed results for perineal pain during specific activities and the 

need for analgesia at 10 days postpartum. Women in the rapidly absorbed suture groups reported 

less pain while walking, sitting, passing urine, and defecating. Only the differences in pain with 

walking were statistically significant (OR = 0.74; 95% CI, 0.56-0.97; P = 0.004). Women in the 

rapidly absorbed group also reported less need for analgesia (8% versus 14%, P = 0.0002). This 

trial randomized women to suture method (continuous versus interrupted), so the investigator 
was able to complete stratified analyses; they showed nonsignificant results by both method of 

suturing and degree of trauma. In other words, improvement in pain was independent of method 

of closure or size of defect. 

Healing and wound breakdown. The poor-quality trial combined all healing outcomes, such 

as infection, gaping wound, or residual material requiring removal, into one group and found that 

at 6 weeks, 30 percent of women whose episiotomies were repaired with standard material and 

1.7 percent of women whose episiotomies were repaired with the rapidly absorbed material 

reported problems. The good-quality trial examined different healing outcomes separately and 

did not find significant differences between the two groups with respect to wound gaping, 

uncomfortable sutures, or tight stitches at 2 or 10 days postpartum. However, groups had 

meaningful differences in need for removal of sutures between 10 days and 3 months. Women 

whose episiotomies were repaired with the rapidly absorbed material required removal less often 

than women who received the standard suture at 10 days, between 10 days and 3 months, and at 

any point before 3 months postpartum (OR = 0.38, 95% CI, 0.23-0.64; OR = 0.19, 95% CI, 0.13-

0.30; and OR = 0.26, 95% CI, 0.18-0.37, respectively). 

Sexual function. Both trials measured dyspareunia, although at different time points in the 

short- and long-term periods of followup. The good-quality trial found no statistically significant 

differences at 3 months or 12 months postpartum. The poor-quality trial found that women with 

repairs using rapidly absorbed material had significantly lower dyspareunia scores than women 

who received standard sutures. This finding extended to 3 months (mean scores 0.05 versus 0.27 

in women who had dyspareunia, P < 0.05) but the authors noted that the scores were very low in 

both groups. 

Untreated Catgut vs. Treated Catgut. Only one fair-quality trial56 investigated the use of 

treated, glycerol-impregnated “softgut” compared to chromic catgut. A followup to the original 

trial occurred at 3 years57 (Evidence Table 7, Appendix C). 

Perineal pain and analgesia use. Women in the softgut group reported significantly greater 

perineal pain (P = 0.015) at 10 days postpartum. Women in the softgut group were also 

significantly more likely to have used a perineal salt bath to relieve pain (42% versus 34%, P = 

0.03) and to use more doses of oral analgesia (P = 0.18), though this difference was not 

statistically significant. At 3 months postpartum, self-report of perineal pain did not differ by 

type of catgut used. 

Healing and wound breakdown. Sutures were removed more often in the chromic-catgut 

group both by 10 days (2.4% versus 11.5%, P < 0.001) and 3 months (6.9% versus 16.4%, P < 

0.0001). Removals were described as being for maternal discomfort. Based on assessment by a 

midwife at 10 days, risk of perineal breakdown and healing by secondary intention did not differ 

by group. 

Sexual function. Sexual function was assessed at 3 months postpartum and 3 years. More 

women in the chromic-catgut group reported pain-free sexual intercourse than women in the 

softgut group (50.7% versus 38.0%, P < 0.025). This difference was significant for both 

transient and persistent pain. At 3 years, more women in the softgut group still reported painful 

intercourse (OR = 1.17; 95% CI, 1.1-2.6; P < 0.02); a majority with pain described the pain as 

“soreness.” 

Nonabsorbable vs. Absorbable. One good-quality trial, the Southmead suture study by 

Mahomed and colleagues,58 and one fair trial by Buchan and Nicholls54compare absorbable 

sutures for repair of the perineal skin with nonabsorbable, silk sutures (Evidence Table 8, 

37 
Appendix C). The good-quality trial randomized using a 2x3x2 factorial design and randomized 

women to one of three material groups for suturing of the perineal skin; polyglycolic-acid, 

chromic-catgut, or silk sutures. Balance was obtained between use of polyglycolic acid and 

chromic catgut for repair of the deeper tissue and between continuous and interrupted methods of 

suturing. The fair-quality trial randomized women to either silk sutures or polyglycolic-acid 

sutures for repair of the perineal skin and chromic catgut was used in both groups for repair of 

the deeper tissues. In this study, method of repair of the perineal skin has potential to confound 

outcomes because the silk-suture group was repaired using an interrupted method and the 

polyglycolic-acid suture group was repaired using a subcuticular method. The trial is included 

under this heading because the authors frame the primary goal of the trial as a comparison of silk 

suture and polyglycolic-acid suture. 

Perineal pain and analgesia use. The Mahomed et al. study reported no statistically 

significant differences among the material groups with respect to perineal pain or use of 

analgesia at 2 and 10 days postpartum or at 3 months. The Buchan and Nicholls trial did report 

differences between the groups, but the results were inconsistent by the day 6 postpartum. The 

investigators used the mean number of analgesic tablets used by the women to make inferences 

about the level of perineal pain experienced by the women. Women with repairs made with silk 

sutures used more analgesia than women whose episiotomies were repaired with polyglycolicacid suture, but the results were only significant for days 3 through 5 (P < 0.001). 

Healing and wound breakdown. The Mahomed et al. study reported no significant 

differences among the groups with regard to bruising, edema, or healing, outcomes that were 

clinically assessed at 2 days postpartum. In the long-term postpartum period, the silk suture 

group needed the absorbable suture materials removed from perineal tissue significantly less than 

the polyglycolic-acid or chromic-catgut groups (7 percent versus 39 percent versus 23 percent, 

P < 0.001).58 No other results were reported and the fair-quality trial did not contribute to this 

outcome assessment. 

Sexual function. In the good-quality trial, more women in the silk-suture group had not 

resumed intercourse by 3 months postpartum (15 percent versus 9 percent and 11 percent, 

P < 0.05). Among women who had resumed intercourse, dyspareunia risk was comparable. 

Conflicting evidence was reported by the fair-quality trial: at 4 months postpartum, more 

women in the silk-suture group reported no pain at all during intercourse (21 percent versus 11 

percent, P < 0.001). 

Polyglycolic Acid vs. Chromic Catgut. Eight RCTs compared polyglycolic-acid sutures 

with chromic-catgut sutures, both absorbable materials (Evidence Table 9, Appendix C). 

Information on these trials, ordered from the most recent to the oldest, appears in Table 7. Check 

marks indicate whether one type of sutures had better outcomes than the other; “ND” indicates 

no difference. 

Both the Mahomed et al.58 and the Mackrodt et al.61,63 trials were of good quality; they

contributed to other sections of this key question because of their factorial design. Four trials 

were of fair quality.50,53,59,65

 Finally, two trials were of poor quality;

51,52 both used methods of 

randomization that are not considered to be truly randomized; thus, we considered them to have a 

fatal flaw. 

38 
Table 7. Trial results for polyglycolic-acid and chromic-catgut sutures 

Superior Material 

for Pain 

Superior 

Material for 

Healing 

Author’s 

Overall 

Trial Conclusions

Information 

Description 

of Pain 

Outcome PGA CC ND

Description 

of Healing 

Outcome PGA CC ND

Upton et al., 

200265* 

Australia 

N = 391 

Quality: Fair 

Short-term 

perineal pain 

(any, 

moderate to 

severe) 

U Short-term 

problems 

with sutures

U No statistically

significant 

differences

between 

groups but 

leaned in 

favor of 

polyglycolic 

acid 

Short-term 

perineal pain 

(any, mild, 

moderate) 

U Short-term 

healing 

problems 

(tight 

stitches,

uncomfortab

le stitches, 

gaping

perineum) 

Ipswich U

Childbirth 

Study, 

Mackrodt et 

al., 1998 and 

Grant et al., 

200161,63* 

United 

Kingdom 

N = 1,780 

Quality: 

Good 

Long-term 

perineal pain 

(mild, 

moderate, or 

severe) 

U Long-term 

need for 

resuturing 

U

Clear 

advantages of

polyglycolic 

acid 

Olah, 199059

United 

Kingdom 

N=120 

Quality: Fair 

Short-term 

perineal pain 

(10 cm VAS) 

U Short-term 

edema and 

bruising 

U Does not 

substantiate 

previous trials

that show a 

benefit to 

polyglycolic 

acid 

Short- and 

long-term 

perineal pain 

(none, mild, 

mod, 

severe) 

U Short- and 

long-term 

edema, 

bruising and 

healing 

U

Short-term 

use of 

analgesics 

U Long-term 

need for 

removal of 

sutures 

U

Mahomed et 

al., 198958* 

United 

Kingdom 

N = 1,574 

Quality: 

Good 

Long-term 

use of 

analgesics 

U Long-term 

need for 

resuturing 

U

Not much 

evidence to 

support 

polyglycolic 

acid but the 

little they have 

is consistent 

with other 

trials 

39 
Table 7. Trial results for polyglycolic-acid and chromic-catgut sutures (continued) 

Superior Material 

for Pain 

Superior 

Material for 

Trial Healing 

Information 

Description 

of Pain 

Outcome PGA CC ND

Description 

of Healing 

Outcome PGA CC ND

Author’s 

Overall 

Conclusions

Ping and 

Kee, 197553

Malaysia 

N = 122 

Quality: Fair 

Short-term 

perineal pain 

(No pain, mild, 

moderate, 

severe) 

U Not measured --- --- --- Polyglycolic-acid

sutures have

considerable

advantage over 

chromic-catgut

sutures in 

episiotomy repair

Beard et al., 

197450

United 

Kingdom 

N = 200 

Quality: Fair 

Short-term 

perineal pain 

(none, mild, 

moderate, 

severe) 

U Short-term

wound 

breakdown 

and 

inflammation 

U Polyglycolic-acid 

sutures should

be used 

Livingstone et

al., 197451

Scotland 

N = 100 

Quality: Poor 

Short-term 

perineal pain 

(none, 

uncomfortable, 

painful, very 

painful, 

unbearably 

painful) 

U Short-term

edema 

U Significant

reduction in pain 

and edema with 

polyglycolic acid, 

no evident 

disadvantage in 

the use of 

polyglycolic acid 

Rogers, 

197452

United States 

N = 600 

Quality: Poor 

Short-term 

perineal pain 

(none, degree 

of pain) 

U Not measured --- --- --- Polyglycolic acid

decreased the 

pain by half 

Note: PGA, polyglycolic acid; CC, chromic catgut; ND, no difference. 

*Three trials also investigated long-term sexual function outcomes with regards to polyglycolic-acid and chromic-catgut sutures. 

Two trials58,65 found no differences between the sutures and one trial61,63 found polyglycolic-acid sutures to be superior at 1 year

postpartum regarding resumption of pain-free intercourse and dyspareunia. 

40 
Perineal pain and analgesia use. All eight trials investigated differences in perineal pain 

outcomes between the two groups. All but two provided consistent evidence that polyglycolicacid sutures have an advantage over chromic catgut with regards to perineal pain. Two of the 

fair-quality trials59,65 found no significant differences between the groups; in one trial, the 

estimate of effect favored polyglycolic-acid suture for their pain measures on postpartum day 3 

(OR = 0.70; 95% CI, 0.46-1.08). The same group of women who were in the polyglycolic-acid 

suture group, however, were more likely to have perineal pain at 6 months (OR = 1.77; 95% CI, 

0.57-5.47), although the precision of that estimate is much less than that others in the study. 

Two fair50,53 and two poor trials51,52 also reported less perineal pain and less need for 

analgesics in women who received polyglycolic-acid sutures in the short-term postpartum period. 

All four trials used Likert scales (mild, moderate, severe, or the equivalent) to measure pain; one 

trial

50 counted the proportion of women requiring analgesia (tablets or injections). Although 

these trials offer only fair- or poor-quality evidence, they do contribute consistent evidence that 

polyglycolic-acid sutures may be associated with less short-term perineal pain. 

The best evidence comes from the two good-quality trials.58,61,63 In the short-term

postpartum period, both trials reported pain outcomes at 24 to 48 hours and 10 days. At 24 to 48 

hours, more women in the chromic-catgut group in the Mahomed et al. trial required analgesia 

(54 percent versus 48 percent, P < 0.05;58 47 percent versus 42 percent, P = 0.0361,63). This 

requirement for analgesia continued at 10 days postpartum in both trials and remained 

statistically significant in the Ipswich trial (10 percent versus 6 percent, P = 0.01). In the 

Ipswich trial,61,63 women in the chromic-catgut group reported more perineal pain and greater 

severity of pain at 24 to 48 hours (P for trend = 0.002) and at 10 days postpartum (P for trend = 

0.05). The earlier trial had not identified significant differences for perineal pain at these two 

time points.58 Neither trial found significant differences between the groups regarding perineal 

pain at 3 months. In addition, the Ipswich trial found no differences at 1 year. 

Healing and wound breakdown. Six of the eight trials examined healing and woundbreakdown outcomes between the two suture groups. Three fair trials50,59,65 and the Mahomed et 

al. study58 did not report statistically significant differences between the groups with respect to 

removal of sutures, resuturing, wound breakdown, inflammation, edema, bruising, or infection, 

most of which were measured before 3 months. One of the poor trials51 reported significantly 

more edema (P < 0.05 at the perineotomy site on day 3 postpartum) in the chromic-catgut group. 

The Ipswich trial results favored polyglycolic-acid suture at various followup time points and on 

various measures. At 24 to 48 hours and 10 days postpartum, more women in the chromic-catgut 

group reported uncomfortable stitches (40 percent versus 33 percent, P = 0.003, and 26 percent 

versus 19 percent, P = 0.001, respectively). The midwives reported more “wound gaping” in the 

chromic-catgut women at 10 days postpartum (26 percent versus 16 percent, P < 0.00001) but 

not at 24 to 48 hours. By 10 days, neither group was more likely to have sutures removed, but 

fewer women in the chromic-catgut group reported ever having any sutures removed by 3 

months (7 percent versus 12 percent, P = 0.002). This finding is the only outcome representing a 

disadvantage among those who received polyglycolic-acid sutures in this trial. 

Sexual function. Three trials, two of good quality58,61,63 and one of fair quality,65

investigated the effect of suture type on outcomes of sexual function. The fair-quality trial found 

no significant differences between the groups at 6 weeks, 3 months, or 6 months postpartum. 

The adjusted odds ratios (adjusted for parity) indicated a possible association between 

polyglycolic-acid sutures and less resumption of intercourse and more dyspareunia among 

41 
women who had resumed intercourse. In one good-quality trial, women whose repairs were 

made with polyglactin 910, a polyglycolic acid-based suture, were less likely to suffer from

dyspareunia at 1 year (RR = 0.59; 95% CI, 0.39-0.91; P = 0.002) and less likely to fail to resume

pain-free intercourse (RR = 0.57; 95% CI, 0.38-0.87; P < 0.01).61,63 In both of the good-quality 

trials, all other comparisons yielded nonsignificant differences between the two suture groups at 

3 months and 1 year. 

Results on Combined Approaches to Repair: Methods and Materials 

Two additional trials investigated approaches to repair of perineal defects but did not 

distinguish between methods and materials49 (Evidence Table 10, Appendix C).55 Because of 

this, the trials are not directly comparable to other trials included in this review, and they do not 

contribute to the separate bodies of evidence for methods or materials. However, the results may 

be more applicable in the clinical setting where using a particular technique with a certain suture 

material, because of the properties of the materials themselves, may be more practical. We

briefly describe these two trials and their results below. 

One trial randomized women to one of two groups, both of which used the standard chromiccatgut approach to repair the deeper vaginal defect. In one group, the perineal skin was repaired 

with chromic catgut using an interrupted method of suturing; in the other, perineal skin was 

repaired with PROLENETM, a nonabsorbable suture material, using a subcuticular approach.49 A 

similar set of groups was seen in the Buchan and Nichols trial (included above in the 

“Nonabsorbable versus Absorbable” section).54 However, the Doyle trial, unlike the Buchan and 

Nicholls trial, was clear in its intent to investigate an entire approach to repair rather than a 

particular method or material. 

The Doyle trial is of poor quality because it used a fair-quality randomization and 

implementation approach, had a small number of post-randomization exclusions, and had poor 

retention of subjects at followup, even in the short-term, immediate postpartum period. 

As assessed by the midwife at 2 and 10 days, the groups did not differ with respect to 

perineal pain, need for analgesia, or bruising. The groups did not differ in pain or pain during 

sexual intercourse at 3 months. 

Another trial randomly allocated women to one of three groups.55 The first group had the 

episiotomy repaired using chromic catgut for the deep tissues and perineal muscles and an 

interrupted method using nylon for the perineal skin. The second group received polyglycolicacid sutures for the deep tissues and perineal muscles and an interrupted method using 

polyglycolic-acid sutures for the perineal skin. The third group is described more ambiguously 

and had a repair done with polyglycolic-acid sutures for the deep tissues and perineal muscles 

and a subcuticular method using polyglycolic-acid sutures for the perineal skin. 

This trial is of fair quality because of fair definitions and measurements of the outcomes and 

post-randomization exclusion of 98 women whom the authors were unable to follow because of 

relocation. These exclusions were nondifferential across the three randomized groups. 

More women who had a repair with subcuticular polyglycolic suturing had no discomfort at 5 

days than did women who had repairs with interrupted nylon or interrupted polyglycolic-acid 

sutures (40%, 12%, and 18%, respectively, P < 0.001). The groups that had repairs with the 

interrupted method did not differ. The authors reported significant differences between women 

who had repairs with subcuticular polyglycolic-acid sutures and the interrupted method group 

42 
including pain during sitting, walking, and bowel movements at 5 days. As assessed by the 

midwife at 5 days, the group repaired with subcuticular polyglycolic-acid sutures experienced 

less edema (11 percent versus 30 percent versus 23 percent, P < 0.005). No significant 

differences were found with respect to infection or hematoma. 

At 3 months, the polyglycolic-acid suture groups differed significantly. Women whose 

episiotomies were repaired with the subcuticular approach were less likely to suffer from 

dyspareunia, discomfort with defecation, incontinence of flatus or discomfort when sitting 

(P < 0.025) than women whose episiotomies were repaired with the interrupted approach. 

Key Question 4: 

Episiotomy and Urinary Incontinence, Fecal Incontinence, 

and Pelvic Floor Defects 

Literature Search and Included Studies 

Overview. We identified 16 publications that prospectively collected data about some 

aspect of continence or pelvic floor muscle function with good documentation of perineal status 

and episiotomy use at the time of the index birth. Outcomes of interest included physiologic 

measures of muscle strength, clinical urodynamic testing, or self report by interview or 

questionnaire. No studies directly compared type of incision and future pelvic floor function. 

The 16 publications include four reports from two randomized clinical trials (RCTs) of liberal 

versus restrictive use of episiotomy, 11 prospective studies of representative cohorts of women 

delivering at particular facilities or with a particular practice group (including two publications 

from a cohort of women who participated in an RCT of perineal massage versus none in the third 

trimester), and one cohort composed of all women in a region who had third-degree lacerations 

at the time of the index birth. The last study followed the cohort to assess risk of fecal 

incontinence at 3 months. 

Two publications came from the same population in the United Kingdom: a primary analysis 

of the RCT outcomes at 3 months,23 and a secondary analysis after 3 years of followup.33 Two 

Canadian reports also present analyses of the same study population.29,34 In this case, both 

publications report 3-month followup data: one analysis by the initial trial groups of liberal 

versus restrictive use of episiotomy and the other an analysis based on classification of perineal 

trauma at the index birth. Of the remaining 12 prospective studies, three were conducted in the 

United Kingdom, two in Denmark (separate populations), two in Canada (separate populations), 

two in Sweden (separate populations), one in Italy, one in Turkey, and one in the United States. 

In total, the 16 publications represent 12 unduplicated study populations from seven countries. 

Study Participants. All but the study of third-degree lacerations restricted study 

participants to those with term, singleton gestations at the time of the index birth. Four of 16 

studies restricted their study populations to primiparous women;68-71 four studies restricted to 

spontaneous vaginal deliveries.23,33,71,72 To assess what component of change in pelvic floor 

muscle function could be attributed to pregnancy and what component was most influenced by 

vaginal births, two studies included a nonpregnant comparison group and a group of women who 

had cesarean birth in their physiologic measures.68,73 In each case the comparison groups were 

43 
recruited contemporaneously to the women who had vaginal deliveries generally from the same

practice. 

Episiotomy Type. We did not identify any studies that compared the influence of 

mediolateral versus midline (also called median) episiotomy on pelvic floor function or 

continence. The remainder of the studies reflects the dominant practice patterns in the countries 

in which the studies were conducted. Mediolateral episiotomy was the rule (with very rare 

exceptions) in European and Turkish cohorts; midline episiotomy predominated in the United 

States and Canada. This implies that to some degree European and North American studies are 

investigating fundamentally different exposures. The anatomic location, involved tissue planes, 

extent of perineal body disruption, and risk for extension associated with mediolateral compared 

to midline episiotomy would be expected to be distinctly different. 

A single randomized trial comparing the two methods has documented that the risk of

extension into and/or through the rectal sphincter is more than 2.5 times more likely with midline 

episiotomy; sphincter involvement occurred in 24 percent of deliveries with midline episiotomy

in their trial.36 They also noted that local extension, not involving the sphincter, was 1.8-fold 

more likely with midline episiotomy. These differential outcomes are believed to represent 

differences in the tissue planes involved. They may also represent differences in familiarity with 

midline episiotomy technique since reported risk of extension is lower in prospective cohorts in 

countries where midline episiotomy is routine. Because no trials or prospective studies directly 

compare the pelvic floor muscle function across type of episiotomy, the long-term differences in 

continence and pelvic floor muscle outcomes that would be anticipated secondary to differences 

in the type is unknown. These differences must be taken into consideration when synthesizing 

the findings relevant to this key question. 

Outcomes Measured. This question was aimed at identifying research publications that 

undertook long-term followup, measured in years. However, we identified only five publications 

from four study populations with followup of a year or longer.33,68-70,74

 In response, we have 

included the entire literature that assesses continence and pelvic floor function at any time after 

the arbitrary 8-week window that can be used to define the postpartum period. Shorter-term

continence and pelvic floor outcomes in the days and weeks around birth are described in the 

section on the outcomes of routine use of episiotomy. 

To summarize outcomes, we grouped measures into four categories: those that assess urinary 

incontinence by self-report, those that assess continence of stool and flatus by self-report, those 

based on physical examination findings to describe anatomy, and those measures intended to 

document physiologic function, such as perioneometry. Seven studies assessed urinary 

incontinence by self-report; timeframes for self-report included 3 months,23,29,34,70,71,75,76

 12 

months,70 3 years,33 4 years,74 and 5 years.69 Three studies assessed continence of stool and/or 

flatus by self-report at 3 months,71,75,77 and one study collected self-report data at an average of 

10 months postpartum. Two studies described physical examination findings related to 

prolapse71and anal sphincter function and anorectal anatomy.

77 Five studies used perineometry 

measures to document characteristics of muscle function such as maximum strength of 

contraction and maximum sustained contraction over 10 seconds.29,34,68,71,73 A single study 

reports findings from urodynamic testing that included observation of stress incontinence with 

strain and timing of interval required to stop urine flow;71 one study used weighted vaginal cones 

recording the heaviest weight that could be retained while standing or walking antepartum and 2 

44 
months postpartum. The highest-quality studies combined types of measures and reported data 

in standardized fashion that concurs with definitions of the International Continence Society. 

Quality. Quality assessment is described in detail in Chapter 2 (Methods); key components 

of quality assessment and an overall quality score are provided in Evidence Table 11 (Appendix 

C). Four publications for this key question derive from the conduct of two RCTs that had goodquality ratings for assessing outcomes of liberal versus restrictive use of episiotomy. For this 

question, we also rated the breadth of measures used to characterize outcomes, the clarity of 

specification of the outcome measures (including documentation of how participants were asked 

self-reported measures), use of measures with documented validity and reliability, and loss to 

followup. For prospective cohort studies, we assessed these features and the representativeness 

of the participants to reflect a base population of women having births, as well as use of adjusted 

models to control for potential confounding factors. 

Table 8 summarizes the methods and findings of the individual studies identified. 

Publications are listed in order from older to more recent reports. We then separately consider 

the findings from randomized trials of liberal versus restrictive use of episiotomy and 

prospective studies that employ episiotomy or perineal trauma categories as the primary 

exposure of interest. The findings are further grouped within study type by urinary incontinence 

outcomes, rectal continence outcomes, anatomic findings, and pelvic muscle function measures 

obtained using physiologic measurements. 

Results 

Randomized Clinical Trials. Both randomized clinical trials, Sleep and colleagues in the 

United Kingdom23 and Klein and colleagues in Canada,29 conducted trials that required providers 

to alter their use of episiotomy. These trials randomized women to receive “liberal use” versus

“restricted use” of episiotomy, with the latter category intended to restrict use to circumstances 

such as fetal distress or maternal exhaustion with an “unyielding perineum.” Both trials enrolled 

singleton, vertex presentation pregnancies at term and randomized in the delivery suite close to 

the time of birth. 

The United Kingdom trial had a 10.2 percent use of episiotomy in the restrictive group (2.6 

percent for maternal indications; 6.6 percent for fetal distress), compared to 51.4 percent use of 

episiotomy in the liberal group. The Canadian trial had greater difficulty modifying provider 

behavior as background rates of episiotomy exceeded 80 percent. Restrictive use resulted in 57.2 

percent of the women having an episiotomy compared to 81.4 percent in the liberal-use arm. 

Each of these research groups published an analysis as randomized for 3-month postpartum data. 

The sole violation of intention to treat was Klein’s elimination of five women with cesarean 

section from analysis of pelvic floor outcomes. Both trials achieved good balance of baseline 

45 
Table 8. Episiotomy and urinary incontinence, fecal incontinence, and pelvic floor defects 

Author, 

Year 

Country

Study

Design 

N 

Timing of 

Outcome 

Assessment 

after Birth 

Approach 

Outcome(s) 

Assessed 

Definitions 

Provided 

Outcome 

among 

Those with 

Episiotomy

Outcome 

among Those 

without 

Episiotomy

Results of 

Multivariable

Models 

Authors’ 

Conclusions

Sleep et 

al., 

198423

United 

Kingdom 

RCT 

N = 1,000 

3 months

Mailed 

questionnaire

Urinary 

incontinence

“involuntary 

loss of urine” 

“Need to 

wear a pad” 

for loss of 

urine 

Incontinence:

19% 

Pad: 6% 

Incontinence:

19% 

Pad: 6% 

Incontinence 

was more

common 

among 

multiparas 

than 

primiparas 

but did not 

differ 

significantly 

between the 

two trial 

groups when 

stratified by 

parity. 

There is no 

evidence that

episiotomy 

prevents 

urinary 

incontinence.

Gordon 

and 

Logue, 

198568

United 

Kingdom 

Prospective 

cohort

N = 70 

12 months

Physiologic 

testing in 

women with all 

perineal 

outcomes and 

cesarean

Perineometry

pressure 

readings

Methods 

summarized in 

text; average 

of five 

measures 

used

Maximum 

pressure epis:

11.7 mm 

water 

Maximum 

pressure 

forceps and 

epis: 

9.4 mm water 

Maximum 

pressure 

intact: 

11.1 

Maximum 

pressure 

second

degree: 10.8

Maximum 

pressure 

cesarean: 12.5 

Not reported 

No significant

difference 

between the 

groups. 

Differences 

between 

postnatal 

exercise levels

were highly

significant with

more exercise 

associated 

with greater 

perineal 

muscle 

strength. 

46 
Table 8. Episiotomy and urinary incontinence, fecal incontinence, and pelvic floor defects 

(continued)

Author, 

Year 

Country

Study

Design 

N 

Timing of 

Outcome 

Assessment 

after Birth 

Approach 

Outcome(s) 

Assessed 

Definitions 

Provided 

Outcome 

among 

Those 

with 

Episiotomy

Outcome among 

Those without 

Episiotomy

Results of 

Multivariable

Models 

Authors’ 

Conclusions

Sleep et 

al., 

198733

United 

Kingdom 

RCT 

N = 674 

3 years 

Mailed 

questionnaire

Urinary 

incontinence

“Lost urine 

when they 

did not mean

to” 

“Severe 

enough to 

wear pad” 

“Loss when 

coughing, 

laughing, 

sneezing” 

“Loss with 

urgent desire 

to pass urine 

but no toilet 

nearby” 

Incontinence

< once past wk: 22%

1-2x past wk: 12% 

≥ 3x past wk: 2% 

Pad sometimes: 8% 

Pad daily: 2% 

SUI: 33% 

Urge incont.: 13% 

Incontinence

< once past wk: 25%

1-2x past wk: 11% 

≥ 3x past wk: 2% 

Pad sometimes: 7% 

Pad daily: 1% 

SUI: 31% 

Urge incont: 13% 

Not reported 

No difference 

in prevalence

of urinary 

incontinence,

even when 

severity and 

nature of the 

incontinence,

and 

subsequent 

deliveries, 

were taken 

into account. 

Rockner, 

199074

Sweden 

Prospective 

Cohort 

N = 185 

4 years 

Mailed 

questionnaire

Urinary 

incontinence

Frequency 

Severity 

(data 

corresponds 

to definitions)

Urinary incontinence:

Occas.: 37 (26%) 

1x/week: 10 (7%) 

2-3x/wk: 2 (1%) 

>3x/wk: 1 (1%)

With 

cough/laugh/sneeze:

48 (34%) 

Sufficiently severe to 

wear pad 

Sometimes: 13 (9%) 

Always: 1 (1%) 

Urinary incontinence:

Occas.: 12 (28%) 

1x/week: 1 (2%) 

2-3x/wk: 1 (2%) 

>3x/wk: 1 (2%)

With cough/laugh/ 

sneeze

13 (30%) 

Sufficiently severe to 

wear pad 

Sometimes: 6 (14%) 

Always: 0 (0%) 

Not reported. 

Episiotomy 

and 

spontaneous 

tear groups 

had the same

frequency of 

urinary 

incontinence 

symptoms, 

giving no 

support to the 

suggestion 

that 

episiotomy 

prevents longterm damage

of the pelvic 

floor. 

47 
Table 8. Episiotomy and urinary incontinence, fecal incontinence, and pelvic floor defects 

(continued)

Author, 

Year 

Country

Study

Design 

N 

Timing of 

Outcome 

Assessment 

after Birth 

Approach 

Outcome(s) 

Assessed 

Definitions 

Provided 

Outcome 

among 

Those 

with

Episiotomy

Outcome 

among 

Those 

without 

Episiotomy

Results of 

Multivariable

Models 

Authors’ 

Conclusions

Rockner et 

al, 199178

Sweden 

Prospective 

cohort

N = 92 

2 months

Physiologic 

measure 

Pelvic floor 

muscle function 

measured 

using weighted

vaginal cones 

at 36 wks 

gestation and

postpartum 

Details 

provided in text

Mean 

decrease in 

muscle 

function 

(gms): 30.0 ± 

11.8 

Mean 

decrease in 

muscle 

function (gms) 

Intact: 19.2 ± 

10.2 

Spontaneous 

tear: 18.9 ± 9.1 

(P < 0.001) 

Not reported 

Pelvic floor 

muscle function 

was most

decreased in the 

episiotomy 

group. The 

results do not

support the 

concept that 

episiotomy 

reduces damage 

to the pelvic floor 

muscles. 

Klein et 

al., 199229

Canada 

RCT 

N = 703 

3 months

In-person 

interview 

Physiologic 

measure: 

Antepartum 

and 3 months 

postpartum 

Urinary 

incontinence

Not defined – 

used 4-point 

scale, 

dichotomized

as present/ 

absent 

Subjective 

sense of 

“perineal 

bulging”; 4-

point scale 

dichotomized

as present/ 

absent 

Perineometry

Incontinence

Primip: 14.5%

Multip: 21.5%

Bulging 

Primip: 7.9% 

Multip: 9.5% 

EMG 

Primip ante: 

2.1 (1.8) 

Primip post: 

2.3 (1.8) 

Multip ante: 

1.7 (1.5) 

Multip post: 

2.1 (1.5) 

Incontinence

Primip: 21.1% 

Multip: 12.9% 

Bulging 

Primip: 9.1% 

Multip: 5.4% 

EMG 

Primip ante: 

2.0 (1.6) 

Primip post: 

2.3 (1.6) 

Multip ante: 1.9 

(1.6) 

Multip post: 2.1 

(1.5) 

Not reported 

None of the 

differences in 

urinary 

incontinence 

were statistically 

significant after 

controlling for 

antepartum 

history of urinary 

incontinence. 

48 
Table 8. Episiotomy and urinary incontinence, fecal incontinence, and pelvic floor defects 

(continued)

Author, 

Year 

Country

Study

Design 

N 

Timing of 

Outcome 

Assessment 

after Birth 

Approach 

Outcome(s) 

Assessed 

Definitions 

Provided 

Outcome 

among 

Those 

with

Episiotomy

Outcome 

among 

Those 

without 

Episiotomy

Results of 

Multivariable

Models 

Authors’ 

Conclusions

Viktrup et 

al., 199270

Denmark 

Prospective 

cohort

N = 305 

3 months

12 months

Telephone 

interview 

Questionnaire 

using 

International 

Continence 

Society 

definitions 

Urinary 

incontinence 

provoked by 

physical 

exertion; daily

incontinence;

incontinence 

as hygienic or

social problem

Data not 

provided 

Data not 

provided 

Not reported 

Women who 

had an 

episiotomy 

developed 

stress

incontinence 

significantly (P < 

0.05) more 

frequently after 

delivery. 

However, 

episiotomy was 

performed more 

often in women 

with an 

increased length 

of second stage 

(P < 0.01). 

Differences in

stress

incontinence 

associated with 

episiotomy had 

resolved by 1

year. 

Klein et 

al., 199434

Canada 

Prospective 

cohort

assembled 

from 

participants 

in liberal vs. 

restrictive 

episiotomy 

trial 

N = 697 

3 months

In-person 

interview 

Physiologic 

measures 

antepartum 

and 

postpartum 

Self-reported 

urinary 

incontinence 

(4 point scale)

Perineometry

scores 

(electronic 

vaginal 

myography) 

Methods 

described in 

text 

No difference 

(data not 

shown)

Epis, no 

exten. 

Net change: 

Primip: 0.19 

Multip: 0.05 

Third/fourth 

degree 

Net change: 

Primip: 0.08 

Multip: -0.07 

No 

difference 

(data not 

shown)

In tact

Net change: 

Primip: 0.47 

Multip: 0.57 

Spontaneous 

tear 

Net change: 

Primip: 0.29 

Multip: 0.39 

Not reported 

Episiotomy fails 

to prevent the

trauma or pelvic 

floor relaxation 

that it was 

designed to 

prevent. 

49 
Table 8. Episiotomy and urinary incontinence, fecal incontinence, and pelvic floor defects 

(continued)

Author, 

Year 

Country

Study

Design 

N 

Timing of 

Outcome 

Assessment 

after Birth 

Approach 

Outcome(s) 

Assessed 

Definitions 

Provided 

Outcome 

among 

Those 

with

Episiotomy

Outcome 

among 

Those 

without 

Episiotomy

Results of 

Multivariable

Models 

Authors’ 

Conclusions

Walsh et 

al., 199677

United 

Kingdom 

Prospective 

cohort of

women with 

Thirddegree tears 

N = 81 

3 months Physical 

examination 

by colorectal 

surgeon 

100% of 

women with 

abnormal 

exam and 

fecal 

incontinence 

had 

episiotomy 

60% of 

women with 

abnormal 

exam and no

incontinence 

had 

episiotomy 

No cases of 

fecal 

incontinence 

among women 

without 

episiotomy 

40% of women 

with abnormal 

exam and no

incontinence 

did not have 

episiotomy 

Not reported 

Obstetric 

trauma causes

significant 

anorectal 

dysfunction 

and patients 

with thirddegree tears 

require 

assessment.

MacArthur 

et al., 

199779

United 

Kingdom 

Prospective 

cohort

N = 906 

10 months

N = 906 

In-person 

Interview 

Fecal 

incontinence

“Loss of bowel 

control with no

warning 

needed to go”;

“soiling or

staining”; “felt

need to go but

couldn’t hold 

on” 

One or more 

considered 

incontinence

Primp.: 4.6% 

Multip.:8.8% 

Intact

Primp.: 5.2% 

Multip.:2.9% 

Second 

degree 

Primip: 5.2% 

Multip: 4.2% 

In 

multivariable 

models: 

episiotomy not 

an 

independent 

predictor of 

fecal 

incontinence

50 
Table 8. Episiotomy and urinary incontinence, fecal incontinence, and pelvic floor defects 

(continued)

Author, 

Year 

Country

Study

Design 

N 

Timing of 

Outcome 

Assessment 

after Birth 

Approach 

Outcome(s) 

Assessed 

Definitions 

Provided 

Outcome 

among 

Those with 

Episiotomy

Outcome 

among Those 

without 

Episiotomy

Results of 

Multivariable

Models 

Authors’ 

Conclusions

Viktrup 

and Lose, 

200169

Denmark 

Prospective 

cohort

N = 305 

5 years Telephone 

interview 

Questionnaire 

using 

International 

Continence 

Society 

definitions; 

urinary 

incontinence 

provoked by 

physical 

exertion; daily

incontinence;

incontinence 

as hygienic or

social problem

Not provided by episiotomy 

status 

Episiotomy contributed to 

prediction of risk of 

incontinence at 5 years when 

comparing women who had

incontinence during their 

pregnancy to those without

any incontinence associated

with pregnancy or postpartum. 

Episiotomy not risk factor 

among women with only 

postpartum symptoms. 

In 

multivariable 

modes, 

episiotomy at 

the first 

delivery was 

significantly 

associated 

with stress

incontinence 5 

years after 

delivery, even

after 

adjustment for 

the few with 

coexistence of

anal sphincter 

rupture. 

Eason et 

al., 200275

Canada 

Prospective 

cohort

assembled 

from 

participants 

in perineal 

massage 

RCT 

N = 949 

3 months

Mailed 

questionnaire

Incontinence 

of stool 

Incontinence 

of flatus 

“Involuntary 

loss of stool or

flatus” 

Frequency 

(never, less 

than 1 a week, 

1 to 6 times a 

week, daily, or 

more than 

once a day) 

Loss of stool:

RR: 5.4% 

Loss of flatus: 

RR: 30.2% 

Loss of stool:

RR: 2.5% 

Loss of flatus: 

RR: 24.4% 

Loss of 

stool/flatus: 

No perineal 

injury: RR 1.0 

First degree: 

1.2 (0.8, 1.7) 

Episiotomy 

without 

extension: 1.3 

(0.9, 1.8) 

Third/fourth 

degree: 2.1 

(1.4, 3.1) 

Anal 

incontinence is

associated 

with sphincter 

laceration, 

which was 

more common 

among those 

with 

episiotomy. 

51 
Table 8. Episiotomy and urinary incontinence, fecal incontinence, and pelvic floor defects 

(continued)

Author, 

Year 

Country

Study

Design 

N 

Timing of 

Outcome 

Assessment 

after Birth 

Approach 

Outcome(s) 

Assessed 

Definitions 

Provided 

Outcome 

among 

Those with 

Episiotomy

Outcome 

among Those 

without 

Episiotomy

Results of 

Multivariable

Models 

Authors’ 

Conclusions

Fleming et 

al., 200373

United 

States 

Prospective 

cohort

N = 102 

6 months

Baseline 

perineometry 

during 

pregnancy; 

and at 6 wks 

Physiologic 

testing in 

women with all 

perineal 

outcomes and 

cesarean

Perineometry

scores 

(electronic 

vaginal 

myography) 

Methods 

detailed in 

text; average 

of three 

measures of 

each type of 

contraction 

used for 

analysis 

Difference in 

antepartum 

and 

postpartum 

scores 

Mean score 

(SD)

Peak: -1.7 

(2.1) 

Hold: -1.7 

(2.1) 

Mean score 

(SD)

Intact

Peak: 2.7 (2.8) 

Hold: 2.8 (3.5) 

Second- or

third-degree 

laceration 

Peak: 0.8 (2.6) 

Hold: 0.8 (2.3) 

Not reported 

No significant

differences in 

absolute 

postpartum 

perineal 

muscle 

strength or 

endurance 

between 

episiotomy 

and laceration

groups. 

Women who 

had 

episiotomy 

were only 

group with net

loss of 

perineal 

muscle 

function after 

delivery. 

Karacam 

and 

Eroglu, 

200372

Turkey 

Prospective 

cohort

N = 100 

3 months

Telephone 

questionnaire

Stress

incontinence

Not defined

12/50 (24%) 15/50 (30%) No significant

differences in 

stress

incontinence 

before labor, 

or if after 

delivery of first 

child, or if after 

delivery of 

second child 

that was 

related to 

episiotomy. 

52 
Table 8. Episiotomy and urinary incontinence, fecal incontinence, and pelvic floor defects 

(continued)

Author, 

Year 

Country

Study

Design 

N 

Timing of 

Outcome 

Assessment 

after Birth 

Approach 

Outcome(s) 

Assessed 

Definitions 

Provided 

Outcome 

among Those 

with

Episiotomy

Outcome 

among Those 

without 

Episiotomy

Results of 

Multivariable

Models 

Authors’ 

Conclusions

Eason et 

al., 200476

Canada 

Prospective 

cohort

participants 

in perineal 

massage 

RCT 

N = 949 

3 months

Mailed 

questionnaire

Frequency of 

involuntary 

loss of urine 

when

coughing, 

sneezing,

laughing, 

running 

Any stress

urinary 

incontinence:

29% 

Any stress

urinary 

incontinence:

35% 

OR: 0.68 (0.47, 

1.01) 

No significant

association 

between 

episiotomy and 

urinary 

incontinence.

Sartore et 

al., 200471

Italy 

Prospective 

cohort

N = 519 

3 months

Physical exam

Physiologic 

measures: 

Perineometry

Uroflowmeter 

In-person 

interview 

Perineometry

with 

highest/best 

single 

recording used

for analysis 

Baden and 

Walker

classification 

of urogenital 

prolapse 

Urine stream 

interruption 

test

SVI – visible 

involuntary 

loss of urine 

by ICS 

standards 

Self-reported 

urge and anal

incontinence 

of stool or 

flatus, 

classified by

frequency 

SUI: 12.9% 

Anal incont: 

2.8% 

Ante prolapse: 

41p.5% 

Post prolapse: 

15.8% 

Vaginal 

manometry: 

12.2 (5.1) 

Urine stream 

interrupt: 3.9 

(3.5) 

Vaginal 

manometry 

percent 

abnormal: 

40.6% 

SUI: 12.1% 

Anal incont: 

1.9% 

Ante prolapse: 

42.1 

Post prolapse: 

14.6% 

Vaginal 

manometry: 

13.8 (4.7) 

Urine stream 

interrupt: 3.8 

(2.9) 

Vaginal 

manometry: 

percent 

abnormal: 

27.7% 

OR: 1.01 (0.61, 

1.7) 

OR: 1.47 (0.46, 

4.7) 

OR: 0.97 (0.69, 

1.4) 

OR: 1.1 (0.68, 1.8)

P < 0.001 

P = 0.85 

OR: 1.79 (1.2, 2.6)

Mediolateral 

episiotomy does 

not protect against 

urinary and anal 

incontinence.

Episiotomy is 

associated with 

lower pelvic floor 

muscle strength 

than spontaneous 

tears. 

53 
characteristics through randomization. Both trials assessed urinary incontinence outcomes; 

neither assessed continence of stool or flatus. 

The Canadian trial also assessed self-reported sensation of perineal “bulging” and conducted 

perineometry. The Canadian team has published two analyses: an analysis as randomized and 

an analysis by perineal trauma sustained. The randomized analyses produced no meaningful 

differences in self-reported urinary incontinence, subjective sensation of perineal bulging, or 

perineometry readings, including when baseline antepartum readings and parity were 

incorporated. Likewise, the analysis by perineal status (intact, episiotomy, spontaneous tear, 

third- and fourth-degree tear) revealed no differences in self-reported incontinence or in 

perineometry scores. These analyses were stratified by parity and suggest some effect 

modification; however, the authors did not provide adjusted models or note any statistically 

significant results. 

The research team from the United Kingdom has published two analyses as randomized: a 3-

month and 3-year followup, both conducted by mailed questionnaire followup.23,33 The 3-month 

followup found no difference by group in risk of involuntary loss of urine (19 percent in both 

arms) or in need to wear a pad because of urine loss (6 percent in both arms). Their 3-year 

followup was more detailed and included involuntary loss of urine; use of a pad; loss of urine 

with coughing, sneezing, laughing; and loss with urgent need to void. No aspect of these 

symptoms or their severity varied by restrictive versus liberal episiotomy group. For the 3-year 

followup, this lack of difference across groups persisted when taking into account subsequent 

obstetric history. The 3-year followup was also marred by loss, although the authors were able 

to use 3-month data to demonstrate little evidence of response bias. Adjustment using 

multivariable models is alluded to but numeric data are not provided. 

Neither trial collected data about continence of flatus or stool, descriptive data from physical 

examination, or urodynamic studies. Both research teams concluded that they did not observe 

any benefits associated with episiotomy. Klein and colleagues, based on perineometry measures, 

also concluded that episiotomy fails to prevent pelvic floor relaxation. 

Prospective Studies. The Italian study by Sartore and colleagues provided the most global 

assessment of continence and pelvic floor function; they addressed each of our four categories of 

outcomes.71 They enrolled 519 primiparous women who had singleton, spontaneous vaginal 

births in lithotomy position. Women with pre-existing incontinence were excluded. Measures of 

outcomes at 3 months included in-person interviews, physical examination, perineometry, a test 

to provoke stress urinary incontinence, and a urine-stream-interruption test. The study team

clearly described methods, used a standard scheme for classifying prolapse, and collected data 

about urinary and anal incontinence. Overall measures and implementation were good. For the 

entire panel of outcomes (stress urinary incontinence, anal incontinence, anterior prolapse, 

posterior prolapse, vaginal manometry, and urine-stream interruption), there was only one 

statistically significant difference in perineometry findings. Women who did not have an 

episiotomy (all mediolateral) had higher contraction strength on perineometry (13.8 compared to 

12.2; P < 0.001); moreover, the proportion of women with abnormal manometry was higher 

among women with episiotomy (40.6 percent compared to 27.7 percent without episiotomy). 

The adjusted relative risk for abnormal manometry was 1.8 (95% CI, 1.2-2.6). The study team

concluded that episiotomy is associated with lower pelvic floor muscle strength than spontaneous 

tears. All self-reported symptoms of urinary and anal incontinence and degree of prolapse on 

physical examination were equivalent across groups so the clinical significance of this finding is 

54 
unclear. Overall interpretation must be that episiotomy does not protect against incontinence, 

prolapse, or decrements in pelvic floor muscle function by 3 months postpartum. 

Studies focused on self-reported urinary continence. Excluding the clinical trial populations 

and the study by Sartore et al. described above, five studies (in four study populations) evaluated 

self-report of urinary continence.69,70,72,74,76 Two used a telephone interview,70,72 the other three 

mailed questionnaires. 

Karacam and Eroglu provided the least-detailed information:72 no details about how stress 

incontinence was queried or defined for data analysis and no report of adjusting for factors that 

might influence outcomes by using stratified analyses or multivariable models. They reported, 

from bivariate data at 3 months (N = 100), that 24 percent of women with episiotomy and 30 

percent of women without episiotomy had stress incontinence. 

Eason and colleagues asked about occurrence and frequency of “involuntary loss of urine 

when coughing, sneezing, laughing, or running” in a cohort of 949 women also at 3 months.76 

For analysis, they reported that any stress incontinence occurred in 29 percent of those with 

episiotomy and in 35 percent of those without. Multivariable models for stress urinary 

incontinence comparing episiotomy to no episiotomy yielded an odds ratio of 0.68 (95% CI, 

0.47-1.01). 

Viktrup and colleagues reported using a questionnaire to obtain all the facets of the 

International Continence Society definitions of incontinence from 305 women.70 They reported 

no differences but do not provide numeric data. In summary, they stated that although women 

with episiotomy had more incontinence postpartum, differences had resolved by 3 months and 

remained equivalent at 1 year. Their followup survey at 5 years revealed in multivariable models 

that episiotomy in a first birth was significantly associated with stress incontinence.69 An 

adjusted point estimate is not provided. 

Rockner’s followup of a cohort of 185 women with either episiotomy or spontaneous tear at 

4 years after the index pregnancy asked women about symptoms before, during, and after all 

pregnancies; information about the index pregnancy focused on frequency and severity of 

urinary incontinence; need for pad; and loss of urine provoked by cough, laugh, or sneeze.74 

Symptom profiles were very similar across groups; for instance, 34 percent of women who had 

an episiotomy and 30 percent without reported incontinence provoked by cough, laugh, or 

sneeze. No stratified or adjusted models are provided. The author concluded that episiotomy

and spontaneous-tear groups had the same frequency of incontinence symptoms. Overall, each 

research team investigating self-reported urinary incontinence concluded that no evidence 

supported the view that episiotomy prevents pelvic floor defects. 

Studies focused on self-reported incontinence of stool or flatus. Three cohort studies asked 

women about rectal incontinence symptoms.

75,77,79 One study also conducted physical 

examinations.77

The earliest of these studies was conducted on a cohort constructed of 81 women who had 

third-or fourth-degree lacerations.77 The prevalence of episiotomy among women without thirdor fourth-degree lacerations was known as well as their episiotomy history in the index 

pregnancy. They were followed up at 3 months when their symptoms were evaluated and they 

received a physical examination. All women who had fecal incontinence and abnormal rectal 

examination at three months had had an episiotomy. Of those with an abnormal exam and no 

incontinence 60 percent had had an episiotomy, meaning relative risk of abnormal exam was 50 

percent greater among those with history of episiotomy. These authors focused on the high 

55 
prevalence of anorectal dysfunction at 3 months with episiotomy as a key risk factor. None of 

the research teams that focused on incontinence of flatus or stool found episiotomy to be 

significantly associated with reduced risk. 

MacArthur and colleagues sent questionnaires at 6 to 7 months and then followed up all 

women who had a variety of symptoms at 10-months with an in-person interview. 79 Their 

questionnaire and interview classified several types of fecal incontinence and staining (not 

including simple flatus); any one or more of the symptoms was considered evidence of 

incontinence. At 10 months, episiotomy was not an independent predictor of fecal incontinence 

in multivariable models. Because episiotomy was not a key focus of their analysis, they do not 

provide a point estimate. 

Eason and colleagues inquired about involuntary loss of stool or flatus and the frequency at 3 

months.75 Women with episiotomy reported higher prevalence of loss of stool (5.4 percent) and 

loss of flatus (30.2 percent) than did women without episiotomy (2.5 percent and 24.4 percent, 

respectively). Adjusted models revealed that episiotomy without extension was associated with 

a relative risk of 1.3 (95% CI, 0.9-1.8), and third- to fourth-degree lacerations (virtually all after 

episiotomy) were associated with 2.1-fold increased risk of anal incontinence (95% CI, 1.4-3.1). 

The study team concluded that anal incontinence was associated with severe lacerations that are 

most likely to result from episiotomy. 

Studies focused on physiologic measures of pelvic floor function. In 1985, Gordon and 

Logue published the first use of perineometry to evaluate prospectively a group of 70 women.68 

They included a nonpregnant and a cesarean comparison group to take into account changes 

associated with pregnancy and labor, respectively. They did not compare women with their own 

measures in pregnancy. No difference in maximum contraction strength was seen across groups. 

However, the researchers did note that postnatal exercise level was highly associated with 

perinatal muscle strength. 

Fleming and colleagues refined the Gordon and Logue study design.73 They conducted 

perineometry antepartum, at 6 weeks, and again at 6 months among 102 women with singleton 

spontaneous vaginal births. Detailed measurement protocols are provided and their analysis 

focused on mean difference between antepartum scores and 6-month scores. No differences in 

perineal muscle strength or endurance were identified between laceration and episiotomy groups. 

In another approach to measuring muscle strength, Rockner and colleagues conducted studies 

with weighted vaginal cones at 36 weeks gestation and again at 2 months postpartum. They 

calculated decrements in weight that could be retained while standing or walking: women with 

episiotomy had the greatest decrement in function (30 gm decrease in maximum weight held), 

compared to 19.2 gram decrease with intact perineum, and 18.9 gm decrease with spontaneous 

tears (P < 0.001).78 

Overall, none of these research teams concluded that episiotomy had advantages, and one 

identified a decrease in functional muscle strength. These intermediate findings concur with the 

self-report and clinical examination findings of other studies that detected no evidence of benefit 

from episiotomy with respect to preserving continence or pelvic floor muscle function. 

56 
Key Question 5: 

Episiotomy and Future Sexual Function 

Literature Search and Included Studies 

Overview of the Evidence. Nine publications were identified that prospectively collected 

outcome data about sexual function among women who did or did not have a routine episiotomy. 

Evidence Table 12 in Appendix C provides details. One study compared incision type and 

assessed sexual function.36 These 10 publications include three randomized trials of restrictive 

versus liberal use of episiotomy;

23,29,33 one trial of median versus midline episiotomy;36 and five 

prospective cohort studies.34,71,72,80,81 One study (the only study conducted in the United States), 

described by the authors as “retrospective,” included a single followup time point (6 months) for 

which the data collection about sexual function was prospective.38 Two publications reflect a 

primary analysis from a randomized clinical trial (RCT) with 3 months of followup23 and a 

secondary analysis after 3 years of followup33 in the same study population from the United 

Kingdom. Two publications by a Canadian research team are also analyses of the same study 

population.29,34 In this case, both publications report 3-month followup data: one analysis 

focused on randomization to liberal versus restrictive episiotomy groups, and the other took the 

perspective of exposure groups classified by perineal trauma at the time of delivery. Two of the 

prospective studies were conducted in Sweden (separate study populations), one in Italy, and one 

in Turkey. Thus, in total, this literature represents seven distinctive study populations from six 

countries. 

Study Participants. In current practice in the United States, women who are giving birth for 

the first time are most likely to have a routine episiotomy. Several studies that evaluated sexual 

function restricted the study population to primiparous women. This approach assures that the 

influence of episiotomy, spontaneous laceration, or intact perineum reflects only the potential 

influences of the index birth, rather than both the index birth and any prior history of perineal 

trauma among women who have had prior births. Those studies that did not restrict their study 

of sexual function to primiparous patients adjusted for prior episiotomy in data analysis as a 

method to account for the influence of prior birth experiences. All studies restricted participation 

to singleton births; and some specifically included only women who had a spontaneous vaginal 

birth. 

Episiotomy Type. Only one study directly compared mediolateral to median (midline) 

episiotomy.

36 The remainder of the studies reflects the dominant practice patterns of the 

countries in which the studies were conducted. Mediolateral episiotomy is routine in the 

countries represented, with the exception of the United States and Canada, where median 

episiotomy is routine. Overall, when episiotomy was performed in the U.S. and Canadian 

studies, it was a median incision;29,34,38 this phenomenon stands in contrast to 98.9 percent 

mediolateral episiotomies in the European and Turkish studies.

72 33,71,80,80,81

This factor introduces a fundamental difference in the “exposure” across studies. The 

anatomic location, involved tissues plains, extent of perineal disruption, and risk for extension 

associated with mediolateral as compared to median episiotomy are distinctly different. Once 

healed, the scar from each type of episiotomy and from spontaneous lacerations will be subject to 

different amounts and types of contact, pressure, and stretch depending on position of partners 

57 
during sexual intercourse. Thus, the literature reflects two distinct types of procedures, the 

effects of which need to be addressed separately. 

Outcome Measures. Of the 10 studies included for this key question, eight were not 

designed to address sexual function as the primary outcome. Only the Signorello et al. and 

Karacam and Eroglu studies reported that a primary objective of the study was to assess the 

relationship between perineal trauma (spontaneous versus episiotomy) and postpartum sexual 

function.38,72 

The most consistently reported outcome was “dyspareunia.” In three of these 10 

publications, the researchers provide no detail to document how they phrased a question or 

questions about pain with intercourse or how they recorded participant responses; no reports 

distinguished between pain on insertion, deep dyspareunia with thrusting, or residual pain (deep 

or perineal) after intercourse. Four studies used a written questionnaire to collect information 

about sexual function.23,33,38,80 One study conducted telephone interviews,72 and four conducted 

in-person interviews.29,34,71,81 In-person interview methods for assessing sexual function 

outcome tended to be more detailed than those obtained from written questionnaires. However, 

none of the publications distinguish between pain on insertion, deep dyspareunia with thrusting, 

or residual pain (deep or perineal) after intercourse. 

Across all 10 studies, investigators used three approaches for summarizing when women 

experienced dyspareunia. The most common was to inquire about any dyspareunia since 

resuming intercourse. Other authors inquired about dyspareunia with episodes of intercourse 

near the time of the followup. To differentiate this approach from measures of any experience of 

dyspareunia, we have called inquiry about recent status “current dyspareunia” in this report. 

Less often, authors reported about pain at the time of the first episode of intercourse after the 

index birth. 

In a related measure, four research teams also asked women to recall when they resumed 

having intercourse. This question allows the investigators to report both continuous and 

categorical data about the proportion of women who had resumed intercourse by particular 

points in time, for example, by 2 months postpartum.

23,29,34,80 Few authors clearly explained if 

the prevalence of dyspareunia reported is appropriately calculated as a proportion (number of 

women with pain with intercourse divided by number of women who have resumed intercourse). 

The most common timeframe for assessment of outcomes was 3 months. One group assessed 

dyspareunia at postpartum exams between 2 and 3 months;81 one used a mailed questionnaire at 

6 months;38 and the longest followup was conducted by questionnaire mailed at 3 years.33 

The two publications by Klein and colleagues had the most elaborate approach to collecting 

several types of information. These authors reported greater detail about how participant 

responses were collected and analyzed. In interviews at 3 months postpartum, they asked 

women when they resumed intercourse and assessed recalled pain at the first postpartum episode 

of intercourse using the McGill Pain Scale. They inquired about sexual satisfaction using an 

unspecified number of items measured on a 4-point scale and reported a summary measure of 

“sexual satisfaction” in their tables.29,34

 Two other groups classified degree of pain with 

intercourse using an approach that assigned levels: none, mild, moderate, and severe.71 34

Quality. None of the identified studies was designed exclusively to examine sexual 

function. We classified primary and secondary outcomes based on objectives provided in the 

introduction of the publication or used stated research questions to classify primary and 

secondary objectives. 

58 
None of the 10 studies met criteria that we consider necessary to be a good study of sexual 

function after episiotomy. Our criteria included (1) documentation of a representative sample of 

women who had spontaneous vaginal births, (2) use of outcomes that provide a well-rounded 

picture of sexual function, (3) clear specification of outcome measurement approach (including 

specification of items asked of participants on surveys or in interviews), (4) use of measures with 

documented validity and reliability, (5) use of adjusted models in prospective data to control for 

potential confounding factors, (6) minimal to modest loss to followup, and (7) use of intentionto-treat analysis in randomized clinical trials. 

Results 

Table 9 summarizes the methods and findings of the individual studies identified. 

Publications are listed in order from older to more recent reports. We also separately consider 

the findings of controlled trials of liberal use versus restricted use of episiotomy and other 

prospective cohort studies of episiotomy that include sexual function outcomes (Table 10). The 

single study that compared type of episiotomy incision and included assessment of sexual 

function is reviewed on pages 30 and 31; no differences in pain with initiation of intercourse or

with satisfaction with intercourse were noted by episiotomy type. 

Randomized Controlled Trials. Two publications present results from RCTs of restrictive 

compared to liberal use of episiotomy; the investigators used an intention-to-treat analysis. 

These trials provide evidence about the long-term effects of a particular type of policy about 

episiotomy use on the sexual outcomes of populations of women. The earlier of the two trials 

was conducted in the United Kingdom in 1982.23 Perineal outcomes in the West Berkshire 

Perineal Management Trial differed clinically and statistically by group. Among women in the 

liberal-use group, 51.4 percent had had an episiotomy (all mediolateral), 6.0 percent had an 

episiotomy with extension to third- or fourth-degree laceration, 24.5 percent had a spontaneous 

perineal tear only, and 24.3 percent had no perineal trauma. In the restrictive-use group, 10.2 

percent had an episiotomy, 1.2 percent had an episiotomy with extension, 55.8 percent had a 

spontaneous perineal tear only, and 33.9 percent had no trauma. By 1 month after delivery, 37 

percent of the restrictive group and 27 percent in the liberal group had resumed sexual 

intercourse (P < 0.01). The proportion of women with resumption of intercourse by 3 months, 

current dyspareunia at 3 months, or any dyspareunia within the 3 months of followup did not 

differ significantly by group.23 By the third year of followup, the likelihood of “ever suffering 

painful intercourse” remained comparable across groups.33 

The trial conducted by Klein and colleagues in Canada also found less episiotomy use in the 

restrictive group with higher rates of spontaneous lacerations.

29 Among women in the liberal-use 

group, 67.2 percent had an episiotomy (midline), 14.2 percent had an episiotomy with extension 

to third- or fourth-degree laceration or sulcal tear high in the vaginal vault, 12 percent had a 

spontaneous perineal tear only, and 6.6 percent had no perineal trauma. In the restrictive-use 

group, 42 percent had an episiotomy, 15 percent had an episiotomy with extension, 35 percent 

had a spontaneous perineal tear only, and 7.5 percent had no perineal trauma. Women in the 

restrictive group resumed intercourse an average of 1 week earlier that those in the liberal group; 

however, all other measures of sexual function were equivalent by 3 months.29 

59 
Table 9. Episiotomy and future sexual function 

Citation 

Epis. Type 

Country

Study

Design 

N 

Timing of 

Outcome 

Assessment 

after Birth; 

Approach 

Outcome 

Assessed 

Definitions 

Provided 

Outcome 

among 

Those with 

Episiotomy

Outcome 

among 

Those 

without 

Episiotomy

Results of 

Multivariable

Models 

Authors’ 

Conclusions

Sleep et al., 

198423

Mediolateral 

UK 

RCT 

N = 1000 

3 months

Mailed 

questionnaire

Resumption of 

intercourse by 3 

months (not 

defined) 

Current 

dyspareunia: 

“pain during 

sexual 

intercourse” 

Any 

dyspareunia: 

“pain during 

sexual 

intercourse, at 

some time” in 

prior 3 months

90% 

22% 

52% 

90% 

18% 

51% 

Not reported 

Only difference 

was tendency

for women 

allocated to 

restrictive 

episiotomy to 

resume 

intercourse 

sooner. 

Sleep and 

Grant, 

198733

Mediolateral 

UK 

Prospective 

cohort that 

included 

RCT 

participants 

N =326 

3 years 

Mailed 

questionnaire

Any 

dyspareunia: 

“ever suffering

painful sexual

intercourse” 

16% 13% RR 1.21 (0.84,

1.75); 

No significant

difference 

Rockner et 

al., 198880

Mediolateral 

(88%) 

Sweden 

Prospective 

cohort

N =205 

3 months

Questionnaire 

(setting not 

specified) 

Resumption of 

intercourse 

(Y/N) 

Current 

dyspareunia 

(not defined) 

Any dypareunia 

in prior 3 

months

(not defined) 

92% 

20% 

44% 

92% 

20% 

43% 

Not reported 

No significant

difference 

Larsson et 

al., 199181

Mediolateral 

Sweden 

Prospective 

cohort

N =1889 

2 to 3 months

In-person 

interview with 

midwife 

Dyspareunia 

(not defined) 

16% 11% Not reported

None made

regarding 

sexual function 

60 
Table 9. Episiotomy and future sexual function (continued) 

Citation 

Epis. Type 

Country

Study

Design 

N 

Timing of 

Outcome 

Assessment 

after Birth; 

Approach 

Outcome 

Assessed 

Definitions 

Provided 

Outcome 

among 

Those with 

Episiotomy

Outcome 

among 

Those 

without 

Episiotomy

Results of 

Multivariable

Models 

Authors’ 

Conclusions

Klein et al., 

199229

Midline 

Canada 

RCT: 

Liberal vs 

restrictive 

N = 703 

3 months

In-person 

interview 

Resumption of 

intercourse 

(“weeks 

between birth

and first 

intercourse”) 

Dyspareunia: 

“Pain at first 

postpartum 

intercourse” 

assessed using 

McGill Pain 

Scale 

Sexual 

satisfaction at 3 

months X items 

using “4 point

scale” – actual 

items not 

provided 

Primip: 5.8 

(2.1) 

Multip: 5.8 

(2.6) 

Primip: 2.2 

(1.3) 

Multip: 1.3 

(1.1) 

Primip: 3.1 

(0.7) 

Multip: 3.3 

(0.7) 

Primip: 5.9 

(2.5) 

Multip: 5.4 

(2.3) 

Primip: 2.2 

(1.3) 

Multip: 1.2 

(1.0) 

Primip: 3.0 

(0.8) 

Multip: 3.3 

(0.6) 

Time to 

resumption of 

intercourse 

similar; those 

with intact

perineum 

began 

intercourse 1 

week earlier 

than others. 

Pain with 

resumption, 3-

month sexual

satisfaction 

and proportion

not resuming

by 3 months 

similar across

groups. 

61 
Table 9. Episiotomy and future sexual function (continued) 

Citation 

Epis. Type 

Country

Study

Design 

N 

Timing of 

Outcome 

Assessment 

after Birth; 

Approach 

Outcome 

Assessed 

Definitions 

Provided 

Outcome 

among 

Those with 

Episiotomy

Outcome 

among Those 

without 

Episiotomy

Results of 

Multivariable

Models 

Authors’ 

Conclusions

Klein et al., 

199434

Midline 

Canada 

Prospective 

cohort

derived from 

RCT 

N = 697 

3 months

In-person 

interview 

Resumption of 

intercourse by

week 6 

Dyspareunia: 

“Pain at first 

postpartum 

intercourse: 

none, mild, 

discomforting,

distressinghorrible”

Sexual 

satisfaction at

3 months; 

items using “4-

point scale” –

actual items 

not provided 

Epis alone: 

61.7% 

Third-

/fourthdegree: 

55.4% 

Epis alone: 

Mild: 22.7% 

Discomf: 

34.1% 

Distress:

28.8% 

Third-

/fourthdegree: 

Mild: 23.0% 

Discomf: 

39.3% 

Distress:

29.5% 

Epis alone: 

Not 

satisfied:

16.3% 

Third/fourth 

degree: 

Not 

satisfied:

21.3% 

Intact: 76.5% 

Spont. tear: 

62.5% 

Intact: 

Mild: 37.6% 

Discomf: 

22.8% 

Distress: 6.9%

Spont. tear: 

Mild: 27.3% 

Discomf: 

27.3% 

Distress:

24.6% 

Intact: 

Not satisfied: 

5% 

Spont: 

Not satisfied: 

15.8% 

Women with 

spontaneous 

perineal tears 

had less pain

on first 

intercourse 

than those 

with 

episiotomy 

alone. Those 

with third- to 

fourth-degree

episiotomy 

extensions 

had the most 

pain on 

resumption of 

intercourse. 

Signorello et 

al., 200138

Midline 

United 

States 

Cohort with 

a single 

prospective

window 

N = 921 

6 months

Mailed 

questionnaire

Current 

dyspareunia: 

“pain on 

sexual 

intercourse” 

at 6 months 

Multivariate models for type 

of perineal trauma: 

None: Referent 

Second degree:1.3 (0.8, 

2.2) 

Third/fourth degree: 1.5 

(0.7, 3.5) 

Degree of

perineal 

trauma, not 

episiotomy 

per se 

associated 

with 

dyspareunia.

62 
Table 9. Episiotomy and future sexual function (continued) 

Citation 

Epis. Type 

Country

Study

Design 

N 

Timing of 

Outcome 

Assessment 

after Birth; 

Approach 

Outcome 

Assessed 

Definitions 

Provided 

Outcome 

among 

Those with 

Episiotomy

Outcome 

among 

Those 

without 

Episiotomy

Results of 

Multivariable

Models 

Authors’ 

Conclusions

Karacam 

and Eroglu, 

200372

Mediolateral 

Turkey 

Prospective 

cohort

N = 100 

3 months

Telephone 

interview 

Any 

dyspareunia 

(not defined) 

64.58% 54.17% Not reported

No significant

differences

between 

groups in rate 

of mothers’ 

dyspareunia.

Sartore et 

al., 200471

Mediolateral 

Italy 

Prospective 

cohort

N = 519 

3 months

In-person 

interview 

Current 

dyspareunia 

(not 

defined); 

classified as 

“absent, 

mild, 

moderate, 

severe”; 

reported Y/N

7.9% 3.4% Summary

measure: 

RR: 2.43 

(1.05, 5.45) 

These trials were designed primarily to assess rates of episiotomy and perineal trauma under 

different strategies to guide use of episiotomy. Restrictive use, as addressed in KQ 1, was 

hypothesized to result in less severe trauma among women with lacerations and in a higher 

proportion of women without perineal lacerations. If women experienced less perineal trauma, 

this improvement would be expected to be associated with less pain with future intercourse. 

Therefore, the Canadian trial team also undertook a separate analysis of the relationship between 

the degree of perineal trauma and sexual function. Using data from the 3-month interviews, they 

regrouped participants by perineal status that was systematically documented at the time of the 

index birth, creating a prospective cohort. In this cohort analysis, women with an intact 

perineum were most likely to have resumed intercourse by 6 weeks (76.5 percent), followed by 

those with spontaneous tears (62.5 percent), episiotomy alone (61.7 percent) and third- and 

fourth-degree lacerations (55.4 percent). Women with episiotomy had the slowest return to 

intercourse. Pain with the first intercourse followed a similar pattern.34

Prospective Cohorts. Signorello and colleagues were the sole research team from the

United States to assess sexual function.38 They documented trauma at the time of childbirth by 

chart review and followed up women at 6 months. They reported that the degree of trauma, 

rather than whether it resulted from episiotomy or spontaneous tear, was the primary determinant 

of pain with intercourse at 6 months. In prospective 6-month data, the risk of pain with 

intercourse was higher among those with second-degree trauma compared to no trauma (RR 1.3, 

95% CI, 0.8-2.2), and highest with third- and fourth-degree trauma (RR 1.5; 95% CI, 0.7-3.5), 

although not statistically significant. 

63 
Table 10. Episiotomy and dyspareunia 

Dyspareunia at 3 Months

Citation 

Country

Study Design 

Episiotomy

Type

Timing of 

Outcome 

Assessment 

after Birth 

Approach 

Outcome 

Assessed 

Definitions 

Provided 

Outcome 

among 

Those with 

Episiotomy*

Outcome 

among Those 

without 

Episiotomy*

Authors 

Conclusions

Rockner et 

al., 198880

Sweden 

Prospective 

cohort

Mediolateral: 

88% 

3 months

Questionnaire 

(method not 

specified) 

Current 

dyspareunia 

(not defined)

31/154 (20%) 9/46 (20%) No significant

difference 

Larsson et 

al., 199181

Sweden 

Prospective 

cohort

Mediolateral: 

98% 

2 to 3 months 

In-person 

interview with 

midwife 

Dyspareunia 

(not defined)

66/410 (16%) 69/627 (11%) None made

regarding 

sexual 

function 

Sartore et 

al., 200471

Italy 

Prospective 

cohort

Mediolateral: 

100% 

3 months

In-person 

interview 

Current 

dyspareunia 

(not 

defined); 

classified as 

“absent, 

mild, 

moderate, 

severe”; 

reported Y/N

20/254 

(7.9%)

9/265 (3.4%) RR: 2.43 

(1.08, 5.45) 

Dyspareunia within 3 Months 

Rockner et 

al., 198880

Sweden 

Prospective 

cohort

Mediolateral:

88% 

3 months

Questionnaire 

(method not 

specified) 

Any 

dyspareunia 

(not defined)

68/154 (44%) 20/46 (43%) No significant

difference 

Karacam 

and 

Eroglu, 

200372

Turkey 

Prospective 

cohort

Mediolateral:

100% 

3 months

Telephone 

interview 

Any 

dyspareunia 

(not defined)

31/48 

(64.58%) 

26/48 

(54.17%) 

No significant

differences

between 

groups in rate 

of mothers’ 

dyspareunia 

Note: RR, relative risk; Y, yes; N, no. 

64 
These cohort studies do not find large or statistically significant differences in sexual 

function. Only one study identified lasting differences in dyspareunia at 3 months. Sartore and 

colleagues reported that women with episiotomy were more than twice as likely to have pain 

than those without episiotomy.

71 An aggregate estimate for current dyspareunia at 3 months can 

be estimated from three of the cohort studies using 818 women with episiotomy and 938 women 

without episiotomy.

71,80,81 We used meta-analysis techniques to calculate an aggregate risk ratio 

for the combined population of the prospective cohorts. In these studies, women with 

episiotomy were 54 percent more likely to have pain with intercourse 3 months after delivery 

(RR: 1.54, 95% CI: (I: 1.19, 2.00), with an absolute increase in risk of dyspareunia of 5 percent 

among women who had episiotomy: 14.3 percent versus 9.3 percent. Similar estimates for the 

two studies that assessed any dyspareunia during the 3 months after childbirth reveal no 

difference in the overall probability of having had painful intercourse. Among 50 women with 

episiotomy, 65 percent have had pain with intercourse and 50 women without episiotomy, 54 

percent had had pain with intercourse but this was not statistically significant.72

65 

Chapter 4. Discussion 

The RTI International–University of North Carolina Evidence-based Practice Center (RTI–

UNC EPC) identified a modest body of literature addressing the relationship between episiotomy 

and maternal outcomes. This chapter presents the conclusions from each of our key questions 

and discusses these conclusions in the context of our ratings of the strength of the body of 

evidence that we reviewed in detail in Chapter 3. Additionally, we discuss limitations of the 

review and this literature in general. Finally, we summarize needs for future research. 

The focus of this systematic review is on maternal outcomes of “routine” episiotomy, with 

specific emphasis on five key questions: 

KQ 1. Does the practice of liberal or routine episiotomy, compared to more selective use of

episiotomy, influence maternal postpartum outcomes?

KQ 2. Does episiotomy incision type (i.e., midline or mediolateral) influence maternal 

postpartum outcomes?

KQ 3. Does the repair of the perineal defect (suture type and repair approach) influence 

maternal postpartum outcomes?

KQ 4. Does episiotomy have a long-term influence on urinary incontinence, fecal incontinence, 

or pelvic floor defects? 

KQ 5. Does episiotomy or incision type, or both, influence future sexual function? 

We have not assessed literature on maternal or fetal outcomes at the time of use in response 

to a maternal or fetal emergency or concurrent with use of vacuum or forceps. Moreover, much 

of the literature we did review to answer these key questions did not examine a full range of

maternal outcomes. 

Several elements of our review and approach to documentation warrant emphasis. First, 

conceptualizing “routine use” is a challenge because many studies describe the category by 

negatives such as “not for fetal distress” and “not for dystocia.” Thus, we provide the 

operational definitions of “routine” (sometimes denoted as “liberal”) and “restricted” use that 

authors of included publications used; in this way, readers may apply this information as a filter 

through which to view study findings. Second, readers need to appreciate that the majority of the 

included studies reflect outcomes of mediolateral episiotomy, rather than midline; the latter is the 

predominant approach used in the United States. For that reason, we specifically note the type of 

episiotomy used in individual studies in the text and tables throughout this report. Finally, we 

have developed detailed evidence tables (Appendix C∗

) that include these details as well as 

numerous other specifics of study design, measurement methods, and outcomes. 

This systematic evidence review assessed 7 randomized controlled trials of routine versus 

restricted use of episiotomy and identifies the sole trial of midline versus median episiotomy. We

present evidence from 17 randomized controlled trials (RCTs) that is relevant to choosing among 

options for repair methods. We have also extended prior reviews to encompass longer-term

maternal outcomes. Specifically, we have systematically assessed the evidence from 3 trials and 

12 prospective cohorts related to the influence of episiotomy on measures of pelvic floor 

relaxation and urinary and fecal continence and the evidence from 4 trials and 6 prospective 

cohorts that provide information about sexual function and satisfaction. 

 

∗

 Appendixes are provided electronically at http://www.ahrq.gov/clinic/tp/epistp.htm

67
As described in Chapter 3 and documented in our evidence tables, we gave close attention to 

grading the quality of individual studies. To complete the picture of the strength of evidence, we 

used that information and the collective picture of relevant work on each key question to arrive at 

a systematic rating of the overall strength of the evidence. To accomplish this, we created four 

ratings, based largely on past methods for this step from previous evidence reports of the RTIUNC EPC, including systematic reviews performed for the U.S. Preventive Services Task Force. 

This approach employs four categories to describe the strength of evidence, as defined below: 

I. The evidence is from studies of strong design; results are both clinically important and 

consistent with minor exceptions at most; results are free from serious doubts about 

generalizability, bias, or flaws in research design. Studies with negative results have 

sufficiently large samples to have adequate statistical power. 

II. The evidence is from studies of strong design, but some uncertainty remains because of

inconsistencies or concern about generalizability, bias, research design flaws, or adequate 

sample size. Alternatively, the evidence is consistent but derives from studies of weaker 

design. 

 III. The evidence is from a limited number of studies of weaker design. Studies with strong

design either have not been done or are inconclusive. No published literature. 

Table 11 uses these four categories to document our assessment of the strength of evidence 

for our main key questions (or subquestions). No key question reflected Grade I evidence (the 

best possible). The strength of evidence was Grade II for KQ 1 and one part of KQ 3. The 

evidence was poorer – Grade III – for KQ 2, most of KQ 3, KQ 4, and KQ 5. All key questions 

had some degree of evidence, so Grade IV was not relevant. 

Table 11. Overall strength of the evidence for this body of literature 

Key Question 

Grade 

(I-IV Scale)* 

1. Episiotomy and maternal postpartum outcomes II 

2. Episiotomy incision type and maternal morbidity III 

3. Repair of perineal defect and maternal morbidity 

Methods: 2-layer vs. 3-layer repair III 

Methods: Continuous vs. interrupted sutures III 

Materials: Absorbable vs. tissue adhesive III 

Materials: Absorbable sutures — standard vs. rapidly absorbed III 

Materials: Untreated catgut vs. treated catgut III 

Materials: Nonabsorbable vs. absorbable III 

Materials: Polyglycolic acid vs. chromic catgut II 

Combined methods and materials III 

4. Episiotomy and urinary incontinence, fecal incontinence, and pelvic floor defects II 

5. Episiotomy and future sexual function II 

68
Principal Findings 

Key Question 1: Episiotomy and Maternal Postpartum Outcomes 

This literature, spanning two decades from the mid-1980s to the present, has high internal 

consistency with respect to the postpartum effects of routine (or liberal) versus restrictive 

strategies for episiotomy use.22,23,28-32

 We found few if any meaningful discrepancies in findings, 

and overall we regarded this body of evidence as Grade II. 

Across studies, women in the restrictive-use groups had less severe posterior perineal trauma, 

more frequent but not severe anterior vaginal trauma, less overall need for suturing, and higher 

probability of having an intact perineum when compared to routine- or liberal-use policies. 

These differences in perineal trauma were associated with less pain in the short term among 

those in restrictive-use groups, with fairly prompt resolution of pain regardless of trial arm. 

Women in restrictive use arms had no greater or lesser risk of wound healing complications and 

were more likely to resume intercourse earlier. Overall loss to followup was pronounced during 

the weeks after birth; remarkably little is known about recovery trajectory or complications 

thereafter. 

Although these trials are of fair to poor quality overall, we base our conclusion that this 

evidence does not support routine use of episiotomy on the notable consistency of findings. 

Routine episiotomy does not achieve any of the short-term goals it has been hypothesized to 

achieve. Indeed, routine use is harmful to the extent that it creates a surgical incision of greater 

extent than many women might have experienced had episiotomy not been performed. 

Key Question 2: Episiotomy Incision Type and Maternal Morbidity

On the question of midline vs. mediolateral episiotomy, only a single study found that 

women who had a midline episiotomy had a significantly greater rate of anal sphincter injuries 

than women in the mediolateral episiotomy group.36 Treatment groups did not report differences 

in pain or satisfaction with intercourse at 3 months after the intervention. 

Because of considerable methodological flaws in this trial (poor internal validity), any 

conclusions must be drawn cautiously, and we rate this “body” of evidence as Grade III. 

However, because differences in sphincter injury rates are clinically important, we consider the 

finding of increased risk of severe injury with midline episiotomy compared to mediolateral to be 

relevant observational evidence. 

Key Question 3: Repair of Perineal Defect and Maternal Morbidity

Methods. Because of the heterogeneity of methods used for repair of episiotomies and 

perineal lacerations, overall conclusions are applicable only to the repair method under study. 

Generally, we rate the strength of evidence for these issues as Grade III except in one instance, 

mentioned below. 

Two trials60,63,66 studied a two-layer approach, in which the perineal skin is left unsutured, 

against a three-layer approach, in which the skin is sutured closed. Two trials48,58 investigated 

the differences between a continuous (or subcuticular) method and an interrupted (or 

transcutaneous) method. Specific limitations of the trials and conclusions can be found below, 

69
grouped by the particular method comparison under study. Overall limitations in this body of 

evidence and suggestions for future research are presented later in this chapter. 

Two-layer vs. three-layer repair. Both trials provided consistent evidence that favored the 

two-layer approach, although statistically significant differences between the two approaches 

were not always found. The Ipswich Childbirth study had an overall good quality with adequate 

definitions and measurement of outcomes, reported masking of the outcome assessors and 

patients, and less than 15 percent loss to followup at 1 year.60,63

 Definitions and measurement of

the outcomes were only fair in the other trial,66 making it harder to compare to other trials. The 

latter trial also reported outcomes only on women who had completed all followup assessments; 

it did not report on possible differences between completers and the women who missed one or 

more followup assessments. 

Because the two-layer approach involves less suturing, it also means less inflammation and 

bruising; this in turn could result in less pain and perineal morbidity. Another explanation for 

the differences may lie with suture type. In the first trial, which produced fewer significant 

differences between the approaches, the investigators balanced polyglycolic acid and chromic 

catgut sutures.60,63In the other trial, a portion of the significant differences between the groups 

may be explained by an imbalance in suture type used. Chromic catgut was predominantly used 

and is hypothesized to be associated with increased pain, edema, and inflammation.66

Even with the limitations discussed above, the pool of evidence from both trials suggests that 

less overall perineal morbidity is associated with the two-layer repair approach, which leaves the 

perineal skin unsutured, than with the three-layer approach. The reduction in pain, need for 

analgesia, wound healing problems, and sexual morbidity, as well as a decrease in the time and 

cost required for initial suturing of the perineal skin, removal, and possible resuturing, may make 

the two-layer approach more beneficial than the traditional three-layer approach. 

Continuous vs. interrupted sutures. Although the evidence is unclear, it suggests that a 

continuous method of repair, though it may be technically more difficult, may be superior to the 

interrupted method. Two good-quality trials produced inconsistent evidence that the continuous 

method of repair has less perineal morbidity and more patient satisfaction associated with it than 

the interrupted method of repair.48,58

Both trials, through a factorial design of randomization, also randomized women to different 

suture material groups. Both trials achieved valance with respect to suture type; authors 

represented results for methods of repair regardless of suture type. Both trials defined and 

measured outcomes well and achieved good followup. In both trials, the authors describe greater 

familiarity with the interrupted method of repair, which is said to be technically easier to perform 

than the continuous method. One clinical group (for the trials conducted in Southmead, United 

Kingdom) even suggests that their inconsistencies with other trials might have be attributable to 

the lack of practice with the method and subsequent unpopularity with the operators that 

performed the repair.58 Whether such differences in outcome arise for clinicians and women 

outside the United Kingdom, where methods of repair and training of those performing the repair 

could be different compared to other countries, remains to be seen. 

Materials. Because this review includes trials dating back to 1974, the materials used differ 

over time. Two trials47,64 compared absorbable sutures with tissue adhesive; two trials48,62

compared absorbable sutures with their rapidly absorbed versions; one trial56 compared untreated 

with treated catgut; two trials54,58 compared nonabsorbable sutures with absorbable sutures; and 

eight trials50-53,58,59,61,63,65

 compared polyglycolic acid with chromic catgut. Because of this 

heterogeneity, specific limitations of the trials and conclusions can be found below, grouped by 

70
the particular material comparison under study. Overall limitations in this body of evidence and 

suggestions for future research can be found later in this chapter. 

Absorbable vs. tissue adhesive. Both trials47,64 were of poor quality because the method of 

randomization was inadequate or broken. However, even though sample size was small (n < 65 

in both trials), both groups did define and measure perineal pain well and achieved good 

followup. These trials contribute possible evidence that repair with tissue adhesive may decrease 

perineal pain experienced in different situations in the immediate postpartum. This conclusion 

must be weighed in light of the inadequate randomization of these studies. Our review suggests 

that this question merits further study in a well-randomized trial. 

Absorbable sutures: standard vs. rapidly absorbed. The mixed results from the good trial48

and lack of significant differences between groups in the poor trial62 suggest that evidence is 

insufficient about any difference in perineal pain between standard and rapidly absorbed sutures. 

We saw stronger evidence that women who had rapidly absorbed sutures required less removal 

of the material, presumably because it had been absorbed more quickly in the postpartum period. 

We had difficulty assessing the effect of type of absorbable suture on other healing outcomes 

because the poor trial grouped all outcomes together. Although the two trials evaluated sexual 

functioning at different time points, evidence suggests that rapidly absorbed sutures may 

decrease the amount of dyspareunia and the severity thereof in the puerperium. One item to note 

in the good-quality trial was the masking of the suture material. The trial acquired undyed 

sutures direct from the manufacturer, thereby achieving a very high level of internal validity and 

decreasing the amount of bias in assessment of the outcomes. 

Untreated catgut vs. treated catgut. Only one trial addressed treated and untreated catgut.56 

This trial achieved fair randomization and was able to blind the assessors and the patients. Loss 

to followup at 10 days and 3 months was minimal, but at 3 years, loss to followup was only fair 

(70 percent). A small amount of crossover to the other suture material group occurred, but the 

investigations did perform an intent-to-treat analysis. 

This trial produced no evidence that “softgut” (i.e., treated catgut) is superior to untreated 

catgut with regard to perineal morbidity. In fact, the trial may indicate that softgut may be 

associated with higher morbidity, as there appeared to be more perineal pain in the immediate 

postpartum period and more painful sexual intercourse in the longer-term period. Though 

untreated catgut sutures needed to be removed more often, the authors attributed the difference to 

the tendency for the sutures to dry out. However, they speculated that such drying out could not 

completely explain the differences in perineal pain. 

The women were repaired using different techniques, but the randomized groups were 

balanced in that respect. Investigators used the interrupted method approximately 60 percent of 

the time in both groups. Stratifying by technique of repair showed more marked dyspareunia and 

need for suture removal in women who were repaired using interrupted sutures, a finding that is 

consistent with other trials investigating method of repair 

Nonabsorbable vs. absorbable. Because of the study design of the fair-quality trial54 and 

lack of control for possible confounding by method of repair, we cannot draw conclusions about 

the role of silk sutures in perineal morbidity from this trial. The authors present data by suture 

material and then do not mention differences in the methods until the conclusions section of their 

article. They concluded that the subcuticular method lent itself to short-term advantages, but 

they did not present the data to support their conclusion. Thus, although this trial may contribute 

to a body of evidence that looks at combinations of materials and methods, it does not contribute 

to the overall understanding of the role of suture materials in perineal morbidity, separate from

methods of repair. The Mahomed et al. trial58 found no differences between the two groups in 

71
the short-term postpartum period, but did find differences at 3 months, indicating a possible 

delayed effect of the suture material. 

Polyglycolic acid vs. chromic catgut. In 2004, the Cochrane Library published a systematic 

review and meta-analysis of information on polyglycolic acid versus catgut suture material for 

repair of perineal trauma.

82 In it, they report that polyglycolic acid sutures were associated with 

less pain in the short-term postpartum period (Odds ratio [OR] = 0.62; 95% confidence interval 

[CI], 0.54-0.71) and with less need for analgesia (OR = 0.63; 95% CI, 0.52-0.77). No 

differences were found in long-term pain outcomes or in reports of dyspareunia. 

Our systematic evidence review includes six of the eight trials that were included in the 

Cochrane review and an additional two trials. Overall, the evidence is from a combination of

poor, fair, and good trials, but we considered the strength of evidence as Grade II; moreover, it is 

consistent with the previous Cochrane review. Basically, evidence indicates that polyglycolic 

acid sutures are associated with less perineal pain, a lesser need for analgesia use, and fewer 

healing problems in the short-term postpartum. For long-term outcomes, the evidence is 

consistent that outcomes of the use of polyglycolic acid sutures and chromic catgut do not differ 

substantially. One trial not in the Cochrane review

65 did report more perineal pain and 

dyspareunia in the polyglycolic-acid group at 6 months, an outcome the authors attributed to the 

slower absorption rate of polyglycolic-acid sutures; however, these results were neither 

statistically significant nor precise. Overall, the body of evidence for the comparison of 

polyglycolic-acid sutures versus chromic-catgut sutures suggests that using polyglycolic-acid 

sutures for perineal repair offers many short-term advantages. 

Combined Methods and Materials. Instead of investigating methods and materials 

separately, two trials49,55 compared entire approaches, combining both materials and methods in 

a single randomization design. The poor trial49 found no differences between the groups; the 

fair-quality trial55 found that women repaired with polyglycolic-acid sutures using a continuous, 

subcuticular approach suffered less perineal morbidity. This result is consistent with other trials 

that investigated subcuticular suturing and polyglycolic-acid sutures separately, perhaps 

reinforcing the notion that this method and suture type are superior to other options available to 

obstetric clinicians. Overall limitations in this body of evidence and suggestions for future 

research are provided later in this chapter. 

Summary. The heterogeneity of methods and materials used for repair of episiotomy and 

perineal laceration arises in part from the passage of time and differences in practice across 

continents. Another set of issues to consider in studying the repair of episiotomy are the 

economic and geographic differences among clinical practices across the world. The choice of 

suture material might be restricted in resource-poor settings. If a clinic cannot afford or does not 

have access to polyglycolic acid, which, as reported in one of the studies,66 is more expensive 

than other absorbable sutures, then the clinic may have to make do with available sutures but 

perhaps supplement them with a method of repair that can decrease perineal morbidity. 

During the time period that this review encompasses, investigators studied three major 

classes of suture material (nonabsorbable, absorbable, and tissue adhesive) and two subtypes of 

sutures (treated versus untreated and standard versus rapidly absorbed). These materials were all 

studied in the presence of different approaches to the method of suturing; therefore, individual 

effects of the materials themselves cannot be examined. Likewise, the methods of repair were 

examined in the context of different materials among the studies and within them for different 

stages of repair. For these reasons, truly determining the effects of a certain method of repair is 

impossible, because we are unable to tell whether the outcomes are confounded or modified by 

suture material. 

72
Key Question 4: Episiotomy and Urinary Incontinence, Fecal 

Incontinence, and Pelvic Floor Defects 

The literature that provides evidence about routine episiotomy, continence, and pelvic floor 

defects and function is limited in several domains. All but two of the cohorts34,75 report 

outcomes for use of mediolateral episiotomy rather than midline episiotomy. The length and 

incompleteness of followup limits the usefulness of the data. We aimed to identify publications 

with followup ranging from years to decades after births to women with known episotomy 

histories. However, at completion, only five of 16 publications provide data with followup at 1 

year or longer;33,68-70,74

the longest interval was 5 years.69 Followup conducted within 6 months 

of birth, as in 10 percent of the 16 studies, does not reflect full recovery of the pelvic floor from

vaginal birth. For that reason, we considered 6 months followup as an intermediate point of 

comparison rather than an evaluation of final pelvic floor and continence status. 

All measures for followup at or beyond a year were self-reported by interview or 

questionnaire except a single study with perineometry conducted at 12 months.68 Neither selfreport for many urinary and rectal continence symptoms nor perineometry and physiologic 

measures have been adequately validated. These measures do not relate directly to physical 

examination findings or individual functional status. Indeed, urodynamic testing and physical 

examination have very limited documentation of their ability to predict or classify continence 

status. These limitations must be kept in mind. The greatest clinical relevance would be to 

assess continence and pelvic floor deficits among women with known episiotomy histories 

beginning in their 40s and proceeding through their lifetimes. None of the identified studies 

provided such data. 

Given these limitations of timing and methods of followup, these prospective studies did not 

identify improvements in continence for urine or stool or in pelvic floor muscle function among 

women who had had episiotomy compared to those who had not. This finding includes 

comparison to women who had spontaneous lacerations of similar severity. Several authors 

reported decrements in pelvic floor function among women who had episiotomy. Only a single 

study, using multivariable models, found that episiotomy was an independent predictor of 

urinary continence.69 In the majority of other studies using multivariate models, adjusting for 

factors such as parity, neonatal weight, and length of second-stage labor revealed that episiotomy

was not an independent risk factor for incontinence. Taken in total, this literature, predominantly 

of fair to poor quality, does not support use of episiotomy for the purpose of preventing pelvic 

floor defects, urinary incontinence, or incontinence of stool or flatus. Table 11 shows this as 

graded strength of evidence Grade III. 

In summary, these prospective studies are limited because they do not follow women long 

enough to detect disease occurrence. At present, the assumption that intermediate variables such 

as pelvic muscle strength measured by perineometry, urodynamic test results, or early reports of 

symptoms can predict later disease has not been validated. Prospective evaluation only during 

the months after birth when the pelvic floor is still in a recovery and stabilization period may be 

misleading. Conclusions about whether episiotomy prevents or increases risk for incontinence 

and prolapse later in adult life cannot be reached from currently available randomized and cohort 

studies. 

73
Key Question 5: Episiotomy and Future Sexual Function 

The studies addressing this question need to be considered in three groups: the six studies 

that virtually exclusively evaluate effects of mediolateral incision,23,33,71,72,80,81 three that evaluate 

midline (median) incision,

29,34,38 and one that compared the two incision types.36 From just the 

clinical trials of episiotomy strategy — liberal versus restrictive — one trial addresses each type 

of incision, and one directly compares the two incision types. None finds substantive differences 

in sexual function. Overall, this body of literature supports a conclusion that perineal trauma is 

associated with probability of pain with intercourse in a dose-response fashion such that greater 

perineal injury is associated with greater probability of pain. 

The quality of the evidence (to which we assigned Grade III) to assess this question is limited 

for reflecting on the consequences of episiotomy. Both the clinical trials and the prospective 

cohorts assess overly simplified measures of sexual function. Definitions and specification of 

approaches to measurement are insufficient in many studies to assure accurate interpretation of

findings. Validated instruments intended to assess nuances of sexual function such as type of 

pain, location of pain, severity of pain, orgasm, lubrication, and libido have not been deployed in 

the published research to assess prospectively the influence of perineal trauma in childbirth on 

future sexual function. More complex measures would need to be used to understand properly 

relationships between perineal trauma and future sexual function. Specific factors such as prior 

sexual function and current libido, in addition to factors such as duration of second-stage labor, 

size of infant, and lactation status need to be incorporated into multivariable models to generate 

more-informative and less-biased estimates of the long-term effects of episiotomy in this area. 

With these caveats, the evidence does not suggest that episotomy results in improved sexual 

function outcomes. 

Limitations of This Review and the Literature 

Deficiencies in The Literature 

Our systematic review should be interpreted in the context of several limitations. First, as 

with all systematic reviews, its findings depend on the predefined approach to searching the 

literature and on the quality of the published literature identified. The limitations of the available

studies (see Chapter 3) include the following: 

• age of the data (trials from the 1980s and early 1990s were conducted in an era when 

background rate of episiotomy was higher); 

• insufficient size of most trials for assessing clinically relevant endpoints (third- and 

fourth-degree lacerations, long-term incontinence); 

• inadequate specification of a priori primary and secondary outcomes with few references 

to power calculations to determine required study size; 

• infrequent use of multivariate modeling to account for shortcomings of randomization or 

need for stratification within RCTs or potential confounders in prospective cohort 

studies; 

• infrequent use of masking of the assessor for outcomes; 

74
• use of a wide variety of measures and timepoints for maternal postpartum outcomes, 

making comparisons among studies difficult; 

• rare use of validated outcome measures; 

• limited reporting of precise definitions of self-reported outcomes, particularly for pain, 

sexual function, and incontinence; and 

• inconsistent reporting of appropriate statistical measures (i.e., use of P values without 

measures of magnitude or confidence intervals), making it difficult to determine if null 

findings represent lack of effect or limitations in power. 

An additional limitation of the literature on KQ 1 results from the nature of the intervention. 

In essence, KQ 1 reviews studies of clinician behavior when asked to implement different 

policies for episitomy use. Differences in episiotomy rates observed in groups assigned to 

routine (i.e., liberal) use vary from a low of 23 percent29 to a high of 52 percent,30 suggesting that 

clinician behavior is not easily modified, even in the context of an RCT. Inconsistencies in the 

way that clinicians define and interpret routine use and restricted use of episiotomy within and 

across trials may temper differences between protocol groups. Additionally, violations of 

protocol can invalidate initial power calculations and lead to results that cannot be interpreted. 

Limitations to Our Review Procedures 

Our review process also had some limitations. Because of time and resource constraints, we 

did not conduct dual, independent, blinded review of articles for inclusion or abstraction of 

information into evidence tables. Instead, one reviewer performed the initial review, and a 

second reviewer examined that input and recommended changes. Differences were reconciled 

between the two reviewers. We used dual review for grading the quality of individual articles, 

allowing us to evaluate rigorously systematic bias in these assessments. 

Future Research 

Studies comparing restrictive to liberal use of episiotomy report that, even under a restrictive 

approach, episiotomy rates vary between 8 percent and 52 percent.22,23,28-32

 This disparity 

suggests that episiotomy is considered to be clinically indicated for a substantial number of 

women even at the lowest levels recorded by our review. Currently, the evidence suggests that 

the putative benefits of episiotomy do not outweigh the harms in the general population. Instead, 

outcomes from episiotomy are worse because some proportion of women who would have had 

lesser injury instead had a surgical incision. 

The majority of these studies to assess outcomes of routine episiotomy used mediolateral 

episiotomy. We do not, however, conclude that additional study of outcomes of routine use 

versus liberal use of midline episiotomy is warranted. Observational studies other than RCTs 

clearly and consistently relate midline episiotomy to higher rates of anal sphincter and rectal 

injury than those observed with mediolateral episiotomy.

9,40,42,83 Thus, we would expect trials of 

routine use of midline episiotomy to have more numerous unfavorable outcomes than those 

observed in these studies, an effort not worth replicating given the lack of benefit of episiotomy

supported by existing evidence. 

If episiotomy were restricted to indicated use, an important question remains for women and 

their care providers: Which, if any, of the prevailing indications for episiotomy are supported by 

an adequate research base? A two-stage research agenda could address this need. First, a 

75
systematic review may clarify current knowledge about outcomes of episiotomy for the leading 

presumed indications. Second, primary data collection may be needed to fill in research gaps 

identified by such a review and to improve understanding of whether these are indeed indications 

for episiotomy. Work relating to the latter element of such a research agenda is under way on 

several topics including recent publication of a retrospective cohort study that suggests that use 

of episiotomy conferred no benefit in averting neonatal injury at the time of births complicated 

by shoulder dystocia.84 Additional evidence will be required to fully investigate what 

circumstances should be considered indications for episiotomy. 

Establishing an evidence base for indications would lead to a health services research agenda 

focused on variations in rates and outcomes. Several issues are paramount: What safe and 

conservative rates of episiotomy are attainable? Should measures of quality of childbirth care 

include episiotomy rates? What approaches are most successful in reducing unnecessary use of 

episiotomy? 

Furthermore, if the professional community accepts that routine episiotomy is not an

effective means to reduce perineal injury, that attitude should enable them to redouble efforts to 

understand fully various (other) approaches to attending the second stage of labor that can 

promote maternal and infant safety, minimize perineal trauma, and maximize maternal comfort. 

The failure of one intervention-oriented method such as episiotomy to deliver such results does 

not reduce the likelihood that other approaches, or combinations of approaches, may be useful. 

These approaches include giving attention to maternal position, avoiding fundal pressure, 

reducing coached pushing, providing perineal support, and employing “hands poised” versus 

hands on techniques to support the perineum, and the role for lubrication and types of lubrication 

for use during crowning of the infant head. Any or all of these techniques may help women and 

their care providers reach desired outcomes more frequently and deserve to be subjected to 

rigorous study. 

Researchers must also continue to investigate the relationship between self-care practices 

such as Kegel pelvic floor exercises, general physical fitness, and nutrition, and the risk for 

pelvic floor defects including incontinence and prolaspes. To the degree that pelvic floor 

recovery can be facilitated or “rehabilitation” achieved by nonsurgical means, numerous women 

would benefit from such research. To understand pelvic floor defects and childbirth experiences 

properly, including history of episiotomy, studies need to be designed to identify populations of 

women who have a known episiotomy history to evaluate their continence and pelvic organ 

prolapse status in the age groups between 40 and 70 years. 

Understanding the relationship of pelvic floor morbidity to childbirth experiences will 

require increasingly sophisticated analysis methods and study designs. Evaluation and 

incorporation of confounders and modifiers of the effect of exposure must become the norm for 

prospective data analysis. Factors such as maternal race and ethnicity, body mass index, infant 

birth weight, duration of second-stage labor, duration of strenuous pushing, and elements of 

reproductive history such as outcomes of prior births require attention. Cohorts of women who 

participated in perinatal research in the 1980s will soon enter the timeframe in which meaningful 

followup of pelvic floor status can be obtained. 

Future research on sexual function and sexuality after childbirth is needed. Very limited data 

are available even to describe what women should expect as normal. Research will need to take 

into account breastfeeding status, episiotomy and laceration history, repair methods, and 

contraceptive type. Greater attention is needed to distinguish dyspareunia and characteristics 

that help describe dypareunia (an anatomic symptom), from “satisfaction” with its components 

of relationship quality, sexual aptitude, and cerebral contribution, and from ability to achieve and

76
consistency of achieving orgasm. Sexual function outcomes need to be regarded as appropriate 

primary research aims so that these concerns do not remain secondary measures with insufficient 

attention to reach meaningful answers.

Our review of the literature on the repair of perineal defects points to another avenue for 

further research. Clinical judgment suggests that the perineal outcome of repair is a function of 

both materials and methods. Consistencies in the evidence from the studies of repair (e.g., 

polyglycolic-acid sutures are better than chromic catgut; continuous suturing is better than 

interrupted suturing) can be used to inform future studies in more creative randomization designs 

or multivariate analyses. More sophisticated designs might allow a trial to compare complete 

approaches to repair rather than individual components, such as the studies performed by Doyle 

et al.49 and Isager-Sally et al.55 

One clinically relevant study might compare combinations of the materials and methods that 

seem to decrease morbidity (e.g., subcuticular polyglycolic-acid sutures) with new materials such 

as tissue adhesive that enter the market with (unproven) claims of reduced perineal morbidity. 

Unless multivariate models are used to tease out mixed-effects of methods and materials or 

future research begins randomizing groups to entire approaches to repair, results can be 

informative and applicable to a population only to a certain point. The gap in information may 

mean that, in the future, women who are receiving appropriate episiotomies may still not receive 

a thorough repair. Some observers, however, may regard mounting such a trial as questionable. 

Thus, a useful first step might be to develop sample-size estimates based on a range of important 

outcomes and, in this way, to determine whether such a trial is even feasible to attempt. 

Conclusion 

Our systematic review finds no health benefits from episiotomy. We found fair to good 

evidence suggesting that the immediate outcomes for routine (liberal-use policies) episiotomy

are no better than those for indicated use of episiotomy under more restrictive-use policies. 

Indeed, routine use is harmful to the extent that it creates a surgical incision of greater extent 

than many women might have experienced had episiotomy not been performed. Weak trial 

evidence, consistent with observational data, suggests that the harms of midline episiotomy are 

greater than the harms of mediolateral episiotomy. 

For outcomes of repairing an episiotomy, fair to good evidence, albeit across different 

comparisons of methods and materials, suggests that leaving the perineal skin unsutured may 

confer some benefit; if suturing is indicated, then a continuous, subcuticular method is better 

than an interrupted, transcutaneous method. Regarding suture material, the evidence is 

consistent and clear that absorbable sutures are preferred and that polyglycolic-acid sutures have

significantly less perineal morbidity associated with them. Newer materials, such as tissue 

adhesive, may offer further benefits, but the data are at present wholly inadequate to inform care 

practices. 

The level of evidence for long-term sequelae, specifically fecal and urinary incontinence, 

pelvic floor function, and future sexual function is fair to poor. Nonetheless, it is consistent in 

demonstrating the lack of benefit of the procedure in a comparatively early timeframe. For 

women in later adult life, when morbidity is most likely to occur in the form of severe and 

persistent incontinence or pelvic organ prolapse, the expected results of routine episiotomy are 

unknown. 

77
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83
84
Listing of Excluded Studies 

Codesheet for Episiotomy SER ProCite Database

Field in ProCite Code Meaning of Code Description & Comments

I Abstract included Article was pulled for review 

E Abstract excluded Article was NOT pulled for review 

Field Number: 11 

Original field name: 

Title 

Labeled as: Abstract 

Inclusion/Exclusion 

(From the Abstract Review 

Form)

B Background Article was excluded from the review 

but pulled for background 

Field in ProCite Code* Meaning of Code Description & Comments

I Full text included “Full text INCLUDED” is checked at 

the end of the form

B Background 

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87 
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3(2):46-51. 

Full text inclusion/exclusion: E1 

Webb DA, Culhane J. Time of day variation in rates 

of obstetric intervention to assist in vaginal delivery. 

J Epidemiol Community Health 2002; 56(8):577-8.

Full text inclusion/exclusion: B, E2 

Webb JC, Gilson G, Gordon L. Late second stage 

rupture of the uterus and bladder with vaginal birth

after cesarean section: a case report and review of the 

literature. J Matern Fetal Med 2000; 9(6):362-5. 

Full text inclusion/exclusion: E1 

Weerasekera DS, Premaratne S. A randomised 

prospective trial of the obstetric forceps versus 

vacuum extraction using defined criteria. J Obstet

Gynaecol 2002; 22(4):344-5. 

Full text inclusion/exclusion: E1 

Welch RA, Bottoms SF. Reconsideration of head 

compression and intraventricular hemorrhage in the 

vertex very-low-birth-weight fetus. Obstet Gynecol 

1986; 68(1):29-34. 

Full text inclusion/exclusion: E1 

Wen SW, Liu S, Kramer MS, et al. Comparison of 

maternal and infant outcomes between vacuum

extraction and forceps deliveries. Am J Epidemiol 

2001; 153(2):103-7.

Full text inclusion/exclusion: E1 

100 
Whalen TVJ, Kovalcik PJ, Wilson GG. Traumatic 

perineal laceration. Am Surg 1982; 48(4):145-8. 

Full text inclusion/exclusion: E1 

Wheeler DG. Intrapartum bleeding. NAACOG's 

Clinical Issues in Perinatal and Women's Health

Nursing 1991; 2(3):381-4. 

Full text inclusion/exclusion: E1 

Whelton J. Pain control in labour. Nursing (Lond) 

1990; 4(2):14-8.

Full text inclusion/exclusion: E1 

White CA, Koontz FP. Emolytic streptococcus 

infections in postpartum patients. Obstet Gynecol 

1973; 41(1):27-32. 

Full text inclusion/exclusion: E1 

Widmark C, Tishelman C, Ahlberg BM. A study of

Swedish midwives' encounters with infibulated

African women in Sweden. Midwifery 2002; 

18(2):113-25.

Full text inclusion/exclusion: E1 

Wiklund I, Matthiesen A, Klang B, et al. A 

comparative study in Stockholm, Sweden of labour

outcome and women's perceptions of being referred

in labour. Midwifery 2002; 18(3):193-9. 

Full text inclusion/exclusion: E1 

Wilcox LS, Strobino DM, Baruffi G, et al. 

Episiotomy and its role in the incidence of perineal 

lacerations in a maternity center and a tertiary 

hospital obstetric service. Am J Obstet Gynecol 

1989; 160(5 Pt 1):1047-52. 

Full text inclusion/exclusion: E4 

Wilkerson VA. The use of episiotomy in normal

delivery. Midwives Chron 1984; 97(1155):106-10. 

Full text inclusion/exclusion: E4 

Williams A. Third-degree perineal tears: risk factors 

and outcome after primary repair. J Obstet Gynaecol 

2003; 23(6):611-4. 

Full text inclusion/exclusion: E4 

Williams B. Care and repair of the perineum. Nurs 

Times 1974; 70(9):301-2. 

Full text inclusion/exclusion: E1 

Williams FL, du VFC, Mires GJ, et al. Episiotomy

and perineal tears in low-risk UK primigravidae. J 

Public Health Med 1998; 20(4):422-7. 

Full text inclusion/exclusion: E4 

Williams FL, Florey CV, Ogston SA, et al. UK study

of intrapartum care for low risk primigravidas: a 

survey of interventions. J Epidemiol Community 

Health 1998; 52(8):494-500. 

Full text inclusion/exclusion: E4 

Williams JL, Cohen-Dodge K. Unveiling ritual 

mutilation. Midwifery Today Childbirth Educ 1993;

(25):17-9, 41.

Full text inclusion/exclusion: E1 

Williams MC, Knuppel RA, O'Brien WF, et al. A 

randomized comparison of assisted vaginal delivery

by obstetric forceps and polyethylene vacuum cup. 

Obstet Gynecol 1991; 78(5 Pt 1):789-94.

Full text inclusion/exclusion: E1 

Willmott J. Community nursing: no need to flaw the 

pelvic floor. Nurs Mirror 1979; 148(13):31.

Full text inclusion/exclusion: E1 

Willmott J. Too many episiotomies. Midwives Chron

1980; 93(1105):46-8.

Full text inclusion/exclusion: E1 

Wilson BL. Delivery outcomes of low risk births: 

comparison of certified nurse midwives and 

obstetricians. J Am Acad Nurs Pract1989; 1(1):9-13. 

Full text inclusion/exclusion: E4 

Wilson E. The unusual anal fistula. Dis Colon 

Rectum 1968; 11(5):348-55.

Full text inclusion/exclusion: E1 

Wittich AC. Endometriosis in an episiotomy scar: 

review of the literature and report of case. J Am

Osteopath Assoc 1982; 82(1):22-3. 

Full text inclusion/exclusion: E1 

Wood C, Ng KH, Hounslow D, et al. Proceedings: A 

control trial demonstrates that speeding birth 

favourably affects cord blood pH. J Reprod Fertil 

1974; 36(2):472-3. 

Full text inclusion/exclusion: E3,E4 

Wood C, Ng KH, Hounslow D, et al. Time--an 

important variable in normal delivery. J Obstet

Gynaecol Br Commonw 1973; 80(4):295-300. 

Full text inclusion/exclusion: E3, E4 

Wood J, Amos L, Rieger N. Third degree anal 

sphincter tears: risk factors and outcome. Aust N Z J 

Obstet Gynaecol 1998; 38(4):414-7. 

Full text inclusion/exclusion: B, E4 

101 
Woodman PJ, Graney DO. Anatomy and physiology

of the female perineal body with relevance to

obstetrical injury and repair. Clin Anat 2002; 

15(5):321-34.

Full text inclusion/exclusion: B, E1 

Worth AM, Dougherty MC, McKey PL.

Development and testing of the Circumvaginal

Muscles Rating Scale. Nurs Res 1986; 35(3):166-8. 

Full text inclusion/exclusion: E1 

Wray J. 'Being hard'. Reflections on making it to be a

midwife. Pract Midwife 2001; 4(7):23.

Full text inclusion/exclusion: E1 

Yackovich FH, Bender GN, Tsuchida AM. Case 

report: peri-anal episiotomy scar endometrioma 

imaged by CT and sector endoluminal ultrasound. 

Clin Radiol 1994; 49(8):578-9. 

Full text inclusion/exclusion: E1 

Yeo S, Fetters M, Maeda Y. Japanese couples'

childbirth experiences in Michigan: implications for 

care. Birth 2000; 27(3):191-8. 

Full text inclusion/exclusion: E1 

102 
Table 1. Inclusion/exclusion criteria 

Category Criteria 

Study population Humans 

Study settings and geography Inpatient, outpatient, home; all geographical locations subject to 

publication language and study design criteria 

Time period 1950 through 2004 

Publication languages English only 

Sample size N greater than or equal to 40 

Admissible evidence (study design 

and other criteria) 

Original research studies that provide sufficient detail regarding 

methods and results to enable use and adjustment of the data 

and results 

For studies on KQ 1 and KQ 3

RCTs: double-blinded and single-blinded designs 

For studies on KQ 2, KQ 4 and KQ 5

RCTs: double-blinded and single-blinded designs 

Non-RCTs: prospective cohort studies 

Relevant outcomes must be able to be abstracted from data 

presented in the papers 
Table 2. Focused search terms and results from MEDLINE®

Search Terms Results 

"Episiotomy" [MeSH] Field: All Fields, Limits: English, 

Randomized Controlled Trial, Human 

75 

"Episiotomy" [MeSH], English, Review, Human 68 

Labor Stage, Second [mh], English, Review, Human 40 

Labor Stage, Second [mh], English, Randomized Controlled Trial, Human 58 
Table 3. Additional search terms and results from MEDLINE®

Search 

Number Search Terms Results 

#1 "Episiotomy"[MeSH:NoExp] Field: All Fields, Limits: English, Human 676 

#2 "Episiotomy” English, Editorial, Human 14 

#3 "Episiotomy" English, Letter, Human 58 

#4 "Episiotomy" English, Review, Human 68 

#5 "Episiotomy" English, Meta-Analysis, Human 3 

#6 "Episiotomy" English, Practice Guideline, Human 0 

#7 #2 OR #3 OR #4 OR #5 OR #6 140 

#8 #1 NOT #7 536 

#9 Repair 138,222 

#10 #1 AND #9 86 

#11 labor stage, second [mh] 638 

#12 #9 AND #11 6 

#13 (("Episiotomy" OR “pregnancy”) AND (“midline" AND "mediolateral")) 

[MeSH:NoExp] Field: All Fields, Limits: English, Human 

11 

#14 (("Episiotomy" OR “pregnancy”) AND (“sphincter")) [MeSH:NoExp] 

Field: All Fields, Limits: English, Human 

3 
Table 4. Results of randomized controlled trials of liberal versus restrictive use of episiotomy: Perineal 

Citation Country Episiotomy Type Number 

Inclusion Parity 

Groups Episiotomy Use Outcome(s) 

Outcome among LiberalUse Group 

Outcome among RestrictiveUse Group 

Sleep et al., 198423

United Kingdom Mediolateral N = 1,000 

Term, singleton pregnancy Anticipated NSVD 40%-46% primiparous 

G1: Liberal = “try to prevent a tear” G2: Restrictive = “try to avoid episiotomy and restrict to fetal indications” G1: 51.4% G2: 10.2% 

Intact Third or fourth degree Any suturing 

24.3% n = 1 Primip: 89% Multip: 69% 

33.9% n = 4 Primip: 74% Multip: 66% 

Harrison et al., 198422

Ireland Mediolateral N = 181 

Term, primigravid, anticipated vaginal birth 

G1: Mediolateral episiotomy routinely conducted G2: No episiotomy unless “medically necessary” G1: 44.9% G2: 7.6% 

Intact Third or fourth degree 

Not reported 6% 

21% None 

House et al., 198628

United Kingdom Mediolateral N = 165 

Term, vertex, anticipated NSVD 53%-68% primiparous 

G1: Standard current management G2: Episiotomy not performed to prevent laceration G1: 69% G2: 18% 

Intact or first degree Second degree = Episiotomy or second degree Third degree 

Primip: 4% Multip: 26% Primip: 96% Multip: 70% Primip: 4% Multip: 4% 

Primip: 32% Multip: 54% Primip: 68% Multip: 45% Primip: None Multip: None 
Table 4. Results of randomized controlled trials of liberal versus restrictive use of episiotomy: Perineal 

Citation CountryEpisiotomyTypeNumber 

Inclusion Parity

Groups Episiotomy Use Outcome(s) 

Outcome among Liberal-Use Group 

Outcome amonRestrictive-Use Group 

Klein et al., 199229

Canada Midline N = 730 

Term, singleton; anticipated NSVD 50%-52% primiparous 

G1: Liberal = avoid tear G2: Restrictive = attempt to avoid episiotomy G1: Primip: 81% Multip: 52% G2: Primip: 47% Multip: 31% 

Intact (no suturing) Episiotomy alone Third or fourthdegree 

Primip: 6.6% Multip: 19.3% Primip: 67.2% Multip: 45.2% Primip: 7.9% Multip: 0% 

Primip: 7.5% Multip: 30.7% Primip: 42.2% Multip: 29.0% Primip: 13.9% Multip: 0% 

Argentine Episiotomy Trial Collaborative Group, 199330

Argentina Mediolateral N = 2,606 

Term, singleton first or second vaginal birth; no prior cesareanor severeperineal trauma 40%-41% primiparous 

G1: Routine G2: Selective G1: 82.6% G2: 30.1% 

Perineal suturing Third or fourthdegree 

88.1% Primip: 1.8% Multip: 0.9% 

63.1% Primip: 1.4% Multip: 0.8% 

2 
Table 4. Results of randomized controlled trials of liberal versus restrictive use of episiotomy: Perineal 

Citation CountryEpisiotomyTypeNumber 

Inclusion Parity

Groups Episiotomy Use Outcome(s) 

Outcome among Liberal-Use Group 

Outcome amonRestrictive-Use Group 

Eltorkey and Nuaim, 199431

Saudi Arabia(British staff) Mediolateral N = 200 

Term, singleton, vertex, primiparous; anticipated NSVD 

G1: Elective G2: Selective = essential G1: 83%* G2: 53%* 

IntactSecond degree or episiotomy without extension Third degree or episiotomy with extension 

7% 71%* None

28% 49%* None

Dannecker etal., 200432

Germany Mediolateral N = 109 

>34 weeks, singleton, primiparous; anticipated NSVD 

G1: Liberal = if tear imminent and/or fetal indicationsG2: Restrictive = fetal indicationsonly G1: 77% G2: 41% 

IntactThird degree 

10% 8% 

29% 4% 

G, group; primip, primiparous; multip, multiparous; NSVD, normal spontaneous vaginal delivery. *Text and tables in this publication are not concordant; overall incidence from text; second degree and episiotomy totals from table. 

3 
Table 5. Results of randomized controlled trials of liberal versus restrictive use of episiotomy: Pain outc

Citation Country Episiotomy Type Number 

Inclusion Parity 

Groups Episiotomy Use 

Outcome(s): How Measured? When? 

Outcome among Liberal-Use Group 

Outcome among RestrictiveUse Group 

Sleep, 198423

United Kingdom Mediolateral N =1000 

Term, singleton pregnancy, anticipated NSVD* 40%-46% primiparous 

G1: Liberal = “try to prevent a tear” G2: Restrictive = “try to avoid episiotomy and restrict to fetal indications” G1: 51.4% G2: 10.2% 

Pain severity in prior 24 hours; questionnaire administered by midwife; 10 days postpartum Worst pain in past week; postal questionnaire; 3 months postpartum 

10 days Mild: 14.6% Mod: 7.8% Severe: 0.2% 3 months Mild: 5.7% Mod: 1.8% Severe: 0.2% 

10 days Mild: 14.1% Mod: 7.5% Severe: 0.9% 3 months Mild: 4.6% Mod: 2.5% Severe: 0.5% 

House et al., 198628

United Kingdom Mediolateral N = 165 

Term, vertex, anticipated NSVD* 53%-68% primiparous. 

G1: Standard current management G2: Episiotomy not performed to prevent laceration G1: 69% G2: 18% 

Pain severity; interview by one of authors using VAS scale 1 to 10 with 1-3 grouped as minimal; 4-6 moderate; 7-10 severe; 3 days; 6 weeks; 3 months 

3 days Mild: 55% Mod: 34% Severe: 11% No differences at 6 weeks and 3 months 

3 days Mild: 68% Mod: 22% Severe: 10% No women in either group with more than minimal pain at 3 months 
Table 5. Results of randomized controlled trials of liberal versus restrictive use of episiotomy: Pain outc

Citation CountryEpisiotomyTypeNumber 

Inclusion Parity

Groups Episiotomy Use 

Outcome(s) How Measured? When? 

Outcome among Liberal-Use Group 

Outcome among RestrictiveUse Group 

Klein et al., 199229

Canada Midline N = 730 

Term, singleton; anticipated NSVD 50%-52% primiparous 

G1: Liberal = avoid tear G2: Restrictive = attempt to avoid episiotomy G1: Primip: 81% Multip: 52% G2: Primip: 47% Multip: 31% 

Perineal pain measured by 10 individually scored items using the McGill Pain Questionnaire at 1, 2, and 10 days postpartum 

First day Primip: 1.8±0.8

Multip:1.3±0.8 Second day Primip: 1.3±0.7

Multip:0.9±0.7 Tenth day Primip:0.5±0.5 Multip: 0.3±0.4 

First day Primip: 1.7±0.8

Multip:1.3±0.9 Second day Primip: 1.4±0.8

Multip: 0.9±0.8 Tenth day Primip: 0.5±0.5

Multip: 0.3±0.5 

Argentine Episiotomy Trial Collaborative Group, 199330

Argentina Mediolateral N = 2,606 

Term, singleton first or second vaginal birth; no prior cesareanor severeperineal trauma 40%-41% primiparous 

G1: Routine = do according to hospital’s policy before trial G2: Selective = try to avoid, do only for fetal indications or if severe tear isimminent G1: 82.6% G2: 30.1% 

Perineal pain (not clearly defined), assessment method not clearly delineated, physician masked to allocation evaluated on day of discharge 

42.5% 30.7% 

G, group; primip, primiparous; mod, moderate; multip, multiparous; NSVD, normal spontaneous vaginal delivery. 

2 
Table 5. Results of randomized controlled trials of liberal versus restrictive use of episiotomy: Pain outc

Citation CountryEpisiotomyTypeNumber 

Inclusion Parity

Groups Episiotomy Use 

Outcome(s) How Measured? When? 

Outcome among Liberal-Use Group 

Outcome among RestrictiveUse Group 

Dannecker etal., 200432

Germany Mediolateral N = 109 

>34 weeks, singleton, primiparous; anticipated NSVD 

G1: Liberal = if tear imminent and/or fetal indicationsG2: Restrictive = fetal indicationsonly G1: 77% G2: 41% 

Perineal pain in postpartum period(days 1 to 5) on 100 mm visual analogscale anchored at “not at all” and “very much” for a range ofactivities; approach to measurement not clearly specified 

Bedrest: 39±28 

Sitting: 69±23Walking: 56±24 Defecation: 36±30 

Bedrest: 22±21 

Sitting: 51±25Walking: 37±24 Defecation: 21±21 

3 
Table 6. Description of trials of episiotomy repair relating to methods, materials, or both 

Trial Trial Groups Setting Trial Size 

Percentage Primiparous 

Percentage Instrumental Delivery 

Type of Repair Oboro et al., 200366 2 layer vs. 3 

layer 

Nigeria N =1,077 53% 23% 

Ipswich Childbirth Study, Gordon et al., 1998,60 Grant 

et al., 200163

2 layer vs. 3 layer 

United Kingdom N =1,780* 61% 17% 

Kettle, 200267 Continuous vs.

interrupted 

United Kingdom N =1,542 56% 0% 

Mahomed et al., 198958 Continuous vs.

interrupted 

United Kingdom N =1,574† 51% 23% 

Materials for Repair Bowen and Selinger, 200264 Absorbable vs.

adhesive 

United Kingdom N = 62 100% NR 

Adoni and Anteby, 199147 Absorbable vs.

adhesive 

Israel N = 60 NR NR 

Kettle, 200267 Absorbable vs.

rapidly absorbable 

United Kingdom N = 1,542 56% 0% 

McElhinney et al., 200062 Absorbable vs.

rapidly absorbable 

Ireland N = 153 55% NR 

Spencer et al., 1986,56 Grant 

et al., 198957

Untreated vs. treated CC 

United Kingdom N = 737 47% 0% 

Buchan and Nicholls, 198054 Nonabsorbable

vs. absorbable 

United Kingdom N = 140 100% 0% 

Mahomed et al., 198958 a. Absorbable vs. 

absorbable vs. nonabsorbable 

b. PGA vs. CC 

United Kingdom N = 1,574 52% 23% 

Upton et al., 200265 PGA vs. CC Australia N = 391 47% 0% 
Table 6. Description of trials of episiotomy repair relating to methods, materials, or both (continued) 

Trial Trial Groups Setting Trial Size 

Percentage Primiparous 

Percentage InstrumentalDelivery

Ipswich Childbirth Study, Mackrodt et al., 1998,61 Grant 

et al., 200163

PGA vs. CC United Kingdom N = 1,780* 61% 17% 

Olah, 199059 PGA vs. CC United Kingdom N = 120 46% 100% Ping and Kee, 197553 PGA vs. CC Malaysia N = 122 61% 38% Rogers, 197452 PGA vs. CC United States N = 600 NR NR Livingstone et al., 197451 PGA vs. CC Scotland N = 100 100% 62% Beard et al., 197450 PGA vs. CC United Kingdom N = 200 51% NR Repair Techniques and Materials Doyle et al., 199349 Absorbable

sutures (plaincatgut, PGA) and combination of methods 

United Kingdom N = 199 72% NR 

Isager-Sally et al., 198655 Combination of

absorbable and nonabsorbable sutures and combination of methods 

Denmark N = 900‡ 61% NR 

Note: CC, chromic catgut; NR, not reported; PGA, polyglycolic acid.*The Ipswich Childbirth Study61,63 reported a 1-year followup of results63 that included a subset (n= 793) of the original trial’s population. Percentage

population. †The trial used a 2x3x2 factorial design to investigate both methods and materials for repair. The methods for the repair arm of the trial investigated methods for absorbable sutures, a subset (N= 1,057) of the entire population (N = 1,574). Percentages of primiparous and instrumental deliveries wdenominator of 1,057. ‡900 women were randomized but 98 were excluded because they transferred to another hospital or left the hospital before the fifth day after delivein age, parity, or frequency of previous episiotomy.

2 
Table 7. Trial results for polyglycolic-acid and chromic-catgut sutures 

Superior Material 

for Pain 

Superior 

Material for 

Healing 

Author’s 

Overall 

Trial Conclusions 

Information 

Description 

of Pain 

Outcome PGA CC ND 

Description 

of Healing 

Outcome PGA CC ND 

Upton et al., 

200265* 

Australia 

N = 391 

Quality: Fair 

Short-term 

perineal pain 

(any, 

moderate to 

severe) 

√ Short-term 

problems 

with sutures 

√ No statistically 

significant 

differences 

between 

groups but 

leaned in 

favor of 

polyglycolic 

acid 

Short-term 

perineal pain 

(any, mild, 

moderate) 

√ Short-term 

healing 

problems 

(tight 

stitches, 

uncomfortab

le stitches, 

gaping 

perineum) 

Ipswich √

Childbirth 

Study, 

Mackrodt et 

al., 1998 and 

Grant et al., 

200161,63* 

United 

Kingdom 

N = 1,780 

Quality: 

Good 

Long-term 

perineal pain 

(mild, 

moderate, or 

severe) 

√ Long-term 

need for 

resuturing 

√

Clear 

advantages of 

polyglycolic 

acid 

Olah, 199059

United 

Kingdom 

N=120 

Quality: Fair 

Short-term 

perineal pain 

(10 cm VAS) 

√ Short-term 

edema and 

bruising 

√ Does not 

substantiate 

previous trials 

that show a 

benefit to 

polyglycolic 

acid 

Short- and 

long-term 

perineal pain 

(none, mild, 

mod, 

severe) 

√ Short- and 

long-term 

edema, 

bruising and 

healing 

√

Short-term 

use of 

analgesics 

√ Long-term 

need for 

removal of 

sutures 

√

Mahomed et 

al., 198958* 

United 

Kingdom 

N = 1,574 

Quality: 

Good 

Long-term 

use of 

analgesics 

√ Long-term 

need for 

resuturing 

√

Not much 

evidence to 

support 

polyglycolic 

acid but the 

little they have 

is consistent 

with other 

trials 
Table 7. Trial results for polyglycolic-acid and chromic-catgut sutures (continued) 

Superior Material 

for Pain 

Superior 

Material for 

Trial Healing 

Information 

Description 

of Pain 

Outcome PGA CC ND

Description 

of Healing 

Outcome PGA CC ND

Author’s 

Overall 

Conclusions

Ping and 

Kee, 197553

Malaysia 

N = 122 

Quality: Fair 

Short-term 

perineal pain 

(No pain, mild, 

moderate, 

severe) 

√ Not measured --- --- --- Polyglycolic-acid

sutures have

considerable

advantage over 

chromic-catgut

sutures in 

episiotomy repair

Beard et al., 

197450

United 

Kingdom 

N = 200 

Quality: Fair 

Short-term 

perineal pain 

(none, mild, 

moderate, 

severe) 

√ Short-term

wound 

breakdown 

and 

inflammation 

√ Polyglycolic-acid

sutures should

be used 

Livingstone et

al., 197451

Scotland 

N = 100 

Quality: Poor 

Short-term 

perineal pain 

(none, 

uncomfortable, 

painful, very 

painful, 

unbearably 

painful) 

√ Short-term

edema 

√ Significant

reduction in pain 

and edema with 

polyglycolic acid, 

no evident 

disadvantage in 

the use of 

polyglycolic acid 

Rogers, 

197452

United States 

N = 600 

Quality: Poor 

Short-term 

perineal pain 

(none, degree 

of pain) 

√ Not measured --- --- --- Polyglycolic acid

decreased the 

pain by half 

Note: PGA, polyglycolic acid; CC, chromic catgut; ND, no difference. 

*Three trials also investigated long-term sexual function outcomes with regards to polyglycolic-acid and chromic-catgut sutures. 

Two trials58,65 found no differences between the sutures and one trial61,63 found polyglycolic-acid sutures to be superior at 1 year

postpartum regarding resumption of pain-free intercourse and dyspareunia. 

2 
Table 8. Episiotomy and urinary incontinence, fecal incontinence, and pelvic floor defects 

Author, 

Year 

Country 

Study 

Design 

N 

Timing of 

Outcome 

Assessment 

after Birth 

Approach 

Outcome(s) 

Assessed 

Definitions 

Provided 

Outcome 

among 

Those with 

Episiotomy 

Outcome 

among Those 

without 

Episiotomy 

Results of 

Multivariable 

Models 

Authors’ 

Conclusions 

Sleep et 

al., 

198423

United 

Kingdom 

RCT 

N = 1,000 

3 months 

Mailed 

questionnaire 

Urinary 

incontinence 

“involuntary 

loss of urine” 

“Need to 

wear a pad” 

for loss of 

urine 

Incontinence: 

19% 

Pad: 6% 

Incontinence: 

19% 

Pad: 6% 

Incontinence 

was more 

common 

among 

multiparas 

than 

primiparas 

but did not 

differ 

significantly 

between the 

two trial 

groups when 

stratified by 

parity. 

There is no 

evidence that 

episiotomy 

prevents 

urinary 

incontinence. 

Gordon 

and 

Logue, 

198568

United 

Kingdom 

Prospective 

cohort 

N = 70 

12 months 

Physiologic 

testing in 

women with all 

perineal 

outcomes and 

cesarean 

Perineometry 

pressure 

readings 

Methods 

summarized in 

text; average 

of five 

measures 

used 

Maximum 

pressure epis:

11.7 mm 

water 

Maximum 

pressure 

forceps and 

epis: 

9.4 mm water 

Maximum 

pressure 

intact: 

11.1 

Maximum 

pressure 

second 

degree: 10.8 

Maximum 

pressure 

cesarean: 12.5 

Not reported 

No significant 

difference 

between the 

groups. 

Differences 

between 

postnatal 

exercise levels 

were highly 

significant with 

more exercise 

associated 

with greater 

perineal 

muscle 

strength. 
Table 8. Episiotomy and urinary incontinence, fecal incontinence, and pelvic floor defects 

(continued)

Author, 

Year 

Country

Study

Design 

N 

Timing of 

Outcome 

Assessment 

after Birth 

Approach 

Outcome(s) 

Assessed 

Definitions 

Provided 

Outcome 

among 

Those 

with 

Episiotomy

Outcome among 

Those without 

Episiotomy

Results of 

Multivariable

Models 

Authors’ 

Conclusions

Sleep et 

al., 

198733

United 

Kingdom 

RCT 

N = 674 

3 years 

Mailed 

questionnaire

Urinary 

incontinence

“Lost urine 

when they 

did not mean

to” 

“Severe 

enough to 

wear pad” 

“Loss when 

coughing, 

laughing, 

sneezing” 

“Loss with 

urgent desire 

to pass urine 

but no toilet 

nearby” 

Incontinence

< once past wk: 22%

1-2x past wk: 12% 

≥ 3x past wk: 2% 

Pad sometimes: 8% 

Pad daily: 2% 

SUI: 33% 

Urge incont.: 13% 

Incontinence

< once past wk: 25%

1-2x past wk: 11% 

≥ 3x past wk: 2% 

Pad sometimes: 7% 

Pad daily: 1% 

SUI: 31% 

Urge incont: 13% 

Not reported 

No difference 

in prevalence

of urinary 

incontinence,

even when 

severity and 

nature of the 

incontinence,

and 

subsequent 

deliveries, 

were taken 

into account. 

Rockner, 

199074

Sweden 

Prospective 

Cohort 

N = 185 

4 years 

Mailed 

questionnaire

Urinary 

incontinence

Frequency 

Severity 

(data 

corresponds 

to definitions)

Urinary incontinence:

Occas.: 37 (26%) 

1x/week: 10 (7%) 

2-3x/wk: 2 (1%) 

>3x/wk: 1 (1%)

With 

cough/laugh/sneeze:

48 (34%) 

Sufficiently severe to 

wear pad 

Sometimes: 13 (9%) 

Always: 1 (1%) 

Urinary incontinence:

Occas.: 12 (28%) 

1x/week: 1 (2%) 

2-3x/wk: 1 (2%) 

>3x/wk: 1 (2%)

With cough/laugh/ 

sneeze

13 (30%) 

Sufficiently severe to 

wear pad 

Sometimes: 6 (14%) 

Always: 0 (0%) 

Not reported. 

Episiotomy 

and 

spontaneous 

tear groups 

had the same

frequency of 

urinary 

incontinence 

symptoms, 

giving no 

support to the 

suggestion 

that 

episiotomy 

prevents longterm damage

of the pelvic 

floor. 

2 
Table 8. Episiotomy and urinary incontinence, fecal incontinence, and pelvic floor defects 

(continued)

Author, 

Year 

Country

Study

Design 

N 

Timing of 

Outcome 

Assessment 

after Birth 

Approach 

Outcome(s) 

Assessed 

Definitions 

Provided 

Outcome 

among 

Those 

with

Episiotomy

Outcome 

among 

Those 

without 

Episiotomy

Results of 

Multivariable

Models 

Authors’ 

Conclusions

Rockner et 

al, 199178

Sweden 

Prospective 

cohort

N = 92 

2 months

Physiologic 

measure 

Pelvic floor 

muscle function 

measured 

using weighted

vaginal cones 

at 36 wks 

gestation and

postpartum 

Details 

provided in text

Mean 

decrease in 

muscle 

function 

(gms): 30.0 ± 

11.8 

Mean 

decrease in 

muscle 

function (gms) 

Intact: 19.2 ± 

10.2 

Spontaneous 

tear: 18.9 ± 9.1 

(P < 0.001) 

Not reported 

Pelvic floor 

muscle function 

was most

decreased in the 

episiotomy 

group. The 

results do not

support the 

concept that 

episiotomy 

reduces damage 

to the pelvic floor 

muscles. 

Klein et 

al., 199229

Canada 

RCT 

N = 703 

3 months

In-person 

interview 

Physiologic 

measure: 

Antepartum 

and 3 months 

postpartum 

Urinary 

incontinence

Not defined – 

used 4-point 

scale, 

dichotomized

as present/ 

absent 

Subjective 

sense of 

“perineal 

bulging”; 4-

point scale 

dichotomized

as present/ 

absent 

Perineometry

Incontinence

Primip: 14.5%

Multip: 21.5%

Bulging 

Primip: 7.9% 

Multip: 9.5% 

EMG 

Primip ante: 

2.1 (1.8) 

Primip post: 

2.3 (1.8) 

Multip ante: 

1.7 (1.5) 

Multip post: 

2.1 (1.5) 

Incontinence

Primip: 21.1% 

Multip: 12.9% 

Bulging 

Primip: 9.1% 

Multip: 5.4% 

EMG 

Primip ante: 

2.0 (1.6) 

Primip post: 

2.3 (1.6) 

Multip ante: 1.9 

(1.6) 

Multip post: 2.1 

(1.5) 

Not reported 

None of the 

differences in 

urinary 

incontinence 

were statistically 

significant after 

controlling for 

antepartum 

history of urinary 

incontinence. 

3 
Table 8. Episiotomy and urinary incontinence, fecal incontinence, and pelvic floor defects 

(continued)

Author, 

Year 

Country

Study

Design 

N 

Timing of 

Outcome 

Assessment 

after Birth 

Approach 

Outcome(s) 

Assessed 

Definitions 

Provided 

Outcome 

among 

Those 

with

Episiotomy

Outcome 

among 

Those 

without 

Episiotomy

Results of 

Multivariable

Models 

Authors’ 

Conclusions

Viktrup et 

al., 199270

Denmark 

Prospective 

cohort

N = 305 

3 months

12 months

Telephone 

interview 

Questionnaire 

using 

International 

Continence 

Society 

definitions 

Urinary 

incontinence 

provoked by 

physical 

exertion; daily

incontinence;

incontinence 

as hygienic or

social problem

Data not 

provided 

Data not 

provided 

Not reported 

Women who 

had an 

episiotomy 

developed 

stress

incontinence 

significantly (P < 

0.05) more 

frequently after 

delivery. 

However, 

episiotomy was 

performed more 

often in women 

with an 

increased length 

of second stage 

(P < 0.01). 

Differences in

stress

incontinence 

associated with 

episiotomy had 

resolved by 1

year. 

Klein et 

al., 199434

Canada 

Prospective 

cohort

assembled 

from 

participants 

in liberal vs. 

restrictive 

episiotomy 

trial 

N = 697 

3 months

In-person 

interview 

Physiologic 

measures 

antepartum 

and 

postpartum 

Self-reported 

urinary 

incontinence 

(4 point scale)

Perineometry

scores 

(electronic 

vaginal 

myography) 

Methods 

described in 

text 

No difference 

(data not 

shown)

Epis, no 

exten. 

Net change: 

Primip: 0.19 

Multip: 0.05 

Third/fourth 

degree 

Net change: 

Primip: 0.08 

Multip: -0.07 

No 

difference 

(data not 

shown)

In tact

Net change: 

Primip: 0.47 

Multip: 0.57 

Spontaneous 

tear 

Net change: 

Primip: 0.29 

Multip: 0.39 

Not reported 

Episiotomy fails 

to prevent the

trauma or pelvic 

floor relaxation 

that it was 

designed to 

prevent. 

4 
Table 8. Episiotomy and urinary incontinence, fecal incontinence, and pelvic floor defects 

(continued)

Author, 

Year 

Country

Study

Design 

N 

Timing of 

Outcome 

Assessment 

after Birth 

Approach 

Outcome(s) 

Assessed 

Definitions 

Provided 

Outcome 

among 

Those 

with

Episiotomy

Outcome 

among 

Those 

without 

Episiotomy

Results of 

Multivariable

Models 

Authors’ 

Conclusions

Walsh et 

al., 199677

United 

Kingdom 

Prospective 

cohort of

women with 

Thirddegree tears 

N = 81 

3 months Physical 

examination 

by colorectal 

surgeon 

100% of 

women with 

abnormal 

exam and 

fecal 

incontinence 

had 

episiotomy 

60% of 

women with 

abnormal 

exam and no

incontinence 

had 

episiotomy 

No cases of 

fecal 

incontinence 

among women 

without 

episiotomy 

40% of women 

with abnormal 

exam and no

incontinence 

did not have 

episiotomy 

Not reported 

Obstetric 

trauma causes

significant 

anorectal 

dysfunction 

and patients 

with thirddegree tears 

require 

assessment.

MacArthur 

et al., 

199779

United 

Kingdom 

Prospective 

cohort

N = 906 

10 months

N = 906 

In-person 

Interview 

Fecal 

incontinence

“Loss of bowel 

control with no

warning 

needed to go”;

“soiling or

staining”; “felt

need to go but

couldn’t hold 

on” 

One or more 

considered 

incontinence

Primp.: 4.6% 

Multip.:8.8% 

Intact

Primp.: 5.2% 

Multip.:2.9% 

Second 

degree 

Primip: 5.2% 

Multip: 4.2% 

In 

multivariable 

models: 

episiotomy not 

an 

independent 

predictor of 

fecal 

incontinence

5 
Table 8. Episiotomy and urinary incontinence, fecal incontinence, and pelvic floor defects 

(continued)

Author, 

Year 

Country

Study

Design 

N 

Timing of 

Outcome 

Assessment 

after Birth 

Approach 

Outcome(s) 

Assessed 

Definitions 

Provided 

Outcome 

among 

Those with 

Episiotomy

Outcome 

among Those 

without 

Episiotomy

Results of 

Multivariable

Models 

Authors’ 

Conclusions

Viktrup 

and Lose, 

200169

Denmark 

Prospective 

cohort

N = 305 

5 years Telephone 

interview 

Questionnaire 

using 

International 

Continence 

Society 

definitions; 

urinary 

incontinence 

provoked by 

physical 

exertion; daily

incontinence;

incontinence 

as hygienic or

social problem

Not provided by episiotomy 

status 

Episiotomy contributed to 

prediction of risk of 

incontinence at 5 years when 

comparing women who had

incontinence during their 

pregnancy to those without

any incontinence associated

with pregnancy or postpartum. 

Episiotomy not risk factor 

among women with only 

postpartum symptoms. 

In 

multivariable 

modes, 

episiotomy at 

the first 

delivery was 

significantly 

associated 

with stress

incontinence 5 

years after 

delivery, even

after 

adjustment for 

the few with 

coexistence of

anal sphincter 

rupture. 

Eason et 

al., 200275

Canada 

Prospective 

cohort

assembled 

from 

participants 

in perineal 

massage 

RCT 

N = 949 

3 months

Mailed 

questionnaire

Incontinence 

of stool 

Incontinence 

of flatus 

“Involuntary 

loss of stool or

flatus” 

Frequency 

(never, less 

than 1 a week, 

1 to 6 times a 

week, daily, or 

more than 

once a day) 

Loss of stool:

RR: 5.4% 

Loss of flatus: 

RR: 30.2% 

Loss of stool:

RR: 2.5% 

Loss of flatus: 

RR: 24.4% 

Loss of 

stool/flatus: 

No perineal 

injury: RR 1.0 

First degree: 

1.2 (0.8, 1.7) 

Episiotomy 

without 

extension: 1.3 

(0.9, 1.8) 

Third/fourth 

degree: 2.1 

(1.4, 3.1) 

Anal 

incontinence is

associated 

with sphincter 

laceration, 

which was 

more common 

among those 

with 

episiotomy. 

6 
Table 8. Episiotomy and urinary incontinence, fecal incontinence, and pelvic floor defects 

(continued)

Author, 

Year 

Country

Study

Design 

N 

Timing of 

Outcome 

Assessment 

after Birth 

Approach 

Outcome(s) 

Assessed 

Definitions 

Provided 

Outcome 

among 

Those with 

Episiotomy

Outcome 

among Those 

without 

Episiotomy

Results of 

Multivariable

Models 

Authors’ 

Conclusions

Fleming et 

al., 200373

United 

States 

Prospective 

cohort

N = 102 

6 months

Baseline 

perineometry 

during 

pregnancy; 

and at 6 wks 

Physiologic 

testing in 

women with all 

perineal 

outcomes and 

cesarean

Perineometry

scores 

(electronic 

vaginal 

myography) 

Methods 

detailed in 

text; average 

of three 

measures of 

each type of 

contraction 

used for 

analysis 

Difference in 

antepartum 

and 

postpartum 

scores 

Mean score 

(SD)

Peak: -1.7 

(2.1) 

Hold: -1.7 

(2.1) 

Mean score 

(SD)

Intact

Peak: 2.7 (2.8) 

Hold: 2.8 (3.5) 

Second- or

third-degree 

laceration 

Peak: 0.8 (2.6) 

Hold: 0.8 (2.3) 

Not reported 

No significant

differences in 

absolute 

postpartum 

perineal 

muscle 

strength or 

endurance 

between 

episiotomy 

and laceration

groups. 

Women who 

had 

episiotomy 

were only 

group with net

loss of 

perineal 

muscle 

function after 

delivery. 

Karacam 

and 

Eroglu, 

200372

Turkey 

Prospective 

cohort

N = 100 

3 months

Telephone 

questionnaire

Stress

incontinence

Not defined

12/50 (24%) 15/50 (30%) No significant

differences in 

stress

incontinence 

before labor, 

or if after 

delivery of first 

child, or if after 

delivery of 

second child 

that was 

related to 

episiotomy. 

7 
Table 8. Episiotomy and urinary incontinence, fecal incontinence, and pelvic floor defects 

(continued)

Author, 

Year 

Country

Study

Design 

N 

Timing of 

Outcome 

Assessment 

after Birth 

Approach 

Outcome(s) 

Assessed 

Definitions 

Provided 

Outcome 

among Those 

with

Episiotomy

Outcome 

among Those 

without 

Episiotomy

Results of 

Multivariable

Models 

Authors’ 

Conclusions

Eason et 

al., 200476

Canada 

Prospective 

cohort

participants 

in perineal 

massage 

RCT 

N = 949 

3 months

Mailed 

questionnaire

Frequency of 

involuntary 

loss of urine 

when

coughing, 

sneezing,

laughing, 

running 

Any stress

urinary 

incontinence:

29% 

Any stress

urinary 

incontinence:

35% 

OR: 0.68 (0.47, 

1.01) 

No significant

association 

between 

episiotomy and 

urinary 

incontinence.

Sartore et 

al., 200471

Italy 

Prospective 

cohort

N = 519 

3 months

Physical exam

Physiologic 

measures: 

Perineometry

Uroflowmeter 

In-person 

interview 

Perineometry

with 

highest/best 

single 

recording used

for analysis 

Baden and 

Walker

classification 

of urogenital 

prolapse 

Urine stream 

interruption 

test

SVI – visible 

involuntary 

loss of urine 

by ICS 

standards 

Self-reported 

urge and anal

incontinence 

of stool or 

flatus, 

classified by

frequency 

SUI: 12.9% 

Anal incont: 

2.8% 

Ante prolapse: 

41p.5% 

Post prolapse: 

15.8% 

Vaginal 

manometry: 

12.2 (5.1) 

Urine stream 

interrupt: 3.9 

(3.5) 

Vaginal 

manometry 

percent 

abnormal: 

40.6% 

SUI: 12.1% 

Anal incont: 

1.9% 

Ante prolapse: 

42.1 

Post prolapse: 

14.6% 

Vaginal 

manometry: 

13.8 (4.7) 

Urine stream 

interrupt: 3.8 

(2.9) 

Vaginal 

manometry: 

percent 

abnormal: 

27.7% 

OR: 1.01 (0.61, 

1.7) 

OR: 1.47 (0.46, 

4.7) 

OR: 0.97 (0.69, 

1.4) 

OR: 1.1 (0.68, 1.8)

P < 0.001 

P = 0.85 

OR: 1.79 (1.2, 2.6)

Mediolateral 

episiotomy does 

not protect against 

urinary and anal 

incontinence.

Episiotomy is 

associated with 

lower pelvic floor 

muscle strength 

than spontaneous 

tears. 

8 
Table 9. Episiotomy and future sexual function 

Citation 

Epis. Type 

Country 

Study 

Design 

N 

Timing of 

Outcome 

Assessment 

after Birth; 

Approach 

Outcome 

Assessed 

Definitions 

Provided 

Outcome 

among 

Those with 

Episiotomy 

Outcome 

among 

Those 

without 

Episiotomy 

Results of 

Multivariable 

Models 

Authors’ 

Conclusions 

Sleep et al., 

198423

Mediolateral 

UK 

RCT 

N = 1000 

3 months 

Mailed 

questionnaire

Resumption of 

intercourse by 3 

months (not 

defined) 

Current 

dyspareunia: 

“pain during 

sexual 

intercourse” 

Any 

dyspareunia: 

“pain during 

sexual 

intercourse, at 

some time” in 

prior 3 months 

90% 

22% 

52% 

90% 

18% 

51% 

Not reported 

Only difference 

was tendency 

for women 

allocated to 

restrictive 

episiotomy to 

resume 

intercourse 

sooner. 

Sleep and 

Grant, 

198733

Mediolateral 

UK 

Prospective 

cohort that 

included 

RCT 

participants 

N =326 

3 years 

Mailed 

questionnaire

Any 

dyspareunia: 

“ever suffering 

painful sexual 

intercourse” 

16% 13% RR 1.21 (0.84, 

1.75); 

No significant 

difference 

Rockner et 

al., 198880

Mediolateral 

(88%) 

Sweden 

Prospective 

cohort 

N =205 

3 months 

Questionnaire 

(setting not 

specified) 

Resumption of 

intercourse 

(Y/N) 

Current 

dyspareunia 

(not defined) 

Any dypareunia 

in prior 3 

months 

(not defined) 

92% 

20% 

44% 

92% 

20% 

43% 

Not reported 

No significant 

difference 

Larsson et 

al., 199181

Mediolateral 

Sweden 

Prospective 

cohort 

N =1889 

2 to 3 months

In-person 

interview with 

midwife 

Dyspareunia 

(not defined) 

16% 11% Not reported 

None made 

regarding 

sexual function 
Table 9. Episiotomy and future sexual function (continued) 

Citation 

Epis. Type 

Country

Study

Design 

N 

Timing of 

Outcome 

Assessment 

after Birth; 

Approach 

Outcome 

Assessed 

Definitions 

Provided 

Outcome 

among 

Those with 

Episiotomy

Outcome 

among 

Those 

without 

Episiotomy

Results of 

Multivariable

Models 

Authors’ 

Conclusions

Klein et al., 

199229

Midline 

Canada 

RCT: 

Liberal vs 

restrictive 

N = 703 

3 months

In-person 

interview 

Resumption of 

intercourse 

(“weeks 

between birth

and first 

intercourse”) 

Dyspareunia: 

“Pain at first 

postpartum 

intercourse” 

assessed using 

McGill Pain 

Scale 

Sexual 

satisfaction at 3 

months X items 

using “4 point

scale” – actual 

items not 

provided 

Primip: 5.8 

(2.1) 

Multip: 5.8 

(2.6) 

Primip: 2.2 

(1.3) 

Multip: 1.3 

(1.1) 

Primip: 3.1 

(0.7) 

Multip: 3.3 

(0.7) 

Primip: 5.9 

(2.5) 

Multip: 5.4 

(2.3) 

Primip: 2.2 

(1.3) 

Multip: 1.2 

(1.0) 

Primip: 3.0 

(0.8) 

Multip: 3.3 

(0.6) 

Time to 

resumption of 

intercourse 

similar; those 

with intact

perineum 

began 

intercourse 1 

week earlier 

than others. 

Pain with 

resumption, 3-

month sexual

satisfaction 

and proportion

not resuming

by 3 months 

similar across

groups. 

2 
Table 9. Episiotomy and future sexual function (continued) 

Citation 

Epis. Type 

Country

Study

Design 

N 

Timing of 

Outcome 

Assessment 

after Birth; 

Approach 

Outcome 

Assessed 

Definitions 

Provided 

Outcome 

among 

Those with 

Episiotomy

Outcome 

among Those 

without 

Episiotomy

Results of 

Multivariable

Models 

Authors’ 

Conclusions

Klein et al., 

199434

Midline 

Canada 

Prospective 

cohort

derived from 

RCT 

N = 697 

3 months

In-person 

interview 

Resumption of 

intercourse by

week 6 

Dyspareunia: 

“Pain at first 

postpartum 

intercourse: 

none, mild, 

discomforting,

distressinghorrible”

Sexual 

satisfaction at

3 months; 

items using “4-

point scale” –

actual items 

not provided 

Epis alone: 

61.7% 

Third-

/fourthdegree: 

55.4% 

Epis alone: 

Mild: 22.7% 

Discomf: 

34.1% 

Distress:

28.8% 

Third-

/fourthdegree: 

Mild: 23.0% 

Discomf: 

39.3% 

Distress:

29.5% 

Epis alone: 

Not 

satisfied:

16.3% 

Third/fourth 

degree: 

Not 

satisfied:

21.3% 

Intact: 76.5% 

Spont. tear: 

62.5% 

Intact: 

Mild: 37.6% 

Discomf: 

22.8% 

Distress: 6.9%

Spont. tear: 

Mild: 27.3% 

Discomf: 

27.3% 

Distress:

24.6% 

Intact: 

Not satisfied: 

5% 

Spont: 

Not satisfied: 

15.8% 

Women with 

spontaneous 

perineal tears 

had less pain

on first 

intercourse 

than those 

with 

episiotomy 

alone. Those 

with third- to 

fourth-degree

episiotomy 

extensions 

had the most 

pain on 

resumption of 

intercourse. 

Signorello et 

al., 200138

Midline 

United 

States 

Cohort with 

a single 

prospective

window 

N = 921 

6 months

Mailed 

questionnaire

Current 

dyspareunia: 

“pain on 

sexual 

intercourse” 

at 6 months 

Multivariate models for type 

of perineal trauma: 

None: Referent 

Second degree:1.3 (0.8, 

2.2) 

Third/fourth degree: 1.5 

(0.7, 3.5) 

Degree of

perineal 

trauma, not 

episiotomy 

per se 

associated 

with 

dyspareunia.

3 
Table 9. Episiotomy and future sexual function (continued) 

Citation 

Epis. Type 

Country

Study

Design 

N 

Timing of 

Outcome 

Assessment 

after Birth; 

Approach 

Outcome 

Assessed 

Definitions 

Provided 

Outcome 

among 

Those with 

Episiotomy

Outcome 

among 

Those 

without 

Episiotomy

Results of 

Multivariable

Models 

Authors’ 

Conclusions

Karacam 

and Eroglu, 

200372

Mediolateral 

Turkey 

Prospective 

cohort

N = 100 

3 months

Telephone 

interview 

Any 

dyspareunia 

(not defined) 

64.58% 54.17% Not reported

No significant

differences

between 

groups in rate 

of mothers’ 

dyspareunia.

Sartore et 

al., 200471

Mediolateral 

Italy 

Prospective 

cohort

N = 519 

3 months

In-person 

interview 

Current 

dyspareunia 

(not 

defined); 

classified as 

“absent, 

mild, 

moderate, 

severe”; 

reported Y/N

7.9% 3.4% Summary

measure: 

RR: 2.43 

(1.05, 5.45) 

4 
Table 10. Episiotomy and dyspareunia 

Dyspareunia at 3 Months 

Citation 

Country 

Study Design 

Episiotomy 

Type 

Timing of 

Outcome 

Assessment 

after Birth 

Approach 

Outcome 

Assessed 

Definitions 

Provided 

Outcome 

among 

Those with 

Episiotomy* 

Outcome 

among Those 

without 

Episiotomy* 

Authors 

Conclusions

Rockner et 

al., 198880

Sweden 

Prospective 

cohort 

Mediolateral: 

88% 

3 months 

Questionnaire 

(method not 

specified) 

Current 

dyspareunia 

(not defined)

31/154 (20%) 9/46 (20%) No significant 

difference 

Larsson et 

al., 199181

Sweden 

Prospective 

cohort 

Mediolateral: 

98% 

2 to 3 months 

In-person 

interview with 

midwife 

Dyspareunia 

(not defined)

66/410 (16%) 69/627 (11%) None made 

regarding 

sexual 

function 

Sartore et 

al., 200471

Italy 

Prospective 

cohort 

Mediolateral: 

100% 

3 months 

In-person 

interview 

Current 

dyspareunia 

(not 

defined); 

classified as 

“absent, 

mild, 

moderate, 

severe”; 

reported Y/N

20/254 

(7.9%) 

9/265 (3.4%) RR: 2.43 

(1.08, 5.45) 

Dyspareunia within 3 Months 

Rockner et 

al., 198880

Sweden 

Prospective 

cohort 

Mediolateral: 

88% 

3 months 

Questionnaire 

(method not 

specified) 

Any 

dyspareunia 

(not defined)

68/154 (44%) 20/46 (43%) No significant 

difference 

Karacam 

and 

Eroglu, 

200372

Turkey 

Prospective 

cohort 

Mediolateral: 

100% 

3 months 

Telephone 

interview 

Any 

dyspareunia 

(not defined)

31/48 

(64.58%) 

26/48 

(54.17%) 

No significant 

differences 

between 

groups in rate 

of mothers’ 

dyspareunia 

Note: RR, relative risk; Y, yes; N, no. 
Table 11. Overall strength of the evidence for this body of literature 

Key Question 

Grade 

(I-IV Scale)* 

1. Episiotomy and maternal postpartum outcomes II 

2. Episiotomy incision type and maternal morbidity III 

3. Repair of perineal defect and maternal morbidity 

Methods: 2-layer vs. 3-layer repair III 

Methods: Continuous vs. interrupted sutures III 

Materials: Absorbable vs. tissue adhesive III 

Materials: Absorbable sutures — standard vs. rapidly absorbed III 

Materials: Untreated catgut vs. treated catgut III 

Materials: Nonabsorbable vs. absorbable III 

Materials: Polyglycolic acid vs. chromic catgut II 

Combined methods and materials III 

4. Episiotomy and urinary incontinence, fecal incontinence, and pelvic floor defects II 

5. Episiotomy and future sexual function II 
Figure 1. Conceptual framework for routine use of episiotomy in obstetric care 

Anticipated

Spontaneous

Vaginal Birth

Episiotomy

Integrity of

Perineum

Incision/

laceration:

3⁄4 Location

3⁄4 Number

3⁄4 Severity

Postpartum

Outcomes

3⁄4 Pain

3⁄4 Need for suturing

3⁄4 Blood loss/transfusion

3⁄4 Infection

3⁄4 Wound breakdown

3⁄4 Satisfaction with birth

experie nce

3⁄4 Sexual concerns and/

or deficits in sexual

function

Later

Outcomes

3⁄4 Pelvic floor

defects

3⁄4 Urinary

incontinence

3⁄4 Fecal

incontinence

3⁄4 Deficits in sexual

function

Repair Perineal Defect

3⁄4 Suture type

3⁄4 Repair approach

KQ1 KQ2

KQ4 KQ5

KQ3

3⁄4 Routine

3⁄4 Indicated

3⁄4 None

3⁄4 Urinary

incontinence

3⁄4 Fecal

incontinence
Figure 2. Episiotomy article disposition 

Citations excluded

n=659

Full text articles

reviewed

n= 323

Potentially eligible but

full text unavailable

n=4

Full text articles excluded for

one or more reason listed below n= 292

• 156 Not original research

including episiotomy

• 4 Wrong population

• 40 Small sample size

(n<40)

• 98 Wrong outcome and/or

study design

Pulled for

background

n=56

Hand -

searched

references

n=11

Marked as

background

n= 29

Hand -

searched

references

n=8

Full text articles

included in review

n= 45

RCT

n= 30

Prospective

cohort

n= 15

7 KQ1

1 KQ2

20 KQ3

3 KQ4

4 KQ5

12 KQ4

6 KQ5

Non -duplicate articles

identified in searches

n=986
Appendix A 

Exact Search Strings 
Exact Search Strings 

Focused search terms and results from MEDLINE 

Search Terms Results 

"Episiotomy"[MeSH] Field: All Fields, Limits: English, Randomized 

Controlled Trial, Human 

75 

"Episiotomy"[MeSH], English, Review, Human 68 

Labor Stage, Second [mh], English, Review, Human 40 

Labor Stage, Second [mh], English, Randomized Controlled Trial, Human 58 

Additional Search Terms and Results from MEDLINE 

Search 

Number Search Terms Results

#1 "Episiotomy"[MeSH:NoExp] Field: All Fields, Limits: English, Human 676 

#2 "Episiotomy” English, Editorial, Human 14 

#3 "Episiotomy" English, Letter, Human 58 

#4 "Episiotomy" English, Review, Human 68 

#5 "Episiotomy" English, Meta-Analysis, Human 3 

#6 "Episiotomy" English, Practice Guideline, Human 0 

#7 #2 OR #3 OR #4 OR #5 OR #6 140 

#8 #1 NOT #7 536 

#9 Repair 138222

#10 #1 AND #9 86 

#11 labor stage, second [mh] 638 

#12 #9 AND #11 6 

Search Terms and Results from CINAHL 

Search 

Number Search Terms Results 

#1 "Episiotomy"[MeSH:NoExp] Field: All Fields, Limits: English, Human 306 

Search Terms and Results from COCHRANE 

Search 

Number Search Terms Results 

#1 "Episiotomy"[MeSH:NoExp] Field: All Fields, Limits: English, Human 49 

A-1
Appendix B 

Sample Abstraction Forms/ 

Quality Rating Forms 
B-1 

Systematic Review of Episiotomy 

Abstract Review Form 

First Author: _____________________________________________________________ 

Journal: _________________________________________________________________ 

Year of Article: ________ Abstractor Initials: ___ ___ ___ 

1. Original research 

 (Exclude editorials, commentaries, letters to editor, reviews, etc.) 

Yes No Cannot 

Determine 

2. Includes females of reproductive age Yes No Cannot 

Determine 

3. Addresses one or more of the following. (Check all that apply.) 

____ Outcomes of routine episiotomy (KQ1) 

____ Outcomes of episiotomy incision type (KQ2) 

____ Approach/outcomes of repair of perineal defects (KQ3) 

____ Urinary/fecal incontinence/pelvic floor defects/prolapse (KQ4) 

____ Sexual function (KQ5) 

If any KQ is checked, circle “Yes” in box. 

Yes No Cannot 

Determine 

4. Study N is greater than or equal to 40 subjects. Yes No Cannot 

Determine 

5. Study published between 1950 and 2004. Yes No Cannot 

Determine 

6. If KQ1, 2 or 3 (outcomes of routine episiotomy / episiotomy incision 

type / repair of the perineal defect on maternal postpartum outcomes): 

 RCT study design used. 

Yes No Cannot 

Determine 

7. If KQ4 or KQ5 (outcomes of episiotomy on urinary and fecal 

incontinence/pelvic floor/prolaspe/sexual function): 

____ RCT study design used 

____ Prospective cohort 

If either is checked, circle “Yes” in box. 

Yes No Cannot 

Determine 

8. Published in English. 

If non-English, specify language: _______________________ 

Applies to key question # _____________________________ 

Yes No Cannot 

Determine 

_____ CHECK HERE IF ARTICLE TO BE PULLED FOR BACKGROUND CITATION. 

 IF ANY ITEMS IN GRAY BOX, THE ARTICLE IS EXCLUDED. 

 IF ITEMS 7, 8 OR 9 MARKED “NO,” ARTICLE MAY BE EXCLUDED IN FUTURE. 

 IF CANNOT DETERMINE, ARTICLE WILL BE PULLED FOR REVIEW. 
B-1 

Systematic Review of Episiotomy 

Full Text Inclusion/Exclusion Form 

Article #: __________ First Author: ______________ Reviewer’s Initials: ___ ___ 

Criteria for Inclusion/Exclusion Meets criteria

1. Original research that includes routine episiotomy (i.e., not for 

distress or assisted vaginal deliveries) 

 (Excludes editorials, commentaries, letters to editor, reviews, etc.) 

Yes No (STOP!)

2. Addresses sequelae of vaginal child birth Yes No (STOP!)

3. N is greater than or equal to 40 subjects Yes No

4. Addresses at least one of the key questions with the 

 appropriate study design 

 (See below to determine. If at least one line has both columns of 

 boxes checked, circle Yes. Otherwise, circle No.) 

Yes No

5. Published in English 

 If no, what language: _________________________ Yes No

6. Published between 1950 and 2004 Yes No

Please check all outcomes that apply. If outcome is checked, please check if the listed design applies to the study: 

Outcomes and Key Questions Study Design

KQ1 □ Outcomes of routine episiotomy □ RCT 

KQ2 □ Outcomes of episiotomy incision type □ RCT 

KQ3 □ Outcomes of repair and/or repair method of perineal defects □ RCT 

KQ4 □ Urinary/fecal incontinence/pelvic floor defects/prolapse □ RCT 

 □ Prospective cohort 

KQ5 □ Sexual function □ RCT 

 □ Prospective cohort 

If “Yes” is circled for ALL criteria... □ Full text INCLUDED

If ANY “No” is circled... □ Full text EXCLUDED OR... 

□ Full text EXCLUDED but used for BACKGROUND 

 CITATION
B-1 

SYSTEMATIC REVIEW OF EPISIOTOMY: Data Abstraction Form 

SECTION 1: ABSTRACTION IDENTIFIERS

1. Article number: _______________________________ 

2. Abstractor Name: _______________________________ 

3. Date of abstraction: __ / __ / ___ 

4. Name of second abstractor/reviewer: _______________________________ 

5. Date of review: __ / __ / ___ 

SECTION 2: ARTICLE IDENTIFIERS

6. Year Published: _______________________________ 

7. Surname of first author: _______________________________ 

SECTION 3: HEALTH & GEOGRAPHIC SETTINGS

 

8. Healthcare Setting 

 a. Labor & Delivery/Maternity Unit  Yes  No 

 b. ED  Yes  No 

 c. ICU  Yes  No 

 d. Other (Please specify :_________________________)  Yes  No 

 e. Not specified  Yes  No 

9. Where was the study conducted? (List all countries) 

 _____________________________________________ 

 _____________________________________________ 

 _____________________________________________ 

 _____________________________________________ 

SECTION 4: FUNDING SOURCE

10. What is the funding source of the study? (Mark all that apply) 

a. Industry  Yes  No

b. Government  Yes  No

c. Professional Society  Yes  No

d. Hospital/Managed Care Organization  Yes  No

e. Foundation  Yes  No

f. Consumer/Patient Organization  Yes  No

g. Not reported  Yes  No

h. Unclear  Yes  No

i. Other (specify): ___________________________________  Yes  No
B-2 

SECTION 5: OBJECTIVE OF THE STUDY

11. _______________________________________________________________________________ 

__________________________________________________________________________________ 

__________________________________________________________________________________ 

__________________________________________________________________________________ 

__________________________________________________________________________________ 

__________________________________________________________________________________ 

SECTION 6: INCLUSION/EXCLUSION CRITERIA, STUDY DESIGN, DATA 

COLLECTION

12. Inclusion Criteria __________________________________________________ 

 __________________________________________________ 

 __________________________________________________ 

 __________________________________________________ 

13. Exclusion Criteria __________________________________________________ 

 __________________________________________________ 

 __________________________________________________ 

 __________________________________________________ 

14. Is the study an RCT?  Yes (Continue)

  No (Skip to Question #18) 

15. Total number of randomization arms in this study ___________________ 

16. Description of each randomization arm 

 

Group 1: _______________________________________________________________________ 

 Group 2: _______________________________________________________________________ 

 Group 3. _______________________________________________________________________ 

 

17. Describe randomization methods 

_____________________________________________________________________________________ 

_____________________________________________________________________________________ 

_____________________________________________________________________________________ 

_____________________________________________________________________________________ 
B-3 

18. Describe blinding/masking methods and how maintained 

_____________________________________________________________________________________ 

_____________________________________________________________________________________ 

_____________________________________________________________________________________ 

_____________________________________________________________________________________ 

Comments: ___________________________________________________________________________ 

______________________________________________________________________________________ 

______________________________________________________________________________________ 
B-4 

SECTION 7: CHARACTERISTICS OF PARTICIPANT

Group #1 Group #2 Group #3 or 

Totals for Whole 

Study 

Overall (t 

tests/p values 

were given) 

19. Defining characteristic of each group/ 

trial arm (Please label all subsequent table 

columns with characteristic) 

20. Age at enrollment/randomization 

a. Minimum age 

b. Maximum age 

c. Mean age 

d. Standard deviation 

21. Number of participants at 

enrollment/randomization (see section #10 

on page 9 for numbers of participants 

available at followup) 

22. Race (Record as presented in article, as N or %. Follow percent with %. If race categories do not match the below list, 

please describe each category as explained in the article)* 

a. White 

b. Hispanic 

c. African-American 

d. Asian 

e. Native American 

f. Other (describe) 

23. Parity (Record as presented in article, as N or %. Follow percent with %)* 

a. Nulliparous 

b. Primiparous 

c. Multiparous 

24. Education (please describe categories)

a. 

b. 

c. 

d. 

e. 

f. 

g. 
SECTION 7: CHARACTERISTICS OF PARTICIPANT (continued)

D

G

_

_

_

_

_

G

_

_

_

_

_

G

T

S

_

_

_

on’t forget to label your columns! 

B-5 

roup #1 

____________

____________

____________

____________

____________

roup #2 

____________

____________

____________

____________

____________

roup #3 or

otals for Whole 

tudy 

____________

____________

____________

Overall (t 

tests/p values

were given) 

25. Other demographic variable #1 (please describe) 

 

26. Other demographic variable #2 (please describe) 

 

27. Other demographic variable #3 (please describe) 

 

*If percent is calculated from the numbers abstracted from the table, please describe how calculated. 

Comments: _______________________________________________________________________________

__________________________________________________________________________________________

__________________________________________________________________________________________
SECTION 8: CHARACTERISTICS OF LABOR & DELIVERY

Don’t forget to label your

columns!

Group #1 

_____________

_____________

_____________

_____________

_____________

Group #2 

_____________

_____________

_____________

_____________

_____________

Group #3 or

Totals for Whole 

Study 

_____________

_____________

_____________

Overall (t tests/p 

values were given) 

28. Duration of second stage labor 

(Describe definition from article and list 

quantitative values if possible) 

29. Delivery attendant (Record as presented in article, as N or %. Follow percent with %. If categories below do no match 

those presented in article, please adjust the categories) 

a. Unspecified

b. Student

c. Midwife

d. Obstetrician

e. Other (e.g., family 

physician...please specify)

30. Anesthesia at time of delivery (Record as presented in article, as N or %. Follow percent with %)

a. None

b. Local

c. Epidural

d. Spinal

e. Sacral block 

31. Delivery Position (Describe-will be

classified at a later time. Possible 

positions include: dorsal/supine, 

horizontal, lateral, semisitting, squatting, 

kneeling) 

32. Episiotomy use (Record as presented in article, as N or %. Follow percent with %)

a. None

b. Midline

c. Mediolateral

d. Done, not specified 

33. Mode of Delivery (Record as presented in article, as N or %. Follow percent with %)

a. Spontaneous

b. Vacuum

c. Forceps

d. Other (specify) 

B-6 
SECTION 8: CHARACTERISTICS OF LABOR & DELIVERY (continued)

Don’t forget to label your columns! 

Group #1 

_____________

_____________

_____________

_____________

_____________

Group #2 

_____________

_____________

_____________

_____________

_____________

Group #3 or

Totals for Whole 

Study 

_____________

_____________

_____________

Overall (t 

tests/p values

were given) 

34. Birthweight (Specify units of weight) 

a. Minimum weight

b. Maximum weight

c. Mean weight 

d. Standard deviation 

e. Other (please specify)

35. Estimated gestational age (specify units) 

a. Minimum age 

b. Maximum age 

c. Mean age 

d. Standard deviation 

e. Other (please specify)

Comments: _______________________________________________________________________________

_________________________________________________________________________________________

_________________________________________________________________________________________

B-7 
SECTION 9: CHARACTERISTICS OF REPAIR

Don’t forget to label your columns! 

Group #1 

_____________

_____________

_____________

_____________

_____________

Group #2 

_____________

_____________

_____________

_____________

_____________

Group #3 or

Totals for Whole 

Study 

_____________

_____________

_____________

Overall (t 

tests/p values

were given) 

36. Description of repair approach 

37. Repair done by (Record as presented in article, as N or %. Follow percent with %. If categories below do no match those 

presented in article, please adjust the categories)

a. Unspecified

b. Student

c. Midwife

d. Obstetrician

e. Other (e.g., family physician...please 

specify)

38. Suture Type (Record as presented in article, as N or %. Follow percent with %)

a. Chromic catgut 

b. Polyglycolic acid

c. Other (specify) 

Comments: ______________________________________________________________________________

_________________________________________________________________________________________

_________________________________________________________________________________________

B-8 
SECTION 10: DESCRIPTION OF PARTICIPANTS AVAILABLE @ EACH POINT OF 

FOLLOWUP 

Please describe the number of participants that contributed data to each timepoint of followup 

during the study and reasons for missing data if applicable. Please refer to section 7, question 

#20 on page 4 of this form for number of participants in each group at the time of 

randomization or enrollment. 

Don’t forget to label your columns! 

Group #1 

_____________

_____________

_____________

_____________

_____________

Group #2 

_____________

_____________

_____________

_____________

_____________

Group #3 or

Totals for Whole 

Study 

_____________

_____________

_____________

If data is

missing, please

describe why 

39. Timepoint #1: 

40. Timepoint #2: 

41. Timepoint #3: 

42. Timepoint #4: 

43. Timepoint #5: 

Comments: ______________________________________________________________________________

_________________________________________________________________________________________

_________________________________________________________________________________________

_________________________________________________________________________________________

_________________________________________________________________________________________

B-9 
B-10 

SECTION 11: OUTCOMES (Record as presented in article, as N or %. Follow percent with %)

*Additional space for outcomes can be found in the section 11 addendum on page 16. 

Definition of Outcome (Please describe how the 

authors defined/operationalized the outcome in 

the space below the outcome name)

How is outcome 

measured? 

(e.g., visual 

inspection, 

interview) 

Length of 

time since 

delivery 

(Specify 

units) 

Group #1 

_____________ _____________ _____________ _____________ _____________ 

Group #2 

_____________ _____________ _____________ _____________ _____________ 

Gr

Tota

_________

44.Posterior Lacerations/Defects 

a. Intact perineum _______________________________________________________________________________________ b. First degree tear _______________________________________________________________________________________ c. Second degree tear _______________________________________________________________________________________ d. Third degree tear _______________________________________________________________________________________ 

Definition of Outcome (Please describe how the 

authors defined/operationalized the outcome in 

the space below the outcome name)

How is outcome 

measured? 

(e.g., visual 

inspection, 

interview) 

Length of 

time since 

delivery 

(Specify 

units) 

Group #1 

_____________ _____________ _____________ _____________ _____________ 

Group #2 

_____________ _____________ _____________ _____________ _____________ 

Gr

Tota

_________
B-11 

e. Fourth degree tear _______________________________________________________________________________________ f. Third/fourth degree tear combined _______________________________________________________________________________________ 

45. Other Lacerations/Defects

a. Anterior _______________________________________________________________________________________ b. Other vaginal _______________________________________________________________________________________ 

46. Perineal Pain (see page 17 for additional room) ___________________________________________________________________________________________________ 

Definition of Outcome (Please describe how the 

authors defined/operationalized the outcome in 

the space below the outcome name)

How is outcome 

measured? 

(e.g., visual 

inspection, 

interview) 

Length of 

time since 

delivery 

(Specify 

units) 

Group #1 

_____________ _____________ _____________ _____________ _____________ 

Group #2 

_____________ _____________ _____________ _____________ _____________ 

Gr

Tota

_________

47. Analgesia Requirements ___________________________________________________________________________________________________ 
B-12 

48. Suturing Required ___________________________________________________________________________________________________ 49. Infection ___________________________________________________________________________________________________ 50. Wound breakdown ___________________________________________________________________________________________________ 51. Texture/appearance of scar ___________________________________________________________________________________________________ 52. Satisfaction with birth experience ___________________________________________________________________________________________________ 

Definition of Outcome (Please describe how the 

authors defined/operationalized the outcome in 

the space below the outcome name)

How is outcome 

measured? 

(e.g., visual 

inspection, 

interview) 

Length of 

time since 

delivery 

(Specify 

units) 

Group #1 

_____________ _____________ _____________ _____________ _____________ 

Group #2 

_____________ _____________ _____________ _____________ _____________ 

Gr

Tota

_________

53. Pelvic floor defects ___________________________________________________________________________________________________ 54. Urinary Incontinence
B-13 

a. Stress incontinence _______________________________________________________________________________________ b. Urgency incontinence _______________________________________________________________________________________ 

55. Fecal Incontinence

a. Incontinence of flatus _______________________________________________________________________________________ 

Definition of Outcome (Please describe how the 

authors defined/operationalized the outcome in 

the space below the outcome name)

How is outcome 

measured? 

(e.g., visual 

inspection, 

interview) 

Length of 

time since 

delivery 

(Specify 

units) 

Group #1 

_____________ _____________ _____________ _____________ _____________ 

Group #2 

_____________ _____________ _____________ _____________ _____________ 

Gr

Tota

_________

56. Fecal Incontinence (continued)

b. Incontinence of liquid stool _______________________________________________________________________________________ c. Incontinence of formed stool _______________________________________________________________________________________ 
B-14 

57. Dyspareunia ___________________________________________________________________________________________________ 58. Recommencement of sexual intercourse ___________________________________________________________________________________________________ 

Definition of Outcome (Please describe how the 

authors defined/operationalized the outcome in 

the space below the outcome name)

How is outcome 

measured? 

(e.g., visual 

inspection, 

interview) 

Length of 

time since 

delivery 

(Specify 

units) 

Group #1 

_____________ _____________ _____________ _____________ _____________ 

Group #2 

_____________ _____________ _____________ _____________ _____________ 

Gr

Tota

_________

59. Satisfaction from sexual intercourse ___________________________________________________________________________________________________ 60. Additional outcome #1 ___________________________________________________________________________________________________ 61. Additional outcome #2 ___________________________________________________________________________________________________ 
B-15 

62. Additional outcome #3 ___________________________________________________________________________________________________ 
B-16 

ADDENDUM: SECTION 11

Please use this table for additional information on outcomes from above 

Definition of Outcome (Please describe how the 

authors defined/operationalized the outcome in 

the space below the outcome name)

How is outcome 

measured? 

(e.g., visual 

inspection, 

interview) 

Length of 

time since 

delivery 

(Specify 

units) 

Group #1 

_____________ _____________ _____________ _____________ _____________ 

Group #2 

_____________ _____________ _____________ _____________ _____________ 

Gr

Tota

_________

Additional information for outcome # _____ in section 11 above. (Enter a number between 42 and 60)Additional information for outcome # _____ in section 11 above. (Enter a number between 42 and 60)Additional information for outcome # _____ in section 11 above. (Enter a number between 42 and 60)
B-17 

PAIN ADDENDUM: SECTION 11, #46 PERINEAL PAIN

Please use this table for additional information on perineal pain 

Definition of perineal pain (Please describe how 

the authors defined/operationalized the outcome 

in the space below the outcome name)

How is outcome 

measured? 

(e.g., visual 

inspection, 

interview) 

Length of 

time since 

delivery 

(Specify 

units) 

Group #1 

_____________ _____________ _____________ _____________ _____________ 

Group #2 

_____________ _____________ _____________ _____________ _____________ 

Gr

Tota

_________
SECTION 12: QUALITY ASSESSMENT 

Abstractor’s Initials ___ ___ 

Article #: ________________ 

63. Was the 

randomization plan 

adequate? 

 Yes  No  N/A 

(prospective 

cohort) 

64. Was the 

randomization plan 

carried out adequately? 

 Yes  No  N/A 

(prospective 

cohort) 

65. Was similarity of 

groups at baseline 

reported? 

 Yes  No 

a. Were statistics 

reported? 

 Yes  No 

b. Were there 

statistically 

significant 

differences between

the groups at 

baseline? 

 Yes  No  Not 

reported

B-18 
66. Were eligibility 

criteria specified? 

 Yes  No 

67. Were the outcome 

assessors masked? 

 Yes  No  Not 

reported

68. Was crossover (from 

one group to another) 

reported? 

 Yes  No 

69. Was loss-to-followup 

reported? 

 Yes  No 

70. Please give the 

number of participants 

remaining in the 

analyses for each group 

in the study for the 

primary outcome (see 

section 10).

i.e.: # 

remaining

 # at 

randomization 

Group 1 Group 2 Group 3 

B-19 
71. Were there postrandomization 

exclusions? 

 Yes  No  Not 

reported

72. Was intention-totreat (ITT) analysis 

reported? 

 Yes  No  Not 

reported

73. Overall quality 

rating 

 Good  Fair  Poor 

B-20 
Assessment of Quality of Individual Articles for RCT’s 

Randomization 

Approach 

Randomization 

Implementation 

Masking of Outcome 

Assessors and/or 

Participants 

Operational 

Definitions and 

Measurements 

Is there description of

the approach to

randomization?

Yes No 

Is there a fatal flaw in

the approach (such as 

lottery cards)?

Yes1 No

Explain:

Is there proven good

balance with statistical 

significance?

Yes No 

Is there good balance 

achieved as shown in

table?

Yes No 

Overall Randomization Approach and 

Implementation 

(Please circle one)

Good2 Fair Poor 

(Please circle one)

Good Fair Poor 

NR 

Notes: 

(Please circle one)

Good Fair Poor 

Notes: 

Post-Randomization 

Exclusions 

Loss to Follow-up: 

Short-term 

Loss to Follow-up: 

Long-term Overall Quality3

(Please circle one)

Yes No

Please describe: 

(Please list numbers 

and percentages for 

each follow-up time 

point) 

T1 (describe): 

T2 (describe): 

T3 (describe): 

T4 (describe): 

(Please list numbers 

and percentages for 

each follow-up time 

point) 

T1 (describe): 

T2 (describe): 

T3 (describe): 

T4 (describe): 

(Please circle one)

GOOD 

FAIR

POOR

1

 If fatal flaw in randomization approach exists, overall randomization approach and implementation is 

poor and overall quality of the article/trial is also poor 2 Approach must be described and there must be good balance in order to achieve an overall randomization

and implementation score of good 3 All component ratings must be good with minimal loss to follow-up for the article/trial to receive an

overall quality rating of good. If an article has one or two fair or poor ratings, an overall quality score of 

fair should be assigned. If an article/trial has three or more fair or poor ratings and/or large loss to followup, the overall quality should be poor. 

B-21 
Appendix C 

Evidence Tables 

Glossary for Evidence Tables 

AP antepartum

BMI body mass index 

CC chromic catgut 

cm centimeter 

cont continuous 

deg degree 

diff difference 

ext extension 

G group 

g grams 

GA gestational age 

GP General Practitioner 

hrs hours 

instr instrumental 

interr interrupted 

int interview 

L&D/MU Labor and Delivery Maternity Unit 

LSCS lower segment cesarean section 

mL millileter 

mm millimeter 

mod moderate 

mos months 

N number 

NA not applicable 

NR not reported 

NS not significant 

OR odds ratio 

PFMS pelvic floor muscles 

PGA polyglycolic acid 

PNC prenatal care 

pt point 

quest postal questionnaire, self-report questionnaire 

RCT randomized controlled trial 

RR relative risk/risk ratio 

SD standard deviation 

sec second (adjective) 

SHO senior house officer 

sig diff significant differences 

spont spontaneous 

subcut subcuticular 

transcut transcutaneous 

UK United Kingdom

VAS Visual Analog Scale 

wks weeks 

yr year 

C-1 
Evidence Table 1. Key Question 2: Liberal versus restrictive use of episiotomy

Study

Characteristics

Demographic

Characteristics

Labor, Delivery, 

and Repair 

Characteristics

Perineal Trauma 

Outcomes Pain Outcomes 

Author 

Sleep, 1984 

Setting 

UK 

Study design 

RCT 

Inclusion criteria 

• Live singleton 

fetus of at least 

37 wks GA 

• Presented

cephalically

• Spont vaginal 

delivery 

expected at end 

of sec stage 

labor 

Exclusion criteria 

• Elected 

episiotomy 

• No consent 

• Private patient

• Precipitate 

delivery 

Groups

G1: Liberal

(instructed to “try to 

prevent a tear”) 

G2: Restrictive

(instructed to “try to 

avoid episiotomy

and restrict 

episiotomy to fetal 

indications”) 

N at enrollment 

G1: 502 

G2: 498 

Total: 1000 

Followup

10 days to 3 mos 

Age (mean ± SD) 

G1: 26.7yrs ± 5.3 

G2: 26.6yrs ± 5.2 

Primiparous 

G1: 46.3% 

G2: 40.4% 

Delivery by

Student and

midwife 

G1: 35.9% 

G2: 35.2% 

Midwife 

G1: 32.1% 

G2: 30.1% 

Obstetrician

G1: 1.8% 

G2: 8% 

Other (“sister”) 

G1: 31.3% 

G2: 32.7% 

Estimated GA

G1: 39.8wks ± 1.2 

G2: 39.8wks ± 1.2 

Birthweight 

(mean+ SD) 

G1: 3367g ± 438 

G2: 3393g ± 4.48 

Episiotomy rate 

(all mediolateral) 

G1: 51.4% 

G2: 10.2%

Third/fourth deg 

tear 

(ext through anal 

sphincter or 

through to the 

rectal mucosa or 

to the upper third 

of vagina) 

G1: 1 

G2: 4 

Anterior labial

tears 

G1: 17.3% 

G2: 26.3% 

χ2 = 11.29 

P < 0.00l 

RR = 1.52 

(1.19-1.94)

Short term: 10 days 

Mild pain 

G1: 14.6% 

G2: 14.1% 

Mod pain 

G1: 7.8% 

G2: 7.5% 

Severe pain 

G1: 0.2% 

G2: 0.9% 

All levels: 

G1: 22.6% 

G2: 22.6% 

χ2 = 1.91 NS 

Long term: 3 mos

Mild pain 

G1: 5.7% 

G2: 4.6% 

Mod pain 

G1: 1.8% 

G2: 2.5% 

Severe pain 

G1: 0.2% 

G2: 0.5% 

All levels 

G1: 7.7% 

G2: 7.6% 

χ2=2.58 NS 

C-2 
Evidence Table 1. Key Question 1: Liberal versus restrictive use of episiotomy (continued) 

Sexual Function 

Outcomes 

Repair and Healing 

Outcomes 

Incontinence and

Pelvic Floor 

Outcomes Other Outcomes 

Quality and 

Comments 

Short term: 1 mo 

Recommencement

of sexual 

intercourse 

G1: 27% 

G2: 37% 

χ2

 = 8.67 

P < 0.01 

Long term: 3 mos

Resumed sexual 

intercourse 

90% overall, similar 

within groups 

Dyspareunia 

G1: 18% 

G2: 22% 

Dyspareunia 

“At some time” 

G1: 51% 

G2: 52% 

Long term 

NR 

Short term 

Required suturing 

G1: 78% 

G2: 69% 

χ2

 = 9.99 

P = < 0.01 

Long term

NR 

Short term 

Involuntary loss of 

urine (3 mos) 

G1: 19% 

G2: 19% 

NS 

Long term

NR 

Short term 

NR 

Long term

NR 

Overall quality

Good 

Randomization 

approach and 

implementation 

Good 

Masking 

Good+

Operator

performing 

repair blind to

allocation

Mother in most

cases blind to 

allocation

Operational 

definitions and 

measures 

Good 

Postrandomization 

exclusions 

No 

Retention of 

participants 

Good 

10 days

G1: 446 (89%)

G2: 439 (88%)

Total: 885 (89%) 

3 mos 

G1: 457 (91%)

G2: 438 (88%)

Total: 895 (90%) 

C-3 
Evidence Table 1. Key Question 1: Liberal versus restrictive use of episiotomy (continued) 

Study

Characteristics

Demographic

Characteristics

Labor, Delivery, 

and Repair 

Characteristics

Perineal Trauma 

Outcomes Pain Outcomes* 

Author 

Harrison, 1984

Setting 

Ireland 

Study design 

RCT

Inclusion 

criteria 

• 16 yrs and 

older 

• ≥ 38 wks GA 

• Vaginal 

delivery 

• Primigravid 

Exclusion 

criteria 

• Psychiatric or 

medical 

condition 

• Eclampsia 

Groups

G1: Routine

Defined as 

mediolateral 

episiotomy 

routinely 

conducted 

G2: Restrictive 

Defined as no 

episiotomy 

except when 

medically 

necessary

N at 

randomization 

G1: 89 

G2: 92 

Total: 181 

Followup

1 to 5 days 

Age 

NR 

Primiparous 

G1: 100% 

G2: 100% 

Mode of delivery

G1: NR 

G2: 

• Spont: 92% 

• Vacuum: 2% 

• Forceps: 3% 

Birthweight 

(mean ± SD) 

NR 

Episiotomy rate 

G1: 44.9% (40/89) 

G2: 7.6% (7/92)

Suture method 

and type 

G1 and G2: 

Mattress sutures 

with CC 

Intact perineum

G1: NR 

G2: 21%

First deg tears

G1: 0 to 2%

G2: 25% 

Sec deg tears

G1: None

G2: 47% 

Third deg tears

G1: 6%

G2: 0%

Short term 

NR 

Long term

NR

Comment 

*All analyses were 

completed on a 

subset of 

participants: 40

participants from

G1 who had a 

spont vertex

delivery and 37

participants from

G2 who had 

sustained a sec 

deg tear during

delivery (these 

participants had 

not undergone 

episiotomy). 

Outcomes 

analyzed do not 

address 

differences 

between routine 

and restrictive 

policies of 

episiotomy and

are not reported

here 

C-4 
Evidence Table 1. Key Question 1: Liberal versus restrictive use of episiotomy (continued) 

Sexual Function 

Outcomes 

Repair and Healing 

Outcomes 

Incontinence and

Pelvic Floor 

Outcomes Other Outcomes

Quality and 

Comments 

Short term 

NR 

Long term

NR

Short term 

NR 

Long term

NR

Short term 

NR 

Long term

NR

Short term 

NR 

Long term

NR

Overall quality

Poor: Not possible 

to see outcome as 

randomized

analysis does not 

take advantage of 

having done a trial 

Randomization 

approach and 

implementation 

Poor: No detail

about method, 

allocation, 

concealment or 

balance 

Masking

NR 

Operational 

definitions and 

measures 

Good 

Postrandomization 

exclusions

Yes 

Retention of 

participants 

Good 

G1: NR 

G2: NR 

Total: NR 

C-5 
Evidence Table 1. Key Question 1: Liberal versus restrictive use of episiotomy (continued) 

Study

Characteristics

Demographic

Characteristics

Labor, Delivery, 

and Repair 

Characteristics

Perineal Trauma 

Outcomes Pain Outcomes 

Author 

House et al., 1986

Setting 

UK 

Study design 

RCT 

Inclusion criteria 

NR 

Exclusion criteria 

• Labor at 

< 37 wks 

pregnant 

• Presentation 

other than vertex 

• Cesarean 

section 

• Forceps delivery

Groups

G1: Liberal 

Defined: Received 

standard current 

management 

Episiotomy was 

performed if 

perineum appeared 

too rigid to permit 

delivery without

laceration 

G2: Restricted

Defined: 

Episiotomy not

performed 

specifically to 

prevent laceration 

N at enrollment 

G1: 71

G2: 94

Total: 165 

Followup

3 mos (no data in 

article) 

Age 

NR 

Primiparous 

G1: 68% 

G2: 53% 

Mode of delivery

G1: 

• Spont: 86% 

• Forceps: 14% 

G2: 

• Spont: 89% 

• Forceps: 11% 

Duration of sec

stage labor

(mean ± SD) 

G1: 53min ± 41

G2: 46min ± 40

Birthweight 

(mean ± SD) 

G1: 3400g ± 429 

G2: 3282g ± 399 

Episiotomy rate 

(all mediolateral) 

G1: 69% 

G2: 18% 

Among primigravidae

participants 

Intact or first deg tear

(exam) 

G1: 4% 

G2: 32% 

P < 0.001 

Sec deg tear (exam) 

Defined: Laceration 

involving more than 

superficial mucosa 

requiring more than three 

sutures to repair 

G1: 17% 

G2: 36% 

P < 0.05 

Third deg tear (exam) 

Defined: Involved anal 

sphincter 

G1: 0% 

G2: 0% 

NS 

Among multigravidae

participants 

Intact or first deg tear

(exam) 

G1: 26% 

G2: 54% 

P < 0.05 

Sec deg tear (exam) 

Defined: Laceration 

involving more than 

superficial mucosa 

requiring more than three 

sutures to repair 

G1: 22% 

G2: 43% 

NS 

Third deg tear (exam) 

Defined: Involved anal 

sphincter 

G1: 4% 

G2: 0% 

NS 

Short term: 3 days

Perineal pain (int) 

(10 pt VAS scale 

where 1 to 3 

minimal, 4 to 6 

mod, 7 to 10 

severe) 

G1: 

• Mild: 55% 

• Mod: 34% 

• Severe: 11% 

G2: 

• Mild: 68% 

• Mod: 22% 

• Severe: 10% 

Short term: 6 wks

No diff, details NR 

Long term: 3 mos

No diff, details NR 

C-6 
Evidence Table 1. Key Question 1: Liberal versus restrictive use of episiotomy (continued) 

Sexual Function 

Outcomes 

Repair and Healing 

Outcomes 

Incontinence and

Pelvic Floor 

Outcomes Other Outcomes

Quality and 

Comments 

Short term 

NR 

Long term

NR 

Short term: 3 days

Tenderness (int) (10 

pt VAS scale where 

1 to 3 minimal, 4 to

6 mod, 7 to 10 

severe) 

G1: 

• Minimal: 51% 

• Mod: 39% 

• Severe: 10% 

G2: 

• Minimal: 79% 

• Mod: 18% 

• Severe: 3% 

P = 0.001 

Infection (exam) 

G1: 4% 

G2: 5% 

Primary healing 

(exam) 

Defined: Complete 

skin apposition

G1: 92% 

G2: 88% 

Secondary healing 

(exam) 

Defined: Significant 

granulation 

G1: 8% 

G2: 12% 

Long term 

NR 

Short term 

NR 

Long term

NR 

Short term

Blood loss

G1: 214mL ± 162 

G2: 272mL ± 160 

P = 0.01 

Long term: 3 mos

Prolapse, details NR 

but NS 

Overall quality

Poor 

Randomization 

approach and 

implementation 

Good 

Masking

NR 

Operational 

definitions and 

measures 

Good 

Postrandomization 

exclusions

Yes: loss of 

multigravidae 

participants from

early discharge, 

loss to immediate 

postnatal follow-up

by one of the 

authors. The 

method is 

adequate, 

describes 

concealment and 

reports balance in 

multiple factors

except imbalance 

that resulted from 

post-randomization 

exclusions 

Retention of 

participants 

Short term: 3 days 

Good 

G1: 71 (100%)

G2: 94 (100%)

Total: 165 (100%) 

Short term: 6 wks 

Good 

G1: NR 

G2: NR 

Total: 88 (53%) 

Long term: 3 mos

Poor 

G1: NR 

G2: NR 

Total: 88 (53%)

C-7 
Evidence Table 1. Key Question 1: Liberal versus restrictive use of episiotomy (continued) 

Study

Characteristics

Demographic

Characteristics

Labor, Delivery, 

and Repair 

Characteristics

Perineal Trauma 

Outcomes Pain Outcomes 

Author 

Klein et al., 1992

Setting 

Canada 

Study design 

RCT 

Inclusion criteria 

• 18 to 40 yrs old 

• Parity of 0, 1, 2 

• Single fetus 

• Spoke English or 

French 

• Low medical and 

obstetrical risk 

Exclusion criteria 

• Prematurity

(gestation 

< 37 wks)

• Fetal distress

• Cesarean 

deliveries

• Planned forceps

• Medical 

condition 

developed late in 

pregnancy

Groups

G1: Primiparous 

G1a: Liberal

(attempted to avoid 

a tear/separated by

parity) 

G1b: Restricted

(attempted to avoid 

an episiotomy/ 

separated by

parity) 

G2: Multiparous 

G2a: Liberal 

G2b: Restricted

N at enrollment 

G1a: 184 

G1b: 175 

G2a: 166 

G2b: 178 

Total: 703

Followup

1 day to 3 mos

Age (mean ± SD) 

G1a: 27.9yrs ± 3.9 

G1b: 27.9yrs ± 4.4 

G2a: 31.0yrs ± 3.7 

G2b: 30.3yrs ± 9.1 

Primiparous 

G1: 100% 

G2: 100% 

Previous 

episiotomy 

NS 

Education (yrs) 

(sig diff NR) 

G1a: 15.4 

G1b: 15.0 

G2a: 15.4 

G2b: 15.0 

Stable 

Relationship 

Diff NS 

Employment 

Diff NS

Episiotomy rate 

(all median) 

G1a: 81% 

G1b: 52% 

G2a: 47% 

G2b: 31% 

Birthweight (mean

+SD) 

G1a: 3325g ± 416 

G1b: 3377g ± 432 

G2a: 3496g ± 449 

G2b: 3467g ± 497 

GA 

NS 

Intact Perineum 

Measured at 

delivery

G1a: 12 (6.6%)

G1b: 13 (7.5%)

OR = 1.16 

(0.48, 2.8) 

G2a: 32 (19.3%) 

G2b: 54 (30.7%) 

OR = 1.85 

(1.1, 3.2) 

Sec degree tear 

measured at 

delivery

G1a: 22 (12.6%) 

G1b: 61 (35.3%) 

OR = 3.99 

(2.2, 7.1) 

G2a: 56 (33.7%) 

G2b: 68 (38.6%) 

NS 

Short term: 1 day 

G1a: 1.8 ± 0.8

G1b: 1.7 ± 0.8 

G2a: 1.3 ± 0.8

G2b: 1.3 ± 0.9 

Short term: 2 days 

G1a: 1.3 ± 0.7

G1b: 1.4 ± 0.8 

G2a: 0.9 ± 0.7

G2b: 0.9 ± 0.8 

Short term: 10 days 

G1a: 0.5 ± 0.5

G1b: 0.5 ± 0.5 

G2a: 0.3 ± 0.4

G2b: 0.3 ± 0.5 

Long term

NR 

C-8 
Evidence Table 1. Key Question 1: Liberal versus restrictive use of episiotomy (continued) 

Sexual Function 

Outcomes 

Repair and Healing 

Outcomes 

Incontinence and

Pelvic Floor 

Outcomes Other Outcomes 

Quality and 

Comments 

Short term: 3 mos 

Time to resumption 

of sexual 

intercourse

NS 

Mean degree of

pain at resumption

of sexual 

intercourse

NS 

Female sexual

satisfaction

NS 

Long term

NR 

Short term 

NR 

Long term

NR 

Short term: 3 mos 

Urinary

incontinence 

G1a: 26 (14.5%) 

G1b: 35 (21.1%) 

P = 0.11 

G2a: 34 (21.5)

G2b: 22 (12.9) 

P = 0.04 

Long term

NR 

Short term: 3 mos 

Pelvic floor 

function 

NS 

Perineal bulging 

NS 

Long term

NR 

Overall quality

Fair 

Randomization 

approach and 

implementation 

Good 

Masking 

Fair 

Operational 

definitions and 

measures 

Good for short 

term 

Poor for long term 

Postrandomization 

exclusions 

Cesarean only

Retention of 

participants 

Fair 

C-9 
Evidence Table 1. Key Question 1: Liberal versus restrictive use of episiotomy (continued) 

Study

Characteristics

Demographic

Characteristics

Labor, Delivery, 

and Repair 

Characteristics

Perineal Trauma 

Outcomes Pain Outcomes 

Author 

Argentine, 1993

Setting 

Argentina 

Study design 

RCT 

Inclusion criteria 

• Uncomplicated

labor at 37 to 42

wks

• Nulliparous or 

primiparous 

gestation 

• Single fetus in 

cephalic 

presentation

• No history of 

cesarean 

delivery or 

severe perineal

tears 

Exclusion criteria 

NR 

Groups

G1: Routine 

Defined: Performed 

episiotomy 

according to 

hospital’s policy 

prior to the trial

G2: Selective 

Defined: Tried to 

avoid episiotomy

unless fetal 

distress or severe 

perineal trauma 

judged to be

imminent 

N at 

randomization 

G1: 1298 

G2: 1308 

Total: 2606 

Followup

7 days 

Age 

NR 

Primiparous* 

G1: 60% 

G2: 59% 

Previous

episiotomy

G1: 33% 

G2: 34% 

*Note: The article 

identifies the 

women, at the time 

of gestation, as

nulliparous or 

primiparous. For 

our purposes, the 

nullips from the

article are our 

primips (meaning 

this was their first 

birth).

Mode of delivery

G1: Operative: 3%

G2: Operative: 2% 

Oxytocin at sec 

stage 

G1: 59% 

G2: 58% 

Birthweight 

(mean ± SD) 

G1: 3244g ± 418.3 

G2: 3244g ± 427.3 

Cephalic

perimeter 

(mean ± SD) 

G1: 34.2cm ± 15.5 

G2: 34.3cm ± 17.5 

Episiotomy rate 

(all mediolateral) 

G1: 83% 

G2: 30% 

Suture type 

NR 

Suture method 

NR 

Third deg tear (exam) 

Defined: Vaginal middle 

and/or upper third tear 

G1: 2.2% 

G2: 2.9% 

RR = 1.38 

(0.84, 2.21) 

NS 

Severe perineal trauma 

(exam) 

Defined: Ext through the 

anal sphincter and/or the 

anal or rectal mucosa; third 

deg and fourth deg 

lacerations 

G1: 1.8% 

G2: 1.4% 

RR = 0.78 

(0.40, 1.54) 

NS 

Anterior perineal trauma 

(exam) 

G1: 8% 

G2: 19% 

RR = 2.36 

(1.89, 2.94) 

Short term: 

Discharge

Perineal pain

(int) 

G1: 43% 

G2: 31% 

RR = 0.72 

(0.65, 0.81) 

Long term

NR 

C-10 
Evidence Table 1. Key Question 1: Liberal versus restrictive use of episiotomy (continued) 

Sexual Function 

Outcomes 

Repair and Healing 

Outcomes 

Incontinence and

Pelvic Floor 

Outcomes Other Outcomes

Quality and 

Comments 

Short term 

NR 

Long term

NR 

Short term: 

Discharge

Hematoma

(exam) 

G1: 4% 

G2: 4% 

RR = 0.96 

(0.65, 1.42) 

NS 

Short term: 7 days

Healing 

complications

(exam) 

G1: 30% 

G2: 21% 

RR = 0.69 

(0.56, 0.85) 

Local infection

(exam) 

G1: 2% 

G2: 2% 

RR = 0.91 

(0.37, 2.21) 

NS 

Dehiscence

(exam) 

G1: 9% 

G2: 5% 

RR = 0.45 

(0.30, 0.75) 

Long term 

NR 

Short term 

NR 

Long term

NR 

Short term 

NR 

Long term

NR 

Overall quality

Fair 

Randomization 

approach and 

implementation 

Good+

Masking

Fair 

Operational 

definitions and 

measures 

Fair 

Postrandomization 

exclusions

No 

Retention of 

participants

Good 

At discharge

G1: NR (93%)

G2: NR (93%)

Total: NR (93%)

7 days

G1: NR (43%)

G2: NR (43%)

Total: NR (43%)

C-11 
Evidence Table 1. Key Question 1: Liberal versus restrictive use of episiotomy (continued) 

Study

Characteristics

Demographic

Characteristics

Labor, Delivery, 

and Repair 

Characteristics

Perineal Trauma 

Outcomes Pain Outcomes 

Author 

Eltorkey and 

Nuaim, 1994

Setting 

Saudi Arabia 

Study design 

RCT 

Inclusion criteria 

• Live singleton 

fetus of at least 

37 wks GA 

• Presenting 

cephalically

• No important 

medical or 

psychiatric 

illness 

• Spont vaginal 

delivery 

expected toward

the end of sec 

stage labor 

Exclusion criteria 

NR 

Groups

G1: Elective 

episiotomy

Defined: Performed 

unless it was 

considered

absolutely 

unnecessary

G2: Selective 

episiotomy

Defined: Only to

prevent extensive 

perineal laceration 

or to accelerate 

labor for fetal 

distress 

N at 

randomization 

G1: 100 

G2: 100 

Total: 200 

Followup

Immediate 

postpartum 

Age (mean ± SD) 

G1: 21.0yrs ± 3.5 

G2: 21.2yrs ± 3.9 

Primiparous 

G1: 100% 

G2: 100% 

Mode of delivery

G1: 

• Spont: 95% 

• Forceps: 3% 

• Vacuum: 2% 

G2: 

• Spont: 96% 

• Forceps: 2% 

• Vacuum: 2% 

Anesthesia at 

delivery

G1: 

• Epidural: 14% 

• Pethidine: 56%

• Gas and air: 

30% 

G2: 

• Epidural: 20% 

• Pethidine: 47%

• Gas and air: 

33% 

Birthweight 

(mean ± SD) 

G1: 3080g ± 399 

G2: 3069g ± 438 

Estimated GA

(mean ± SD)

G1: 279days ± 8 

G2: 280days ± 9 

Episiotomy rate 

(all mediolateral) 

G1: 83% 

G2: 53% 

P < 0.001 

Suture type 

G1 and G2: CC

Suture method 

G1 and G2: 

“Continuous suture 

was used to repair 

the vagina, 

interrupted sutures 

were used for the 

deeper tissues and 

interrupted or 

subcuticular 

sutures to repair 

the perineal skin.” 

Intact perineum (exam) 

G1: 7% 

G2: 28% 

OR = 5.17 

P < 0.001 

No posterior trauma

(exam) 

G1: 25% 

G2: 40% 

P < 0.05 

No anterior trauma (exam) 

G1: 82% 

G2: 88% 

NS 

First deg tear

Defined: Injury only to 

anterior of perineum and 

related posterior wall of 

vagina (exam)

G1: 3% 

G2: 4% 

NS 

Sec deg tear 

Defined: Tear up to but not 

including anal sphincter 

(exam) 

G1: 1% 

G2: 8% 

P < 0.05 

Episiotomy alone (exam) 

G1: 64% 

G2: 41% 

P <0.01 

Ext of episiotomy (exam) 

G1: 7% 

G2: 7% 

NS 

Para-urethral laceration 

(exam) 

G1: 4% 

G2: 5% 

NS 

Lateral vaginal wall 

laceration (exam) 

G1: 14% 

G2: 7% 

NS 

Short term

NR 

Long term

NR 

C-12 
Evidence Table 1. Key Question 1: Liberal versus restrictive use of episiotomy (continued) 

Sexual Function 

Outcomes 

Repair and Healing 

Outcomes 

Incontinence and

Pelvic Floor 

Outcomes Other Outcomes

Quality and 

Comments 

Short term 

NR 

Long term

NR 

Short term 

NR 

Long term

NR 

Short term 

NR 

Long term

NR 

Short term 

NR 

Long term

NR 

Overall quality

Fair 

Randomization 

approach and 

implementation 

Good 

Masking

NR 

Operational 

definitions and 

measures 

Good 

Postrandomization 

exclusions

No 

Retention of 

participants 

Good 

1 to 5 days

G1: 100 (100%)

G2: 100 (100%)

Total: 100 (100%) 

C-13 
Evidence Table 1. Key Question 1: Liberal versus restrictive use of episiotomy (continued) 

Study

Characteristics

Demographic

Characteristics

Labor, Delivery, 

and Repair 

Characteristics

Perineal Trauma 

Outcomes Pain Outcomes 

Author 

Dannecker et al., 

2004

Setting 

Germany

Study design 

RCT 

Inclusion criteria 

• Primiparous 

• > 34 wks of 

gestation 

• Uncomplicated

pregnancy 

• Live singleton 

fetus 

• Intention of 

vaginal delivery 

Exclusion criteria 

• Previous surgery

at pelvic floor 

• Neurological

disorder 

Groups

G1: Liberal

Defined: Tear 

imminent, fetal 

indications

G2: Restrictive

Defined: Fetal 

indications only 

N at 

randomization 

(randomized at

outpatient clinic) 

G1: 76 

G2: 70 

Total: 146 

N at delivery

G1: 60 

G2: 49 

Followup

1 to 5 days 

Age (mean ± SD) 

G1: 28.6yrs ± 4.5 

G2: 28.3yrs ± 5.0 

Primiparous 

G1: 100% 

G2: 100% 

Mode of delivery

G1: Vacuum: 7%

G2: Vacuum: 18% 

Anesthesia at 

delivery

G1: Epidural: 72% 

G2: Epidural: 63% 

Birthweight 

(mean ± SD) 

G1: 3535g ± 429 

G2: 3313g ± 455 

Cephalic

perimeter 

(mean ± SD)

G1: 35.2cm ± 1.6 

G2: 34.8cm ± 1.4 

Episiotomy rate 

(all mediolateral) 

G1: 77% 

G2: 41% 

RR = 0.47 

(0.3, 0.7) 

P < 0.001 

Suture type 

NR 

Suture method 

G1 and G2: 

“Continuous suture 

was used to repair 

the vagina, deeper 

perineal tissues, 

subcuticular and

skin.” 

Intact perineum

(exam) 

G1: 10% 

G2: 29% 

RR = 2.9 

(1.2, 6.9) 

P = 0.023 

Minor perineal

trauma (exam) 

Defined: First deg 

tear or intact 

perineum 

G1: 13% 

G2: 39% 

RR = 2.9 

(1.6, 10.5) 

P = 0.003 

Third deg tear

(Severe perineal 

trauma) (exam) 

Defined: Ext 

through the anal 

sphincter or 

through rectal 

mucosa 

G1: 8% 

G2: 4% 

RR = 0.43 

(0.1, 2.1) 

P = 0.46 

Anterior trauma 

(exam) 

Defined: Labial and 

vaginal tears 

G1: 42% 

G2: 55% 

RR = 1.1 

(0.8, 1.8) 

P = 0.25 

Short term 1 to 5 days

Perineal pain during

bedrest (int) 

mean ± SD from 100mm 

VAS

G1: 39 ± 28 

G2: 22 ± 21 

Diff = 16 (2, 30) 

P = 0.025 

Perineal pain during

sitting (int) 

mean ± SD from 100mm 

VAS 

G1: 69 ± 23 

G2: 51 ± 25 

Diff = 18 (5, 31) 

P = 0.009 

Perineal pain during

walking (int) 

mean ± SD from 100mm 

VAS G1: 56 ± 24 

G2: 37 ± 24 

Diff = 19 (6, 33) 

P = 0.005 

Perineal pain during

defecation (int) 

mean ± SD from 100mm 

VAS 

G1: 36 ± 30 

G2: 21 ± 21 

Diff = 15 (0, 30) 

P = 0.048

Long term

NR 

C-14 
Evidence Table 1. Key Question 1: Liberal versus restrictive use of episiotomy (continued) 

Sexual Function 

Outcomes 

Repair and Healing 

Outcomes 

Incontinence and

Pelvic Floor 

Outcomes Other Outcomes

Quality and 

Comments 

Short term 

NR 

Long term

NR

Short term 

NR 

Long term

NR 

Short term 

NR 

Long term

NR 

Short term 

NR 

Long term

NR 

Overall quality

Fair 

Randomization 

approach and 

implementation 

Good 

Masking

NR 

Operational 

definitions and 

measures 

Good 

Postrandomization 

exclusions

Yes: but given 

enrollment during 

PNC appropriate. 

37 participants did 

not receive 

allocated 

intervention due to 

cesarean section 

(n = 24), preterm 

labor (n = 4), 

delivery elsewhere 

(n = 8), and refusal 

(n = 1) 

Retention of 

participants* 

Short term: 1 to 5 

days

Good 

G1: 31 (52%) 

G2: 22 (45%) 

Total: 53 (49%) 

Long term 

Poor 

48% in postpartum 

pain measures

Comment 

*Percentage of

participants 

retained for followup in the 1 to 5

days postpartum 

period was 

calculated with a 

denominator of 

randomized

participants who 

were not postrandomization 

exclusions.

C-15 
Evidence Table 2. Key Question 2: Midline versus mediolateral episiotomy

Study

Characteristics

Demographic

Characteristics

Labor, Delivery, 

and Repair 

Characteristics

Perineal Trauma 

Outcomes Pain Outcomes 

Author 

Coats et al., 1980 

Setting 

UK 

Study design 

RCT 

Inclusion criteria 

• Primigravidae 

• Admitted to 

delivery suite 

Exclusion criteria 

NR 

Groups

G1: Midline 

episiotomy 

G2: Mediolateral 

episiotomy 

N at 

randomization 

G1: 163 

G2: 244 

Total: 407 

Note: Only women 

who were

randomized and 

underwent 

episiotomy were

reported. Total 

number 

randomized, 

including women 

who did not 

undergo 

episiotomy, was 

not reported. 

Followup

3 mos 

 

Age (mean ± SD) 

G1: 26.38yrs ± 6.94 

G2: 26.58yrs ± 7.22 

Primiparous 

G1: 100% 

G2: 100% 

Mode of delivery

G1 

• Spont: 75% 

• Breech: 1% 

• Forceps: 21% 

• Venthouse: 4%

G2 

• Spont: 68% 

• Breech: 5% 

• Forceps: 23% 

• Venthouse: 3%

Anesthesia 

G1 

• Local: 71% 

• Pudendal block: 15% 

• Epidural: 14% 

• General: 1% 

G2 

• Local: 65% 

• Pudendal block: 14% 

• Epidural: 18% 

• General: 3% 

GA (mean ± SD) 

G1: 40.3wks ± 1.78 

G2: 40.0wks ± 1.48 

Birthweight (mean ± 

SD) 

NR 

Suture type and 

method 

G1 and G2: Subcut skin 

closure with PGA suture 

Sutured by

G1 

• SHO: 69% 

• Registrar: 12%

• Student: 19% 

G2 

• SHO: 65% 

• Registrar: 17%

• Student: 19% 

No ext of

episiotomy

G1: 54%

G2: 79%

Local ext of

episiotomy

G1: 22%

G2: 12% 

Ext of 

episiotomy into 

sphincter 

G1: 12%

G2: 7% 

Ext of 

episiotomy

through

sphincter 

G1: 6%

G2: 2% 

Ext of 

episiotomy into 

rectal mucosa

G1: 6%

G2: 0.4% 

P < 0.001 across 

all groups 

Short term: At discharge

“The total pain 

experienced by the 

women from their 

episiotomies was similar.” 

“The numbers who 

required analgesics were 

also not significantly

different.”

Long term: 3 mos

“No difference was 

experienced in the pain 

felt from their 

episiotomies.” 

C-16 
Evidence Table 2. Key Question 2: Midline versus mediolateral episiotomy (continued) 

Sexual Function 

Outcomes Healing Outcomes 

Incontinence 

and Pelvic Floor 

Outcomes 

Other 

Outcomes 

Quality and 

Comments 

Outcomes reported 

apply to KQ5 and 

are included in 

Evidence Table 5 

Short term discharge

Bruising 

G1 had significantly less 

bruising than G2

P < 0.001 

Texture of scar 

G1: 

• Thick: 14% 

• Normal: 79% 

• Lax: 7% 

G2: 

• Thick: 19% 

• Normal: 79% 

• Lax: 2% 

NS 

Appearance of scar 

G1: 

• Good: 43% 

• Fair: 44% 

• Poor: 13% 

G2: 

• Good: 27% 

• Fair: 56% 

• Poor: 18% 

P < 0.02 across all groups 

Long term

NR 

Outcomes 

reported apply to 

KQ4 and are 

included in

Evidence Table 4 

Short term

NR 

Long term

NR 

Overall quality

Poor 

Randomization 

approach and 

implementation 

Poor 

Masking 

NR 

Operational 

definitions and 

measures 

Poor 

Postrandomization 

exclusions

Yes: If episiotomy

performed was other 

than allocated, 

participant was

removed from trial 

Retention of 

participants 

Before discharge 

G1: 163 (100%)

G2: 244 (100%)

Total: 407 (100%) 

3 mos 

G1: NR 

G2: NR 

Total: 311 (76%) 

C-17 
Evidence Table 3. Key Question 3: Methods of repair – 2-layer versus 3-layer repair 

Study

Characteristics

Demographic

Characteristics

Labor and Delivery

Characteristics

Episiotomy and 

Repair 

Characteristics Pain Outcomes

Author 

Oboro et al., 2003 

Setting 

Nigeria 

Study design 

RCT 

Inclusion criteria 

Episiotomy or a sec 

deg tear during

vaginal delivery 

Exclusion criteria 

• First deg 

lacerations (rarely

require suturing) 

• Third deg tears

(need for specialist 

repair) 

Groups

G1: 2-layered: 

perineal skin not 

sutured 

G2: 3-layered: skin 

repair with either 

subcut or interr

number 00 CC or 

polyglycolic sutures 

N at randomization 

Total: 1077 

N at 48 hrs 

G1: 417 

G2: 406 

Total: 823 

Followup

6 wks 

3 mos 

Age (mean ± SD) 

G1: 26.3yrs ± 4.0 

G2: 26.2yrs ± 3.8 

Primiparous 

G1: 54% 

G2: 52% 

NS 

Previous perineal

repair 

G1: 31% 

G2: 29% 

NS 

Mode of delivery 

G1: 

• Spont: 76% 

• Vacuum/forceps: 24% 

G2: 

• Spont: 77% 

• Vacuum/forceps: 23% 

Birthweight 

(mean ± SD) 

G1: 3184g ± 461 

G2: 3188g ± 459 

NS 

Episiotomy rate vs. 

sec deg tear 

G1: 38% vs. 62% 

G2: 36% vs. 64% 

NS 

Duration of repairs

(mean time ± SD) 

G1: 21min ± 11.3 

G2: 25min ± 12

P < 0.001 

Delivery attendant 

G1: 

• Midwife: 71% 

• Medical officers/ 

consultants: 29% 

G2: 

• Midwife: 68% 

• Medical officers/ 

consultants: 32% 

Short term: 48 hrs

(int) 

Perineal pain

G1: 57% 

G2: 65% 

RR = 0.87 

(0.78, 0.97) 

Analgesia use 

G1: 34% 

G2: 49% 

RR = 0.71 

(0.60, 0.83) 

Short term: 14 days

(int) 

Perineal pain

G1: 22% 

G2: 29% 

RR = 0.77 

(0.61, 0.98) 

Analgesia use

G1: 5% 

G2: 9% 

RR = 0.54 

(0.32, 0.90) 

Short term: 6 wks 

(int) 

Perineal pain

G1: 10% 

G2: 15% 

RR = 0.64 

(0.44, 0.93) 

Analgesia use

G1: 1% 

G2: 2% 

RR = 0.56 

(0.16, 1.89) 

Long term: 3 mos

(quest) 

Perineal pain

G1: 1% 

G2: 5% 

RR = 0.19 

(0.06, 0.54) 

Analgesia use

G1: 0% 

G2: 1% 

RR = 0.16 

(0.02, 1.34) 

NS 

C-18 
Evidence Table 3. Key Question 3: Methods of repair – 2-layer versus 3-layer repair 

(continued)

Sexual Function 

Outcomes Healing Outcomes

Incontinence and

Pelvic Floor 

Outcomes Other Outcomes

Quality and 

Comments 

Short term: 6 wks

(int) 

Superficial 

dyspareunia

G1: 11% 

G2: 18% 

RR = 0.60 

(0.42, 0.85) 

Deep dyspareunia 

G1: 8% 

G2: 9% 

RR = 0.89 

(0.56, 1.41) 

Resumed

intercourse

pain free 

G1: 26% 

G2: 10% 

RR = 2.54 

(1.82, 3.55) 

Tried but too

painful 

G1: 10% 

G2: 22% 

RR = 0.43 

(0.39, 0.99) 

Long term: 3 mos

(quest) 

Resumed

intercourse < 2 

mos 

G1: 59% 

G2: 50% 

RR = 1.16 

(1.03, 1.32) 

Resume 

intercourse 2 to 3 

mos 

G1: 22% 

G2: 16% 

RR = 1.39 

(1.05, 1.85) 

Short term: 48 hrs

(exam) 

Tight stitches 

G1: 25% 

G2: 38% 

RR = 0.67 

(0.54, 0.82) 

Inflammation/ 

bruising 

G1: 7% 

G2: 14% 

RR = 0.50 

(0.33, 0.77) 

Wound gaping

(edges > 0.5 cm 

apart) 

G1: 26% 

G2: 5% 

RR = 4.96 

(3.17, 7.76) 

Primary healing 

(skin edges 

apposed) 

G1: 56% 

G2: 62% 

RR = 0.91 

(0.81, 1.02) 

Secondary healing 

(skin edges not

apposed but < 0.5 

cm apart) 

G1: 53% 

G2: 59% 

RR = 0.89 

(0.79, 1.01) 

Short term 

NR 

Long term

NR 

Short term 

NR 

Long term

NR 

Overall quality

Fair 

Randomization 

approach and 

implementation 

Good 

Masking

Assessor blind to 

allocation

Good 

Operational 

definitions and 

measures 

Fair 

Intention-to-treat 

analyses

No 

Postrandomization 

exclusions

Yes 

Retention of 

participants 

48 hrs 

Total: 1077 (100%)

14 days

Total: 823 (76%) 

6 wks 

Total: 823 (76%) 

3 mos 

Total: 823 (76%) 

C-19 
Evidence Table 3. Key Question 3: Methods of repair – 2-layer versus 3-layer repair 

(continued)

Study

Characteristics

Demographic

Characteristics

Labor and Delivery

Characteristics

Episiotomy and 

Repair 

Characteristics Pain Outcomes

Author 

Oboro et al., 2003 

(continued) 

C-20 
Evidence Table 3. Key Question 3: Methods of repair – 2-layer versus 3-layer repair 

(continued)

Sexual Function 

Outcomes Healing Outcomes

Incontinence and

Pelvic Floor 

Outcomes Other Outcomes

Quality and 

Comments 

Long term: 3 mos

Superficial 

dyspareunia

G1: 6% 

G2: 12% 

RR = 0.52 

(0.33, 0.81) 

Deep dyspareunia 

G1: 4% 

G2: 5% 

RR = 0.83 

(0.44, 1.56) 

Short term: 14 days 

(exam/int) 

Suturing removed 

G1: 5% 

G2: 9% 

RR = 0.58 

(0.35, 0.96) 

Wound breakdown 

G1: 3% 

G2: 2% 

RR = 1.27 

(0.56, 2.85) 

Wound gaping

(edges > 0.5 cm 

apart) 

G1: 21% 

G2: 17% 

RR = 1.25 

(0.94, 1.67) 

Short term: 6 wks 

(exam/int) 

Suturing removed 

G1: 6% 

G2: 10% 

RR = 0.58 

(0.36, 0.93) 

Resuturing

required 

G1: 3% 

G2: 4% 

RR = 0.63 

(0.30, 1.33) 

Long term: 3 mos

(quest) 

Suturing removed 

G1: 6% 

G2: 10% 

RR = 0.62 

(0.39, 0.99) 

Resuturing

required 

G1: 3% 

G2: 5% 

RR = 0.60 

(0.31, 1.19) 

Short term 

NR 

Long term

NR 

Short term 

NR 

Long term

NR 

C-21 
Evidence Table 3. Key Question 3: Methods of repair – 2-layer versus 3-layer repair 

(continued)

Study

Characteristics

Demographic

Characteristics

Labor and 

Delivery

Characteristics

Episiotomy and 

Repair 

Characteristics Pain Outcomes

Author 

Gordon et al., 

1998 

Setting 

UK 

Study design 

RCT 

2x2 factorial 

Inclusion 

criteria 

• First and sec 

deg laceration 

or episiotomy 

• Spont delivery

• Simple instr 

delivery (nonrotational 

forceps or 

vacuum 

extraction) 

Exclusion 

criteria 

NR 

Groups

G1: 2-stage 

(unsutured 

perineal skin) 

G2: 3-stage 

(sutured perineal 

skin) 

N at 

randomization 

G1: 890 

G2: 890 

Total: 1, 780 

Followup

3 mos 

Age (mean ± SD) 

G1: 28.5yrs ± 4.8 

G2: 28.2yrs ± 5.0 

Primiparous 

NR 

Previous vaginal 

delivery

G1: 40% 

G2: 43% 

Previous perineal

suturing 

G1: 37% 

G2: 35% 

Mode of delivery

G1: 

• Spont: 83% 

• Instr: 17% 

G2: 

• Spont: 82% 

• Instr: 18% 

Birthweight 

(mean ± SD) 

G1: 3507g ± 500 

G2: 3503g ± 482 

Episiotomy rate 

G1: 36% 

G2: 38% 

Lacerations

G1: 

• First deg: 1% 

• Sec deg: 62% 

• Third deg: 1% 

G2: 

• First deg: 2% 

• Sec deg: 60% 

• Third deg: 0% 

Suture type 

G1: 

• PGA: 49% 

• CC: 51% 

• Both: 1% 

G2: 

• PGA: 50% 

• CC: 49% 

• Both: 1% 

Suture method 

G1: 

• 2-stage only: 87% 

• Subcut: 2% 

• Interr: 10% 

• Both: 0% 

G2: 

• 2-stage only: 1%

• Subcut: 26% 

• Interr: 72% 

• Both: 0% 

Short term: 24 to 48 hrs

(int) 

Any pain in past 24 hrs 

Mild: NS 

Mod: NS 

Severe: NS 

Analgesia 

requirements in past 24 

hrs 

G1: 42% 

G2: 7% 

P = 0.03 

Short term: 10 days 

(int) 

Any pain in past 24 hrs 

Mild: NS 

Mod: NS 

Severe: NS 

Analgesia 

requirements in past 24 

hrs

NS 

Long term: 3 mos

(quest) 

Any pain in past 24 hrs 

G1: 

• Mild: 6% 

• Mod: 1% 

• Severe: 0% 

G2: 

• Mild: 7% 

• Mod: 2% 

• Severe: 0% 

P (for trend) = 0.01 

C-22 
Evidence Table 3. Key Question 3: Methods of repair – 2-layer versus 3-layer repair 

(continued)

Sexual Function 

Outcomes Healing Outcomes

Incontinence 

and Pelvic Floor 

Outcomes 

Other 

Outcomes Quality and Comments 

Short term

NR 

Long term: 3 mos

Resumption of 

sexual intercourse 

(quest) 

Tried but 

too painful: NS

By 3 mos: NS 

By 2 mos: NS 

By 1 mo: NS 

Not known: NS

Dyspareunia at 

first, if resumed 

(quest) 

NS 

Dyspareunia now,

if resumed (quest) 

Mild: NS 

Mod: NS 

Severe: NS 

Not known: NS

Short term: 24 to 48 

hrs (int) 

Gaping perineum 

(exam) 

G1: 23%

G2: 4% 

P < 0.0000001

Tight stitches 

NS 

Stitches not

comfortable

NS 

Short term: 10 days 

Tight stitches (int) 

G1: 14%

G2: 18% 

P = 0.02 

Stitches not

comfortable (int) 

NS 

Gaping perineum 

(exam) 

G1: 26%

G2: 16% 

P < 0.00001

Nature of healing: 

First intention 

(exam) 

G1: 75% 

G2: 84% 

P < 0.0001 

Nature of healing: 

Other levels (exam) 

Sec intention: NS 

Breaking down: NS 

Not known: NS

Sutures removed 

(exam) 

G1: 3%

G2: 8% 

P < 0.0001 

Long term: 3 mos

(quest) 

Sutures removed at 

any time

G1: 7% 

G2: 11% 

P = 0.002 

Resutured 

NS 

Short term

NR 

Long term

NR 

Short term

NR 

Long term

NR 

Overall quality

Good 

Randomization approach

and implementation 

Good 

Masking 

Good 

Operational definitions 

and measures 

Good 

Post-randomization 

exclusions

No 

Retention of participants

24 to 48 hrs 

G1: 885 (99%)

G2: 889 (100%)

Total: 1774 (100%) 

10 days 

G1: 886 (100%)

G2: 885 (99%)

Total: 1771 (99%) 

3 mos 

G1: 828 (93%)

G2: 836 (94%)

Total: 1664 (93%) 

C-23 
Evidence Table 3. Key Question 3: Methods of repair – 2-layer versus 3-layer repair 

(continued)

Study

Characteristics

Demographic

Characteristics

Labor and 

Delivery

Characteristics

Episiotomy and Repair 

Characteristics Pain Outcomes

Author 

Grant et al., 2001 

Setting 

UK 

Study design 

RCT 

2x2 factorial 

Inclusion 

criteria 

• First and sec 

deg laceration 

or episiotomy 

• Spont delivery

• Simple instr 

delivery (nonrotational 

forceps or 

vacuum 

extraction) 

from early

1993 

Exclusion 

criteria 

NR 

Groups

G1: Unsutured 

perineal skin 

(2-stage) 

G2: Sutured 

perineal skin 

(3-stage repair 

including skin 

closure with interr 

or subcut 

sutures) 

N at 

randomization 

G1: 890 

G2: 890 

Total: 1789 

Followup 

1 yr (restricted to 

a subset of those 

randomized) 

N at 1 yr

G1: NR 

G2: NR 

Total: 919 

Age (mean ± SD) 

G1: 29.1yrs ± 4.7 

G2: 28.6yrs ± 4.9 

Primiparous 

G1: 48% 

G2: 55% 

Previous vaginal 

delivery 

G1: 35% 

G2: 36% 

Previous perineal

suture 

G1: 34% 

G2: 33% 

Mode of delivery

G1: 

• Spont: 69% 

• Instr: 31% 

G2: 

• Spont: 69% 

• Instr: 31% 

Other labor 

characteristics 

Birthweight 

(mean ± SD) 

G1: 3556g ± 528 

G2: 3504g ± 487 

Episiotomy use 

G1: 43% 

G2: 47% 

Episiotomy rate 

G1: 36% 

G2: 38% 

Lacerations

G1: 

• First deg: 1% 

• Sec deg: 62% 

• Third deg: 1%

G2: 

• First deg: 2% 

• Sec deg: 60% 

• Third deg: 0% 

Repair by

G1: 

• Student: 1% 

• Midwife: 60% 

• Registrar: 33%

• SHO: 7% 

G2: 

• Student: 1% 

• Midwife: 62% 

• Registrar: 32%

• SHO: 6% 

Suture type 

G1: 

• PGA: 49% 

• CC: 50% 

• Both: 1% 

G2: 

• PGA: 50% 

• CC: 50% 

• Both: 1% 

Suture method 

G1: 

• Subcut: 2% 

• Subcut and interr: 0% 

• Interr: 0% 

• 2-stage only: 89% 

G2: 

• Subcut: 34% 

• Subcut and interr: 0% 

• Interr: 64% 

• 2-stage only: 2%

Short term

NR 

Long term: 1 yr

(quest) 

Still pain or general 

discomfort where 

stitched

Mild: NS 

Mod: NS 

Severe: NS 

C-24 
Evidence Table 3. Key Question 3: Methods of repair – 2-layer versus 3-layer repair 

(continued)

Sexual Function 

Outcomes Healing Outcomes

Incontinence 

and Pelvic Floor 

Outcomes 

Other 

Outcomes Quality and Comments 

Long term: 1 yr

(quest) 

Timing of 

resumption of

sexual 

intercourse

Tried but too 

painful: NS 

By 6 mos: NS 

By 3 mos: NS 

Could not 

remember: NS

No partner: NS 

Not known: NS

Dyspareunia at 

first, if resumed 

NS 

Dyspareunia 

now, if resumed 

NS 

Failure to 

resume painfree intercourse 

NS 

Long term: 1 yr

(quest) 

Area cut or torn 

feels different

G1: 30% 

G2: 40% 

P < 0.01 

Resutured

NS 

Long term

NR 

Long term

NR 

Overall quality

Good 

Randomization approach

and implementation 

Good 

Masking 

Good 

Operational definitions and 

measures 

Good 

Post-randomization 

exclusions

No 

Retention of participants

1 yr 

G1: 396 

G2: 397 

Total: 793 

C-25 
Evidence Table 4. Key Question 3: Methods – Continuous versus interrupted sutures 

Study

Characteristics

Demographic

Characteristics

Labor and 

Delivery

Characteristics

Episiotomy and Repair 

Characteristics Pain Outcomes 

Author 

Kettle et al, 2002 

Setting 

UK 

Study design 

RCT 

2x2 factorial 

Inclusion criteria 

Spont vaginal 

delivery with sec 

deg perineal tear 

or episiotomy 

Exclusion criteria 

• Instr delivery 

• Extensive 

perineal trauma 

beyond scope of 

midwife’s 

practice 

• Previous 

perineal surgery 

other than 

primary repair 

after childbirth 

• Stillbirth or baby 

with extensive 

congenital 

abnormalities 

• Women with 

AIDS or 

Hepatitis B, 

severe perineal

warts, or 

extensive 

varicose veins of 

external genitalia 

• < 16 yrs 

• Unable to read, 

write or 

understand 

English 

 

Age (mean ± SD) 

G1: 27.2yrs ± 5.4 

G2: 27.2yrs ± 5.3 

Previous sutured 

perineal trauma 

G1: 41% 

G2: 39% 

Primiparous 

G1: 54% 

G2: 57% 

Mode of delivery

Spont 

G1: 100% 

G2: 100% 

Birthweight 

(mean ± SD) 

NR 

Episiotomy rate 

G1: 41% 

G2: 42% 

Lacerations

G1: 

• Sec deg: 58% 

• Third/fourth deg: <1% 

G2 

• Sec deg: 58% 

• Third/fourth deg: <1%

Episiotomy extend to 

third deg tear

G1: 1% 

G2: 0% 

Identity of the operator 

Student midwife

G1: 0 

G2: <1%

Midwife grade E 

G1: 25% 

G2: 29% 

Midwife grade F

G1: 26% 

G2: 32% 

Midwife grade G/H 

G1: 48% 

G2: 36% 

Doctor/other 

G1: 2% 

G2: 2% 

P < 0.0001 

Suture method 

G1: Cont: 100% 

G2: Interr: 100% 

 

Short term: 24 hrs

(quest) 

Pain relief 

G1: 8.5% 

G2: 13.5% 

OR = 0.60 

(0.40, 0.92) 

P = 0.002 

Pain walking 

G1: 32% 

G2: 43% 

OR = 0.62 

(0.47, 0.82) 

P < 0.0001 

Pain sitting

G1: 39% 

G2: 55% 

OR = 0.54 

(0.41, 0.70) 

P < 0.0001 

Pain passing urine 

G1: 26% 

G2: 36% 

OR = 0.63 

(0.47, 0.83) 

P < 0.0001 

Short term: 2 days 

(quest) 

Pain at the time of 

response 

G1: 69% 

G2: 79% 

OR = 0.59 

(0.44, 0.79) 

P < 0.0001 

Short term: 10 days 

(quest) 

Pain at the time of 

response 

G1: 26% 

G2: 44% 

OR = 0.47 

(0.35, 0.61) 

P < 0.0001 

C-26 
Evidence Table 4. Key Question 3: Methods – Continuous versus interrupted sutures 

(continued)

Sexual Function 

Outcomes Healing Outcomes

Incontinence and

Pelvic Floor 

Outcomes Other Outcomes

Quality and 

Comments 

Long term: 3 mos

(quest filled by

mother) 

Dyspareunia 

NS 

Long term: 12 mos

(quest filled by

mother) 

Dyspareunia 

NS 

Short term: 2 days 

(quest) 

Wound gaping 

OR = 0.69 

(0.30, 1.61) 

NS 

Sutures 

uncomfortable 

G1: 35% 

G2: 41% 

OR = 0.78 

(0.64, 0.96) 

Sutures tight 

G1: 2% 

G2: 4% 

OR = 0.40 

(0.22, 0.74) 

Short term: 10 days 

(quest) 

Wound gaping 

G1: 3% 

G2: 7% 

OR = 0.46 

(0.29, 0.74) 

Sutures 

uncomfortable 

G1: 17% 

G2: 27% 

OR = 0.58 

(0.46, 0 .74) 

Sutures tight 

G1: 3% 

G2: 7% 

OR = 0.43 

(0.27, 0.69) 

Sutures removed 

G1: 0.5% 

G2: 7.2 

OR = 0.17 

(0.10, 0.28) 

Short term

NR 

Long term

NR 

Short term

NR 

Long term: 3 mos

Back to normal 

G1: 59% 

G2: 48% 

OR: 1.55 

(1.26, 1.92) 

Satisfaction with

repair 

G1: 84% 

G2: 76% 

OR: 1.64 

(1.28, 2.11) 

Long term: 12 mos

Satisfaction with

repair 

G1: 86% 

G2: 77% 

OR: 1.68 

(1.27, 2.21)

Overall quality

Good 

Randomization 

approach and 

implementation 

Good 

Masking

Good 

Operational 

definitions and 

measures 

Good 

Post-randomization 

exclusions

2 fetal deaths 

Retention of 

participants 

24 to 48 hrs 

Total: 1540 (100%) 

Day 10 

Total: 1539 (100%) 

3 mos 

Total: 1492 (96.7%) 

12 mos 

Total: 1389 (90.1%) 

C-27 
Evidence Table 4. Key Question 3: Methods – Continuous versus interrupted sutures 

(continued)

Study

Characteristics

Demographic

Characteristics

Labor and 

Delivery

Characteristics

Episiotomy and 

Repair 

Characteristics Pain Outcomes

Author 

Kettle et al., 2002 

(continued) 

Groups

G1: Cont suture

G2: Interr suture 

N at 

randomization 

G1: 771 

G2: 771 

Followup

1 yr

Materials (all 

PGA)

G1: 

• Rapidly 

absorbed: 50% 

• Standard: 50% 

G2: 

• Rapidly 

absorbed: 50% 

• Standard: 50%

Number of 

sutures packets 

used

1 

G1: 79% 

G2: 32% 

2 

G1: 21% 

G2: 67% 

3 

G1: < 1% 

G2: 1% 

Short term: 24 hrs

(quest) (cont) 

Pain opening bowels 

G1: 41% 

G2: 48% 

OR = 0.74 

(0.57, 0.97) 

P = 0.004 

Long term: 3 mos

(quest) 

Pain at the time of 

response 

G1: 9% 

G2: 13% 

OR = 0.70 

(0.46, 1.07) 

P = 0.03 

Long term: 12 mos

(quest) 

Pain at the time of 

response 

G1: 4% 

G2: 7% 

OR = 0.64 

(0.35, 1.16) 

P = 0.05 

C-28 
Evidence Table 4. Key Question 3: Methods – Continuous versus interrupted sutures 

(continued)

Sexual Function 

Outcomes Healing Outcomes

Incontinence and

Pelvic Floor 

Outcomes Other Outcomes

Quality and 

Comments 

Short term: 10 days

Sutures 

G1: 3% 

G2: 9% 

OR = 0.36 

(0.23, 0.55) 

Short term: before 

3 mos (after 10 

days)

Sutures removed 

G1: 3% 

G2: 12.5% 

OR: 0.27 

(0.19, 0.40) 

Short term

NR 

Long term

NR 

Short term

NR 

Long term: 3 mos

Back to normal 

G1: 54% 

G2: 48% 

OR: 1.55 

(1.26, 1.92) 

Satisfaction with

repair 

G1: 84% 

G2: 76% 

OR: 1.64 

(1.28, 2.11) 

Long term: 12 mos

Satisfaction with

repair 

G1: 86% 

G2: 79% 

OR: 1.68 

(1.27, 2.21) 

C-29 
Evidence Table 4. Key Question 3: Methods – Continuous versus interrupted sutures 

(continued)

Study

Characteristics

Demographic

Characteristics

Labor and 

Delivery

Characteristics

Episiotomy and 

Repair 

Characteristics Pain Outcomes

Author 

Mahomed et al., 

1989 

Setting 

UK 

Study design 

RCT 

2x3x2 factorial 

Inclusion 

criteria 

Required perineal 

repair 

Exclusion 

criteria 

NR 

Groups

G1: Cont subcut 

sutures 

G2: Interr 

transcut sutures 

N at 

randomization 

G1: 533 

G2: 524 

Followup

3 mos 

Age (mean ± SD) 

G1: 26.0yrs ± 4.8 

G2: 25.9yrs ± 5.0 

Primiparous 

G1: 48% 

G2: 55% 

Mode of delivery

Operative 

G1: 23% 

G2: 23% 

Birthweight 

(mean ± SD) 

G1: 3383g ± 477 

G2: 3341g ± 480 

Episiotomy rate 

G1: 

• Episiotomy alone: 54% 

• Episiotomy+ext: 10% 

• Tear: 36% 

G2: 

• Episiotomy alone: 48% 

• Episiotomy+ext: 16% 

• Tear: 37% 

Suture type 

Vagina, deep tissues 

G1: 

• PGA: 49% 

• CC: 51% 

G2: 

• PGA: 48% 

• CC: 52% 

Perineal skin

G1: 

• PGA: 46% 

• CC: 49% 

• Silk: 2% 

G2: 

• PGA: 45% 

• CC: 48% 

• Silk: 2% 

Skin closure

G1: 

• Subcut: 70% 

• Interr: 18% 

• Both: 9% 

• None: 3% 

G2: 

• Subcut: 2% 

• Interr: 93% 

• Both: 1% 

• None: 4% 

Operator

G1: 

• Midwife: 25% 

• SHO: 64% 

• Registrar: 9% 

• GP: 3% 

G2: 

• Midwife: 34% 

• SHO: 53% 

• Registrar: 0% 

• GP: 3% 

Short term: 48 hrs

(assessed by

postnatal staff or

community

midwife) 

Use of oral 

analgesia 

NS 

Perineal pain

“now” measured 

NS 

Short term: 10 

days 

Use of oral 

analgesia 

NS 

Perineal pain

(assessed by

mother) 

None: NS 

Mild: NS 

Mod: NS 

Severe: NS 

Long term: 3 mos 

(assessed by

mother) 

Perineal pain

None: NS 

Mild: NS 

Mod: NS 

Severe: NS 

C-30 
Evidence Table 4. Key Question 3: Methods – Continuous versus interrupted sutures 

(continued)

Sexual Function Repair and Healing Incontinence

Other description of

Outcome 

Quality and 

Comments 

Short term

NR 

Long term: 3 mos

Sexual intercourse 

not resumed 

NS 

Dyspareunia 

NS 

Short term

NR 

Long term: 3 mos

(quest) 

Absorbable 

material removed 

G1: 26% 

G2: 37% 

P < 0.001 

Resutured 

NS 

Short term

NR 

Long term

NR 

Short term

NR 

Long term

NR 

Overall quality

Good 

Randomization 

approach and 

implementation 

Good 

Masking 

Good 

Operational 

definitions and 

measures 

Good 

Postrandomization 

exclusions

No 

Retention of 

participants 

Short term: <3 mos

48 hrs 

G1: 509 (95%)

G2: 515 (98%)

Total: 1024 (97%) 

Day 10

G1: 447 (84%)

G2: 461 (88%)

Operator

G1: 

• Midwife: 25% 

• SHO: 64% 

• Registrar: 9% 

• GP: 3% 

G2: 

• Midwife: 34% 

• SHO: 53% 

• Registrar: 0% 

• GP: 3% 

Long term: 3 mos

GI: 465 (87%) 

G2: 451 (86%)

Total: 916 (87%) 

C-31 
Evidence Table 5. Key Question 3: Materials – Absorbable sutures versus tissue adhesive 

Study Characteristics 

Demographic

Characteristics

Labor and 

Delivery

Characteristics

Episiotomy and Repair 

Characteristics Pain Outcomes 

Author 

Bowen and Selinger, 

2002 

Setting 

UK 

Study design 

RCT 

Inclusion criteria 

Primiparous female 

expecting a normal 

delivery and requiring 

an episiotomy repair 

Exclusion criteria 

• Multiparous 

• Perineal tear 

• Unable to give 

consent 

• Prenatal treatment 

of vulvo-vaginal

problems and 

symptoms where 

subjective 

assessment of pain 

scores would be 

difficult 

Groups

G1: Enbucrilate tissue 

adhesive 

G2: Subcut PGA 

sutures 

N at randomization 

G1: 32 

G2: 30 

Followup

3 to 6 wks 

Age (mean ± SD) 

G1: 26yrs ± 4.2 

G2: 26yrs ± 5.4 

Primiparous 

G1: 100% 

G2: 100% 

Mode of delivery

NR 

Birthweight (mean ± 

SD) 

NR 

Episiotomy rate 

G1: 100% mediolateral 

G2: 100% mediolateral 

Suture type 

G1: 100% enbucrilate

tissue adhesive 

G2: 100% PGA 

Repair by

G1: Gynecologist: 100% 

G2: Midwife: at least 

90% or greater (not 

specified) 

Short term: Days 1 to 6 

Definition: Mean score of 

perineal pain (1 to 10 VAS) 

days 1, 2, 3, 4, 5 

Short term: Day 1

Micturation 

G1: 4.5 

G2: 6.3 

P = 0.025 

Other pain measures 

NS 

Short term: Day 2 

Walking 

G1: 2.7 

G2: 4.0 

P = 0.0015 

Other pain measures 

NS 

Short term: Day 3

Micturation 

G1: 3.0 

G2: 4.0 

P = 0.025 

Defecation 

G1: 2.2 

G2: 4.3 

P = 0.003 

Other pain measures 

NS 

Short term: Day 4

Walking 

G1: 2.1 

G2: 2.8 

P = 0.029 

Defecation 

G1: 2.1 

G2: 3.7 

P = 0.015 

Other pain measures 

NS 

Short term: Day 5

All pain measures 

NS 

Short term: 3 to 6 wks

Mean time taken to 

achieve zero pain score 

G1: 18 

G2: 25 

P = 0.0017 

Long term

NR 

C-32 
Evidence Table 5. Key Question 3: Materials – Absorbable sutures versus tissue adhesive

(continued)

Sexual Function 

Outcomes Healing Outcomes 

Incontinence and

Pelvic Floor 

Outcomes Other Outcomes

Quality and 

Comments 

Short term: 3 to 6 

wks

(quest) 

Mean time taken to 

achieve pain-free sex 

G1: 34

G2: 52 

P = 0.0009 

Long term

NR 

Short term 

• No cases of wound 

infection or 

dehiscence 

• No patients required

the suture to be 

removed 

Long term

NR 

Short term 

NR 

Long term

NR 

Short term 

NR 

Long term

NR 

Overall quality 

Poor 

Randomization 

approach and 

implementation 

Poor

(randomization

broken)

Masking

Fair 

Operational 

definitions and 

measures 

Good 

Postrandomization 

exclusions

Yes 

Retention of 

participants 

Days 1 to 5 

Total: 57 (92%) 

C-33 
Evidence Table 5. Key Question 3: Materials – Absorbable sutures versus tissue adhesive

(continued)

Study

Characteristics

Demographic

Characteristics

Labor and 

Delivery

Characteristics

Episiotomy and 

Repair 

Characteristics Pain Outcomes

Author 

Adoni and 

Anteby, 1991 

Setting 

Israel 

Study design 

RCT

Inclusion 

criteria 

Episiotomy 

Exclusion 

criteria 

NR 

Groups

G1: First 

episiotomy, cont 

CC stitches 

G2: Repeat 

episiotomy, cont 

CC stitches 

G3: First 

episiotomy, 

Histoacryl-tissue

adhesive 

N at 

randomization 

G1: 20

G2: 20 

G3: 20 

(G2 not 

randomized, not 

included in

outcomes) 

Followup

2 days 

Age (mean ± SD) 

NR 

Parity

NR 

Other 

demographics 

NR 

Mode of delivery

NR 

Other labor 

characteristics 

Birthweight 

(mean ± SD) 

NR 

Suture type 

G1: CC: 100%

G2: CC: 100%

G3: Histoacryl: 100% 

Short term: 48 hrs

(quest) 

Needed analgesia 

drugs 

G1: 40% 

G3: 0% 

Mean score of

perineal pain 

(1=minimum, 

5=maximum)

At episiotomy site 

G1: 3.3 

G3: 1.95 

P < 0.001 

Walking 

G1: 2.6 

G3: 1.6 

P < 0.001 

Sitting 

G1: 3.6 

G3: 1.75 

P < 0.0001 

Lying down

G1: .2.35 

G3: 1.0 

P < 0.001 

Micturition 

G1: 1.7 

G3: 1.0 

P < 0.03 

Long term

NR

C-34 
Evidence Table 5. Key Question 3: Materials – Absorbable sutures versus tissue adhesive

(continued)

Sexual Function 

Outcomes Healing Outcomes

Incontinence and

Pelvic Floor 

Outcomes Other Outcomes

Quality and 

Comments 

Short term 

NR 

Long term

NR 

Short term 

NR 

Long term

NR 

Short term 

NR 

Long term

NR 

Short term 

Needed sitting aids

G1: 20% 

G3: 0% 

Long term

NR 

Overall quality

Poor 

Randomization 

approach and 

implementation 

Poor 

Masking

Good 

Operational 

definitions and 

measures 

Good 

Postrandomization 

exclusions

No 

Retention of 

participants 

2 days

Total: 60 (100%) 

C-35 
Evidence Table 6. Key Question 3: Materials: Absorbable sutures – standard versus rapidly

absorbed sutures 

Study

Characteristics

Demographic

Characteristics

Labor and 

Delivery

Outcomes 

Episiotomy and 

Repair 

Characteristics Pain Outcomes

Author 

Kettle et al., 2002 

Setting 

UK 

Study design 

RCT 

2x2 factorial 

Inclusion criteria 

Spont vaginal 

delivery with sec deg 

perineal tear or

episiotomy 

Exclusion criteria 

• Instr delivery 

• Extensive perineal 

trauma beyond 

scope of midwife 

practice 

• Previous perineal 

surgery other than 

primary repair 

after childbirth 

• Stillbirth or baby 

with extensive 

congenital 

abnormalities 

• Women with AIDS 

or Hepatitis B, 

severe perineal

warts, extensive 

varicose veins of 

external genitalia 

• <16 yrs 

• Unable to read, 

write, understand 

English 

Groups

G1: Rapidly

absorbed 

(polyglactin) 

G2: Standard 

(polyglactin) 

N 

G1: 772 

G2: 770 

Followup

1 yr

Age (mean ± SD) 

G1: 27.3yrs ± 5.4 

G2: 27.1yrs ± 5.4 

Primiparous 

G1: 54% 

G2: 57% 

Previous sutured 

perineal trauma 

G1: 41% 

G2: 39% 

Mode of 

delivery

Spont 

G1: 100% 

G2: 100% 

Birthweight 

(mean ± SD) 

NR 

Episiotomy rate 

G1: 40% 

G2: 43% 

Lacerations

G1: 

• Sec deg: 59% 

• Third/fourth deg: <1% 

• Extend to third deg: <1% 

G2: 

• Sec deg: 56% 

• Third/fourth deg tear: <1% 

• Extend to third deg tear: 

1% 

Suture type 

Method 

G1: 

• Cont: 50% 

• Interr: 50% 

G2: 

• Cont: 50% 

• Interr: 50% 

Materials 

G1: 

• Rapidly absorbed: 99% 

• Standard: 1% 

G2: 

• Standard: 100% 

Operator

Doctor 

G1: 2% 

G2: 2% 

Midwife E 

G1: 27% 

G2: 26% 

Midwife F 

G1: 30% 

G2: 28% 

Midwife G/H 

G1: 27% 

G2: 26% 

N suture packets used

1 

G1: 56% 

G2: 55% 

2 

G1: 43% 

G2: 45% 

3 

G1: 1% 

G2: < 1% 

Short term: 10 days

Pain 

Cont 

G1: 27% 

G2: 26% 

OR = 1.06 

(0.70, 1.62) 

Interr 

G1: 39% 

G2: 48% 

OR = 0.70 

(0.48, 1.01) 

Test for heterogeneity

between groups: P = 0.05 

(P for heterogeneity = 0.3) 

NS 

Short term: 24 hrs relief

(10 days quest from 

mother and midwife) 

Pain 

G1: 8% 

G2: 14% 

OR = 0.55 

(0.3, 0.83) 

P = 0.0002 

Pain walking

G1: 34% 

G2: 41% 

OR = 0.74 

(0.56, 0.97) 

P = .004 

Pain sitting 

G1: 45% 

G2: 49% 

OR = 0.84 

(0.65, 1.10) 

P = 0.10 

Pain passing

NS 

Pain opening bowels 

NS 

Long term

NR 

C-36 
Evidence Table 6. Key Question 3: Materials: Absorbable sutures – standard versus rapidly

absorbed sutures (continued) 

Sexual Function 

Outcomes Healing Outcomes

Incontinence and

Pelvic Floor 

Outcomes Other Outcomes

Quality and 

Comments 

Short term

NR 

Long term: 3 mos

(quest) 

Dyspareunia 

NS 

Long term: 12 mos

(quest) 

Dyspareunia 

NS 

Short term: 2 days 

(quest) 

Wound gaping 

OR = 1.20 

(0.52, 2.79) 

Sutures 

uncomfortable 

OR = 1.02 

(0.83, 1.25) 

Sutures tight 

OR = 1.15 

(0.63, 2.12) 

Short term: 10 days 

(quest) 

Wound gaping 

OR = 1.83 

(1.14, 2.92) 

Sutures 

uncomfortable 

OR = 0.88 

(0.69, 1.12) 

Sutures tight 

OR = 0.77 

(0.48, 1.24) 

Sutures removed 

G1: 2% 

G2: 6% 

OR: 0.38 

(0.23, 0.64) 

Short term: 10 days 

to 3 mos

Sutures removed 

G1: 1% 

G2: 10% 

OR: 0.19 

(0.13, 0.30) 

Short term

NR 

Long term

NR 

Short term

NR 

Long term: 3 mos

Back to normal 

OR = 1.22 

(0.99, 1.51) 

Satisfaction with

repair 

OR = 1.25 

(0.97, 1.61) 

Long term: 12 mos

Satisfaction with

repair 

OR = 1.09 

(0.83, 1.44) 

Overall quality

Good 

Randomization 

approach and 

implementation 

Good 

Masking

Good 

Operational 

definitions and 

measures 

Good 

Postrandomization 

exclusions

2 fetal deaths 

Retention of 

participants 

24 hrs 

G1: 770 (100%)

G2: 770 (100%)

Total: 1540 (100%) 

Day 10 

G1: 769 (100%)

G2: 770 (100%)

Total: 1539 

(99.9%) 

3 mos 

G1: 753 (98%)

G2: 739 (96%)

Total: 1492 

(96.9%) 

12 mos 

G1: 703 (91%)

G2: 686 (89%)

Total: 1389 

(90.2%) 

C-37 
Evidence Table 6. Key Question 3: Materials: Absorbable sutures – standard versus rapidly

absorbed sutures (continued) 

Study

Characteristics

Demographic

Characteristics

Labor and 

Delivery

Characteristics

Episiotomy and 

Repair 

Characteristics Pain Outcomes

Author 

McElhinney et al., 

2000 

Setting 

Ireland 

Study design 

RCT 

Inclusion 

criteria 

• Parity of 0 to 2 

• 18 to 40 yrs old 

• Singleton fetus

• Normal vaginal

delivery 

• Required an 

episiotomy or 

sustained a 

sec deg floor 

tear 

Exclusion 

criteria 

NR 

Groups

G1: Vicryl rapide 

G2: Vicryl

N at completion

G1: 75 

G2: 78 

Total: 153 

Followup

12 wks 

Age 

NR 

Primiparous 

G1: 53% 

G2: 56% 

Mode of delivery

NR

Birthweight 

(mean ± SD) 

NR 

NR Short term: 24 hrs 

Perineal pain (measured

with VAS)

NS 

Short term: 3 days 

(Measured by 4-pt pain

scale) 

NS 

Analgesic use

(Prior to discharge) 

NS 

Long term

NR 

C-38 
Evidence Table 6. Key Question 3: Materials: Absorbable sutures – standard versus rapidly

absorbed sutures (continued) 

Sexual Function 

Outcomes Healing Outcomes

Incontinence and

Pelvic Floor 

Outcomes Other Outcomes

Quality and 

Comments 

Short term 

NR 

Long term: 12 wks

Dyspareunia (int) 

G1: Mean score of 

0.05 in 5% of 

patients who had 

dyspareunia 

G2: Mean score of 

0.27 in 20% of 

patients who had 

dyspareunia 

P < 0.05

Short term: 6 wks 

Wound problems

(infection, gaping

wound, pain or 

residual material 

requiring removal) 

G1: 2% 

G2: 30% 

Long term: 12 wks

Wound problems of 

women

experiencing

wound problems at 

6 wks 

G1: 5% 

G2: 95% 

“Still very significant” 

Short term 

NR 

Long term

NR 

Short term 

NR 

Long term

NR 

Overall quality

Poor 

Randomization 

approach and 

implementation 

Fair 

Masking

Poor

Operational 

definitions and 

measures 

Fair 

Postrandomization 

exclusions

No 

Retention of 

participants 

24 hrs 

Total: 153 (100%) 

Day 3 

Total: 153 (100%) 

6 wks 

Total: 118 (77%) 

12 wks 

Total: 118 (77%) 

C-39 
Evidence Table 7. Key Question 3: Materials – Untreated catgut versus treated catgut 

Study

Characteristics

Demographic

Characteristics

Labor and 

Delivery

Characteristics

Episiotomy and 

Repair 

Characteristics Pain Outcomes

Author 

Spencer et al., 

1986 

Grant et al., 1989

Setting 

UK 

Study design 

RCT 

Inclusion 

criteria 

• Spont vaginal 

deliveries 

• Required

perineal 

repairs 

Exclusion 

criteria 

NR 

Groups

G1: Chromic 

“softgut” 

G2: Untreated 

CC 

N at 

randomization 

G1: 377 

G2: 360 

Total: 737 

Followup

3 mos 

Age (mean ± SD) 

G1: 26.5yrs ± 5.1 

G2: 27.1yrs ± 5.3 

Primiparous 

G1: 49.1% 

G2: 44.4% 

Married 

G1: 89.9% 

G2: 88.8 % 

Babies born 

since study

G1: 

• 0: 56% 

• 1: 41% 

• 2: 3% 

G2: 

• 0: 62% 

• 1: 37% 

• 2: 1% 

Mode of delivery

Spont: 100% 

Birthweight (mean

± SD) 

G1: 3419g ± 440 

G2: 3384g ± 435 

(Collected at 3 

year followup)

GA

G1: 39.9wks ± 1.2 

G2: 39.8wks ± 1.1 

(mean, SD) 

Episiotomy

performed in next

pregnancy

G1: 25% 

G2: 14% 

Episiotomy rate 

G1: 36.1% 

G2: 7.8%

Note: Article 

reports 7.8%, 

which we believe 

is a typo because 

the percentages in 

that particular 

column would add 

to 100%. We

believe the correct 

value is 37.8%

Episiotomy and 

ext 

G1: 5.0% 

G2: 4.7% 

Posterior tear 

alone

G1: 53.8% 

G2: 53.9% 

Labial tear alone 

G1: 5.0% 

G2: 3.6% 

Suture type 

G1: 

• CC: 8.0% 

• Soft-gut: 91.8% 

G2: 

• CC: 95.3% 

• Soft-gut: 4.4% 

Suture method 

G1: 

• Subcut: 31.9%

• Interr: 60.9% 

• Both: 7.2% 

G2: 

• Subcut: 32.4%

• Interr: 59.5% 

• Both: 8.1% 

Repair done by

G1: 

• SHO: 87% 

• Student: 8.5% 

• Registrar: 4.5% 

G2: 

• SHO: 85.8% 

• Student: 9.7% 

• Registrar: 4.5% 

Short term: 10 to 12 days 

(quest) 

Experienced perineal pain

within last 24 hrs (asked at 

10 to 12 days)

None

G1: 68.1% 

G2: 76.6% 

Mild 

G1: 20.9% 

G2: 14.3% 

Mod 

G1: 9.6% 

G2: 9.0% 

Severe 

G1: 1.5% 

G2: 0% 

P = 0.15 (overall) 

Used oral analgesics 

NS 

Use of salt bath for pain

on that day 

G1: 42% 

G2: 34% 

P = 0.03 

Long term: 3 mos

Experienced perineal pain

within last 7 days (asked

at 3 mos, quest) 

None: NS 

Mild: NS 

Mod: NS 

Severe: NS 

C-40 
Evidence Table 7. Key Question 3: Materials – Untreated catgut versus treated catgut 

(continued)

Sexual Function Repair and Healing Incontinence

Other description of

Outcome 

Quality and 

Comments 

Short term 

NR 

Long term: 3 mos 

(quest) 

Dyspareunia 

None: 

G1: 38.0% 

G2: 50.7% 

At first but not at 3 

mos 

G1: 36% 

G2: 29.8% 

Mild 

G1: 23.3% 

G2: 18.1% 

Mod 

G1: 2.7% 

G2: 1.4% 

P < 0.025 

Recommencement

of sexual 

intercourse

NS

Long term: 3 yrs

(quest) 

Sexual intercourse 

painful 

G1: 19% 

G2: 11% 

OR: 1.7 

(1.1, 2.6) 

P < 0.02 

Soreness 

G1: 16% 

G2: 11% 

Tightness 

G1: 0.8% 

G2: 0% 

Other 

G1: 2.3% 

G2: 0.4% 

Short term: 10 days 

(assessed by

midwife) 

Sutures removed 

G1: 2.4% 

G2: 11.5% 

P < 0.0001 

Short term: 10 to 12 

days (assessed by

midwife) 

Perineal breakdown 

NS 

Healing by

secondary intention 

NS 

Long term: 3 mos

(quest) 

Sutures removed 

G1: 6.9% 

G2: 16.4% 

P < 0.001 

Short term 

NR 

Long term

NR 

Short term 

NR 

Long term

NR 

Quality

Fair 

Randomization 

approach and 

implementation 

Fair 

Masking

Good 

Postrandomization 

exclusions

No 

Retention of 

participants 

10 to 12 days

G1: 336 (89%)

G2: 322 (89%)

Total: 658 (89%) 

3 mos 

G1: 332 (88%)

G2: 323 (90%)

Total: 655 (89%) 

3 yrs 

G1: 263 (70%)

G2: 253 (70%)

Total: 516 (70%) 

C-41 
Evidence Table 8. Key Question 3: Materials – Nonabsorbable versus absorbable

Study

Characteristics

Demographic

Characteristics

Characteristics of

Labor, Delivery

and Repair 

Episiotomy and 

Repair 

Characteristics Pain Outcomes

Author 

Buchan and 

Nicholls, 1980

Setting 

UK 

Study design 

RCT 

Inclusion criteria 

• Primigravidae 

• Spont vaginal 

delivery

• Mediolateral 

episiotomy

Exclusion criteria 

• Extended 

episiotomy 

• Additional 

lacerations 

Groups

G1: Interr black silk 

sutures (Ethicon 

562) 

G2: Absorbable 

subcut Dexon suture 

N at randomization 

G1: 70 

G2: 70 

Total: 140 

Followup

4 mos 

Age (mean ± SD or

median) 

NR 

Primiparous 

G1: 100% 

G2: 100% 

Mode of delivery

G1: Spont: 100% 

G2: Spont: 100% 

Birthweight (mean

± SD) 

NR 

Suture type 

G1: CC/black silk: 100% 

G2: CC/Dexon: 100% 

Short term: (Days 1

to 6) 

Analgesic 

requirements (mean N 

of tablets ± SD) 

Day 1 

G1: 3.42 ± 2.83

G2: 2.82 ± 2.93

NS 

Day 2 

G1: 5.80 ± 2.89

G2: 5.77 ± 2.63

NS 

Day 3 

G1: 5.31 ± 2.66

G2: 4.34 ± 2.93

(P < 0.001) 

Day 4 

G1: 5.85 ± 3.23

G2: 3.93 ± 3.34

(P < 0.001) 

Day 5 

G1: 5.62 ± 2.94

G2: 3.38 ± 3.28

(P < 0.001) 

Day 6 

G1: 2.61 ± 2.34

G2: 2.28 ± 2.06

NS 

Long term

NR 

C-42 
Evidence Table 8. Key Question 3: Materials – Nonabsorbable versus absorbable (continued)

Sexual Function 

Outcomes Healing Outcomes

Incontinence and

Pelvic Floor 

Outcomes Other Outcomes

Quality and 

Comments 

Short term 

NR 

Long term: 4 mos

(quest) 

Coital assessment 

No pain at all 

G1: 21% 

G2: 11% 

P < 0.001 

Pain for <4 wks 

after initial coitus 

G1: 33% 

G2: 27% 

Pain for <8 wks 

after initial coitus 

G1: 33% 

G2: 45% 

P < 0.001 

Pain for > 8 wks 

after initial coitus 

G1: 13% 

G2: 17% 

P < 0.001 

No association

between timing of 

first coitus and 

presence or

persistence of 

dyspareunia

NR 

Short term 

NR 

Long term

NR

Short term 

NR 

Long term

NR

Short term 

NR 

Long term

NR

Overall quality

Fair 

Randomization 

approach and 

implementation 

Poor 

Masking

NR 

Operational 

definitions and 

measures 

Poor 

Postrandomization 

exclusions

No 

Retention of 

participants 

1 to 6 days: 

G1: 70 

G2: 70 

Total: 140 

4 mos 

G1: 45 (64%) 

G2: 55 (79%) 

Total: 100 

C-43 
Evidence Table 8. Key Question 3: Materials – Nonabsorbable versus absorbable (continued)

Study

Characteristics

Demographic

Characteristics

Labor and 

Delivery

Characteristics

Episiotomy and 

Repair 

Characteristics Pain Outcomes

Author 

Mahomed et al., 

1989 

Setting 

UK 

Study design 

RCT 

2x3x2 factorial 

Inclusion criteria 

Required perineal 

repair 

Exclusion 

criteria 

NR 

Groups

G1: PGA 

G2: CC 

G3: Silk 

N at 

randomization 

G1: 535 

G2: 522 

G3: 517 

Followup

3 mos 

Age (mean ± SD) 

G1: 26.1yrs ± 5.0 

G2: 26.2yrs ± 4.8 

G3: 26.2yrs ± 4.9 

Primiparous 

G1: 52% 

G2: 51% 

G3. 52% 

Mode of delivery

Operative vaginal 

deliveries 

G1: 27% 

G2: 21% 

G3: 21% 

Birthweight 

(mean ± SD) 

G1: 3386g ± 480 

G2: 3338g ± 472 

G3. 3358g ± 488 

Episiotomy rate 

G1: 

• Episiotomy alone: 52% 

• Episiotomy+ext: 13% 

• Tear: 35% 

G2: 

• Episiotomy alone: 50% 

• Episiotomy+ext: 13% 

• Tear: 37% 

G3: 

• Episiotomy alone: 50% 

• Episiotomy+ext: 12% 

• Tear: 38% 

Suture type 

Vagina, deep tissues 

G1: 

• PGA: 52% 

• CC: 48% 

G2: 

• PGA: 44% 

• CC: 55% 

G3: 

• PGA: 48% 

• CC: 51% 

Perineal skin

G1: 

• PGA: 87% 

• CC: 7% 

• Silk: 2% 

• None: 4% 

G2: 

• PGA: 3% 

• CC: 90% 

• Silk: 2% 

• None: 5% 

G3: 

• PGA: 2% 

• CC: 3% 

• Silk: 89% 

• None: 5% 

Skin closure

G1: 

• Subcut: 36% 

• Interr: 54% 

• Both: 6% 

• None: 3% 

G2: 

• Subcut: 36% 

• Interr: 56% 

• Both: 4% 

• None: 3% 

G3: 

• Subcut: 1% 

• Interr: 93% 

• Both: 0% 

• None: 4% 

Short term: 48 hrs

Use of oral analgesia 

(assessed by

postnatal staff or

community midwife) 

NS 

Perineal pain “now” 

measured 

NS 

Short term: Day 10 

(assessed by mother) 

Use of oral analgesia 

NS 

Perineal pain

None: NS 

Mild: NS 

Mod: NS 

Severe: NS 

Long term: 3 mos 

(assessed by mother) 

Perineal pain

None: NS 

Mild: NS 

Mod: NS 

Severe: NS 

C-44 
Evidence Table 8. Key Question 3: Materials – Nonabsorbable versus absorbable (continued)

Sexual Function 

Outcomes Healing Outcomes

Incontinence and

Pelvic Floor 

Outcomes Other Outcomes

Quality and 

Comments 

Short term

NR 

Long term: 3 mos

Sexual intercourse 

not resumed 

G1: 11% 

G2: 9% 

G3: 15% 

P < 0.05 between G2 

and G3 

Dyspareunia 

NS 

Short term: 48 hrs

Edema, bruising, 

healing (clinically

assessed) 

NS 

Long term

Absorbable 

material removed 

G1: 39% 

G2: 23% 

G3: 7% 

P < 0.001 

Long term: 3 mos

Resutured (quest) 

NS 

Short term

NR 

Long term

NR 

Short term

NR 

Long term

NR 

Overall quality

Good 

Randomization 

approach and 

implementation 

Good 

Masking

Good 

Operational 

definitions and 

measures 

Good 

Postrandomization 

exclusions

No 

Retention of 

participants 

48 hrs 

G1: 519 (97%)

G2: 505 (97%)

G3: 498 (96%) 

Total: 1522 (97%) 

Day 10 

G1: 450 (84%)

G2: 458 (88%)

G3: 444 (86%)

Total: 1352 (86%) 

3 mos 

G1: 458 (86%)

G2: 458 (88%)

G3: 450 (87%)

Total: 1366 (87%) 

C-45 
Evidence Table 9. Key Question 3: Materials – Polyglycolic acid versus chromic catgut 

Study

Characteristics

Demographic

Characteristics

Labor and Delivery

Characteristics

Episiotomy and 

Repair 

Characteristics Pain Outcomes

Author 

Upton et al., 2002 

Setting 

Australia 

Study design 

RCT 

Inclusion criteria 

• Singleton 

gestation 

• ≥ 34 wks 

• Episiotomy or 

first/sec deg 

laceration 

• Spont vaginal 

delivery 

Exclusion criteria 

• Third deg tear 

• Forceps/vacuum

(“instr delivery”) 

• Repair by

“medical officer” 

Groups

G1: PGA 

G2: CC 

N at randomization 

G1: 194 

G2: 197 

Total: 391 

Followup

6 mos 

Age (mean ± SD) 

G1: 29.6yrs ± 5.5 

G2: 29.5yrs ± 5.2 

NS 

Primiparous 

G1: 54.6% 

G2: 40.1% 

 

Mode of delivery

G1: Spont: 100% 

G2: Spont: 100% 

Birthweight (mean ± 

SD) 

G1: 3440g ± 467 

G2: 3410g ± 498

Estimated GA 

G1: 39.5wks ± 1.4 

G2: 39.4wks ± 1.4 

Episiotomy rate 

G1: 20.6% 

G2: 17.8% 

Lacerations

G1: 

• First deg: 11.9%

• Sec deg: 67.0% 

G2: 

• First deg: 10.7%

• Sec deg: 70.6% 

Suture method 

Interr for perineal 

muscle and subcut 

perineal skin (all 

repairs) 

Short term: 1 day

Any perineal pain 

G1: 71% 

G2: 76% 

OR: 0.75 

(0.47, 1.22) 

NS 

Mod to severe suture 

pain 

G1: 24% 

G2: 20% 

NS 

Short term: 3 days

Any perineal pain 

G1: 60% 

G2: 66% 

OR: 0.77 

(0.51, 1.17) 

Mod to severe suture 

pain 

G1: 9% 

G2: 8% 

NS 

Short term: 6 wks

Any perineal pain 

G1: 15% 

G2: 13% 

OR: 1.15 

(0.63, 2.07) 

NS 

Long term: 3 mos 

Any perineal pain 

G1: 10% 

G2: 8% 

OR: 1.3 

(0.62, 2.72) 

Long term: 6 mos

Any perineal pain 

G1: 6% 

G2: 3% 

OR: 1.86 

(0.61, 5.68) 

C-46 
Evidence Table 9. Key Question 3: Materials – Polyglycolic acid versus chromic catgut 

(continued)

Sexual Function 

Outcomes Healing Outcomes

Incontinence and

Pelvic Floor 

Outcomes Other Outcomes

Quality and 

Comments 

Short term 6 wks 

(int) 

Dyspareunia 

G1: 35% 

G2: 35% 

OR: 1.03 

(0.51, 2.12) 

Recommencement

of sexual 

intercourse

G1: 35% 

G2: 39% 

OR: 0.83 

(0.54, 1.27) 

Long term: 3 mos 

(int) 

Dyspareunia 

G1: 27% 

G2: 19% 

OR: 1.56 

(0.89, 2.76) 

Recommencement

of sexual 

intercourse

G1: 79% 

G2: 85% 

OR: 0.66 

(0.38, 1.16) 

Long term: 6 mos

Dyspareunia 

G1: 16% 

G2: 13% 

OR: 1.30 

(0.68, 2.50) 

Recommencement

of sexual 

intercourse

G1: 96% 

G2: 95% 

OR: 1.00 

(0.95, 1.05) 

NS 

Long term

NR 

Short term: 6 wks 

(measured by

quest) 

Problems with

sutures 

G1: 4.4% 

G2: 1.6% 

OR: 2.74 

(0.65, 13.26) 

Long term

NR 

Short term 

NR 

Long term

NR 

Short term 

NR 

Long term

NR 

Overall quality

Fair 

Randomization 

approach and 

implementation 

Fair 

Masking

Fair 

Operational 

definitions and 

measures 

Good 

Postrandomization 

exclusions

No 

Retention of 

participants 

Day 1 

G1: 172 (89%)

G2: 174 (88%)

Total: 346 (88%) 

Day 3 

G1: 187 (96%)

G2: 188 (95%)

Total: 375 (96%) 

6 wks 

G1: 184 (95%)

G2: 184 (93%)

Total: 368 (94%) 

3 mos 

G1: 167 (86%)

G2: 174 (88%)

Total: 341 (87%) 

6 mos 

G1: 158 (81%)

G2: 159 (81%)

Total: 317 (81%) 

C-47 
Evidence Table 9. Key Question 3: Materials – Polyglycolic acid versus chromic catgut 

(continued)

Study

Characteristics

Demographic

Characteristics

Labor and 

Delivery

Characteristics

Episiotomy and 

Repair 

Characteristics Pain Outcomes

Author 

Mackrodt et al.,

1998

Setting 

UK 

Study design 

RCT 

Inclusion criteria 

• First and sec 

deg laceration 

or episiotomy 

• Spont delivery

• Simple instr 

delivery (nonrotational 

forceps or 

vacuum 

extraction) 

Exclusion criteria 

NR 

Groups

G1: PGA sutures 

G2: CC sutures 

N at 

randomization 

G1: 889 

G2: 891 

Total: 1780 

Followup

3 mos 

Age (mean ± SD) 

G1: 28.2yrs ± 5.1 

G2: 28.4yrs ± 4.7 

Primiparous 

G1: 62% 

G2: 60% 

Mode of delivery

G1: 

• Spont: 82% 

• Instr: 18% 

G2: 

• Spont: 83% 

• Instr: 17% 

Birthweight 

(mean ± SD) 

G1: 3517g ± 480 

G2: 3492g ± 502 

Previous perineal

suturing 

G1: 36% 

G2: 37% 

Episiotomy rate 

G1: 39% 

G2: 35% 

Laceration

G1: 

• First deg: 1% 

• Sec deg: 59% 

• Third deg: 0% 

G2: 

• First deg: 2% 

• Sec deg: 62% 

• Third deg: 0% 

Suture type 

G1: 

• PGA: 98% 

• CC: 1% 

• Both: 1% 

G2: 

• PGA: 99% 

• CC: 1% 

• Both: 0% 

Method 

G1: 

• Subcut: 14% 

• Interr: 41% 

• 2-Stage only: 44%

• None: 1% 

G2: 

• Subcut: 13% 

• Interr: 42% 

• 2-Stage only: 44%

• None: 1% 

Short term: 24 hrs 

(int) 

Analgesia requirements 

G1: 42% 

G2: 7% 

P = 0.03 

Any pain 

Mild 

G1: 35% 

G2: 37% 

Mod 

G1: 21% 

G2: 28% 

Severe 

G1: 3% 

G2: 2% 

P (for trend) = 0.002 

Short term: 10 days 

(int) 

Analgesia requirements 

G1: 6% 

G2: 10% 

P = 0.01 

Any pain 

Mild 

G1: 14% 

G2: 17% 

Mod 

G1: 7% 

G2: 10% 

Severe 

G1: 2% 

G2: 2% 

P (for trend) = 0.05 

Short term: 24 hrs

Analgesia requirements 

NS 

Any pain 

Mild: NS 

Mod: NS 

Severe: NS 

Long term: 3 mos 

(quest) 

NS 

C-48 
Evidence Table 9. Key Question 3: Materials – Polyglycolic acid versus chromic catgut 

(continued)

Sexual Function 

Outcomes Healing Outcomes

Incontinence and

Pelvic Floor 

Outcomes 

Other 

Outcomes Quality and Comments 

Short term

NR 

Long term: 3

mos (quest) 

Timing of 

resumption of

sexual 

intercourse 

Tried but too 

painful: NS 

By 3 mos: NS 

By 2 mos: NS 

By 1 mo: NS 

Not known: NS

Dyspareunia at 

first, if resumed 

NS 

Dyspareunia 

now, if resumed 

Mild: NS 

Mod: NS 

Severe: NS 

Not known: NS

Failure to 

resume pain-free 

intercourse

NS 

Short term: 24 to 48 

hrs (int) 

Tight stitches 

G1: 17% 

G2: 23% 

P = 0.001 

Stitches not

comfortable

G1: 33% 

G2: 40% 

P = 0.003 

Short term: 24 to 48 

hrs (midwife exam) 

Appearance of 

perineum (gaping) 

NS 

Short term: 10 days

(int) 

Tight stitches 

NS 

Stitches not

comfortable

G1: 19% 

G2: 26% 

P < 0.001 

Appearance of 

perineum (midwife

exam) 

G1: 16% 

G2: 26% 

P < 0.00001 

Nature of healing 

(midwife exam) 

First intention 

G1: 84% 

G2: 74% 

P < 0.00001 

Sec intention

NS 

Breaking down

NS 

Sutures removed 

NS 

Long term: 3 mos

(quest) 

Suture material 

removed at any

time 

G1: 12% 

G2: 7% 

P = 0.002 

Resutured

NS

Short term

NR 

Long term

NR 

Short term

NR 

Long term

NR 

Overall quality

Good 

Randomization approach

and implementation 

Good 

Masking 

Good 

Operational definitions and 

measures 

Good 

Post-randomization 

exclusions

No 

Retention of participants

24 to 48 hrs 

G1: 886 (100%)

G2: 888 (100%)

Total: 1774 (100%) 

10 days

G1: 884 (99%)

G2: 887 (99%)

Total: 1771 (99%) 

3 mos 

G1: 829 (93%)

G2: 835 (94%)

Total: 1664 (93%) 

C-49 
Evidence Table 9. Key Question 3: Materials – Polyglycolic acid versus chromic catgut 

(continued)

Study

Characteristics

Demographic

Characteristics

Labor and 

Delivery

Characteristics

Episiotomy and 

Repair 

Characteristics Pain Outcomes

Author 

Grant et al., 2001 

Setting 

UK 

Study design 

RCT 

Inclusion criteria 

• First and sec 

deg laceration or 

episiotomy 

• Spont delivery

• Simple instr 

delivery (nonrotational 

forceps or 

vacuum 

extraction) 

Exclusion criteria 

NR 

Groups

G1: PGA sutures 

G2: CC sutures 

N at 

randomization 

G1: 889 

G2: 891 

Total: 1780 

Followup

1 yr

N eligible at 

followup 

G1: NR 

G2: NR 

Total: 919 

Note: The 1-yr

postpartum 

followup was not

part of the original 

plan for the study. 

All women 

recruited after June 

1993 who had 

responded at the 

3-mo followup 

were eligible for 1-

yr followup (n = 

919). 

Age (mean ± SD) 

G1: 28.5yrs ± 5.0 

G2: 29.2yrs ± 4.6 

Primiparous 

G1: 65% 

G2: 64% 

Previous perineal

suturing 

G1: 33% 

G2: 33% 

Mode of delivery

G1: 

• Spont: 68% 

• Instr: 32% 

G2: 

• Spont: 70% 

• Instr: 30% 

Birthweight 

(mean ± SD) 

G1: 3556g ± 504 

G2: 3504g ± 512 

Episiotomy rate 

G1: 48% 

G2: 43% 

Laceration

G1: 

• First deg: 1% 

• Sec deg: 50% 

• Third deg: 1% 

G2: 

• First deg: 2% 

• Sec deg: 65% 

• Third deg: 0% 

Repair by

G1: 

• Student: 1% 

• Midwife: 60% 

• Registrar: 34%

• SHO: 6% 

G2: 

• Student: 1% 

• Midwife: 62% 

• Registrar: 30%

• SHO: 7% 

Suture type 

G1: 

• PGA: 99% 

• CC: 1% 

• Both: 1% 

G2: 

• PGA: 1% 

• CC: 99% 

• Both: 1% 

Suture method 

G1: 

• Subcut: 21% 

• Interr: 34% 

• 2-Stage only: 45%

• None: 0% 

G2: 

• Subcut: 15% 

• Interr: 38% 

• 2-Stage only: 45%

• None: 1% 

Long term: 1 yr (quest) 

Pain or general 

discomfort where 

stitched

Mild: NS 

Mod: NS 

Severe: NS 

C-50 
Evidence Table 9. Key Question 3: Materials – Polyglycolic acid versus chromic catgut 

(continued)

Sexual Function Repair and Healing Incontinence

Other 

description of

Outcome Quality and Comments 

Long term: 1 yr

(quest) 

Timing of 

resumption of

sexual 

intercourse 

Tried but too 

painful: NS 

By 6 mos: NS 

By 3 mos: NS 

Could not 

remember: NS

No partner: NS 

Not known: NS

Dyspareunia at 

first, if resumed 

G1: 32% 

G2: 41% 

P = 0.01 

Dyspareunia 

now, if resumed 

G1: 8% 

G2: 13% 

P = 0.02 

Failure to 

resume painfree intercourse 

G1: 8% 

G2: 14% 

P = 0.01 

Long term: 1 yr

(quest) 

Area cut or torn 

feels different

G1: 31% 

G2: 38% 

P = 0.07 

Resutured

NS 

Long term

NR 

Long term

NR 

Overall quality

Good 

Randomization approach

and implementation 

Good 

Masking 

Good 

Operational definitions and 

measures 

Good 

Post-randomization 

exclusions

No 

Retention of participants

1 yr 

G1: 395 

G2: 398 

Total: 793 (86%) 

C-51 
Evidence Table 9. Key Question 3: Materials – Polyglycolic acid versus chromic catgut 

(continued)

Study

Characteristics

Demographic

Characteristics

Labor and 

Delivery

Characteristics

Episiotomy and 

Repair 

Characteristics Pain Outcomes 

Author 

Olah, 1990 

Setting 

UK 

Study design 

RCT 

Inclusion criteria 

Require 

episiotomy repair 

following instr 

delivery (forceps 

or venthouse 

extraction) 

Exclusion criteria 

NR 

Groups

G1: CC 

G2: PGA 

N at 

randomization 

G1: 60 

G2: 60 

Total: 120 

Followup

5 days 

Age (mean ± SD) 

G1: 26.5yrs ± 5.1 

G2: 27.0yrs ± 5.0 

Primiparous 

G1: 47% 

G2: 45% 

Mode of delivery

Instr 100% for both 

groups 

Anesthesia at time 

of delivery

G1: 22% epidural/ 

spinal anesthesia 

G2: 26% epidural/ 

spinal anesthesia 

Estimated GA

• 39.5wks ± 1.2 

• 39.8wks ± 1.1 

Birthweight (mean ± 

SD) 

G1: 3.4kg ± 0.4 

G2: 3.4kg ± 0.4 

Episiotomy rate: 

G1: Type not 

specified 100% 

G2: Type not 

specified 100% 

Ext of episiotomy

G1: 4% 

G2: 6% 

Short term: Days 1 to 5 

Patient’s subjective 

assessment of 

discomfort/pain using a 

10cm visual analog scale on

(mean ± SD) 

Day 1 

NS 

Day 3 

NS 

Day 5 

NS 

Long term

NR 

C-52 
Evidence Table 9. Key Question 3: Materials – Polyglycolic acid versus chromic catgut 

(continued)

Sexual Function 

Outcomes Healing Outcomes 

Incontinence and

Pelvic Floor 

Outcomes Other Outcomes

Quality and 

Comments 

Short term

NR 

Long term

NR 

Short term

Edema (observer 

assessment, 0 

(none) to 3 (severe)) 

NS 

Bruising (observer 

assessment, 0 

(none) to 3 (severe)) 

NS 

Long term

NR 

Short term

NR 

Long term

NR 

Short term

NR 

Long term

NR 

Overall quality

Fair 

Randomization 

approach and 

implementation 

Fair 

Masking 

NR 

Operational 

definitions and 

measures 

Good 

Postrandomization 

exclusions

No 

Retention of 

participants 

1 day 

G1: 60 (100%)

G2: 60 (100%)

Total: 120 (100%) 

(Assumed, not 

stated) 

3 days 

G1: 60 (100%)

G2: 60 (100%)

Total: 120 (100%) 

(Assumed, not 

stated) 

5 days 

G1: 60 (100%)

G2: 60 (100%)

Total: 120 (100%) 

(Assumed, not 

stated) 

C-53 
Evidence Table 9. Key Question 3: Materials – Polyglycolic acid versus chromic catgut 

(continued)

Study

Characteristics

Demographic

Characteristics

Labor and 

Delivery

Characteristics

Episiotomy and 

Repair 

Characteristics Pain Outcomes 

Author 

Mahomed, 1989 

Setting 

UK 

Study design 

RCT 

2x3x2 factorial 

Inclusion criteria 

Required perineal 

repair 

Exclusion criteria 

NR 

Groups

G1: PGA 

G2: CC 

N at 

randomization 

G1: 796 

G2: 778 

Total: 1574 

Followup

3 mos 

Age (mean ± SD or

median) 

G1: 26.0yrs ± 4.9 

G2: 26.1yrs ± 4.9 

Primiparous 

G1: 53% 

G2: 50% 

Mode of delivery

Operative vaginal 

delivery

G1: 23% 

G2: 23% 

Birthweight 

(mean ± SD) 

G1: 3371g ± 488 

G2: 3350g ± 475

Episiotomy rate 

G1: 

• Episiotomy alone: 49%

• Episiotomy+ext: 13% 

• Tear: 38% 

G2: 

• Episiotomy alone: 52%

• Episiotomy+ext: 12% 

• Tear: 35% 

Suture type

Vagina, deep tissues 

G1: 

• PGA: 93% 

• CC: 7% 

G2: 

• PGA: 2% 

• CC: 98% 

Perineal skin

G1: 

• PGA: 35% 

• CC: 30% 

• Silk: 31% 

• None: 4% 

G2: 

• PGA: 28% 

• CC: 36% 

• Silk: 31% 

• None: 5%

Skin closure

G1: 

• Subcut: 25% 

• Interr: 68% 

• Both: 3% 

• None: 3% 

G2: 

• Subcut: 25% 

• Interr: 67% 

• Both: 4% 

• None: 4% 

Midwife 

G1: 30% 

G2: 30% 

SHO 

G1: 55% 

G2: 57% 

GP 

G1: 4% 

G2: 3% 

Registrar 

G1: 11% 

G2: 9% 

Student 

G1: 0% 

G2: 0% 

Short term: 48 hrs

Use of oral analgesia 

(assessed by postnatal 

staff or community

midwife) 

G1: 48% 

G2: 54% 

RR = 0.9 

(0.8, 1.0) 

P = 0.03

Perineal pain “now” 

measured 

NS 

Short term: 10 days

Use of oral analgesia 

NS 

Perineal pain (assessed

by mother) 

None: NS 

Mild: NS 

Mod: NS 

Severe: NS 

Long term: 3 mos 

Perineal pain (assessed

by mother) 

None: NS 

Mild: NS 

Mod: NS 

Severe: NS 

C-54 
Evidence Table 9. Key Question 3: Materials – Polyglycolic acid versus chromic catgut 

(continued)

Sexual Function 

Outcomes Healing Outcomes

Incontinence and

Pelvic Floor 

Outcomes Other Outcomes

Quality and 

Comments 

Long term: 3 mos

Sexual intercourse 

not resumed 

NS 

Dyspareunia 

NS 

Short term: 48 hrs

(clinically

assessed) 

Edema, bruising, 

healing 

NS 

Short term: 10 days

Edema, bruising, 

healing 

NS

Long term

Absorbable 

material removed 

G1: 25% 

G2: 21% 

RR = 1.2 

(1.0, 1.5) 

P = 0.06 

Long term: 3 mos

(quest) 

Resutured

NS 

Short term

NR 

Long term

NR 

Short term

NR 

Long term

NR 

Overall quality

Good 

Randomization 

approach and 

implementation 

Good 

Masking 

Good 

Operational 

definitions and 

measures 

Good 

Postrandomization 

exclusions

No 

Retention of 

participants 

2 days

G1: 768 (96%)

G2: 752 (97%)

Total: 1520 (97%) 

10 days 

G1: 679 (85%)

G2: 670 (86%)

Total: 1349 (86%)

3 mos 

G1: 687 (86%)

G2: 679 (87%)

Total: 1366 (87%) 

C-55 
Evidence Table 9. Key Question 3: Materials – Polyglycolic acid versus chromic catgut 

(continued)

Study

Characteristics

Demographic

Characteristics

Characteristics of

Labor, Delivery and 

Repair 

Episiotomy and 

Repair 

Characteristics Pain Outcomes

Author 

Ping and Kee, 

1975 

Setting 

Malaysia 

Study design 

RCT 

Inclusion criteria 

Mediolateral 

episiotomy 

Exclusion criteria 

• Additional 

lacerations 

• Exts 

Groups

G1: PGA (Dexon) 

G2: CC (Ethicon) 

N at 

randomization 

G1: 61 

G2: 61 

Total: 122 

Note: Not explicitly

stated but can be 

inferred from first 

paragraph of 

results section 

Followup

18 to 36 hrs 

Age (mean ± SD) 

G1: 26.7yrs ± 4.9 

G2: 26.4yrs ± 4.8

Primiparous 

G1: Nulliparous: 59% 

G2: Nulliparous: 65% 

Mode of delivery

G1: 

• Spont: 66% 

• Vacuum: 8%, 

• Forceps: 23% 

• Breech: 3% 

G2: 

• Spont: 59% 

• Vacuum: 8% 

• Forceps: 26% 

• Breech: 7% 

Birthweight 

NR 

Episiotomy rate 

(all mediolateral 

G1: 100% 

G2: 100% 

Short term (NR)

Patients without pain at 

the episiotomy site

G1: 13% 

G2: 1.6% 

P < 0.05 

Deg of pain at

episiotomy site 

Note: 

1 = mild pain, only

volunteered on

questioning; 2 = mod pain, 

complained of when 

patient moved; 3 = severe, 

discomfort even at rest, 

needing analgesics 

G1: 1.207 

G2: 1.666 

P < 0.05 

Long term

NR 

C-56 
Evidence Table 9. Key Question 3: Materials – Polyglycolic acid versus chromic catgut 

(continued)

Sexual Function 

Outcomes Healing Outcomes

Incontinence and

Pelvic Floor 

Outcomes Other Outcomes

Quality and 

Comments 

Short term 

NR 

Long term

NR 

Short term 

NR 

Long term

NR 

Short term 

NR 

Long term

NR 

Short term: (3 days) 

Ease of movement

Good 

G1: 66% 

G2: 56% 

Restricted

G1: 18% 

G2: 56% 

Very restricted

G1: 0% 

G2: 5% 

P < 0.01 

Long term

NR 

Overall quality

Fair 

Randomization 

approach and 

implementation 

Fair 

Masking

NR 

Operational 

definitions and 

measures 

Good 

Postrandomization 

exclusions

No 

Retention of 

participants 

18 to 36 hrs 

G1: 61 (100%)

G2: 61 (100%)

C-57 
Evidence Table 9. Key Question 3: Materials – Polyglycolic acid versus chromic catgut 

(continued)

Study

Characteristics

Demographic

Characteristics

Labor and 

Delivery

Characteristics

Episiotomy and 

Repair 

Characteristics Pain Outcomes*

Author 

Rogers, 1974

Setting 

USA 

Study design 

RCT 

Inclusion 

criteria 

Episiotomy

Exclusion 

criteria 

NR 

Groups

G1: PGA 

G2: CC 

N at 

randomization 

G1: 299 

G2: 301 

Note: These 

numbers were 

not explicitly

stated in the 

article but can be 

inferred from the 

first paragraph of 

the results 

section 

Followup

NR 

Age (mean ± SD) 

G1: 23.5yrs ± 4.5 

G2: 22.8yrs ± 4.7 

Parity

NR 

Mode of delivery

G1: NR 

G2: NR 

Birthweight 

NR 

Episiotomy rate 

Midline 

G1: 90% 

G2: 88% 

Short term: 6 wks 

Pain absent in stitches 

G1: 48% 

G2: 25% 

P < 0.001 

Deg of pain in stitches 

G1: 3.35 

G2: 7.08 

P < 0.001 

Subanalysis by type of 

episiotomy

Deg of pain for median

episiotomies only

Stitches 

G1: 3.13 

G2: 6.39 

P <0.001 

Deg of pain for 

mediolateral episiotomies 

only

Stitches 

G1: 5.33 

G2: 12.03 

P <0.001 

Subanalysis by

complication in delivery

Deg of pain in stitches in 

complicated delivery

G1: 4.06 

G2: 7.75 

P < 0.05 

Deg of pain in stitches in 

uncomplicated delivery

G1: 3.26 

G2: 7.01 

P < 0.001 

Long term

NR 

*Note: Definition: At time of 

analgesic request up to 6 

wks, deg of pain calculated 

as a relative pain code 

(1 = mild, 2 = mod, 

3 = severe) summed 

across each site and 

divided by total N; in 

addition, a total pain factor 

entered by experienced 

obstetric nurses

C-58 
Evidence Table 9. Key Question 3: Materials – Polyglycolic acid versus chromic catgut 

(continued)

Sexual Function 

Outcomes Healing Outcomes

Incontinence and

Pelvic Floor 

Outcomes Other Outcomes

Quality and 

Comments 

Short term 

NR 

Long term

NR 

Short term 

NR 

Long term

NR 

Short term 

NR 

Long term

NR 

Short term 

NR 

Long term

NR 

Overall quality

Poor 

Randomization 

approach and 

implementation 

Poor (suture 

materials in 

envelopes) 

Masking

NR 

Operational 

definitions and 

measures 

Fair 

Postrandomization 

exclusions

No 

Retention of 

participants 

NR 

C-59 
Evidence Table 9. Key Question 3: Materials – Polyglycolic acid versus chromic catgut 

(continued)

Study

Characteristics

Demographic

Characteristics

Labor and 

Delivery

Characteristics

Episiotomy and 

Repair 

Characteristics Pain Outcomes

Author 

Livingstone et al., 

1974 

Setting 

Scotland 

Study design 

RCT 

Inclusion criteria 

• Primigravidae 

• Mediolateral 

episiotomy 

Exclusion criteria 

• Additional 

lacerations 

• If episiotomy 

extended 

Groups

G1: PGA (Dexon) 

G2: Catgut 

(Ethicon) 

N at 

randomization 

G1: 50 

G2: 50 

Followup

3 days 

Age 

NR 

Parity

NR 

Mode of delivery

G1: 

• Spont: 40% 

• Forceps or 

venthouse: 38% 

• Rotation and 

forceps: 22% 

G2: 

• Spont: 36% 

• Forceps or 

venthouse: 46% 

• Rotation and 

forceps: 18% 

Birthweight 

(mean ± SD) 

NR 

Episiotomy rate 

Mediolateral 

G1: 100% 

G2: 100% 

Short term: Day 3 

Pain definition: Measured by

interview using a card with a 

short explanation and a choice

of deg of pain felt 

No pain 

G1: 22% 

G2: 4% 

Uncomfortable

G1: 56% 

G2: 48% 

Painful 

G1: 18% 

G2: 26% 

Very painful 

G1: 4% 

G2: 14% 

Unbearably painful 

G1: 0% 

G2: 8% 

P < 0.005 

Long term

NR 

C-60 
Evidence Table 9. Key Question 3: Materials – Polyglycolic acid versus chromic catgut 

(continued)

Sexual Function 

Outcomes Healing Outcomes

Incontinence and

Pelvic Floor 

Outcomes Other Outcomes

Quality and 

Comments 

Short term 

NR 

Long term

NR 

Short term: Day 3 

(exam) 

Stitch line integrity 

NS 

Edema at 

perineotomy site

None

G1: 86% 

G2: 64% 

Mod 

G1: 14% 

G2: 32% 

Marked

G1: 0% 

G2: 4% 

Long term

NR 

Short term 

NR 

Long term

NR 

Short term: Day 3 

(exam) 

Ease of movement 

Good 

G1: 68% 

G2: 52% 

Restricted 

G1: 28% 

G2: 40% 

Very restricted

G1: 4% 

G2: 4% 

Bad 

G1: 0 

G2: 4% 

Long term

NR 

Overall quality

Poor 

Randomization 

approach and 

implementation 

Poor (lottery

cards) 

Masking

Good 

Operational 

definitions and 

measures 

Good 

Postrandomization 

exclusions

No 

Retention of 

participants 

Good 

Day 3 

G1: 100 (100%)

G2: 100 (100%)

Total: 200 (100%) 

C-61 
Evidence Table 9. Key Question 3: Materials – Polyglycolic acid versus chromic catgut 

(continued)

Study

Characteristics

Demographic

Characteristics

Labor and 

Delivery

Characteristics

Episiotomy and 

Repair 

Characteristics Pain Outcomes

Author 

Beard et al., 1974 

Setting 

UK 

Study design 

RCT 

Inclusion criteria 

• Mediolateral 

episiotomy 

• Normal deliveries 

Exclusion criteria 

• Patients with 

lacerations or those 

booked for 48-hr 

discharge 

Groups

G1: PGA 

G2: CC 

N at randomization 

G1: 100 

G2: 100 

Followup

3 days 

Age 

NR 

Primiparous 

G1: 53% 

 

G2: 48% 

Mode of delivery

NR 

Birthweight 

NR 

Episiotomy rate 

Mediolateral 

G1: 100% 

G2: 100% 

Short term: Days 1 to 3 

N in each pain category 

Days 1 to 2 

NS 

Day 3 

G1: 

• None: 36 

• Slight: 54 

• Mod: 10 

• Severe: 0 

G2: 

• None: 28 

• Slight: 45 

• Mod: 23 

• Severe: 4 

0.02 > P > 0.01

Short term: 3 days

N of patients in perineal pain

category 

G1: 

• None/slight: 90

• Mod/severe: 10 

G2: 

• None/slight: 73

• Mod/severe: 27 

P > 0.01 

Short term: Day 1

N of patients requiring

analgesia 

None

G1: 49 

G2: 31 

Tablets

G1: 46 

G2: 69 

Injections 

G1: 5 

G2: 0 

P < 0.01 

Short term: Day 2

N of patients requiring

analgesia 

None

G1: 63 

G2: 43 

Tablets

G1: 36 

G2: 57 

Injections 

G1: 2 

G2: 0 

P < 0.02

C-62 
Evidence Table 9. Key Question 3: Materials – Polyglycolic acid versus chromic catgut 

(continued)

Sexual Function 

Outcomes Healing Outcomes

Incontinence and

Pelvic Floor 

Outcomes Other Outcomes

Quality and 

Comments 

Short term 

NR 

Long term

NR 

Short term

• Wound breakdown: NS 

• Inflammation: NS 

Long term

NR 

Short term 

NR 

Long term

NR 

Short term 

NR 

Long term

NR 

Overall quality

Fair 

Randomization 

approach and 

implementation 

Poor 

Masking

Good 

Operational 

definitions and 

measures 

Good 

Postrandomization 

exclusions

No 

Retention of 

participants 

3 days

G1: 100 (100%

G2: 100 (100%)

Total: 200 (100%) 

C-63 
Evidence Table 9. Key Question 3: Materials – Polyglycolic acid versus chromic catgut 

(continued)

Study

Characteristics

Demographic

Characteristics

Labor and 

Delivery

Characteristics

Episiotomy and 

Repair 

Characteristics Pain Outcomes

Author 

Beard et al., 1974 

(continued) 

Short term: Day 3

N of patients requiring

analgesia 

NS 

Short term: Days 1 to 3

N of patients requiring

analgesia 

None

G1: 191 

G2: 138 

Tablets

G1: 103 

G2: 162 

Injections 

G1: 7 

G2: 0 

P < 0.001

Long term

NR

C-64 
Evidence Table 9. Key Question 3: Materials – Polyglycolic acid versus chromic catgut 

(continued)

Sexual Function 

Outcomes Healing Outcomes

Incontinence and

Pelvic Floor 

Outcomes Other Outcomes

Quality and 

Comments 

C-65 
Evidence Table 10. Key Question 3: Combination of methods and materials 

Study

Characteristics

Demographic

Characteristics

Labor and 

Delivery

Characteristics

Episiotomy and 

Repair 

Characteristics Pain Outcomes 

Author 

Doyle et al., 1993 

Setting 

UK 

Study design 

RCT 

Inclusion criteria 

Female with

perineal trauma 

following childbirth 

that required a 

surgical repair 

Groups

G1: 

• Vagina: Cont CC 

• Skin: 2-layer 

interr CC 

G2: 

• Vagina: Cont CC 

• Skin: Subcut 

Prolene suture

N at 

randomization 

G1: 95 

G2: 104 

Total: 199 

Followup

3 mos 

Age at enrollment 

NR 

Primiparous 

G1: 68% 

G2: 76% 

Other 

demographics

Previous repair 

G1: 31% 

G2: 18% 

Mode of 

delivery

Normal delivery

G1: 58% 

G2: 45% 

Other baseline 

differences in

clinical 

characteristics 

NS 

Birthweight 

NR 

NR Short term: Day 3 

Perineal pain

Mild: NS 

Mod: NS 

Severe: NS 

“Analgesia” 

Mild: NS 

Mod: NS 

Severe: NS 

Short term: Day 10

Perineal pain

Mild: NS 

Mod: NS 

Severe: NS 

“Analgesia” 

Mild: NS 

Mod: NS 

Severe: NS 

Long term: 3 mos

(quest) 

Perineal pain

Mild: NS 

Mod: NS 

Severe: NS 

C-66 
Evidence Table 10. Key Question 3: Combination of methods and materials (continued)

Sexual Function 

Outcomes Healing Outcomes

Incontinence and

Pelvic Floor 

Outcomes Other Outcomes

Quality and 

Comments 

Short term

NR 

Long term: 3 mos 

(assessed by quest) 

Pain 

NS 

Intercourse yet 

NS 

Painful now

NS 

Mild, mod, severe 

Mild: NS 

Mod: NS 

Severe: NS 

Short term: Day 3

Bruising 

NS 

Long term

NR 

Short term

NR 

Long term

NR 

Short term

NR 

Long term

NR 

Overall quality

Poor 

Randomization 

approach and 

implementation 

Fair 

Masking

NR 

Operational 

definitions and 

measures 

Good 

Post-randomization 

exclusions

Yes: Loss-to-followup (n = 2), declined 

after randomization (n 

= 2), third deg tear (n 

= 1)

3 days

G1: 72 

G2: 82 

Total: 154 (77%) 

10 days

G1: 40 (42%) 

G2: 58 (56%) 

Total: 98 (49%) 

3 mos 

G1: 58 (61%) 

G2: 76 (73%) 

Total: 132 (66%) 

Retention of 

participants 

Note: The text reports 

total followup of 153 

but the tables show a 

total of 154. 

3 days

Total: 153 (77%) 

10 days

Total: 98 (50%) 

3 mos 

Total: 132 (66%) 

C-67 
Evidence Table 10. Key Question 3: Combination of methods and materials (continued)

Study Characteristics 

Demographic

Characteristics

Labor and 

Delivery

Characteristics

Episiotomy and 

Repair 

Characteristics Pain Outcomes

Author 

Isager-Sally et al., 1986 

Setting 

Denmark 

Study design 

RCT 

Inclusion criteria 

Mediolateral episiotomy

Exclusion criteria 

NR 

Groups

G1: 

• Vagina: Cont catgut 

• Muscle: Interr catgut 

• Skin: Interr nylon 

G2: 

• Vagina: Cont PGA 

• Muscle: Interr PGA 

• Skin: Interr PGA 

G3: 

• Vagina: Subcut PGA 

• Muscle: Subcut PGA 

• Skin: Subcut PGA 

N at randomization 

Total: 802 

G1: 272 

G2: 263 

G3: 267 

Note: 900 women were 

randomized but 98 

were excluded because 

they transferred to 

another hospital or left 

the hospital before the 

fifth day after delivery.

Three groups did not 

differ in age, parity, or 

frequency of previous 

episiotomy. 

Followup

3 mos 

Age (mean) 

G1: 27.0 yrs 

G2: 27.5 yrs 

G3: 27.1 yrs 

Primiparous 

G1: 60% 

G2: 60% 

G3: 61% 

Previous

episiotomy

G1: 34% 

G2: 31% 

G3: 33% 

Mode of 

delivery

NR 

Episiotomy

alone

G1: 95% 

G2: 93% 

G3: 95% 

Episiotomy and 

tear of perineal 

muscle 

G1: 3% 

G2: 5% 

G3: 4% 

Episiotomy and 

partial tear of 

sphincter 

G1: 2% 

G2: 2% 

G3: 2% 

Short term: 5 days

Perineal pain

No discomfort 

G1: 12% 

G2: 18% 

G3: 40% 

P < 0.001 

G3 was better 

Slight discomfort 

G1: 60% 

G2: 59% 

G3: 49% 

P < 0.001 

G3 was better 

Pain 

G1: 25% 

G2: 21% 

G3: 8% 

P < 0.001 

G3 was better 

Severe pain 

G1: 2% 

G2: 2% 

G3: 1% 

P < 0.001 

G3 was better 

Hurts when sitting

G1: 59% 

G2: 53% 

G3: 28% 

P < 0.001 

G3 was better 

Hurts when walking

G1: 42% 

G2: 37% 

G3: 29% 

Hurts during bowel motion

G1: 17% 

G2: 13% 

G3: 6% 

P < 0.001 

G3 was better 

Long term

NR 

C-68 
Evidence Table 10. Key Question 3: Combination of methods and materials (continued)

Sexual Function 

Outcomes Healing Outcomes 

Incontinence and

Pelvic Floor 

Outcomes Other Outcomes

Quality and 

Comments 

Short term 

NR 

Long term: 3 mos

(quest) 

Dyspareunia 

G1: 21% 

G2: 23% 

G3: 17% 

(No individual 

statistic reported. 

Combined with other 

complaints and

tested, P < 0.025 for 

G2 vs. G3) 

Short term: 5 days 

(exam) 

Edema of perineum 

G1: 30% 

G2: 23% 

G3: 11% 

P < 0.005 

G3 was better 

Infection of the

wound 

NS 

Hematoma 

NS 

Long term: 3 mos

(quest) 

Cosmetically

unsatisfactory: 

G1: 5% 

G2: 6% 

G3: 3% 

(No individual 

statistic reported. 

Combined with other 

complaints and

tested, P < 0.025 for 

G2 vs. G3) 

Short term 

NR 

Long term: 3 mos

(quest) 

Discomfort with 

defecation

G1: 5% 

G2: 8% 

G3: 4% 

(No individual 

statistic reported. 

Combined with other 

complaints and

tested, P < 0.025 for 

G2 vs. G3) 

Incontinence or

flatus 

G1: 14% 

G2: 20% 

G3: 13% 

(No individual 

statistic reported. 

Combined with other 

complaints and

tested, P < 0.025 for 

G2 vs. G3) 

Discomfort when

sitting 

G1: 2% 

G2: 1% 

G3: 2% 

(No individual 

statistic reported. 

Combined with other 

complaints and

tested, P < 0.025 for 

G2 vs. G3) 

Discomfort during 

micturation 

G1: 2% 

G2: 1% 

G3: 2% 

(No individual 

statistic reported. 

Combined with other 

complaints and

tested, P < 0.025 for 

G2 vs. G3) 

Overall quality

Fair 

Randomization 

app and imp 

Good 

Masking

Good 

Operational defs 

and measures

No 

Postrandomization 

exclusions

Yes (98 women 

who left hospital 

before follow-up) 

Retention of 

participants 

3 days

G1: 272 (100%)

G2: 263 (100%)

G3: 267 (100%)

Total: 802 (100%) 

5 days

G1: 272 (100%)

G2: 263 (100%)

G3: 267 (100%)

Total: 802 (100%) 

3 mos 

G1: 266 (100%)

G2: 250 (100%)

G3: 265 (100%)

Total: 802 (100%) 

C-69 
Evidence Table 11. Key Question 4: Urinary incontinence, fecal incontinence, and pelvic floor 

defects 

Study Characteristics Demographic Characteristics

Labor, Delivery, and Repair 

Characteristics

Author 

Sleep et al., 1984 

Setting 

UK 

Study design 

RCT 

Inclusion criteria 

• Live singleton fetus of at least 

37 wks GA 

• Presented cephalically

• Spont vaginal delivery expected 

at end of sec stage labor 

Exclusion criteria 

• Elected episiotomy

• No consent 

• Private patient

• Precipitate delivery

Groups

G1: Liberal (instructed to “try to 

prevent a tear”) 

G2: Restrictive (instructed to “try to 

avoid episiotomy and restrict 

episiotomy to fetal indications”) 

N at enrollment 

G1: 502 

G2: 498 

Total: 1000 

Followup

10 days to 3 mos

Age (mean ± SD) 

G1: 26.7yrs ± 5.3y

G2: 26.6yrs ± 5.2y

Primiparous 

G1: 46.3% 

G2: 40.4% 

Delivery by

Student and midwife 

G1: 35.9% 

G2: 35.2% 

Midwife 

G1: 32.1% 

G2: 30.1% 

Obstetrician

G1: 1.8% 

G2: 8% 

Other (“sister”) 

G1: 31.3% 

G2: 32.7% 

Episiotomy rate (all mediolateral) 

G1: 51.4% 

G2: 10.2% 

Estimated GA

G1: 39.8wks ± 1.2 

G2: 39.8wks ± 1.2 

Birthweight (mean ± SD) 

G1: 3367g ± 4.38 

G2: 3393g ± 4.48 

C-70 
Evidence Table 11. Key Question 4: Urinary incontinence, fecal incontinence, and pelvic floor 

defects (continued)

Perineal Trauma Outcomes 

Incontinence and Pelvic Floor 

Outcomes Quality and comments 

Third/fourth deg tear 

(ext through anal sphincter or through 

to the rectal mucosa or to the upper 

third of vagina)

G1: 1 

G2: 4 

Anterior labial tears 

G1: 17.3% 

G2: 26.3% 

P < 0.00l 

RR = 1.52 

(1.19 to 1.94)

Short term: 3 mos

Involuntary loss of urine 

G1: 19% 

G2: 19% 

NS 

Need to wear pad for loss of urine 

G1: 69% 

G2: 6% 

NS 

Long term

NR 

Overall quality

Good 

Population 

Good 

Measures 

Good 

Analysis 

Good 

Retention of participants

Good 

C-71 
Evidence Table 11. Key Question 4: Urinary incontinence, fecal incontinence and pelvic floor 

defects (continued)

Study Characteristics Demographic Characteristics

Labor, Delivery, and Repair 

Characteristics

Author 

Gordon and Logue, 1985 

Setting 

UK 

Study design 

Prospective cohort 

Inclusion criteria 

• Participation in a prior 

prospective study of perineal 

wound healing

• European primipara 

• All degs of perineal trauma 

Exclusion criteria 

NR 

Groups

G1: Intact perineum 

G2: Sec deg perineal laceration 

G3: Episiotomy assisted with 

normal vaginal delivery 

G4: LSCS 

N at enrollment 

G1: 14

G2: 14

G3: 14

G4: 14

Control: 14

Total: 70

Followup

1 yr

Age 

NS, details NR

Primiparious 

100% 

Mode of delivery

Spont 

G1: Spont: 100% 

G2: Spont: 100% 

G3: Spont: 100% 

G4: Cesarean: 100% 

Birthweight (mean ± SD) 

NS, details NR

Suture type 

NR 

C-72 
Evidence Table 11. Key Question 4: Urinary incontinence, fecal incontinence and pelvic floor 

defects (continued)

Perineal Trauma Outcomes

Incontinence and Pelvic Floor 

Outcomes Quality and Comments 

Short term 

NR 

Long term

NR 

Short term 

NR 

Long term

NR 

Overall quality

Poor

Population 

Poor

Measures 

Fair: Operator performing repair 

blind to allocation, mother in most 

cases blind to allocation 

Analysis 

Poor 

Retention of participants 

Good 

C-73 
Evidence Table 11. Key Question 4: Urinary incontinence, fecal incontinence and pelvic floor 

defects (continued)

Study Characteristics Demographic Characteristics

Labor, Delivery, and Repair 

Characteristics

Author 

Sleep et al., 1987 

Setting 

UK 

Study design 

RCT 

Inclusion criteria 

Ability to find address 

Exclusion criteria 

• 8 spoke little English 

• 3 gave babies up for adoption

• 1 baby was given to social

services 

• 1 neonatal death 

• 2 refused 

Groups

G1: Restricted 

G2: Liberal 

N at enrollment 

G1: 329 

G2: 345 

Total: 674 

Age (mean ± SD) 

NS 

G1: 27.0yrs ± 4.9 

G2: 27.0yrs ± 5.0 

Primiparous 

G1: 41% 

G2: 44% 

Percent unmarried 

G1: 91% 

G2: 92% 

Episiotomy use 

G1: 12% 

G2: 46% 

Episiotomy rate 

G1: 49% (329/674) 

G2: 51% (345/674) 

Birthweight (mean ± SD) 

G1: 3426g ± 430 

G2: 3407g ± 451 

NS 

Estimated GA

G1: 39.8wks ± 1.2 

G2: 46.0wks ± 1.2 

C-74 
Evidence Table 11. Key Question 4: Urinary incontinence, fecal incontinence and pelvic floor 

defects (continued)

Perineal Trauma Outcomes 

Incontinence and Pelvic Floor 

Outcomes Quality and Comments 

Short term

NR 

Long term

NR 

Short term

NR 

Long term

(quest) 

Urine 

<1x in past week 

G1: 22% 

G2: 25% 

1 to 2 x in past week 

G1: 12% 

G2: 11% 

3+ in past week

G1: 2% 

G2: 2% 

Total

G1: 34% 

G2: 36% 

RR = 0.97 (0.79-1.19) 

P = 0.77 

Incontinence of urine sufficiently

severe to wear a pad, urgency and 

stress incontinence all NS 

Overall quality

Good 

Population 

Good 

Measures 

NA 

Analysis 

NA 

Retention of participants 

NA 

C-75 
Evidence Table 11. Key Question 4: Urinary incontinence, fecal incontinence and pelvic floor 

defects (continued)

Study Characteristics Demographic Characteristics

Labor, Delivery, and Repair 

Characteristics

Author 

Rockner, 1990

Setting 

Sweden 

Study design 

Prospective cohort 

Inclusion criteria 

Consecutive primiparas with 

episiotomy 

Exclusion criteria 

• Consecutive primiparas with 

spont tears 

Groups

G1: Episiotomy 

G2: Spont tears 

N at enrollment 

G1: 157 

G2: 48 

N responders

G1: 140 

G2: 45 

Total: 185 

Followup

4 yrs 

Age (mean) 

G1: 30yrs 

G2: 31yrs 

Parity

NR 

Maternal weight (mean) 

G1: 61kg 

G2: 63kg 

Infants born since earlier study

G1 

• 0 to 39% 

• 1 to 58% 

• 2 to 3% 

• 3 to 0.7% 

G2: 

• 0 to 36% 

• 1 to 59% 

• 2 to 5% 

• 3 to 0% 

Mode of delivery

G1: 

• Spont: 83% 

• Vacuum: 16% 

• Forceps: 1% 

G2: 

• Spont: 95% 

• Vacuum: 5% 

Episiotomy use 

G1: 100% done, not specified

Birthweight (mean ± SD) 

NR 

C-76 
Evidence Table 11. Key Question 4: Urinary incontinence, fecal incontinence and pelvic floor 

defects (continued)

Perineal Trauma Outcomes

Incontinence and Pelvic Floor 

Outcomes Quality and comments 

Short term 

NR 

Long term

NR 

Urinary incontinence after 

delivery

G1: 25% 

G2: 26% 

NS 

Short term 

NR 

Long term: 4 yrs

quest 

Urinary incontinence 

• After first delivery

• After sec delivery

• After third delivery

• Overall 

NS 

Involuntary loss of urine 

(coughing, laughing, sneezing) 

NS 

Climbing stairs

NS 

Urinary incontinence severe

enough to wear a pad 

• Sometimes 

• Always

NS 

Severe urinary incontinence 

symptoms: 

• Occasionally

• Once a wk

• 2 or 3 times/wk

• > 3 times/wk

NS 

Overall quality

Fair 

Population 

Fair 

Measures 

Good 

Analysis 

Poor 

Retention of participants 

Good 

C-77 
Evidence Table 11. Key Question 4: Urinary incontinence, fecal incontinence and pelvic floor 

defects (continued)

Study Characteristics Demographic Characteristics

Labor, Delivery, and Repair 

Characteristics

Author 

Rockner et al., 1991 

Setting 

Sweden 

Study design 

Prospective cohort 

Inclusion criteria 

• > 36 wks gestation 

• Every sec mother 

Exclusion criteria 

NR 

Groups

G1: Episiotomy 

G2: Spont laceration 

G3: Intact perineum 

G4: Cesarean section 

N at enrollment 

92 

N at completion

G1: 21

G2: 26

G3: 24

G4: 16

Followup

8 wks 

Age 

NR 

Parity

NR 

Mode of delivery

G1 

• Spont: 81% 

• Vacuum: 19% 

G2: 

• Spont: 92.3 % 

• Vacuum: 7.7%

G3: Spont: 100% 

G4: Cesarean: 100% 

Episiotomy rate 

G1: 22% (21/97) 

G2: 27% (26/97) 

G3: 25% (24/97) 

G4: 27% (26/97) 

Episiotomy rate

G1: 100% mediolateral 

G2: 0%

G3: 0%

G4: 0% 

Birthweight (mean) 

G1: 3596g

G2: 3640g

G3: 3366g

G4: 3190g 

C-78 
Evidence Table 11. Key Question 4: Urinary incontinence, fecal incontinence and pelvic floor 

defects (continued)

Perineal trauma characteristics 

Incontinence and Pelvic Floor 

Outcomes Quality and Comments 

Short term

NR 

Long term 

NR 

Short term: 8 wks

Decrease in pelvic floor muscle 

(PFMS measured by weight of

heaviest cone retained in vagina for 

1 min while standing erect or 

walking)

G1: 30.0 + 11.8 

G2: 18.9 + 9.1 

G3: 19.2 + 16.2 

G4: 0 

P < 0.001 

PFMS in episiotomy group 

continues to be significantly

decreased compared with spont 

laceration or intact perineum 

Long term

NR 

Overall quality

Fair 

Population 

Fair 

Measures 

Good 

Analysis 

Poor 

Retention of participants 

Good

• 2 patients changed their minds 

• 3 had emergency cesareans 

C-79 
Evidence Table 11. Key Question 4: Urinary incontinence, fecal incontinence and pelvic floor 

defects (continued)

Study Characteristics Demographic Characteristics

Labor, Delivery, and Repair 

Characteristics

Author 

Klein et al., 1992

Setting 

Canada 

Study design 

RCT 

Inclusion criteria 

• 18 to 40 yrs old 

• Parity of 0, 1, 2 

• Single fetus 

• Spoke English or French 

• Low medical and obstetrical risk 

Exclusion criteria 

• Prematurity (gestation < 37wks)

• Fetal distress

• Cesarean deliveries

• Planned forceps

• Medical condition developed late 

in pregnancy

Groups

G1: Primiparous

G1a: Liberal (attempted to avoid a 

tear/separated by parity) 

G1b: Restricted (attempted to avoid 

an episiotomy/separated by parity) 

G2: Multiparous

G2a: Liberal 

G2b: Restricted

N at enrollment 

G1a: 184 

G1b: 175 

G2a: 166 

G2b: 178 

Total: 703

Followup

1 day to 3 mos

Age (mean ± SD) 

G1a: 27.9yrs ± 3.9 

G1b: 27.9yrs ± 4.4 

G2a: 31.0yrs ± 3.7 

G2b: 30.3yrs ± 9.1 

Primiparous 

G1: 100% 

G2: 100% 

Education (yrs) (Sig diff NR) 

G1a: 15.4 

G1b: 15.0 

G2a: 15.4 

G2b: 15.0 

Stable Relationship 

(Diff NS) 

Employment 

(Diff NS) 

Episiotomy rate (all median) 

G1a: 81% 

G1b: 52% 

G2a: 47% 

G2b: 31% 

Height 

Sig diff NR 

Weight during pregnancy 

Sig diff NR 

Previous episiotomy 

NS 

Birthweight (mean ± SD) 

G1a: 3325g ± 416 

G1b: 3377g ± 432 

G2a: 3496g ± 449 

G2b: 3467g ± 497 

GA 

NS 

C-80 
Evidence Table 11. Key Question 4: Urinary incontinence, fecal incontinence and pelvic floor 

defects (continued)

Perineal Trauma Outcomes 

Incontinence and Pelvic Floor 

Outcomes Quality and Comments 

Intact perineum 

Measured at delivery 

G1a: 12 (6.6%)

G1b: 13 (7.5%)

OR = 1.16 

(0.48, 2.8) 

G2a: 32 

G2b: 56 

OR = 1.85 

(1.1, 3.2) 

Sec deg tear 

Measured at delivery

G1a: 22 (12.6%) 

G1b: 61 (35.3%) 

OR = 3.99 

(2.2, 7.1) 

G2a: 56 

G2b: 68 

NS 

Short term

NR

Long term: 3 mos

Urinary incontinence 

G1a: 26 (14.5%) 

G1b: 35 (21.1%) 

P = 0.11 

G2a: 34 (21.5)

G2b: 22 (12.9) 

P = 0.04 

Overall quality

Fair 

Population 

Fair 

Measures 

Fair 

Analysis 

Good 

Retention of participants 

Fair 

C-81 
Evidence Table 11. Key Question 4: Urinary incontinence, fecal incontinence and pelvic floor 

defects (continued)

Study Characteristics Demographic Characteristics

Labor, Delivery, and Repair 

Characteristics

Author 

Viktrup et al., 1992

Setting 

Denmark 

Study design 

Prospective cohort 

Inclusion criteria 

• Primiparas 

• 17 to 42 yrs of age 

Exclusion criteria 

Did not speak Danish

Groups for multivariate analysis

G1: Episiotomy 

G2: No episiotomy

N for Study

Total: 305 

N at 3 mos

Head circumference (median) 

Total: 293 

N at 12 mos 

Total: 292 

Followup

3 mos to 1 yr

Age 

(median) 

Total: 26yrs 

Primiparous 

G1: 100% 

G2: 100% 

GA (median) 

Total: 40wks 

Length of first stage (median) 

Total: 495 min 

Length of sec stage (median)

Total: 35 min 

Total: 33 cm 

Mode of delivery

Spont: 69% 

Vacuum: 13% 

Cesarean: 18% 

Details NR by group 

Episiotomy rate 

72% 

Birthweight (median) 

Total: 3300g 

Details by group 

C-82 
Evidence Table 11. Key Question 4: Urinary incontinence, fecal incontinence and pelvic floor 

defects (continued)

Perineal Trauma Outcomes

Incontinence and Pelvic Floor 

Outcomes Quality and Comments 

Short term 

NR 

Long term 

NR 

Short term 

NR 

Long term 

NR 

Overall quality

Poor 

Population 

Good 

Measures 

Good 

Analysis 

Fair 

Retention of participants 

Good 

C-83 
Evidence Table 11. Key Question 4: Urinary incontinence, fecal incontinence and pelvic floor 

defects (continued)

Study Characteristics Demographic Characteristics

Labor, Delivery, and Repair 

Characteristics

Author 

Klein et al., 1994 

Setting 

Canada 

Study design 

Prospective cohort, secondary 

analysis of an RCT of liberal vs. 

selective midline episiotomy 

Inclusion criteria 

• Parity: 0, 1, 2 

• Low risk 

• 18 to 40 yrs of age 

• Singleton fetus

• Spoke English or French 

Exclusion criteria 

NR 

Groups

G1: Intact 

G2: Spont tear

G3: Episiotomy alone 

G4: Third or fourth deg tear 

N at enrollment 

G1: 110 

G2: 208 

G3: 313 

G4: 66

Followup

3 mos 

Age 

NR 

Parity

Mode of delivery

NR

Suture type 

NR 

Birthweight (mean ± SD) 

NR 

• Overall: Primiparous: 51% 

• Details NR by group 

Other demographics

• Race 

• Employment 

• Marital status 

• Intendedness of pregnancy 

• “No difference”

C-84 
Evidence Table 11. Key Question 4: Urinary incontinence, fecal incontinence and pelvic floor 

defects (continued)

Perineal Trauma Outcomes 

Incontinence and Pelvic Floor 

Outcomes Quality and Comments 

See groups for rates 

OR of third and fouth deg tears

for primiparous women in the 

presence of episiotomy

compared with those not 

receiving episiotomy

22.08 (2.84, 171.53) 

Short Term 

NR 

Long Term

NR 

Overall quality 

Fair 

Population 

Good 

Measures 

Good 

Analysis 

Fair/poor 

Retention of participants

Good 

C-85 
Evidence Table 11. Key Question 4: Urinary incontinence, fecal incontinence and pelvic floor 

defects (continued)

Study Characteristics Demographic Characteristics

Labor, Delivery, and Repair 

Characteristics

Author 

Walsh et al., 1996 

Setting 

UK 

Study design 

Prospective cohort 

Inclusion criteria 

Third deg tear 

Exclusion criteria 

NR 

Groups

G1: Patients with third deg tears 

G2: Total population 

N

G1: 81

Followup

3 mos 

Age (mean) 

Total: 27.9yrs 

Parity 

Total: 79% 

(P < 0.001) 

Mode of delivery

NR by groups

Suture type 

NR 

Birthweight (mean ± SD) 

NR 

C-86 
Evidence Table 11. Key Question 4: Urinary incontinence, fecal incontinence and pelvic floor 

defects (continued)

Perineal Trauma Outcomes

Incontinence and Pelvic Floor 

Outcomes Quality and Comments 

Third deg tears

93/16583 (0.6%) 

Episiotomy use (not exclusive of

breech and/or instr delivery) 

G1: 74% 

G2: 28% 

(P < 0.001) 

Short term 

NR 

Long term

NR 

Overall quality

Poor 

Population 

Poor 

Measures 

Fair 

Analysis 

Poor 

Retention of participants 

Good 

C-87 
Evidence Table 11. Key Question 4: Urinary incontinence, fecal incontinence and pelvic floor 

defects (continued)

Study Characteristics Demographic Characteristics

Labor, Delivery, and Repair 

Characteristics

Author 

MacArthur et al., 1997 

Setting 

UK 

Study design 

Cohort study, selection based on a 

group of symptoms including 

incontinence (final outcome) 

Inclusion criteria 

• Delivered between April and 

September at a maternity 

hospital in Birmingham (UK) 

• After enrollment in the study,

760 women with one or more of 

9 symptoms (including 

incontinence) within 3 mos of 

birth and lasting 6 wks were 

recruited. In addition 146 women 

were randomly chosen from the 

nonsymptomatic group 

Exclusion criteria 

Women with fecal or urge

incontinence related to a previous 

birth 

Groups

G1a: Primiparae new fecal 

incontinence 

G1b: Primiparae, never had fecal 

incontinence 

G2a: Multiparae, 

new fecal incontinence 

G2b: Multiparae, never had fecal 

incontinence 

N eligible for enrollment 

1667 

N interviewed 

906 

Followup

Contacted 6 to 7 mos, interviewed 

45 wks on average 

Age (mean ± SD) 

G1a: 27.9yrs ± 5.5 

G1b: 26.7yrs ± 5.2 

G2a: 30.9yrs ± 4.8 

G2b: 29.6yrs ± 4.6 

Parity

G1: Primiparous: 41% 

G2: Multiparous: 59% 

Mode of delivery

G1a: 

• Spont: 27.8% 

• Vacuum: 16.7% 

• Forceps: 27.8%

• Emergency (cesarean) section: 

27.8% 

G1b: 

• Spont: 53.3% 

• Vacuum: 3.2% 

• Forceps: 23.5%

• Emergency (cesarean) section: 

15.7% 

• Elective (cesarean) section: 

3.8% 

G2a: 

• Spont: 72.2% 

• Vacuum: 5.6% 

• Forceps: 16.7% 

• Emergency (cesarean) section: 

5.6% 

G2b: 

• Spont: 74.1% 

• Vacuum: 0.6% 

• Forceps: 4.3%

• Emergency (cesarean) section: 

10.7% 

• Elective (cesarean) section: 

9.7% 

Episiotomy use 

G1a: 33.3%

G1b: 36.2%

G2a: 27.8%

G2b: 10.5% 

First stage labor ≥ 10hrs 

Sec stage labor ≥ 2hrs 

Active sec stage labor ≥ 2hrs 

Head circumference 

Birthweight (mean ± SD) 

G1a: 3306g ± 804.7 

G1b: 3318g ± 661.3 

G2a: 3443.9g ± 435.3 

G2b: 3431.7g ± 633.5 

C-88 
Evidence Table 11. Key Question 4: Urinary incontinence, fecal incontinence and pelvic floor 

defects (continued)

Perineal Trauma Outcomes 

Incontinence and Pelvic Floor 

Outcomes Quality and Comments 

Short term 

NR 

Long term

NR 

Short term: 10 mos 

Episiotomy has no effect on 

incontinence 

Long term

NR 

Overall quality

Good 

Population 

Fair 

Measures 

Good 

Analysis 

Good 

Retention of participants 

Good 

C-89 
Evidence Table 11. Key Question 4: Urinary incontinence, fecal incontinence and pelvic floor 

defects (continued)

Study Characteristics Demographic Characteristics

Labor, Delivery, and Repair 

Characteristics

Author 

Viktrup and Lose, 2001

Setting 

Denmark 

Study design 

Prospective cohort 

Inclusion criteria 

• Nulliparous 

• 17 to 41 yrs of age 

Exclusion criteria 

NR 

Groups (for multivariate

analysis) 

G1: Episiotomy

G2: No episiotomy

N at enrollment 

305 

Followup

5 yrs 

Age 

NR 

Nulliparous 

G1: 100%

G2: 100%

Mode of delivery

NR 

Suture type 

NR 

Birthweight (mean ± SD) 

NR 

C-90 
Evidence Table 11. Key Question 4: Urinary incontinence, fecal incontinence and pelvic floor 

defects (continued)

Perineal Trauma Outcomes

Incontinence and Pelvic Floor 

Outcomes Quality and Comments 

Short term 

NR 

Long term

NR 

Short term 

NR 

Long term

Adjusted OR for episiotomy on 

long-lasting stress incontinence 

(quest) 

2.0 (0.9, 4.1) 

Overall quality

Good 

Population 

Fair 

Measures 

Good 

Analysis 

Good 

Retention of participants

Good 

C-91 
Evidence Table 11. Key Question 4: Urinary incontinence, fecal incontinence and pelvic floor 

defects (continued)

Study Characteristics Demographic Characteristics

Labor, Delivery, and Repair 

Characteristics

Author 

Eason et al., 2002 

Setting 

Canada 

Study design 

Prospective cohort 

Inclusion criteria 

• Participant of an RCT of 

perineal massage 

• 34 to 35 wks gestation 

Exclusion criteria 

• NR 

Groups (multivariate analysis) 

G1: No episiotomy 

G2: Episiotomy

N at enrollment 

1198 

N for prospective cohort 

949 

Followup

3 mos 

Age 

NR 

Parity

NR 

Mode of delivery

NR by groups overall 

G1: for subset for first vaginal birth

• Spont: 52.4%

• Vacuum: 16.4%

• Forceps: 31.2%

G2: for subset for first vaginal birth 

• Spont: 83.9%

• Vacuum: 10.9%

• Forceps: 5.2%

Anesthesia at time of delivery

(epidural) 

NR by groups 

Episiotomy rate 

26.7% 

NR by groups 

Birthweight (mean ± SD) 

NR by groups 

C-92 
Evidence Table 11. Key Question 4: Urinary incontinence, fecal incontinence and pelvic floor 

defects (continued)

Perineal Trauma outcomes

Incontinence and Pelvic Floor 

Outcomes Quality

Intact perineum

25.7% 

First deg tear

19.2% 

Sec deg tear 

27.1% 

Episiotomy without ext into anal

sphincter 

21.9% 

Third and fourth deg tear

22.7% 

Short term 

NR 

Long term: 3 mos

Frequency of incontinence of 

stool 

• None: 96.9% 

• < once/wk: 2.3% 

• 1 to 6 wks: 0.4%

• Once daily: 0.2% 

• > once daily: 0.1% 

Frequency of incontinence of 

flatus 

• None: 74.5% 

• < once/wk: 16.0% 

• 1 to 6 wks: 6.8%

• Once daily: 1.2% 

• > once daily: 1.5% 

Risk ratio for episiotomy 

NS in univariate or multivariate 

models 

Risk ratio for perineal injury

(classified by extent of laceration

including episiotomy as a 

category)

NS in univariate models. Only third 

or fourth deg tears significant in

multivariate models compared to 

intact perineum

RR: 2.1 (1.4-3.1) 

Adjusted risk ratio compared to

spont with no episiotomy

• Spont with episiotomy: 9.6 (3.2, 

28.5) 

• Vacuum with no episiotomy: 7.4 

(1.9, 28.5) 

• Vacuum with episiotomy: 15.7 

(4.6, 53.2) 

• Forceps with no episiotomy: 12.3 

(3.0, 50.4) 

• Forceps with episiotomy: 25.3 

(8.9, 72.0) 

Overall quality 

Good 

Population 

Good 

Measures 

Good 

Analysis 

Good 

Retention of participants

Fair 

C-93 
Evidence Table 11. Key Question 4: Urinary incontinence, fecal incontinence and pelvic floor 

defects (continued)

Study Characteristics Demographic Characteristics

Labor, Delivery, and Repair 

Characteristics

Author 

Fleming et al., 2003 

Setting 

USA 

Study design 

Prospective cohort 

Inclusion criteria 

• Singleton pregnancies 

• Vertex presentation 

• Term birth 

• Normal pregnancies 

Exclusion criteria 

• Forceps/vacuum deliveries 

• Epidural analgesia 

• Gestational diabetes 

• Preterm pregnancies 

• Multiple gestations 

• Medical complications 

• Those requiring medical 

induction of labor 

Groups (for multivariate

analysis) 

G1: Episiotomy

G2: No episiotomy 

N at enrollment 

102 

Followup

6 mos 

Age 

G1: 28.8yrs 

G2: 29.8yrs 

(weighted mean of means calculated) 

Parity

NR 

Mode of delivery

Overall 

Cesarean: 9.8% 

Suture type 

NR 

Women with episiotomy had higher 

muscle function scores AP than 

other groups, reason for this 

unclear 

Birthweight (mean ± SD) 

G1: 8.1lbs ± 1.2lbs. 

G2: 8.3lbs (weighted mean 

average) 

C-94 
Evidence Table 11. Key Question 4: Urinary incontinence, fecal incontinence and pelvic floor 

defects (continued)

Perineal Trauma Outcomes 

Incontinence and Pelvic Floor 

Outcomes Quality and Comments 

Short term 

NR 

Long term

NR 

Short term 

NR 

Long term

NR 

Overall quality

Fair 

Population 

Poor 

Measures 

Good 

Analysis 

Fair 

Retention of participants

Good 

C-95 
Evidence Table 11. Key Question 4: Urinary incontinence, fecal incontinence and pelvic floor 

defects (continued)

Study Characteristics Demographic Characteristics

Labor, Delivery, and 

Repair Characteristics 

Author 

Karacam and Eroglu 2003 

Setting 

Turkey

Study design 

Prospective cohort 

Inclusion criteria 

• Multiparous 

• Resident of the relevant city

boundaries 

• Had telephone

• Age 18 to 35 yrs 

• 37 and 42 wks GA 

• Singleton live birth 

• Birthweight 2500 to 4500g 

• Vaginal vertex position delivery 

Exclusion criteria 

• Experienced medical illness 

(cardiac disease, diabetes, vaginal/ 

perineal infection, anemia, renal 

disease, pre-eclampsia and/or

antepartum hemorrhage during 

pregnancy) 

• Malpresented/malpositioned

babies 

• “Large” babies

• Intrauterine growth retardation 

• Congenital abnormality 

• Rigid perineal tissue 

• Vacuum/forceps

Groups

G1: Episiotomy (mediolateral) 

G2: No episiotomy

N at enrollment 

G1: 50 

G2: 50 

Followup

6 wks 

Age (mean ± SD) 

G1: 25.96yrs ± 3.9 

G2: 24.34yrs ± 2.7 

Multiparous 

G1: 100% 

G2: 100% 

Other demographics

Mode of delivery

All 100% spont 

Types of intervention in 

labor 

NS 

Duration of labor 

NS 

Duration of the first 

stage 

NS 

Duration of the sec stage 

NS 

Involvement of women in

labor 

NS 

Birthweight 

2500 to 3499g

G1: 59.18% 

G2: 63.27% 

NS 

3500 to 4310g

G1: 40.82% 

G2: 36.73% 

NS

Diameter of infant’s head 

NS 

• Had health insurance NS 

• Graduated from primary school NS 

• Did not have paying jobs NS 

C-96 
Evidence Table 11. Key Question 4: Urinary incontinence, fecal incontinence and pelvic floor 

defects (continued)

Perineal Trauma Outcomes

Incontinence and Pelvic Floor 

Outcomes Quality and comments 

Spont laceration 

G1: 54% 

G2: 78% 

P = 0.011 

Short term: 12 wks

Stress incontinence 

G1: 24% 

G2: 30% 

P = 0.49 

Long term

NR 

Overall quality 

Poor 

Population 

Poor 

Measures 

Poor 

Analysis 

Poor 

Retention of participants 

Good

C-97 
Evidence Table 11. Key Question 4: Urinary incontinence, fecal incontinence and pelvic floor 

defects (continued)

Study Characteristics Demographic Characteristics

Labor, Delivery, and Repair 

Characteristics

Author 

Eason et al., 2004 

Setting 

Canada 

Study design 

Prospective cohort 

Inclusion criteria 

• Pregnant with or without a 

previous vaginal birth 

• Delivering in five secondary and 

tertiary care hospitals in 

Quebec 

• 30 to 35 wks GA 

• Participants in an RCT of 

perineal massage 

Exclusion criteria 

NR 

Groups (multivariate analysis) 

G1: No episiotomy 

G2: Episiotomy

Followup

3 mos 

Age (mean) 

29.8yrs 

Parity

NR 

Other demographics

Education 

15.8 yrs mean education of responders 

Mode of delivery

NR 

Suture type 

NR 

Birthweight (mean ± SD) 

NR 

C-98 
Evidence Table 11. Key Question 4: Urinary incontinence, fecal incontinence and pelvic floor 

defects (continued)

Perineal Trauma Outcomes 

Incontinence and Pelvic Floor 

Outcomes Quality and Comments 

Short term 

NR 

Long term

NR 

Short term 

NR 

Long term: 3 mos

Stress incontinence 

G1: 

• 35% risk 

• Crude OR: 1.00 

G2: 

• 29% risk 

• Crude OR: 0.75 

(0.54, 1.05) 

Adjusted for maternal age, BMI, 

previous vaginal birth, timing, 

onset of urinary incontinence, 

type of delivery, duration of sec 

stage and episiotomy

G1: OR: 1.00 

G2: OR: 0.68 

(0.47, 1.01)

Overall quality

Good 

Population 

Good 

Measures 

Good 

Analysis 

Good 

Retention of participants 

Fair 

C-99 
Evidence Table 11. Key Question 4: Urinary incontinence, fecal incontinence and pelvic floor 

defects (continued) 

Study Characteristics Demographic Characteristics

Labor, Delivery, and Repair 

Characteristics

Author 

Sartore et al., 2004 

Setting 

Italy

Study design 

Prospective cohort 

Inclusion criteria 

• Primiparous 

• Singleton pregnancy 

• Spont vaginal delivery 

• Fetal head in occiput anterior 

position 

Exclusion criteria 

• Delivered in position other than

lithotomy position 

• Cesarean delivery 

• Third and fourth deg perineal 

lacerations 

• Preterm breech 

• Operative delivery

• Anal and urinary incontinence 

that pre-existed vaginal delivery

• History of vaginal or anal 

surgery 

Groups

G1: Received mediolateral 

episiotomy 

G2: Intact perineum and spont 

perineal lacerations (first/sec deg) 

N at enrollment 

G1: 254 

G2: 265 

Followup

3 mos 

Age 

(mean ± SD) 

G1: 30.9yrs ± 3.9 

G2: 30.7yrs ± 4.3 

Primiparous 

G1: 100% 

G2: 100% 

Mode of delivery

Spont 

G1: 100% 

G2: 100% 

Maternal weight before 

pregnancy

NS 

Weight gain in pregnancy

NS 

Epidural rate

G1: 14.2% 

G2: 7.9% 

P = 0.023 

Episiotomy type 

G1: Mediolateral: 100% 

Birthweight (mean ± SD) 

G1: 3334.7g ± 429.5 

G2: 3222.8g ± 428.1 

P = 0.003 

C-100 
Evidence Table 11. Key Question 4: Urinary incontinence, fecal incontinence and pelvic floor 

defects (continued)

Perineal Trauma Outcomes

Incontinence and Pelvic Floor 

Outcomes Quality and Comments 

G2: Intact perineum: 82 

G2: First deg tear: 127 

G2: Sec deg tear: 56 

Short term

NR

Long term: 3 mos 

(0.46, 4.1) 

Stress incontinence 

G1: 12.9% 

G2: 12.1% 

OR = 1.01 

(0.61, 1.69) 

P = 0.95 

Urge incontinence 

G1: 1.9% 

G2: 0.7% 

P = 0.23 

Incidence of frequency and 

urgency 

G1: 0.8% 

G2: 2.3% 

P = 0.17 

Incidence of dyspuria

G1: 1.2% 

G2: 0.8% 

P = 0.61 

Anal incontinence 

G1: 2.8% 

G2: 1.9% 

OR = 01.47 

P = 0.51 

Overall quality

Poor 

Population 

Good 

Measures 

Fair 

Analysis 

Poor 

Retention of participants

Good 

C-101 
Evidence Table 12. Key Question 5: Future sexual function 

Study Characteristics Demographic Characteristics

Labor, Delivery, and Repair 

Characteristics

Author 

Sleep et al., 1984 

Setting 

UK 

Study design 

RCT 

Inclusion criteria 

• Live singleton fetus of at least 37 

wks GA 

• Presented cephalically

• Spont vaginal delivery expected 

at end of sec stage labor 

Exclusion criteria 

• Elected episiotomy

• No consent 

• Private patient

• Precipitate delivery

Groups

G1: Liberal (instructed to “try to 

prevent a tear”) 

G2: Restrictive (instructed to “try to 

avoid episiotomy and restrict 

episiotomy to fetal indications”) 

Followup

10 days to 3 mos 

N at enrollment 

G1: 502 

G2: 498 

N at 10 days

G1: 446 

G2: 439 

N at 3 mos 

G1: 457 

G2: 438 

N at Followup

G1: 329 

G2: 345 

Total: 674 

Age (mean ± SD) 

G1: 26.7yrs ± 5.3 

G2: 26.6yrs ± 5.2 

Primiparous 

G1: 46.3% 

G2: 40.4% 

Mode of delivery

NR

Delivery performed by

Student and midwife

G1: 35.9% 

G2: 35.2% 

Midwife 

G1: 32.1% 

G2: 30.1% 

Obstetrician

G1: 1.8% 

G2: 8% 

Other (“sister”) 

G1: 31.3% 

G2: 32.7% 

Episiotomy rate (all mediolateral) 

G1: 51.4% 

G2: 10.2% 

Suture type 

NR by group 

Estimated GA

G1: 39.8wks ± 1.2 

G2: 39.8wks ± 1.2 

Birthweight (mean ± SD) 

G1: 3367g ± 438 

G2: 3393g ± 4.48 

C-102 
Evidence Table 12. Key Question 5: Future sexual function (continued) 

Perineal Trauma Outcomes Sexual function outcomes Quality and Comments 

Third/fourth deg tear 

(ext through anal sphincter or through 

to the rectal mucosa or to the upper 

third of vagina)

G1: 1 

G2: 4 

Anterior labial tears 

G1: 17.3% 

G2: 26.3% 

P < 0.00l 

RR = 1.52 

(1.19 to 1.94)

Short term: 1 mo 

(quest) 

Recommencement of sexual

intercourse 

G1: 27% 

G2: 37% 

χ2 = 8.67 

P < 0.01 

Long term: 3 mos

Measures 

Good: Operator performing 

repair blind to allocation, mother 

in most cases blind to allocation 

(quest) 

Resumed sexual intercourse 

90% overall, similar within groups 

Dyspareunia 

G1: 18% 

G2: 22% 

Dyspareunia “at some time”

G1: 51% 

G2: 52% 

Overall quality

Good 

Population 

Good 

Analysis 

Good 

Retention of participants 

Good 

C-103 
Evidence Table 12. Key Question 5: Future sexual function (continued) 

Study Characteristics Demographic Characteristics

Labor, Delivery, and Repair 

Characteristics

Author 

Sleep et al., 1987 

Setting 

UK 

Study design 

RCT 

Inclusion criteria 

Ability to find address 

Exclusion criteria 

• 8 spoke little English 

• 3 gave babies up for adoption

• 1 baby was given to social

services 

• 1 neonatal death 

• 2 refused 

Groups

G1: Restricted 

G2: Liberal 

Age (mean ± SD) 

NS 

G1: 27.0yrs ± 4.9 

G2: 27.0yrs ± 5.0 

Primiparous 

G1: 41% 

G2: 44% 

Percent unmarried 

G1: 91% 

G2: 92% 

Mode of delivery

NR 

Episiotomy use 

G1: 12% 

G2: 46% 

Episiotomy rate 

(all mediolateral per Sleep et 

al., 1984) 

G1: 49% (329/674) 

G2: 51% (345/674) 

Birthweight (mean ± SD) 

NS 

G1: 3426g ± 430 

G2: 3407g ± 451 

Estimated GA

G1: 39.8wks ± 1.2 

G2: 46.0wks ± 1.2 

C-104 
Evidence Table 12. Key Question 5: Future sexual function continued 

Perineal Trauma Outcomes Sexual function outcomes Quality and comments 

Short term

NR 

Long term

NR 

Short term

NR 

Long term: 3 yrs

Ever suffering painful sexual 

intercourse

G1: 16% 

G2: 13% 

RR = 1.21 (0.84 to 1.75) 

P = 0.31 

Subanalysis of those with no

more children 

G1: 15% 

G2: 12% 

NS 

Overall quality

Good 

Population 

Good 

Measures 

NA: Operator performing repair

blind to allocation, mother in most 

cases blind to allocation 

Analysis 

NA 

Retention of participants 

NA 

C-105 
Evidence Table 12. Key Question 5: Future sexual function (continued) 

Study Characteristics Demographic Characteristics

Labor, Delivery, and Repair 

Characteristics

Author 

Rockner et al., 1988 

Setting 

Sweden 

Study design 

Prospective cohort 

Inclusion criteria 

• ≥ 18 yrs of age

• ≥ 37 wks gestation 

• Singleton fetus

• Swedish

• Spont tear of ≥ 2 cm 

• Consecutive 

• Primiparous 

Exclusion criteria 

NR (refusal) 

Groups

G1: Episiotomy 

G2: Spont tear

N at enrollment 

G1: 157 

G2: 48 

Followup

1 day to 3 mos

Age 

(median) 

G1: 25.5yrs 

G2: 26.6yrs 

NS 

Parity

All primiparous

Attended antenatal classes 

NS 

Feeling during pregnancy 

NS 

Mode of delivery

G1: Vacuum: 15% 

G2: Vacuum: 4% 

NS 

Duration of sec stage labor 

NS 

Episiotomy type 

G1: 

• Midline: 12% 

• Mediolateral: 88% 

Suture type 

PGA: 100% 

Head circumference 

NS 

Birthweight (mean) 

G1: 3463g 

G2: 3587g 

NS 

C-106 
Evidence Table 12. Key Question 5: Future sexual function (continued) 

Perineal Trauma Outcomes Sexual function outcomes Quality and comments 

First deg tear

G1: Mediolateral: 15% 

G1: Midline: 3%

G2: 90% 

Third deg tear

G1: Mediolateral: 5% 

G1: Midline: 0 

G2: 6% 

Fourth deg tear

G1: Mediolateral: 0% 

G1: Midline: 1%

G2: 4% 

Anterior (labia/clitoris) 

G1: Mediolateral: 18% 

G1: Midline: 0 

G2: 33% 

(P < 0.05) 

Short term

NR 

Long term: 3 mos 

Dyspareunia 

G1: 44% 

G2: 43% 

NS 

Overall quality

Poor

Population 

Good 

Measures 

Poor 

Analysis 

Poor 

Retention of participants 

Good 

C-107 
Evidence Table 12. Key Question 5: Future sexual function (continued) 

Study Characteristics Demographic Characteristics

Labor, Delivery, and Repair 

Characteristics

Author 

Larsson et al., 1991 

Setting 

Sweden 

Study design 

Prospective cohort 

Inclusion criteria 

Consecutive vaginal deliveries 

Exclusion criteria 

Cesarean sections 

Groups

G1: Episiotomy

G2: Spont laceration 

G3: Nontraumatic birth 

N at enrollment 

G1: 569 

G2: 627 

G3: 693 

Followup

1 to 5 days; 8 to 12 wks 

Age (mean ± SD) 

Overall: 27.2yrs ± 3.4 

Diff NS 

Primiparous 

G1: 52% 

G2: 30% 

G3: 38% 

Mode of delivery

NR

Anesthesia at time of delivery

Paracervical blockade 

G1: NA 

G2: 36.7% 

G3: NA 

Pudendal block

G1: 72.4% 

G2: 61.1% 

G3: 53.9% 

P < 0.001 

Epidural

G1: 29.8% 

G2: 9.7% 

G3: 12.3% 

P < 0.001 

Episiotomy type 

G1: Mediolateral: 98% 

Suture type 

NR

Birthweight (mean ± SD) 

Overall: 3548g ± 518 

Diff NS 

C-108 
Evidence Table 12. Key Question 5: Future sexual function (continued) 

Perineal Trauma Outcomes Sexual function outcomes Quality

Third and fourth deg tear (partial

or total rupture of the anal

sphincter) 

G1: 3.9% 

G2: 2.6% 

NS 

Primiparous only

G1: 4.3% 

G2: 4.8% 

NS 

Short term 

Dyspareunia 

G1: 16% 

G2: 11% 

P < 0.05 

Long term

NR 

Overall quality

Poor 

Population 

Fair 

Measures 

Poor 

Analysis 

Poor 

Retention of participants 

Good 

* Tables do not match text on time period 

C-109 
Evidence Table 12. Key Question 5: Future sexual function (continued) 

Study Characteristics Demographic Characteristics

Labor, Delivery and Repair 

Characteristic

Author 

Klein et al., 1992

Setting 

Canada 

Study design 

RCT 

Inclusion criteria 

• 18 to 40 yrs old 

• Parity = 0, 1, 2 

• Single fetus 

• Spoke English or French 

• Low medical and obstetrical risk 

Exclusion criteria 

• Prematurity (gestation < 37wks)

• Fetal distress

• Cesarean deliveries

• Planned forceps

• Medical condition developed late 

in pregnancy

Groups

G1: Primiparous

G1a: Liberal (attempted to avoid a 

tear/separated by parity) 

G1b: Restricted (attempted to avoid 

an episiotomy/ separated by parity) 

G2: Multiparous

G2a: Liberal 

G2b: Restricted 

Age (mean ± SD) 

G1a: 27.9yrs ± 3.9 

G1b: 27.9yrs ± 4.4 

G2a: 31.0yrs ± 3.7 

G2b: 30.3yrs ± 9.1 

Parity

G1: Primiparous: 100% 

G2: Multiparous: 100% 

Education 

G1a: 3.0% 

G1b: 3.1% 

G2a: 3.0% 

G2b: 3.0% 

Sig diff 

NR 

Stable Relationship 

Diff NS 

Employment 

Diff NS 

Mode of delivery

NR 

Episiotomy rate (all median) 

G1a: 81% 

G1b: 52% 

G2a: 47% 

G2b: 31% 

Suture type 

NR 

Height 

Sig diff NR 

Weight during pregnancy 

Sig diff NR 

Previous episiotomy 

NS 

Birthweight (mean ± SD) 

G1a: 3325g ± 416 

G1b: 3377g ± 432 

G2a: 3496g ± 449 

G2b: 3467g ± 497 

GA 

NS 

C-110 
Evidence Table 12. Key Question 5: Future sexual function (continued) 

Perineal Trauma Outcomes Sexual function outcomes Quality and comments 

Intact perineum 

Measured at delivery 

G1a: 12 (6.6%)

G1b: 13 (7.5%)

OR = 1.16 

(0.48, 2.8) 

G2a: 32 

G2b: 56 

OR = 1.85 

(1.1, 3.2) 

Sec deg tear 

Measured at delivery

G1a: 22 (12.6%) 

G1b: 61 (35.3%) 

OR = 3.99 

(2.2, 7.1) 

G2a: 56 

G2b: 68 

NS 

Short term: 3 mos

Time to resumption of sexual 

intercourse

NS 

Mean deg of pain at resumption of 

sexual intercourse 

NS 

Female sexual satisfaction

NS 

Long term

NR 

Overall quality

Fair 

Population 

Fair

Measures 

Fair 

Analysis 

Good 

Retention of participants 

Fair 

C-111 
Evidence Table 12. Key Question 5: Future sexual function (continued) 

Study Characteristics Demographic Characteristics

Labor, Delivery, and Repair 

Characteristics

Author 

Klein et al., 1994 

Setting 

Canada 

Study design 

Prospective cohort, secondary 

analysis of an RCT of liberal vs. 

selective midline episiotomy 

Inclusion criteria 

Mode of delivery

NR

Suture type 

NR 

Birthweight (mean ± SD) 

NR 

• Parity: 0, 1, 2 

• Low risk 

• 18 to 40 yrs 

• Singleton fetus

• Spoke English or French 

Exclusion criteria 

NR 

Groups

G1: Intact 

G2: Spont tear

G3: Episiotomy alone 

G4: Third or fourth deg tear 

N at enrollment 

G1: 110 

G2: 208 

G3: 313 

G4: 66

Followup

3 mos 

Age 

NR 

Parity

• Overall: Primiparous: 51% 

• Details NR by group 

Other demographics

• Race 

• Employment 

• Marital status 

• Intendedness of pregnancy 

• “No difference”

C-112 
Evidence Table 12. Key Question 5: Future sexual function (continued) 

Perineal Trauma outcomes Sexual function outcomes Quality and Comments 

See groups for rates 

Odds ratio of third and fourth deg 

tears for primiparous women in 

the presence of episiotomy

compared with those not 

receiving episiotomy

22.08 (2.84, 171.53) 

Short term: 6 wks

Resumed sex 

G1: 76.5% 

G2: 62.5% 

G3: 61.7% 

G4: 55.4% 

P < 0.016 

Pain on first sex 

None vs. mild vs. discomforting 

vs. distressing (%) 

G1: 32.7 vs. 37.6 vs. 22.8 vs. 6.9 

G2: 20.8 vs. 27.3 vs. 27.3 vs. 24.6 

G3: 14.4 vs. 22.7 vs. 34.1 vs. 28.8 

G4: 8.2 vs. 23.0 vs. 39.3 vs. 29.5 

P < 0.001 

Long term: 3 mos

Sexual satisfaction 

Not satisfied vs. satisfied vs. very

satisfied (%) 

G1: 5 vs. 50 vs. 45 

G2: 15.8 vs. 54.6 vs. 29.5 

G3: 16.3 vs. 51.0 vs. 32.3 

G4: 21.3 vs. 44.3 vs. 34.4 

P = 0.022 

Overall quality 

Fair 

Population 

Good

Measures 

Good 

Analysis 

Fair/poor 

Retention of participants

Good 

C-113 
Evidence Table 12. Key Question 5: Future sexual function (continued) 

Study Characteristics Demographic Characteristics

Labor, Delivery, and Repair 

Characteristics

Author 

Signorello et al., 2001 

Setting 

USA 

Study design 

Cohort identified retrospectively, 

data mostly retrospective with the 

exception of one time point 

Inclusion criteria 

• Parity: 1 

• Singleton fetus

• Vertex

• Term 

• Vaginal delivery

Exclusion criteria 

NR 

Groups at initial assignment 

G1: Episiotomy

G2: No episiotomy but sec, third, 

or fourth deg spont perineal 

laceration 

G3. Intact perineum 

Groups for analysis

G1: Intact 

G2: Sec deg 

G3: High deg 

G4: Not classified 

N eligible from retrospective 

identified cohort 

921 

Followup

6 mos 

Age 

Overall 

• < 20yrs: 4.7% 

• 20 to 24yrs: 10.1% 

• 25 to 29yrs: 28.8% 

• 30 to 34yrs: 38.5% 

• ≥ 35yrs: 17.9% 

Parity

NR 

Mode of delivery

NR 

Episiotomy rate 

33.3% overall 

Suture type 

NR 

Birthweight (mean ± SD) 

NR 

C-114 
Evidence Table 12. Key Question 5: Future sexual function (continued) 

Perineal Trauma Outcomes Sexual function outcomes Quality and Comments 

Long term

NA 

Short term 

NA 

Short term

NA 

Long term

Sexual function at 6 mos (possibly 

includes pain, sexual sensation, 

sexual satisfaction, likelihood of 

reaching orgasm) 

NS, details NR

Overall quality 

Fair 

Population 

Good 

Measures 

Fair 

Analysis 

Good 

Retention of participants 

Poor 

C-115 
Evidence Table 12. Key Question 5: Future sexual function (continued) 

Study Characteristics Demographic Characteristics

Labor, Delivery, and 

Repair Characteristics 

Author 

Karacam and Eroglu 2003 

Setting 

Turkey, L&D/MU 

Study design 

Prospective cohort 

Inclusion criteria 

• Multiparous 

• Resident of the relevant city

boundaries 

• Had telephone

• Age 18 to 35 yrs 

• 37 and 42 wks GA 

• Singleton live birth 

• Birthweight 2, 500g to 4, 500g 

• Vaginal vertex position delivery 

Exclusion criteria 

• Experienced medical illness 

(cardiac disease, diabetes, vaginal/ 

perineal infection, anemia, renal 

disease, pre-eclampsia and/or

antepartum hemorrhage during 

pregnancy) 

• Malpresented/ malpositioned 

babies 

• “Large” babies

• Intrauterine growth retardation 

• Congenital abnormality 

• Rigid perineal tissue 

• Vacuum/forceps

Groups

G1: Episiotomy (mediolateral) 

G2: No episiotomy

N at enrollment 

G1: 50 

G2: 50 

Followup

1, 3, and 12 wks 

Age (mean ± SD) 

G1: 25.96yrs ± 3.9 

G2: 24.34yrs ± 2.7 

Parity

100% multiparous 

Other demographics

Mode of delivery

All 100% spont 

Types of intervention in 

labor 

NS 

Duration of labor 

NS 

Duration of the first 

stage 

NS 

Duration of the sec stage 

NS 

Involvement of women in

labor 

NS 

Suture type 

NR 

Birthweight 

2, 500 to 3, 499g

G1: 59.18% 

G2: 63.27% 

NS 

3, 500 to 4, 310g 

G1: 40.82% 

G2: 36.73% 

NS 

Diameter of infant’s head 

NS 

• Had health insurance NS 

• Graduated from primary school 

• NS 

• Did not have paying jobs NS 

C-116 
Evidence Table 12. Key Question 5: Future sexual function (continued) 

Perineal trauma characteristics Sexual function outcomes Quality

Spont laceration 

G1: 54% 

G2: 78% 

P = 0.011 

Short term

Dyspareunia 

G1: 64.6% 

G2: 54.2% 

P = 0.299 

Long term

NR 

Overall quality 

Poor 

Population 

Poor 

Measures 

Poor 

Analysis 

Poor 

Retention of participants 

Good

C-117 
Evidence Table 12. Key Question 5: Future sexual function (continued) 

Study Characteristics Demographic Characteristics

Labor, Delivery, and Repair 

Characteristics

Author 

Sartore et al., 2004 

Setting 

Italy

Study design 

Prospective cohort 

Inclusion criteria 

• Primiparous 

• Singleton pregnancy 

• Spont vaginal delivery 

• Fetal head in occiput anterior 

position 

Exclusion criteria 

• Delivered in position other than

lithotomy position 

• Cesarean delivery 

• Third and fourth deg perineal 

lacerations 

• Preterm breech 

• Operative delivery

• Anal and urinary incontinence 

that pre-existed vaginal delivery

• History of vaginal or anal 

surgery 

Groups

G1: Received mediolateral 

episiotomy 

G2: Intact perineum and spont 

perineal lacerations (first/sec deg) 

N at enrollment 

G1: 254 

G2: 265 

Followup

3 mos 

Age (mean ± SD) 

G1: 30.9yrs ± 3.9 

G2: 30.7yrs ± 4.3 

Primiparous 

G1: 100% 

G2: 100% 

Mode of delivery

Spont 

G1: 100%

G2: 100% 

Birthweight (mean ± SD) 

G1: 3334.7g ± 429.5 

G2: 3222.8g ± 428.1 

P = 0.003 

Maternal weight before 

pregnancy

NS 

Weight gain in pregnancy

NS 

Epidural rate

G1: 14.2% 

G2: 7.9% 

P = 0.023 

Episiotomy type 

G1: Mediolateral: 100% 

C-118 
Evidence Table 12. Key Question 5: Future sexual function (continued) 

Perineal Trauma Outcomes Sexual function outcomes Quality and Comments 

G2: Intact perineum: 82 

G2: First deg tear: 127 

G2: Sec deg tear: 56 

Short term: 3 mos 

(1.08, 5.45) 

P = 0.26

Mild dyspareunia 

G1: 5.9%

G2: 2.6% 

Mod dyspareunia 

G1: 1.9% 

G2: 0.8% 

Overall dyspareunia 

G1: 7.9% 

G2: 3.4% 

OR = 2.43 

Long term 

NR 

Overall quality 

Good 

Population 

Good 

Measures 

Fair 

Analysis 

Good 

Retention of participants 

Good 

C-119 
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Appendix D 

Acknowledgments 
Appendix D. Acknowledgments

This study was supported by Contract 290-02-0016 from the Agency for Healthcare Research 

and Quality (AHRQ), Task No. 4. We acknowledge the continuing support of Kenneth Fink, 

MD, MGA, MPH, Director of the AHRQ Evidence-Based Practice Center (EPC) Program, and 

Marian James, PhD, the AHRQ Task Order Officer for this project. 

The investigators deeply appreciate the considerable support, commitment, and contributions 

of the EPC team staff at RTI International and the University of North Carolina (UNC). From

UNC, we thank EPC Co-Director, Timothy S. Carey, MD, MPH; EPC Literature Search 

Specialist, B. Lynn Whitener, PhD and Leah Randolph, M.A. and Laura Morgan, M.A Research 

Assistants. We also express our gratitude to Loraine Monroe, EPC word processing specialist, 

and Debra Bost, editor at RTI International. 

Technical Expert Advisory Group 

We also extend our appreciation to the members of our Technical Expert Advisory Group 

(TEAG), who provided advice and input during our research process. The RTI-UNC EPC team

solicited the views of TEAG members from the beginning of the project. TEAG members also 

provided insights into and reactions to work in progress and advice on substantive issues or 

possibly overlooked areas of research. TEAG members participated in refining the analytic 

framework and key questions and discussing the preliminary assessment of the literature, 

including inclusion/exclusion criteria, and also provided input on the information and categories, 

including evidence tables. The TEAG was both a substantive resource and a “sounding board” 

throughout the study. It was also the body from which expertise was formally sought at several 

junctions. TEAG members are listed below: 

Leah Albers, CNM, DrPH 

Professor, College of Nursing and 

Dept. OB-GYN, School of Medicine 

University of New Mexico Health 

Sciences Center 

John O.L. DeLancey, MD 

Professor 

Division of Gynecology 

Department of Obstetrics & Gynecology 

University of Michigan

Jose Belizan, MD, PhD 

Director 

Latin American Center for Perinatology 

and Human Development 

Pan American Health Organization, 

World Health Organization 

William Droegemueller, MD 

Director of Evaluation, 

American Board of OB/GYN 

David A. Grimes, MD 

Vice President Biomedical Affairs, 

Family Health International 

Linda Brubaker, MD 

Professor of Obstetrics/Gynecology 

and Urology 

Loyola University

Dwight J. Rouse, M.D., M.S.P.H. 

Professor 

Obstetrics and Gynecology 

School of Medicine 

University of Alabama at Birmingham 

Pierre Buekens, MD, PhD, MPH 

Dean, School of Public Health 

Tulane University 

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Peer Reviewers 

We gratefully acknowledge the following individuals who reviewed the initial draft of this 

report and provided us with constructive feedback. External reviewers comprised clinicians, 

researchers, representatives of professional societies, and potential users of the report. We would 

also like to extend our appreciation to David Atkins, MD, and Susan Meikle, MD MSPH from

AHRQ for contributing peer review comments. Our peer review panel also includes all members 

of the TEAG. Peer review was a separate duty for these individuals and not part of their 

commitment as TEAG members. All are active professionals in the field. The peer reviewers 

were asked to provide comments on the content, structure, and format of the evidence report and 

to complete a checklist. The peer reviewers’ comments and suggestions formed the basis of our 

revisions to the evidence report. Acknowledgments are made with the explicit statement that this 

does not constitute endorsement of the report. 

Individuals Organizations

William Hueston, MD 

Chair, Department of Family Medicine; 

Professor 

Medical University of South Carolina 

Robin Bell, MB BS PhD MPH FAFPHM 

Cert Health Econ 

Deputy Director of Research 

Jean Hailes Foundation 

Clayton Victoria, Australia 

Michael Klein, MD, CCFP, FAAP, FCFP, 

ABFP UBC

BC Children's Hospital 

Emeritus Professor of Family Practice and 

Pediatrics 

BC, Canada 

Leslie Cragin, CNM,PhD 

Associate Clinical Professor 

UCSF Dept. Ob/Gyn at SFGH 

Anne M. Weber, MD, MS 

Director, Female Pelvic Med & 

Reconstructive Surgery 

Department of Ob/Gyn 

University of Pittsburgh

Magee-Womens Hospital 

Linda Herrick, RNC, BSN, CCE, CD 

Director

Academy of Certified Birth Educators and 

Labor Support Professionals 

2001 East Prairie Circle 

Suite I 

Patricia McLaughlin, RNC, MPA, MSN 

Manager, Professional Development and 

Clinical Programs

Association of Women's Health, Obstetric 

and Neonatal Nurses 

2000 L Street, N.W.

Suite 740 

Washington, DC 20036

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