Randomized Controlled Clinical Trial of Lateral Episiotomy Versus no Episiotomy in Vacuum Assisted Delivery in Non-parous Women
Phase: NA
Conditions: Pelvic Floor Disorders, Fecal Incontinence, Dystocia, Fetal Hypoxia
Sponsor: Karolinska Institutet

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EVA 
Episiotomy in Vacuum Assisted delivery 
A randomized controlled trial of lateral episiotomy vs. no episiotomy 
in vacuum assisted delivery in non-parous women  
 
 
 
 
Sponsor:  
Sophia Brismar Wendel 
 
Coordinating Investigator: 
Sophia Brismar Wendel 
 
 
 

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Table of Contents 
 
1 
PROTOCOL SUMMARY ......................................................................................................................... 4 
2 
ABBREVIATIONS .................................................................................................................................. 6 
3 
ADMINISTRATIVE INFORMATION ......................................................................................................... 7 
4 
BACKGROUND ..................................................................................................................................... 7 
4.1 
PURPOSE AND AIMS ........................................................................................................................... 7 
4.2 
SURVEY OF THE FIELD ......................................................................................................................... 7 
5 
OBJECTIVES ......................................................................................................................................... 8 
5.1 
PRIMARY OBJECTIVE .......................................................................................................................... 8 
5.2 
SECONDARY OBJECTIVES ..................................................................................................................... 8 
6 
ENDPOINTS ......................................................................................................................................... 9 
6.1 
PRIMARY ENDPOINT .......................................................................................................................... 9 
6.2 
SECONDARY ENDPOINTS...................................................................................................................... 9 
7 
DESIGN AND PROCEDURES ................................................................................................................... 9 
7.1 
OUTLINE ........................................................................................................................................ 9 
7.2 
PROCEDURES ................................................................................................................................. 10 
7.3 
END OF STUDY ............................................................................................................................... 11 
8 
SELECTION AND WITHDRAWAL OF SUBJECTS ...................................................................................... 11 
8.1 
INCLUSION CRITERIA ........................................................................................................................ 11 
8.2 
EXCLUSION CRITERIA ........................................................................................................................ 11 
8.3 
SUBJECT LOG ................................................................................................................................. 11 
9 
INTERVENTION .................................................................................................................................. 12 
9.1 
DESCRIPTION OF THE INTERVENTION ..................................................................................................... 12 
9.2 
RANDOMIZATION ............................................................................................................................ 12 
10 
ASSESSMENTS ................................................................................................................................... 12 
10.1 
PERINEAL INJURY ............................................................................................................................ 12 
10.2 
BLOOD LOSS .................................................................................................................................. 13 
10.3 
NEONATAL OUTCOME....................................................................................................................... 13 
10.4 
ADMISSION TO THE NEONATAL WARD ................................................................................................... 13 
10.5 
SCALP TRAUMA AND OTHER NEONATAL TRAUMA ...................................................................................... 13 
10.6 
DURATION OF HOSPITAL STAY ............................................................................................................. 13 
10.7 
PAIN AND BIRTH EXPERIENCE AFTER DELIVERY .......................................................................................... 13 
10.8 
QUESTIONNAIRES ............................................................................................................................ 13 
10.9 
PERINEAL EVALUATION WITH ULTRASOUND AND CLINICAL PELVIC EXAM ........................................................... 14 
10.10 PREGNANCY REGISTER AND PATIENT REGISTER.......................................................................................... 14 
11 
PROCEEDINGS FOR ADVERSE EVENTS ................................................................................................. 14 
11.1 
DEFINITION OF ADVERSE EVENTS ......................................................................................................... 14 
11.2 
ASSESSMENT OF ADVERSE EVENTS ....................................................................................................... 14 
11.3 
METHODS FOR ELICITING ADVERSE EVENTS ............................................................................................ 15 
11.4 
REPORTING OF ADVERSE EVENTS ......................................................................................................... 15 

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11.5 
FOLLOW-UP OF ADVERSE EVENTS ........................................................................................................ 15 
12 
STATISTICS AND DATA MANAGEMENT ............................................................................................... 15 
12.1 
DATA MANAGEMENT ....................................................................................................................... 15 
12.2 
STATISTICAL ANALYSIS ...................................................................................................................... 15 
12.3 
DETERMINATION OF SAMPLE SIZE ........................................................................................................ 16 
13 
QUALITY CONTROL AND QUALITY ASSURANCE ................................................................................... 17 
13.1 
SOURCE DATA ................................................................................................................................ 17 
13.2 
MONITORING ................................................................................................................................ 17 
14 
DIRECT ACCESS TO SOURCE DOCUMENTS ........................................................................................... 17 
15 
ETHICS............................................................................................................................................... 17 
15.1 
INDEPENDENT ETHICS COMMITTEE ....................................................................................................... 17 
15.2 
ETHICAL CONDUCT OF THE STUDY ........................................................................................................ 17 
15.3 
RISK - BENEFIT ASSESSMENT ............................................................................................................... 18 
15.4 
SUBJECT INFORMATION AND INFORMED CONSENT .................................................................................... 18 
16 
DATA HANDLING AND RECORD KEEPING ............................................................................................ 18 
16.1 
CASE REPORT FORMS ....................................................................................................................... 18 
16.2 
RECORD KEEPING ............................................................................................................................ 18 
17 
FINANCING AND INSURANCE ............................................................................................................. 19 
18 
PUBLICATION POLICY ......................................................................................................................... 19 
19 
SUPPLEMENTS ................................................................................................................................... 19 
19.1 
AMENDMENTS ............................................................................................................................... 19 
19.2 
PERSONNEL INFORMATION ................................................................................................................ 19 
20 
REFERENCES ...................................................................................................................................... 19 
21 
SIGNED AGREEMENT OF THE STUDY PROTOCOL ................................................................................. 21 
22 
APPENDICES ...................................................................................................................................... 22 
22.1 
SCHEDULE OF INVESTIGATIONAL EVENTS ................................................................................................ 22 
22.2 
STANDARD OPERATING PROCEDURES .................................................................................................... 23 
22.3 
QUESTIONNAIRES ............................................................................................................................ 23 
 

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1 Protocol Summary 
 
PROTOCOL IDENTITY AND OBJECTIVES 
Protocol Title: 
EVA – Episiotomy in Vacuum Assisted delivery. A 
randomized controlled trial of lateral episiotomy vs. no 
episiotomy in vacuum assisted delivery in non-parous 
women. 
Study Objectives: 
The aims are to investigate if lateral episiotomy can reduce 
the prevalence of obstetrical anal sphincter injury (OASIS) 
in operative vaginal delivery, notably vacuum extraction, in 
non-parous women, and to investigate secondary 
outcomes such as immediate maternal complications like 
post-partum haemorrhage and hospital stay, medium term 
effects like prolapse symptoms, incontinence, sexual 
dysfunction, birthing experience, and aspects of neonatal 
care. In a long-term follow-up, we will investigate if 
episiotomy/spontaneous tear is associated with caesarean 
section, episiotomy or OASIS in a subsequent 
pregnancy/childbirth. We will also re-evaluate symptoms 
of incontinence, prolapse and sexual function after 5 years. 
 
 
METHODOLOGY 
Study Design: 
The study is a randomized controlled trial with parallel 
groups. 
Intervention: 
The effect of lateral episiotomy vs. no episiotomy in 
vacuum assisted delivery in non-parous women in Sweden 
will be studied. Women with a singleton, live fetus in 
cephalic presentation, after week 34+0 requiring vacuum 
assisted vaginal delivery will be randomized to lateral 
episiotomy or no episiotomy. At least three sites are 
planned to participate. 
Primary Endpoint: 
The primary endpoint is third or fourth degree perineal 
tear (OASIS, ICD-10 code O70.2 or O70.3). 
 
 
 
 

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POPULATION OF STUDY SUBJECTS 
Description of Study Subjects: 
Inclusion Criteria: 
• 
Non-parous woman 
• 
Singleton, live fetus in cephalic presentation 
• 
Gestational week 34+0 or more 
• 
Requiring vacuum assisted vaginal delivery 
• 
Signed informed consent 
Exclusion Criteria: 
• 
Previous surgery for incontinence or prolapse 
Number of Subjects: 
1400 subjects 
 
 
STUDY TIMETABLE 
First Subject In: 
June 2017 
Last Subject In: 
June 2021 
Last Subject Out: 
Sept 2031 

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2 Abbreviations 
 
Abbreviation 
Explanation 
AE 
Adverse Event 
BMI 
Body Mass Index 
BSS-R 
Birth Satisfaction Scale-Revised 
CEQ 
Child Experience Questionnaire 
CRF 
Case Report Form 
FSDS 
Female Sexual Distress Scale 
FSFI 
Female Sexual Function Index 
GCP 
Good Clinical Practice 
ICD-10 
International Statistical Classification of Diseases and Related Health Problems 
- Tenth Revision 
ICH 
International Conference of Harmonization 
IEC 
Independent Ethics Committee 
NICU 
Neonatal Intensive Care Unit 
OASIS 
Obstetric Anal Sphincter Injury 
PDB 
Pudendal Block 
POP-Q 
Pelvic Organ Prolapse Quantification  
SAE 
Serious Adverse Event 
SBU 
Statens Beredning för Medicinsk och Social Utvärdering 
SNQ 
Swedish Neonatal Quality Register 
SOP 
Standard Operating Procedure 
VAS 
Visual Analogue Scale 
WMA 
World Medical Association 

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3 Administrative Information 
Sponsor 
Sophia Brismar Wendel 
MD, PhD, senior consultant 
Dept of Women’s Health, Danderyd Hospital 
182 88 Stockholm 
Telephone: +46-(0)8-123 58564, +46-(0)72-2024895 
Email: sophia.brismar-wendel@sll.se  
Email: sophia.brismar@ki.se 
 
Coordinating Investigator 
Sophia Brismar Wendel 
MD, PhD, senior consultant 
Dept of Women’s Health, Danderyd Hospital 
182 88 Stockholm 
Telephone: +46-(0)8-123 58564, +46-(0)72-2024895 
Email: sophia.brismar-wendel@sll.se  
Email: sophia.brismar@ki.se 
 
4 Background 
4.1 Purpose and aims 
The purpose is to improve obstetrical care in Sweden by making the second stage safer, specifically to 
reduce obstetric anal sphincter injury (OASIS) in operative vaginal delivery. OASIS prevalence in all 
vaginal deliveries is 5-7% in Sweden. The prevalence of perineal tears increases with operative vaginal 
delivery, and the frequency of OASIS is 12-14% in vacuum extractions in Sweden.  
 
The aims are to investigate if lateral episiotomy can reduce the rate of OASIS in operative vaginal 
delivery, notably vacuum extraction, in non-parous women, and to investigate secondary outcomes such 
as immediate maternal complications like postpartum hemorrhage and hospital stay, medium term 
effects like prolapse symptoms, incontinence, sexual dysfunction, birthing experience, and aspects of 
neonatal care (cord pH, Apgar score, subcutaneous hemorrhage, birth trauma). In a long-term follow-up, 
we will investigate if episiotomy/spontaneous tear is associated with cesarean section, episiotomy or 
OASIS in a subsequent pregnancy/childbirth. We will also re-evaluate symptoms of incontinence, 
prolapse and sexual function after 5 years. 
 
The proposed study is a randomized controlled trial of lateral episiotomy vs. no episiotomy in vacuum 
assisted delivery in non-parous women in Sweden. Women with a singleton, live fetus in cephalic 
presentation, after week 34+0 requiring vacuum assisted vaginal delivery will be randomized to lateral 
episiotomy or no episiotomy. 
4.2 Survey of the field 
A third or fourth degree tear (OASIS) is considered to be the most important cause of anal incontinence 
in women, and therefore important to avoid. In Finland, the prevalence has been very low since several 
decades, probably due to a different technique (no pushing) at delivery of the fetal head and an effective 
perineal support, as well as a longstanding tradition of lateral episiotomy (1-3). A lateral episiotomy 
involves an incision at least 1 cm from the midline and at least at 30 degrees angle from the midline, as 
measured after healing (4). In Norway, a national prospective multi-center study during 2000-2010, with 

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implementation of a “Finnish” perineal support and lateral episiotomy, decreased anal sphincter injury 
from 4.0% to 1.2% in the total population and from 16.3% to 4.9% in vacuum extractions (5). In an 
American study, a change to mediolateral episiotomies in instrumental deliveries (commonly forceps) 
decreased the prevalence of sphincter tears from 41 to 26% (6). Similarly, a Dutch prospective study, 
showed a risk reduction at instrumental deliveries by 90% using mediolateral episiotomy (7). On the 
contrary, medial (midline) or too small episiotomies are associated with an increased risk of sphincter 
injury (8). In a British study comparing routine (93%) vs. restrictive (52%) use of episiotomy, there was a 
small non-significant difference in the rate of anal sphincter tears (8.1% routine versus 10.9% restrictive, 
OR 0.72, 95% CI 0.28-1.87) but the trial was underpowered (9). There is a recent randomized study 
comparing mediolateral and lateral episiotomy, finding equal although very low prevalence of sphincter 
injury (1.5 vs. 1.3%) (10). The objection that lateral incisions bleed more or causes more pain is 
contradicted by studies comparing incision techniques (11, 12). Little is known about chronic pain after 
episiotomy or spontaneous perineal injury, although there seem to be a correlation between the extent 
of tissue damage and degree of pain (13-15). An SBU report (Statens beredning för medicinsk och social 
utvärdering, www.sbu.se) published in April 2016 concludes that mediolateral episiotomy can protect 
against OASIS in operative vaginal deliveries in non-parous women based on two retrospective cohort 
studies (7, 8) although in Sweden, there is no correlation between a hospital’s rate of episiotomy and 
OASIS. The SBU report states that there is a knowledge gap regarding function and symptoms after 
episiotomy compared to moderate spontaneous tears/OASIS. Several others, including Cochrane and 
DUETS/NICE Evidence Search, state that the protective effect of lateral episiotomy at operative vaginal 
delivery should be investigated in an adequately sized randomized study (8, 16-18). 
5 Objectives 
5.1 Primary Objective 
The primary objective is to investigate if lateral episiotomy protects against obstetrical anal sphincter 
injury (OASIS) compared to no episiotomy in operative vaginal delivery by vacuum extraction, in term 
and late pre-term (gestational week 34+0 or more), non-parous women with one live fetus in cephalic 
presentation. 
5.2 Secondary Objectives 
The secondary objectives are to investigate if lateral episiotomy compared to no episiotomy in the above 
specified group of patients can reduce:  
• 
Prevalence of other degree of perineal injury, prevalence of postpartum hemorrhage, duration 
of hospital stay, pain, and duration of pain medication, compared to spontaneous perineal injury 
of different degrees (1st, 2nd, 3rd and 4th degree) 
• 
Neonatal morbidity measured as prevalence of low Apgar score, metabolic acidosis, prevalence 
of admission to the Neonatal ward, and prevalence of scalp trauma/other birth trauma 
• 
Prevalence of urinary, anal and fecal incontinence, prolapse symptoms, sexual dysfunction, or 
discontent with birthing experience after 2 months 
• 
Prevalence of ultrasound evidence of extended pelvic floor injury at 6-12 months after delivery 
• 
Prevalence of urinary, anal and fecal incontinence, prolapse symptoms, or sexual dysfunction 
after 1 and 5 years 
• 
Prevalence of elective cesarean in a subsequent pregnancy/delivery, the prevalence of OASIS in 
a subsequent pregnancy/delivery, or of episiotomy in a subsequent pregnancy/delivery within 5 
and 10 years 

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6 Endpoints 
6.1 Primary Endpoint 
The primary endpoint is third or fourth degree perineal tear (OASIS, ICD-10 code O70.2 or O70.3). The 
diagnosis is made clinically. Clinical diagnosis is quality controlled in a sub-study in one site by ultrasound 
of the pelvic floor muscles at 6-12 months after delivery. 
6.2 Secondary Endpoints 
The secondary endpoints are: 
• 
other degree of perineal injury (O70.0, O70.1, O71.4 or O71.7) 
• 
blood loss postpartum (ml) 
• 
neonatal outcome (prevalence of Apgar score <7 at 1 min, 5 min and 10 min, umbilical artery 
pH <7.05) 
• 
admission to the Neonatal ward (hours of stay and prevalence) 
• 
fetal trauma (clinical diagnosis of hematoma/fracture/obstetric brachial plexus palsy/hypoxic 
ischemic encephalopathy by neonatologist)  
• 
duration of hospital stay after delivery (days) 
• 
pain and birth experience after delivery (Visual Analog Scale (VAS)) 
• 
duration of pain medication after delivery (days) 
• 
symptoms regarding anal incontinence (Wexner score) (19) at 2 months, 12 months and 5 years 
after delivery 
• 
symptoms regarding urinary incontinence at 2 months, 12 months and 5 years after delivery 
• 
sexual function, prolapse and bowel symptoms at 2 months, 12 months and 5 years after 
delivery 
• 
birthing experience and satisfaction 2 months after delivery 
• 
ultrasound evidence of OASIS or levator ani muscle injury at 6-12 months after delivery 
• 
mode of delivery, episiotomy, and OASIS in a subsequent pregnancy at 5 years and 10 years after 
index delivery 
• 
quality of life at 12 months and 5 years after delivery 
7 Design and Procedures 
7.1 Outline 
The study is a randomized controlled trial with parallel groups. The effect of lateral episiotomy vs. no 
episiotomy in vacuum assisted delivery in non-parous women in Sweden will be studied. Women with a 
singleton, live fetus in cephalic presentation, after week 34+0 requiring vacuum assisted vaginal delivery 
will be randomized to lateral episiotomy or no episiotomy. Lateral episiotomy will be performed after 
local anesthesia at crowning. After delivery routine care is given. 
 
Primary outcome is obstetrical anal sphincter injury (OASIS) diagnosed clinically. In at least one center, 
transperineal, endovaginal and transrectal ultrasound validation of the clinical diagnosis and effects on 
pelvic floor will be made at 6-12 months after delivery. 
 
Follow-up will be performed at 2 months, 12 months and 5 years using web-based questionnaires and at 
5 years and 10 years through the Pregnancy Register. 
 
 

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7.2 Procedures 
The procedures at each time point are described below and can also be found in Appendix 21.1 Schedule 
of Investigational Events. 
7.2.1 
At the maternity clinic 
7.2.1.1 
Before delivery 
After admission to the clinic the women will be given information about the study and asked to 
participate. Before any screening and study related activities take place, written informed consent must 
be obtained from the subject. The Investigator will review the inclusion and exclusion criteria for 
eligibility. If all the inclusion criteria and none of the exclusion criteria are met the subject will be 
included in the study. 
 
Included subjects are randomized to lateral episiotomy at crowning or no episiotomy. Randomization 
and lateral episiotomy is performed as described in 9.1 and 9.2. Lateral episiotomy is also described in 
the study specific Standard Operating Procedure (SOP), see Appendix 21.2 Standard Operating 
Procedures. 
 
Background and explanatory variables to be recorded are maternal age, country of birth, weight at 
registration in the antenatal clinic and height. 
7.2.1.2 
Shortly after delivery  
Perineal incisions and tears are sutured according to the clinical routine or as suggested by the study 
specific SOP, see Appendix 21.2 Standard Operating Procedures. 
 
Perineal injury, blood loss, and neonatal outcomes (Apgar score, umbilical artery pH and birth related 
diagnosis) are recorded.  
 
Background and explanatory variables to be recorded are use of Oxytocin, use of regional or local 
anesthesia, birthweight, head circumference, neonatal length, second stage duration, indication for 
vacuum extraction, fetal position and station, operator skills, number of pulls, and use of sequential 
instruments. 
7.2.1.3 
On the maternity ward  
Pain after delivery (VAS, included in the questionnaires), birth experience (VAS), duration of hospital 
stay, and admission to the Neonatal ward will be recorded. 
 
Assessment of baseline data on pelvic floor function will be performed using the questionnaire 
“Uppgifter om hälsa före graviditeten”. The questionnaires “Female Sexual Function Index” (FSFI) and 
“Female Sexual Distress Scale” (FSDS) will be used for in depth assessment of sexual function. Quality of 
life will be measured using the questionnaire Euro-QoL-5D. 
7.2.2 
Follow up 2 months (up to 6 months after delivery) 
Assessment of duration of pain medication, pelvic floor and sexual function will be performed using the 
questionnaire “Din värdering av behandlingen av förlossningsbristningen (ca 8 veckor)”. Assessment of 
birth satisfaction will be performed using the Birth Satisfaction Scale (BSS-R) and the Child Experience 
Questionnaire (CEQ 2.0). 
 

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7.2.3 
Follow up 6 months (up to 12 months after delivery) 
(In at least one site) The scar after tears/episiotomy will be measured using a ruler and a protractor, 
pelvic organ prolapse will be quantified using a specific score (POP-Q), and transperineal, endovaginal 
and transrectal 2D/3D ultrasound will be used to evaluate occult OASIS and other injuries to the muscles 
of the pelvic floor. In the other sites, an individual clinical follow-up will be offered at six months after 
delivery, without any planned data entry points. 
7.2.4 
Follow up 12 months (up to 18 months after delivery) 
Assessment of pelvic floor and sexual function will be performed using the questionnaire “Din värdering 
av behandlingen av förlossningsbristningen (ca 1 år)”. The questionnaires “Female Sexual Function 
Index” (FSFI) and “Female Sexual Distress Scale” (FSDS) will be used for in depth assessment of sexual 
function. Quality of life will be measured using the questionnaire Euro-QoL-5D.  
7.2.5 
Follow up 5 years (up to 5 years and 6 months after delivery) 
Assessment of pelvic floor and sexual function will be performed using the questionnaire “Din värdering 
av behandlingen av förlossningsbristningen (ca 1 år)”. The questionnaires “Female Sexual Function Index” 
(FSFI) and “Female Sexual Distress Scale” (FSDS) will be used for in depth assessment of sexual function. 
Quality of life will be measured using the questionnaire Euro-QoL-5D. 
 
Data on mode of delivery, episiotomy, and OASIS in a subsequent pregnancy will be collected from the 
Pregnancy Register. 
7.2.6 
Follow up 10 years 
Data on mode of delivery, episiotomy, and OASIS in a subsequent pregnancy will be collected from the 
Pregnancy Register. 
7.3 End of Study 
The end of study is defined as the last follow up for the last subject. 
8 Selection and Withdrawal of Subjects 
8.1 Inclusion Criteria 
• 
Non-parous woman 
• 
Singleton, live fetus in cephalic presentation 
• 
Gestational week 34+0 or more 
• 
Requiring vacuum assisted vaginal delivery 
• 
Signed informed consent 
8.2 Exclusion Criteria 
• 
Previous surgery for incontinence or prolapse   
8.3 Subject Log 
Investigators must keep a record, a screening log, of all patients that were considered for enrolment 
even if they were not subsequently enrolled. In this study, this applies to all women who have given 
consent to participation. This information is necessary to verify that the patient population was selected 

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without bias. The reasons for non-eligibility are to be defined in terms of one or more of the eligibility 
criteria. 
 
Investigators must also keep a Subject identification log of all patients enrolled (equals to randomized) 
which includes sufficient information to link records, i.e. the Case Report Form (CRF) and clinical records.  
9 Intervention 
9.1 Description of the intervention 
Intervention: Lateral episiotomy 
Comparison: No episiotomy 
 
In all women, the urinary bladder should be emptied by catheterization before application of the 
vacuum cup. For pain relief, a pudendal block (PDB) can be administered using for example Mepivakain 
(Carbocain) 10 mg/ml 5-10 ml. The anesthetic substance is injected using a Kobak needle on each side 
localizing the ischiadic spines bilaterally. 
 
For women randomized to the intervention group, lateral episiotomy is performed as follows. 
Local anesthesia is administered using for example Mepivacaine (Carbocain) or Lidocaine (Xylocain) in 
the hymeneal plane, 1 ml subcutaneously at the incision point and 9 ml in a fan-like fashion from the 
incision point.  The vacuum cup is then applied and the extraction is performed until the fetal head is 
crowning, i.e. the cup is visible in the vaginal opening. 
 
Lateral episiotomy is then performed using specific episiotomy scissors, Mayo scissors, or similar. 
• 
Distance from incision point to the posterior fourchette: at least 1 cm, up to 3 cm. 
• 
Angle from the sagittal or parasagittal plane: 60° (45-80°, aim at the ischiadic tuberosity) 
• 
Length of the incision: 4 cm (3-5 cm) 
 
All women will receive perineal support using verbal guiding and manual support of the perineum during 
the delivery of the head and body. The third stage, examination and diagnosis of perineal tears is 
managed according to clinical routine. Suturing is managed according to clinical routine or as suggested 
in the study specific SOP, see appendix 21.2 Standard Operating Procedures. 
9.2 Randomization 
The physician in charge of the operative delivery is responsible for randomization. Women included in 
the study will be randomized to lateral episiotomy or no episiotomy using opaque envelopes on the 
vacuum extractor equipment wagon.   
10 Assessments 
10.1 Perineal injury 
A physician specialist or a senior registrar physician will make the diagnosis clinically. In a subgroup, 
diagnosis will be confirmed by transperineal and transrectal ultrasound at six to 12 months after 
delivery. This will be performed in a participating site where the method is established for the diagnosis 

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of OASIS. Any degree of perineal injury will be recorded. Data will be entered manually and collected 
from the Pregnancy register. 
10.2 Blood loss 
Postpartum hemorrhage is measured in milliliters. Data will be collected from the Pregnancy register. 
10.3 Neonatal outcome 
Assessment of Apgar score is performed according to clinical routine. The score at 1, 5, and 10 min is 
recorded for the study. Umbilical cord blood is sampled routinely in all operative deliveries. Arterial and 
venous blood gases are analyzed using regular equipment in the ward. Data will be collected from the 
Pregnancy register. 
10.4 Admission to the Neonatal ward 
Admission to the Neonatal ward (duration of stay and prevalence) will be collected from the Swedish 
Neonatal Quality Register (SNQ). 
10.5 Scalp trauma and other neonatal trauma 
Clinical diagnosis of cephalic hematoma/subgaleal hematoma/intracranial hemorrhage as well as 
diagnosis of fractures, obstetric brachial plexus palsy and hypoxic ischemic encephalopathy by 
neonatologist. These variables will be collected from the Pregnancy register and the SNQ. 
10.6 Duration of hospital stay 
Duration of hospital stay (days) after delivery will be collected from the Pregnancy register. 
10.7 Pain and birth experience after delivery 
Pain after delivery will be assessed using a simplified VAS (0-10) and this assessment will be included in 
the questionnaires. 
 
Birth experience after delivery will be assessed using a simplified VAS (1-10). This variable will be 
collected from the Pregnancy register. 
10.8 Questionnaires 
The questionnaires ”Uppgifter om hälsa före graviditeten” and “Din värdering av behandlingen av 
förlossningsbristningen” will be used for assessment of pelvic floor and sexual function. The 
questionnaire is identical to the baseline questionnaire used in ”Bristningsregistret”, a national register 
of perineal injuries in obstetric care. The questionnaire consists of a set of questions regarding pelvic 
floor function, i.e. urinary and anal continence, symptoms of vaginal prolapse, sexual function, and 
bowel function. 
 
The questionnaires “Female Sexual Function Index” (FSFI) and “Female Sexual Distress Scale” (FSDS) will 
be used for in depth assessment of sexual function. Both contain questions on sexual arousal, 
lubrication, pain, and orgasm.  
 
The Birth Satisfaction Scale (BSS-R) (20, 21) and The Childbirth Experience Questionnaire (CEQ 2.0)(22) 
will be used for assessment of the birthing experience and satisfaction. The questionnaires contain 
questions regarding self-empowerment, fear, and overall satisfaction with care. 
 

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Euro-QoL-5D will be used for assessment of quality of life. The questionnaire contains 5 questions on 
mobility, personal hygiene, anxiety, and an over-all health evaluation using a VAS scale (23). 
 
All the questionnaires will be managed by the patient survey company ImproveIT AB, with extensive 
experience in web-based questionnaires. Data will be encrypted and kept confidential and forwarded to 
the research team for clinical follow-up. 
10.9 Perineal evaluation with ultrasound and clinical pelvic exam 
In a subgroup of patients at specific sites, a structured clinical pelvic exam at 6-12 months after delivery 
will be done. The scar after tears/episiotomy will be measured, a pelvic organ prolapse quantification 
(POP-Q) score will be applied, and transperineal, endovaginal and transrectal 2D/3D ultrasound will be 
used to evaluate different parts of the pelvic floor. This exam will be accompanied by a questionnaire 
under development called (Q-SOPhIE, Questionnaire on Symptoms of Obstetric Perineal tears).  
10.10 Pregnancy register and patient register 
Data on several background variables, a number of outcome variables, and mode of delivery, 
episiotomy, and OASIS in a subsequent pregnancy will be collected from the Pregnancy Register. Data on 
outcomes regarding pelvic floor function may be collected from the Patient register in a later sub-study. 
11 Proceedings for Adverse Events 
11.1 Definition of Adverse Events 
11.1.1 Definition of Adverse Events 
An Adverse Event (AE) is any untoward medical occurrence in a subject and which does not necessarily 
have a causal relationship with the allocated treatment. An AE can be any unfavourable and unintended 
sign, abnormal laboratory finding, symptom or disease temporally associated with the subject 
participating in the clinical study, whether or not related to the allocated treatment. 
11.1.2 Definition of Serious Adverse Events 
Each AE is to be classified by the investigator as serious or non-serious. Seriousness is not defined by a 
medical term; it is a result or an outcome. An AE is defined as a Serious Adverse Event (SAE) if it: 
• 
results in death 
• 
is life-threatening 
• 
requires admission to an intensive care unit 
• 
results in persistent or significant disability/incapacity 
• 
other medically important event 
11.2 Assessment of Adverse Events 
11.2.1 Assessment of Intensity 
Each AE is to be classified by the investigator as mild, moderate or severe. 
Mild: Acceptable. The subject is aware of symptoms or signs, but these are easily tolerated. 
Moderate: Disturbing. The AE is discomforting enough to interfere with usual daily activities. 
Severe: Unacceptable. The subject is incapable of working or performing usual daily activities. 

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11.2.2 Assessment of Causality 
Unlikely: The event is most likely related to an aetiology other than the allocated treatment. 
Possible: A causal relationship is conceivable and cannot be dismissed. 
Probably: Good reason and sufficient documentation to assume a causal relationship. 
11.3 Methods for Eliciting Adverse Events 
AEs are spontaneously reported by subject, or reported by subject to study personnel during study visit 
or other visits at the participating the clinic, or by laboratory test results. Events will be registered when 
reported in the CRF AE form by date, time, symptoms and course of events. 
11.4 Reporting of Adverse Events 
All AEs will be classified as serious or non-serious and the intensity and causality will be assessed. Only 
AEs that are considered related to the delivery or participation in the trial will be reported in the CRF. In 
addition, all AEs that are classified as serious (SAEs) will be recorded in the CRF. AEs reported in the 
questionnaire at 2 months’ follow-up do not need separate recording in the CRF. SAEs will be reported 
by the investigator to the sponsor within 72 hours after the SAE has been communicated to the 
investigator. Follow-up information describing the outcome of the SAE and actions taken will be 
reported as soon as available.  
11.5 Follow-up of Adverse Events 
For all AEs, the subject will be followed until either the AE has ceased or until the subject is under 
professional medical care and a potential causality between the study treatment and the AE has been 
assessed. 
12 Statistics and Data Management 
12.1 Data Management 
Data will be entered electronically from the Pregnancy register and from the questionnaires into the 
database. Data from the CRF will be entered manually into the database, until an eCRF has been 
developed. 
12.2 Statistical Analysis 
Descriptive statistics will be used to characterize the groups of individuals recruited to the study to 
investigate comparability of the two groups at baseline. T-tests and Chi-square tests will be used 
depending on variable characteristics.  
 
Data will be analysed both by intention to treat and per protocol. The primary analysis will comprise 
intention-to-treat comparisons between the intervention group and the control group for both primary 
and secondary maternal and fetal outcomes. Results will be presented as absolute prevalence (rate of 
OASIS) or measurement (post-partum haemorrhage in millilitres), and after univariable and multivariable 
logistic regression analysis as odds ratios with 95% confidence intervals. The multivariable logistic 
regression models will adjust for possible confounders/effect modifiers such as maternal Body Mass 
Index (BMI) (>30), operator skills (specialist or not), long duration of labour >12 hours, epidural and use 
of oxytocin expressed as binary variables. 
 

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Secondary analyses will compare secondary outcomes using comparison of test of proportions, t-test 
and logistic regression depending on variable characteristics in the research questions. Outcomes based 
on evaluation scores (Wexner score and Birth Satisfaction Scale) will be analysed by non-parametric 
tests (Mann-Whitney, Rank sum or Wilcoxon two unpaired samples) but also paired analyses for change 
over time (up to 5 years after delivery) in the subgroups using Sign test. 
12.3 Determination of Sample Size 
Primary outcome variable is prevalence of OASIS in the intervention group (lateral episiotomy) 
compared to the control group (no episiotomy). The average prevalence of OASIS in operative vaginal 
delivery in all women (not only non-parous women) was 12.4% in Sweden according to the Medical Birth 
Register in 2015. At Danderyd Hospital, the prevalence of OASIS has varied between 14 and 18% in 
primiparous women. In normal vaginal delivery, the prevalence of OASIS is 6-7% in primiparous women 
in Sweden. A reduction of OASIS from 12.4% to 6.2% (“normal delivery rate”) can be detected with 80% 
power and 5% risk of alpha-error (p-value <0.05) with 350 women in each group using Chi-square test 
comparing two independent proportions in a two-sided test (1.5% loss of follow-up). A reduction to 7.8% 
is clinically valuable, thus a sample size of 694 women in each allocation group is needed. Total number 
of patients are 1400 women. We will perform a first interim analysis after 350 randomized women, to 
detect a possible reduction from 12.4% to 2.5% with 80% power and p-value <0.01, and a second interim 
analysis after 700 randomized women, to detect a possible reduction from 12.4% to 6.2% with 80% 
power and p-value <0.05. We are planning at least three sites. Depending on the size of the delivery 
ward, each site will contribute with approximately 5% of non-parous women giving birth vaginally (70-
200 patients annually). Inclusion rate is expected to be 3 patients/week at a site with 300 annual vacuum 
extractions in non-parous women, if 50% of women accept participation. 
 
 

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13 Quality Control and Quality Assurance 
13.1 Source Data 
The requirements regarding information in the medical records follows the “Patientdatalagen” (SFS 
2008:355) and the coming General Data Protection Regulation (from May 2018). Information that is of 
importance for the wellbeing and care of the patient, must be recorded in the medical records. The 
following study specific information should also be recorded: 
 
• 
Study title and a brief description of the study in terms of intervention and assessments 
• 
Date when patient information was given and when signed Informed Consent was obtained 
• 
Subject randomization number 
• 
Medically responsible study doctor, with contact details 
 
Details and information that is study specific and of no interest for the medical care of the subject can be 
recorded in the CRF and other documents and may be considered as source data. Prior to study start the 
expected location of source data (e.g. medical record notes, CRF, work sheets), must be identified and 
documented. This will be done by completing a site-specific Source Data List. 
13.2 Monitoring 
The Sponsor will appoint an independent monitor for quality control of the study. Monitoring will be 
performed before, during and after study completion in accordance with the International Conference of 
Harmonization Good Clinical Practice (ICH GCP) guidelines. The extent of monitoring will be described in 
a monitoring plan, which will be approved by the Sponsor. Study conductance, source data, adherence 
to the study protocol and ICH GCP will be monitored. 
14 Direct Access to Source Documents 
The Investigator(s) will permit study-related monitoring, providing direct access to source data/hospital 
records. The Investigator verifies that each patient has consented in writing to direct access to the 
original source data/hospital records using written patient information and signed Informed Consent. 
During the monitoring, the data recorded in the CRFs by the Investigator will be controlled for 
consistency with the source data/hospital records by the study monitor (source data verification). The 
monitor will sign a secrecy agreement. 
15 Ethics 
15.1 Independent Ethics Committee 
It is the responsibility of the Investigator to obtain approval of the study protocol/protocol amendments, 
the subject information and the Informed Consent from the Independent Ethics Committee (IEC) before 
enrolment of any subject into the study. 
15.2 Ethical Conduct of the Study 
The study will be performed in accordance with the protocol, ICH GCP, and the ethical principles of the 
World Medical Association (WMA) Declaration of Helsinki (as amended by the 64th WMA General 
Assembly, Fortaleza, Brazil, October 2013). 

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15.3 Risk - benefit assessment 
Childbirth is associated with pain and discomfort, which may increase with an episiotomy as well as with 
a perineal injury. An estimated 80% of women sustain at least a 2nd degree perineal injury in operative 
vaginal delivery, which is similar in size to a lateral episiotomy. Thus, the risk of pain and discomfort is 
similar in both allocation groups. Negative sensations are reduced by routine local anesthesia. The risk of 
long term pain is not known, and will be assessed.  
 
The questions in the questionnaires in follow-up are private in nature and can be perceived as 
psychologically disturbing or intrusive. Information about the importance of the answers before 
distribution may reduce discomfort. 
 
Benefits of study participation could be a standardized anesthetic routine before the vacuum extraction, 
a standardized perineal support, and a standardized follow-up including a contact person at the research 
clinic, and an optional follow-up visit at 6 months after delivery. In clinical routine, there is only follow-
up of third-fourth degree tears. 
15.4 Subject Information and Informed Consent 
It is the responsibility of the Investigator, or a person designated by the Investigator, to provide each 
subject with full and adequate verbal and written information about the objectives, procedures and 
possible risks and benefits of the study. All subjects should be given the opportunity to ask questions 
about the study and should be given sufficient time to decide whether to participate in the study or not. 
 
The subjects will be notified of their voluntary participation and of their freedom to withdraw from the 
study at any time and without giving any reason. Subjects must also be informed that withdrawing from 
the study will not affect their future medical care, treatment or benefits to which the subject is 
otherwise entitled.  
The Investigator, or a person designated by the Investigator, is responsible for obtaining written 
Informed Consent from all subjects prior to enrolment in the study. The Informed Consent Form must be 
signed and dated before any study-specific procedures are performed. The Investigator should file the 
signed Informed Consent Forms in the Investigator’s File for possible future audits and inspections. A 
copy of the subject information and the Informed Consent Form should be given to the subject. 
16 Data Handling and Record Keeping 
16.1 Case Report Forms 
Case Report Forms (CRF) will be provided for the recording of all data. The Investigator is responsible for 
ensuring the accuracy, completeness, legibility and timeliness of the data recorded in the CRFs. 
16.2 Record Keeping 
To enable audits and evaluations by the Sponsor, the Investigator shall keep records (essential 
documents) of the study for at least 10 years after end of the study. This includes any original source 
data related to the study, the subject Identification log (with subject numbers, full names and addresses) 
and the original signed Informed Consent Forms.  
The Sponsor is also, as per ICH GCP-requirements, responsible for archiving their part of the study 
documentation. 

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17 Financing and Insurance 
This is a non-commercial study financed by research grants. Subjects in the study are covered by the 
Patient Insurance (LÖF). 
18 Publication Policy 
The results from the study will be published in peer reviewed medical journals. Furthermore, 
information about the study will be publicly accessible in a clinical trial registry (www.clinicaltrials.gov). 
19 Supplements 
19.1 Amendments 
No change in the study procedures shall be effected without the mutual agreement of the Investigator 
and the Sponsor (except where necessary to eliminate an immediate hazard to subjects). All changes of 
the final study protocol must be documented by signed protocol amendments. Any substantial changes 
to the design or procedures of the study should be reviewed and approved by the IEC before 
implementation. 
19.2 Personnel Information 
It is the responsibility of the Investigator to ensure that all personnel involved in the study are fully 
informed of all relevant aspects of the study, including detailed knowledge of and training in all 
procedures to be followed. 
20 References 
1. 
Pirhonen JP, Grenman SE, Haadem K, Gudmundsson S, Lindqvist P, Siihola S, et al. 
Frequency of anal sphincter rupture at delivery in Sweden and Finland--result of difference in manual 
help to the baby's head. Acta Obstet Gynecol Scand. 1998;77(10):974-7. 
2. 
Laine K, Gissler M, Pirhonen J. Changing incidence of anal sphincter tears in four Nordic 
countries through the last decades. Eur J Obstet Gynecol Reprod Biol. 2009;146(1):71-5. 
3. 
Raisanen SH, Vehvilainen-Julkunen K, Gissler M, Heinonen S. Lateral episiotomy protects 
primiparous but not multiparous women from obstetric anal sphincter rupture. Acta Obstet Gynecol 
Scand. 2009;88(12):1365-72. 
4. 
Stedenfeldt M, Pirhonen J, Blix E, Wilsgaard T, Vonen B, Oian P. Episiotomy characteristics 
and risks for obstetric anal sphincter injuries: a case-control study. BJOG. 2012;119(6):724-30. 
5. 
Laine K, Pirhonen T, Rolland R, Pirhonen J. Decreasing the incidence of anal sphincter 
tears during delivery. Obstet Gynecol. 2008;111(5):1053-7. 
6. 
Hirsch E, Haney EI, Gordon TE, Silver RK. Reducing high-order perineal laceration during 
operative vaginal delivery. Am J Obstet Gynecol. 2008;198(6):668 e1-5. 
7. 
de Leeuw JW, de Wit C, Kuijken JP, Bruinse HW. Mediolateral episiotomy reduces the risk 
for anal sphincter injury during operative vaginal delivery. BJOG. 2008;115(1):104-8. 
8. 
Revicky V, Nirmal D, Mukhopadhyay S, Morris EP, Nieto JJ. Could a mediolateral 
episiotomy prevent obstetric anal sphincter injury? Eur J Obstet Gynecol Reprod Biol. 2010;150(2):142-6. 

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9. 
Murphy DJ, Macleod M, Bahl R, Goyder K, Howarth L, Strachan B. A randomised 
controlled trial of routine versus restrictive use of episiotomy at operative vaginal delivery: a multicentre 
pilot study. BJOG. 2008;115(13):1695-702; discussion 702-3. 
10. 
Karbanova J, Rusavy Z, Betincova L, Jansova M, Parizek A, Kalis V. Clinical evaluation of 
peripartum outcomes of mediolateral versus lateral episiotomy. Int J Gynaecol Obstet. 2014;124(1):72-6. 
11. 
Fodstad K, Laine K, Staff AC. Different episiotomy techniques, postpartum perineal pain, 
and blood loss: an observational study. Int Urogynecol J. 2012. 
12. 
Fodstad K, Staff AC, Laine K. Effect of different episiotomy techniques on perineal pain 
and sexual activity 3 months after delivery. Int Urogynecol J. 2014. 
13. 
De Souza A, Dwyer PL, Charity M, Thomas E, Ferreira CH, Schierlitz L. The effects of mode 
delivery on postpartum sexual function: a prospective study. Bjog. 2015;122(10):1410-8. 
14. 
Fodstad K, Staff AC, Laine K. Sexual activity and dyspareunia the first year postpartum in 
relation to degree of perineal trauma. Int Urogynecol J. 2016;27(10):1513-23. 
15. 
Signorello LB, Harlow BL, Chekos AK, Repke JT. 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 8-90. 
16. 
Sagi-Dain L, Sagi S. Morbidity associated with episiotomy in vacuum delivery: a systematic 
review and meta-analysis. Bjog. 2015;122(8):1073-81. 
17. 
Verghese TS, Champaneria R, Kapoor DS, Latthe PM. Obstetric anal sphincter injuries after 
episiotomy: systematic review and meta-analysis. Int Urogynecol J. 2016. 
18. 
Jiang H, Qian X, Carroli G, Garner P. Selective versus routine use of episiotomy for vaginal 
birth. Cochrane Database Syst Rev. 2017;2:Cd000081. 
19. 
Jorge JM, Wexner SD. Etiology and management of fecal incontinence. Dis Colon Rectum. 
1993;36(1):77-97. 
20. 
Hollins Martin CJ, Martin CR. Development and psychometric properties of the Birth 
Satisfaction Scale-Revised (BSS-R). Midwifery. 2014;30(6):610-9. 
21. 
Martin CH, Fleming V. The birth satisfaction scale. Int J Health Care Qual Assur. 
2011;24(2):124-35. 
22. 
Dencker A, Taft C, Bergqvist L, Lilja H, Berg M. Childbirth experience questionnaire (CEQ): 
development and evaluation of a multidimensional instrument. BMC Pregnancy Childbirth. 2010;10:81. 
23. 
Rabin R, de Charro F. EQ-5D: a measure of health status from the EuroQol Group. Ann 
Med. 2001;33(5):337-43. 
 

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21 Signed Agreement of the Study Protocol 
”I agree to the terms of this trial protocol. I will conduct the study in accordance with the procedures 
specified in the protocol, the ethical principles in the latest version of the Declaration of Helsinki and 
ICH GCP.” 
 
Principal Investigator 
 
 
 
 
 
 
Name 
 
 
 
 
 
 
Signature 
 
Date 
 
 
Coordinating Investigator 
Sophia Brismar Wendel, MD PhD 
Department of Women’s Health, Danderyd Hospital 
 
 
 
 
Signature 
 
Date 
 
 
Sponsor 
Sophia Brismar Wendel, MD PhD 
Department of Women’s Health, Danderyd Hospital 
 
 
 
 
Signature 
 
Date 

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22 Appendices 
22.1 Schedule of Investigational Events 
 
 
Before 
delivery 
 
Shortly after 
delivery  
 
At the 
maternity 
ward 
Follow up 
2 months 
Follow up 
6 months 
Follow up 
12 
months 
Follow up 
5 years 
Follow up 
10 years 
Information 
x 
 
 
 
 
 
 
 
Informed consent 
x 
 
 
 
 
 
 
 
Inclusion/exclusion 
criteria 
x 
 
 
 
 
 
 
 
Randomization 
x 
 
 
 
 
 
 
 
Episiotomy/no 
episiotomy 
x 
 
 
 
 
 
 
 
Background variables 
x1 
x2 
 
 
 
 
 
 
Data from Pregnancy 
register (primary and 
secondary endpoints) 
 
x3 
x4 
 
 
 
x5 
x6 
Data from SNQ on 
neonatal outcome 
(secondary 
endpoints) 
 
 
x 
 
 
 
 
 
Questionnaire BR 17 
 
 
x 
 
 
 
 
 
Questionnaire 
FSFI+FSDS 
 
 
x 
 
 
x 
x 
 
Questionnaire 
Euro-Qol-5D 
 
 
x 
 
 
x 
x 
 
Questionnaire BSS-R 
 
 
 
x 
 
 
 
 
Questionnaire CEQ 
2.0 
 
 
 
x 
 
 
 
 
Questionnaire BR 28 
(8 w) 
 
 
 
x 
 
 
 
 
Questionnaire BR 39 
(1 y) 
 
 
 
 
 
x 
x 
 
Ultrasound 
evaluation  
 
 
 
 
x 
 
 
 
POP-Q score 
 
 
 
 
x 
 
 
 
Measurements of 
scar 
 
 
 
 
x 
 
 
 
Questionnaire Q-
SOPhIE 
 
 
 
 
x 
 
 
 
Adverse events 
 
x 
x 
x 
x 
x 
 
 
                                                 
1 maternal age, country of birth, weight at registration in the antenatal clinic and height 
2 use of Oxytocin, use of regional or local anesthesia, birth weight, head circumference, birth length, second stage duration, 
indication for vacuum extraction, fetal position and station, operator skills, number of pulls, use of sequential instruments 
3 perineal injury, blood loss, and neonatal outcomes (Apgar score, umbilical artery pH and birth related diagnosis) 
4 birth experience, duration of hospital stay 
5 mode of delivery, episiotomy, and OASIS in a subsequent pregnancy 
6 mode of delivery, episiotomy, and OASIS in a subsequent pregnancy 
7 ”Uppgifter om hälsa före graviditeten” 
8 ”Din värdering av behandlingen av förlossningsbristningen (ca 8 veckor)” 
9 ”Din värdering av behandlingen av förlossningsbristningen (ca 1 år)” 

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22.2 Standard Operating Procedures 
Lateral episiotomi vid sugklocka 
Primär suturering av bristningar och klipp 
22.3 Questionnaires 
Uppgifter om hälsa före graviditeten 
Din värdering av behandlingen av förlossningsbristningen 
Female Sexual Function Index (FSFI) 
Female Sexual Distress Scale (FSDS) 
Birth Satisfaction Scale (BSS-R) 
Childbirth Experience Questionnaire (CEQ 2.0) 
Euro-QoL-5D 
Questionnaire Q-SOPhIE