One Plus One Equals Two - Will That do? A Randomized Controlled Trial to Evaluate Collegial Midwifery Practice to Prevent Perineal Trauma
Phase: NA
Conditions: Sphincter (Anal); Perineal Rupture, Obstetric, Perineal Tear, Pelvic Floor Disorders, Experience, Life, Second Stage of Labor
Sponsor: Region Skane

 
 
 
 
 
 
 
 
 
One plus one equals two – Will that do?  
 
A randomized controlled trial to evaluate collegial midwifery practice to 
prevent perineal trauma 
 
 
 
Project plan  
2020-02-20 
Ethical approval no 2018/476 
 
 
 
 
 
 
 
 

Purpose and aims 
The purpose of this study is to evaluate a clinical practice to reduce severe perineal trauma. 
This clinical practice involves collegial midwifery assistance during the second stage of 
labor, where an additional midwife is present during the active phase of the second stage of 
labor and the birth of the baby. The midwife responsible for the birth is the primary carer of 
the woman and the other midwife observes the birth or assists the primary midwife if asked 
to.  
Specific aims: 
Does the clinical practice with a second midwife present during the second stage and the 
birth of the baby 
- 
reduce severe perineal trauma (grade III-IV)? 
- 
reduce vaginal tears? 
- 
reduce perineal trauma grade II? 
- 
reduce pelvic floor-related symptoms one year after the birth? 
- 
How do midwives divide work assignments and responsibility between them during 
the second stage of labor? 
- 
How do women experience having one or two midwives attending the birth of the 
baby? 
- 
How do women experience midwifery care methods used during the second stage of 
labor to prevent perineal trauma? 
Background 
Most women sustain some form of perineal trauma when giving birth vaginally (1). Perineal 
injuries are classified as grade I-IV (2). A first-degree tear only includes perineal skin or 
mucosa, whereas a second-degree tear includes muscles in the perineal body. A tear 
involving a part or the whole of the anal sphincter muscle complex is graded III-IV (2). Data 
from the Swedish National Birth Register show that 4% of first-time mothers suffered a tear 
affecting the anal sphincter (3). National registers in Sweden only collect data on severe 
perineal trauma affecting the anal sphincter but in a recent regional Swedish study 78% of 
the primiparous women experienced second-degree tears (4). The consequences of second-
degree tears and severe perineal trauma are pain (5), dyspareunia (6), and an increased risk 
of symptomatic pelvic organ prolapse later in life (7). A severe consequence of perineal 
trauma is anal incontinence, mainly caused by tears affecting the anal sphincter muscle (8, 
9). However, second-degree tears may also lead to anal incontinence (8). This may be 
related to a lack of support from the perineal body due to poor repair. Furthermore, perineal 

trauma is known to be misclassified, with consequent under-reporting of injuries affecting the 
anal sphincter complex (10).  
Risk factors for severe perineal trauma (grade III-IV) are giving birth vaginally for the first 
time, having an assisted vaginal birth, giving birth vaginally after a previous caesarean 
section, or giving birth to a baby that weighs more than 4000g, and the risk increases with 
age (1, 11-13). Some of the midwifery care methods used to prevent perineal injuries have 
been evaluated in clinical trials but there are still gaps in our knowledge (14). Even if 
scientific evidence is lacking for most of the preventive strategies used by midwives except 
for warm compresses held at the perineum (14), midwives believe that a slow and controlled 
birth is a key factor in prevention. Several studies indicate that a combination of strategies 
can be effective in preventing perineal trauma (4, 15-17). Giving birth is a profound 
experience for the woman and her partner and an experience that has significance for the 
woman all her life (18). The second stage is considered to be the most stressful part of the 
labor for the woman and her unborn baby, and consequently also for the midwife (19). 
Despite this, there is still a lack of knowledge about how women experience the second 
stage and the methods midwives use to facilitate birth and prevent perineal trauma (14). 
Traditionally midwives have asked colleagues for a second opinion or to assist in 
complicated situations, or in obstetric emergencies. Recently a new clinical practice has 
been introduced in approximately 50% of the maternity wards in Sweden to reduce severe 
perineal trauma (20). This procedure involves two midwives attending the woman during the 
second stage of labor. The midwife responsible for the birth calls for the second midwife 
when the active phase of the second stage has started and the presenting part of the baby is 
visible. The second midwife observes the birth and can assist the midwife responsible for the 
birth if needed. An unpublished survey from one maternity ward in Sweden showed that 
most of the midwives appreciated this way of working but were uncertain as to whether it 
actually reduced the prevalence of severe perineal trauma (20). Furthermore, this clinical 
practice might have negative side-effects or unintended consequences. The maternity wards 
that practise this method have not increased the number of midwives. It could be argued that 
there is a risk that other women in labor will be left unattended for longer periods when two 
midwives assist at births. How midwives share the responsibility and communicate are 
factors that needs to be evaluated scientifically. 
Project design 
This is a parallel multicentre randomized controlled trial. Women expecting their first child 
will be randomized to either having one midwife assisting the active phase of the second 
stage of labor and the birth of the baby (standard care) or to having two midwives present. 

That means that if the woman is randomized to the intervention, the midwife responsible for 
the birth is assisting the woman as usual but asks a second midwife to be present in the 
birthing room ready to help her if necessary (intervention). The study is designed according 
to CONSORT statements (21). 
The hypothesis in this study is that the collegial presence of another midwife during 
the second stage of labor will reduce perineal trauma grade III-IV (primary outcome).   
Data from the National Birth Register show that 4.1% of first-time mothers suffered severe 
perineal trauma in Sweden 2017. The prevalence of severe perineal trauma varies between 
different regions in Sweden (3). To be able to detect a 50% reduction in severe perineal 
trauma grade III-IV from 4.1% to 2.0% with 80% power and a 95% level of significance, 1052 
women in each group will be needed. The 50% reduction is based on regional figures after a 
change in practice and is therefore clinically significant. Allowing for a possible drop-out rate 
of 20% and another drop-out of 20% for possible cases of obstetric emergencies where 
another midwife will be needed regardless of randomization, this will result in 1473 women in 
each group and 2946 women in total.  
The primary outcome is the prevalence of severe perineal tears grade III-IV.  
Secondary outcomes are the prevalence of second-degree tears, vaginal tears, women’s 
experiences of two midwives attending the birth and midwives’ experiences of the 
intervention. Additional secondary outcomes regarding the woman are: the prevalence of 
episiotomy, first-degree tears, intact perineum (no tear), labial and periurethral tears, 
postpartum bleeding >500 ml, birth position, instrumental delivery, urinary incontinence, anal 
incontinence, symptoms of pelvic organ prolapse and sexual function after one year, and 
self-reported mental health one month and one year after birth. For the one-year follow-up 
the following validated questionnaires will be used: PFIQ7, PFDI-20, and FSFI and EPDS 
(22-24). Secondary outcomes regarding the newborn child are: Apgar scores at 1, 5 and 10 
minutes, umbilical cord blood gases, and breastfeeding within two hours after birth.  
Inclusion criteria: Swedish speaking women expecting their first child or with a prior 
caesarean section opting for a vaginal birth, with a singleton live foetus in cephalic 
presentation from gestational week 37+0.  
Participating clinics: The maternity ward at Karolinska University Hospital Huddinge and 
Solna, and the maternity wards at SUS Malmö and Lund. With four participating clinics the 
time for patient recruitment will be shortened and this will also increase the generalizability of 
the results.  

Randomization process: It will not be possible to blind either women or midwives in this 
study. The participants will be randomly allocated (1:1) to the intervention group (collegial 
presence of another midwife during the second stage) or to the standard care group (one 
midwife is responsible for the care during the second stage). Randomization will take place 
at the start of the second stage. To allow for equal distribution between the groups, block 
randomization in blocks of ten will be used. The midwife in charge will be responsible for the 
randomization process. Sealed and opaque envelopes will be used and will be prepared with 
a unique code consisting of a first code letter identifying each study site, a second code 
letter identifying which group it belonged to (intervention or control) followed by a 
consecutive number.  
Data collection: After the birth the tear will be diagnosed together with a midwife or an 
obstetrician who has not been involved in the birth. Tears will be sutured according to the 
guidelines at each participating study site. The midwife responsible for the birth will complete 
a questionnaire which will contain questions regarding the woman; labor and birth variables, 
methods of preventing perineal trauma, questions regarding the newborn, diagnosis of the 
tear and how the tear was sutured. If a second midwife has been present during the second 
stage (intervention) the responsible midwife (midwife no 1) will also complete questions on 
the assistance she got from the second midwife and how this assistance was experienced. 
Data will also be retrieved from the participating women’s records by using the local 
database of each study site (Obstetrix). When the intervention has taken place the second 
midwife will also complete a questionnaire. This questionnaire will contain questions on what 
assistance she gave the midwife responsible for the woman (if any) and how she 
experienced being present during the second stage of labor. The questionnaires completed 
by the midwives will be coded with the same code as the participating woman received when 
she was allocated to the intervention or standard care.  
The questionnaire regarding women’s experiences of the intervention or standard care and 
the methods used to prevent perineal trauma will be sent by email one month after the birth. 
The questions in the questionnaire are study specific, containing questions regarding the 
experience of the second stage of labour, preventive methods used, initiation of 
breastfeeding, perineal pain, pain medication used, and resumption of sexual intercourse. In 
addition the Edinburgh postnatal depression scale (EPDS) will be used to assess mental 
health (23). The follow-up with validated questionnaires regarding pelvic floor symptoms will 
be sent to the women one year after birth. For the one year follow-up, the questionnaires 
used are Pelvic floor impact questionnaire (PFIQ7), Pelvic floor distress inventory (PFDI-20), 
the Female Sexual Function Index (FSFI) and Edinburgh postnatal depression scale (EPDS) 

(22, 23, 25). If the woman does not complete the questionnaire in two weeks, she will be 
reminded, and the questionnaire will be sent by mail.  
Analysis 
Descriptive statistics will be used to present the data. The means, SD, median, quartiles, 
and 95% CI will be calculated when appropriate as will frequency tables, stratified by the two 
arms. The primary statistical analysis is intention to treat but a per protocol analysis will also 
be performed. For comparison between the two groups, t-tests will be used for continuous 
variables and Chi-square tests for dichotomous variables. A possible preventive effect of 
having two midwives attending the second stage of labour and birth of the baby will be 
calculated as a relative risk of severe perineal trauma (tear grade III-IV) with 95% CI. We will 
adjust for study site using logistic regression. If baseline variables are not balanced by 
randomisation we will adjust for those using multivariate logistic regression. Response 
analyses regarding primary outcome will be undertaken at each study centre. Secondary 
outcomes will be compared using t-tests for continuous variables and Chi-square tests for 
dichotomous variables. The Mann-Whitney U-test will be used for outcomes based on 
scores. The project has access to a statistician from Clinical Studies Sweden, Forum South.  
 
Adverse events 
As approximately 50% of the maternity wards in Sweden already have implemented the 
clinical practice with two midwives without reporting any adverse side-effects, such as 
increased rates of severe perineal trauma or an increase in Apgar scores <4 at five minutes, 
we will not perform routine interim analyses throughout the data collection. Analyses will be 
performed if the maternity wards notice a negative trend in outcomes related to the mother 
(severe perineal trauma, postpartum haemorrhage >1000 ml) or the baby (Apgar scores and 
neonatal resuscitation).  
 
Clinical significance  
The number of women seeking care for pelvic floor problems related to childbirth is 
increasing. Improving the health and well-being for women giving birth is important on a 
personal level but also for society. There is an ongoing debate in the Swedish media and 
among women regarding severe perineal trauma. Childbirth organizations are upset that 
care providers are not able to prevent injuries and find it extraordinary that gaps in our 
knowledge still exist in this field of research. Many women are afraid of giving birth vaginally 
because they fear an extensive tear and the consequences such a tear might have on their 

life. Some women are so fearful that they request a caesarean section. Hence, it is 
imperative to fill this gap in knowledge and implement and implement evidence based care. 
Furthermore, many interventions used in labor and birth have been introduced without any 
evaluation and analyses as to whether they have any unintended consequences. The results 
from this study will show whether this clinical practice, which approximately 50% of all 
maternity wards in Sweden already have adopted is preventive or not, or if it has any 
negative side effects. If the presence of a second midwife can be demonstrated to be 
preventive, the practice can be implemented in all the maternity wards in Sweden. Otherwise 
health care resources could be used more effectively. The results from this study will also 
generate knowledge about women’s experiences of the midwifery care methods to prevent 
perineal trauma. This knowledge is currently lacking and is important as care should be both 
effective and of value to women.  
Ethical approval 2018/476 
The study has ethical approval from the Ethics committee in Lund no 2018/476 and is 
planned in accordance with Swedish law for research concerning humans (SFS 2003:460) 
and the Declaration of Helsinki regarding research involving human subjects. Research 
during labor and birth needs careful planning since giving birth is a profound life-experience 
for the woman and her partner and the woman is in a vulnerable position. At the same time, 
it is important to evaluate preventive methods used in clinical practice. As the intervention is 
already in use it has been considered possible and ethical to evaluate in a clinical trial. The 
study has received financial support from FORTE and SUS Funds. 
 
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