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\begin{document}

\title{Episiotomy and operative vaginal delivery- Do we need more evidence?}



\author[1]{Abdul Sultan}%
\author[2]{Jan Willem de Leeuw}%
\affil[1]{Croydon  University Hospital}%
\affil[2]{Ikazia Hospital}%


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  \date{April 30, 2024}


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\textbf{Episiotomy and operative vaginal delivery- Do we need more
evidence?}

A.H. Sultan

- Urogynaecology and Pelvic Floor Reconstruction Unit, Croydon
University Hospital, London Road, Croydon CR7 7YE

- Honorary Reader, St George's University of London

Email:asultan29@gmail.com

Tel: 00 44 7961386840

(ORCID 0000-0001-8979-2304)

J.W. de Leeuw, Department of Obstetrics and Gynaecology, Ikazia
Ziekenhuis, Rotterdam, the Netherlands

(ORCID 0000-0001-5028-8055)

DISCLOSURE of INTEREST

Abdul Sultan is the co-director of the Croydon Perineal and Anal
Sphincter Trauma courses (www.perineum.net)

Operative vaginal delivery (OVD) is recognised as a major risk factor in
the occurrence of obstetric anal sphincter injuries (OASIs),
particularly during first vaginal deliveries. Randomised controlled
trials (RCTs) have shown the merits of adopting a policy of restrictive
mediolateral episiotomy during normal vaginal delivery, although no RCT
to date has included measurements of the angle or size of the
episiotomy. The benefits of episiotomy performed during OVD demonstrated
in large observational studies are overwhelming \emph{(Sultan et al. Eur
J Obstet Gynecol Reprod Biol. 2019;240:192-196)} .

Ankarcrona et al have added another study to this collection and have
confirmed the results of most such publications. In their study, based
on 11 years of data from the Swedish Medical Birth Register, they have
emulated a RCT using propensity scores. Ultimately, both methods used
showed an almost identical risk reducing effect as the commonly used
logistic regression analysis. demonstrating a significant reduction in
OASIs during vacuum extraction associated with the use of mediolateral
or lateral episiotomies. The Number Needed to Treat to prevent one OASI
was 27, which is known to be fourfold lower in forceps delivery.

Is the episiotomy a treatment for a certain condition or disease? In
reality, episiotomy is an intervention to reduce the risk for an
unwanted side effect of birth. Consequently, the impact is one of risk
modification as opposed to treatment. Similar to the study by Ankarcrona
et al risk factors are commonly established with the use of
observational studies \emph{(RCOG Greentop guideline No 29, 2015)} . In
the last decade, several large observational studies Involving more than
2 million women showed a significantly lower rate of OASI in nulliparous
women undergoing OVD with an episiotomy.

Given the availability of such studies, based on registered databases,
showing significantly lower OASI rates, is there still a need for
further evidence? Ankarcrona et al acknowledge Lund et al who have shown
in their systematic review that there is an association between the risk
reduction for OASI with episiotomy rates; the greatest reduction was
shown in studies with episiotomy rates over 70\%.

Obstetricians opposing the use of routine episiotomy during OVD
highlight the lack of a definitive RCT. RCT's are commonly used to
address the treatment effect of an intervention on a particular
condition with a well described outcome. However, RCT's of episiotomy
during OVD have proven to be very difficult and usually compare no more
than the liberal versus the restricted use of episiotomy. As Ankarcrona
et al mention, there is only one pilot RCT of IVD and episiotomy
indicating that 1600 OVD will need to be included for a definitive
study. However, we believe that the design of such a study should be two
separate arms for forceps and vacuum delivery as the inherent risks
with/without an episiotomy is different. Such a study with vacuum
extraction is currently underway in Sweden.

The challenge now is to identify prior to labour which women are at high
risk of sustaining OASIS using prediction models based on the
pre-existing large national databases.

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