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Author Manuscript
Cochrane Database Syst Rev. Author manuscript; available in PMC 2014 September 25.
Published in final edited form as:
Cochrane Database Syst Rev. ; (1): CD000081. doi:10.1002/14651858.CD000081.pub2.
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Episiotomy for vaginal birth

Guillermo Carroli1 and Luciano Mignini1
1Centro Rosarino de Estudios Perinatales, Rosario, Argentina

Abstract
Background—Episiotomy is done to prevent severe perineal tears, but its routine use has been
questioned. The relative effects of midline compared with midlateral episiotomy are unclear.

Objectives—The objective of this review was to assess the effects of restrictive use of
episiotomy compared with routine episiotomy during vaginal birth.

Search methods—We searched the Cochrane Pregnancy and Childbirth Group’s Trials
Register (March 2008).

Selection criteria—Randomized trials comparing restrictive use of episiotomy with routine use
of episiotomy; restrictive use of mediolateral episiotomy versus routine mediolateral episiotomy;
restrictive use of midline episiotomy versus routine midline episiotomy; and use of midline
episiotomy versus mediolateral episiotomy.

Data collection and analysis—The two review authors independently assessed trial quality
and extracted the data.
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Main results—We included eight studies (5541 women). In the routine episiotomy group,
75.15% (2035/2708) of women had episiotomies, while the rate in the restrictive episiotomy group
was 28.40% (776/2733). Compared with routine use, restrictive episiotomy resulted in less severe
perineal trauma (relative risk (RR) 0.67, 95% confidence interval (CI) 0.49 to 0.91), less suturing
(RR 0.71, 95% CI 0.61 to 0.81) and fewer healing complications (RR 0.69, 95% CI 0.56 to 0.85).
Restrictive episiotomy was associated with more anterior perineal trauma (RR 1.84, 95% CI 1.61
to 2.10). There was no difference in severe vaginal/perineal trauma (RR 0.92, 95% CI 0.72 to
1.18); dyspareunia (RR 1.02, 95% CI 0.90 to 1.16); urinary incontinence (RR 0.98, 95% CI 0.79
to 1.20) or several pain measures. Results for restrictive versus routine mediolateral versus midline
episiotomy were similar to the overall comparison.

Authors’ conclusions—Restrictive episiotomy policies appear to have a number of benefits

compared to policies based on routine episiotomy. There is less posterior perineal trauma, less

Copyright © 2012 The Cochrane Collaboration.

Contact address: Guillermo Carroli, Centro Rosarino de Estudios Perinatales, Moreno 878 piso 6, Rosario, Santa Fe, 2000, Argentina.
gcarroli@crep.org.ar.
CONTRIBUTIONS OF AUTHORS
To be completed.
DECLARATIONS OF INTEREST
Guillermo Carroli is the author of one of the studies included in this review.
Editorial group: Cochrane Pregnancy and Childbirth Group.
Publication status and date: Edited (no change to conclusions), comment added to review, published in Issue 11, 2012.
Review content assessed as up-to-date: 28 July 2008.
 Carroli and Mignini Page 2

suturing and fewer complications, no difference for most pain measures and severe vaginal or
perineal trauma, but there was an increased risk of anterior perineal trauma with restrictive
episiotomy.

Medical Subject Headings (MeSH)

*Episiotomy [adverse effects; methods; standards]; *Parturition; Perineum [*injuries; surgery];
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Randomized Controlled Trials as Topic

MeSH check words

Female; Humans; Pregnancy

BACK GROUND
Description of the condition
Vaginal tears during childbirth are common and may occur spontaneously during birth, or
the midwife or obstetrician may need to make a surgical incision (episiotomy) to increase
the diameter of the vaginal outlet to facilitate the baby’s birth (Kettle 2007). Anterior
perineal trauma is injury to the labia, anterior vagina, urethra, or clitoris, and is usually
associated with little morbidity. Posterior perineal trauma is any injury to the posterior
vaginal wall, perineal muscles, or anal sphincter (Fernando 2007).

Spontaneous tears are defined as:

• first degree (involving the fourchette, perineal skin and vaginal mucous membrane,
but not the underlying fascia and muscle);

• second degree (involving the perineal muscles and skin);

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• third degree (injury to the anal sphincter complex: 3a = < 50% of the external anal
sphincter torn 3b = 50% of the external anal sphincter torn 3c = injury to the
external and internal anal sphincter); and

• fourth degree (injury to the perineum involving the anal sphincter complex and anal
epithelium) (Fernando 2006).

The most common injuries to the vagina during labour occur at the vaginal opening, which
may tear as the baby’s head passes through. For successful vaginal delivery, the vaginal
opening must dilate slowly, in order to allow the appropriate stretching of the tissues. When
the baby descends quickly, the tissues can tear.

Description of the intervention

Episiotomy is the surgical enlargement of the vaginal orifice by an incision of the perineum
during the last part of the second stage of labour or delivery. This procedure is done with
scissors or scalpel and requires repair by suturing (Thacker 1983).

A report dating back to 1741 suggested the first surgical opening of the perineum to prevent
severe perineal tears (Ould 1741). Worldwide, rates of episiotomy increased substantially

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during the first half of this century. At that time there was also an increasing move for
women to give birth in hospital and for physicians to become involved in the normal
uncomplicated birth process. Although episiotomy has become one of the most commonly
performed surgical procedures in the world, it was introduced without strong scientific
evidence of its effectiveness (Lede 1996). Reported rates of episiotomies vary from as low
as 9.70% (Sweden) to as high as 100% (Taiwan) (Graham 2005). Rates of episiotomies
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around the world are 62.50% in USA (Thacker 1983), 30% in Europe (Buekens 1985;
Mascarenhas 1992) and with higher estimates in Latin America. In Argentina, episiotomy is
a routine intervention in nearly all nulliparous and primiparous births (Lede 1991).

How the intervention might work

The suggested maternal beneficial effects of episiotomy are the following: (a) reduction in
the likelihood of third degree tears (Cunningham 1993; Ould 1741; Thacker 1983), (b)
preservation of the muscle relaxation of the pelvic floor and perineum leading to improved
sexual function, and a reduced risk of faecal and or urinary incontinence (Aldridge 1935;
Gainey 1955), (c) being a straight, clean incision, an episiotomy is easier to repair and heals
better than a laceration. For the neonate, it is suggested that a prolonged second stage of
labour (a second stage of labour longer than 120 minutes (Hamilton 1861)), could cause
fetal asphyxia, cranial trauma, cerebral haemorrhage and mental retardation. During delivery
it is also suggested that episiotomy may be necessary to make more room if rotation
manoeuvres are required during a fetal shoulder dystocia.

On the other hand, hypothesized adverse effects of routine use of episiotomy include: (a)
extension of episiotomy either by cutting the anal sphincter or rectum, or by unavoidable
extension of the incision, (b) unsatisfactory anatomic results such as skin tags, asymmetry or
excessive narrowing of the introitus, vaginal prolapse, recto-vaginal fistula and fistula in ano
(Homsi 1994), (c) increased blood loss and haematoma, (d) pain and oedema in the
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episiotomy region, (e) infection and dehiscence (Homsi 1994), (f) sexual dysfunction.

Other important issues to bear in mind are costs and the additional resources that may be
required to sustain a policy of routine use of episiotomy.

Why it is important to do this review

This review aims to evaluate the available evidence about the possible benefits, risks and
costs of the restrictive use of episiotomy versus routine episiotomy. We also evaluate the
benefits and risks of performing a midline episiotomy compared with a mediolateral
episiotomy.The question of whether midline episiotomy results in a better outcome than
mediolateral episiotomy has not been satisfactorily answered. The suggested advantages of
performing a midline episiotomy instead of midlateral episiotomy are: better future sexual
function and better healing with improved appearance of the scar. Those not in favour of
using the midline method suggest it is associated with higher rates of extension of the
episiotomy and consequently an increased risk of severe perineal trauma (Shiono 1990).

We also consider the implications for clinical practice and the need for further research in
this area.

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OBJECTIVES
To determine the possible benefits and risks of the use of restrictive episiotomy versus
routine episiotomy during delivery. We will also determine the beneficial and detrimental
effects of the using midline episiotomy compared with mediolateral episiotomy.
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Comparisons will be made in the following categories.

1. Restrictive episiotomy versus routine episiotomy (all).

2. Restrictive episiotomy versus routine episiotomy (mediolateral).

3. Restrictive episiotomy versus routine episiotomy (midline).

4. Midline episiotomy versus mediolateral episiotomy.

Hypotheses
1. Restrictive use of episiotomy compared with routine use of episiotomy during
delivery will not influence any of the outcomes cited under ‘Types of outcome
measures’.

2. Restrictive use of midline episiotomy compared with routine use of midline

episiotomy during delivery will not influence any of the outcomes cited under
‘Types of outcome measures’.

3. Restrictive use of medio-lateral episiotomy compared with routine use of medio-

lateral episiotomy during delivery will not influence any of the outcomes cited
under ‘Types of outcome measures’.

METHODS
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Criteria for considering studies for this review

Types of studies—Any adequate randomized controlled trial that compares one or more
of the following:

1. restrictive use of mediolateral episiotomy versus routine use of mediolateral

episiotomy;

2. restrictive use of midline episiotomy versus routine use of midline episiotomy;

3. use of midline episiotomy versus mediolateral episiotomy. We did not include

quasi-randomized controlled trials.

Types of participants—Pregnant women having a vaginal birth.

Types of interventions
Primary comparison: The main comparison is restrictive use of episiotomy versus routine
use of episiotomy.

Secondary comparisons: These include:

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• restrictive use of mediolateral episiotomy versus routine use of mediolateral

episiotomy;

• restrictive use of midline episiotomy versus routine use of midline episiotomy;

• use of midline episiotomy versus mediolateral episiotomy.

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Types of outcome measures—Maternal and neonatal outcomes are evaluated.

Primary outcomes: The primary maternal outcomes assessed in the comparison include:
severe perineal trauma and severe vaginal/perineal trauma.

Secondary outcomes: The secondary maternal outcomes assessed in the comparison

include: number of episiotomies, assisted delivery rate, severe vaginal/perineal trauma,
severe perineal trauma, need for suturing, posterior perineal trauma, anterior perineal
trauma, blood loss, perineal pain, use of analgesia, dyspareunia, haematoma, healing
complications and dehiscence, perineal infection, and urinary incontinence.

The neonatal outcome measures are Apgar score less than seven at one minute and need for
admission to special care baby unit.

Search methods for identification of studies

Electronic searches—We searched the Cochrane Pregnancy and Childbirth Group’s
Trials Register by contacting the Trials Search Co-ordinator (March 2008).

The Cochrane Pregnancy and Childbirth Group’s Trials Register is maintained by the Trials
Search Co-ordinator and contains trials identified from:

1. quarterly searches of the Cochrane Central Register of Controlled Trials

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(CENTRAL);

2. weekly searches of MEDLINE;

3. handsearches of 30 journals and the proceedings of major conferences;

4. weekly current awareness alerts for a further 44 journals plus monthly BioMed
Central email alerts.

Details of the search strategies for CENTRAL and MEDLINE, the list of handsearched
journals and conference proceedings, and the list of journals reviewed via the current
awareness service can be found in the ‘Specialized Register’ section within the editorial
information about the Cochrane Pregnancy and Childbirth Group.

Trials identified through the searching activities described above are each assigned to a
review topic (or topics). The Trials Search Co-ordinator searches the register for each
review using the topic list rather than keywords.

We did not apply any language restrictions.

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Data collection and analysis

Trials under consideration were evaluated for methodological quality and appropriateness
for inclusion, without consideration of their results. Included trial data were processed as
described in Higgins 2006.

Selection of studies—Two review authors independently assessed for inclusion all the
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potential studies that were identified as a result of the search strategy. Any disagreements
were resolved through discussion.

Data extraction and management—We designed a form to extract data and two review
authors extracted data using the agreed form. Any discrepancies were resolved through
discussion. Data were entered into Review Manager software (RevMan 2008) and checked
for accuracy.

Assessment of risk of bias in included studies—We assessed methodological

quality in the three dimensions initially described by Chalmers 1989: namely the control for
selection bias at entry (the quality of random allocation, assessing the generation and
concealment methods applied); the control of selection bias after entry (the extent to which
the primary analysis included every person entered into the randomized cohorts); and the
control of bias in assessing outcomes (the extent to which those assessing the outcomes were
kept unaware of the group assignment of the individuals examined).

The two review authors independently assessed risk of bias for each study using the criteria
outlined in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins
2006). Any disagreement was resolved by discussion.

Randomization: We describe for each included study the methods used to generate the
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allocation sequence in sufficient detail to allow an assessment of whether it should produce

comparable groups.

Concelament allocation: We describe for each included study the method used to conceal
the allocation sequence in sufficient detail and determined whether intervention allocation
could have been foreseen in advance of, or during, recruitment.

We assessed the methods as:

• adequate (e.g. telephone or central randomization; consecutively numbered sealed

opaque envelopes);

• inadequate (open random allocation; unsealed or non-opaque envelopes,

alternation; date of birth);

• unclear.

Blinding: We have described the methods used, if any, to blind study participants and
personnel from knowledge of which intervention a participant received.

Incomplete outcome data: We have described loss to follow up for the studies.

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Subgroup analysis and investigation of heterogeneity—In case of heterogeneity

we have conducted subgroup analyses by whether women were primiparous or multiparous
in order to explore possible causes of heterogeneity. When the heterogeneity was not readily
explained by this sensitivity analysis one option is to use a random-effects model. A
random-effects meta-analysis model involves an assumption that the effects being estimated
in the different studies are not identical, but follow similar distribution. However, as we
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have previously demonstrated (Villar 2001), the relative risk summary for the random-
effects model tends to show a larger treatment effect than the fixed-effect model, while not
eliminating the heterogeneity itself.

RESULTS
Description of studies
See: Characteristics of included studies; Characteristics of excluded studies; Characteristics
of ongoing studies.

The search identified 14 studies including 5441 women, of which 8 were included
(Argentine 1993; Dannecker 2004; Eltorkey 1994; Harrison 1984; House 1986; Klein 1992;
Sleep 1984;Rodriguez 2008) and 5 excluded (Coats 1980; Detlefsen 1980; Dong 2004;
Henriksen 1992; Werner 1991). There is one ongoing trial (Murphy 2006). The included
studies varied in the rate of episiotomies between the intervention and control groups from a
difference of 7.6% episiotomies in the restricted group compared with 100% episiotomies in
the routine group (Harrison 1984), and 57.1% in the restricted group and 78.9% in the
routine group (Dannecker 2004).

For details of included and excluded studies, see table of ‘Characteristics of included
studies’ and ‘Characteristics of excluded studies’.
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Risk of bias in included studies

The method of treatment allocation in general is sound except for the Harrison 1984 trial
where the method of treatment allocation is not clearly established raising concerns about
possible selection bias.

Argentine 1993, Dannecker 2004, Eltorkey 1994, House 1986, Klein 1992, Sleep 1984 and
Rodriguez 2008 report random allocation and the concealment of the assignment by sealed
opaque envelopes reducing the risk of selection bias at entry to the trial. Selection bias after
entry is avoided in Dannecker 2004, Eltorkey 1994, Harrison 1984, House 1986, Sleep 1984
and Rodriguez 2008 where all the women randomized are included in the analyses. Sleep
1984 and Dannecker 2004 include long-term follow up, with a loss to follow up of about
33% and 40 % of the participants respectively. Klein 1992 shows a loss to follow up rate of
0.71% for primary outcomes to 5% for secondary outcomes. In the Argentine 1993 trial the
total number of women randomized was included in the analysis of the primary outcome
with a 5% loss to follow up at delivery, 11% at postnatal discharge and 57% at seven
months postpartum. Intention-to-treat analysis was performed in all of the studies.

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In the Sleep 1984 trial, the observer measuring the outcomes was blinded to the treatment
group assignments. In the Argentine 1993 trial only the assessment of the healing and
morbidity outcomes were blinded to the observer. None of the other studies (Eltorkey 1994;
Harrison 1984; House 1986; Klein 1992, Rodriguez 2008) reported any effort to blind the
observer to the treatment group allocation.
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Effects of interventions
The restrictive use of episiotomy shows a lower risk of clinically relevant morbidities
including severe perineal trauma (relative risk (RR) 0.67, 95% confidence interval (CI) 0.49
to 0.91), posterior perineal trauma (RR 0.88, 95% 0.84 to 0.92), need for suturing perineal
trauma (RR 0.71, 95% CI 0.61 to 0.81), and healing complications at seven days (RR 0.69,
95% CI 0.56 to 0.85). No difference is shown in the incidence of major outcomes such as
severe vaginal and perineal trauma nor in pain, dyspareunia or urinary incontinence. The
only disadvantage shown in the restrictive use of episiotomy is an increased risk of anterior
perineal trauma (RR 1.84, 95% CI 1.61 to 2.10). The secondary comparisons, for both
restrictive versus routine mediolateral episiotomy and restrictive versus routine midline
episiotomy, show similar results to the overall comparison.

See Data and analyses section .

No trials comparing mediolateral versus midline episiotomy were included because of poor
methodological quality.

DISCUSSION
The primary question is whether or not to use an episiotomy routinely. The answer is clear.
There is evidence to support the restrictive use of episiotomy compared with routine use of
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episiotomy. This was the case for the overall comparison and the comparisons of subgroups,
that take parity into account.

In light of the available evidence, restrictive use of episiotomy is recommended. However, it

needs to be taken into account that long term outcomes were assessed by studies with high
loss of follow up.

What type of episiotomy is more beneficial, midline or mediolateral? To date there are only
three published trials available (Coats 1980; Detlefsen 1980; Werner 1991), which were
excluded from this review. As described in the ‘Characteristics of excluded studies’ table,
these trials are of poor methodological quality, making their results uninterpretable. This
question, therefore, remains unanswered.

A cost effective analysis study conducted in Argentina (Borghi 2002) has shown that a
restrictive episiotomy policy is more effective and less costly than a routine episiotomy
policy.

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AUTHORS’ CONCLUSIONS
Implications for practice
There is clear evidence to recommend a restrictive use of episiotomy. These results are
evident in the overall comparison and remain after stratification according to the type of
episiotomy: restrictive mediolateral versus routine mediolateral or restrictive midline versus
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routine midline. Until further evidence is available, the choice of technique should be that
with which the accoucheur is most familiar.

Implications for research

Several questions remain unanswered and further trials are needed to address them. What
are the indications for the restrictive use of episiotomy at an assisted delivery (forceps or
vacuum), preterm delivery, breech delivery, predicted macrosomia and presumed imminent
tears? There is a pressing need to evaluate which episiotomy technique (mediolateral or
midline) provides the best outcome.

Acknowledgments
Jean Hay-Smith was the author of previous published version of this review See ’Other published versions of this
review’.

José M Belizán was an author on previous versions of this review and Georgina Stamp was a co-author on the first
version of this review.

Dr Carroli visited theCochrane Pregnancy and Childbirth Review Group’s editorial office in Liverpool in 1996 to
prepare the first version of this review, funded by a Shell Fellowship administered by the Liverpool School of
Tropical Medicine.

SOURCES OF SUPPORT

Internal sources
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• Human Reproduction, World Health Organization, Switzerland.

• Centro Rosarino de Estudios Perinatales, Rosario, Argentina.
• Secretaria de Salud Publica, Municipalidad de Rosario, Argentina.
External sources
• No sources of support supplied

CHARACTERISTICS OF STUDIES

Characteristics of included studies [ordered by study ID]

Argentine 1993

Methods Generation of randomization by computer from a random sample generator programme, organised in
balanced blocks of 100, with stratification by centre and by parity (nulliparous and primiparous)
Allocation concealment by sequentially numbered, sealed, opaque envelopes, divided according to
parity

Participants 2606 women. Uncomplicated labour. 37 to 42 weeks’ gestation. Nulliparous or primiparous. Single
fetus. Cephalic presentation. No previous caesarean section or severe perineal tears

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Interventions Selective: try to avoid an episiotomy if possible and only do it for fetal indications or if severe
perineal trauma was judged to be imminent. Routine: do an episiotomy according to the hospital’s
policy prior to the trial

Outcomes Severe perineal trauma. Middle/upper vaginal tears. Anterior trauma. Any posterior surgical repair.
Perineal pain at discharge. Haematoma at discharge. Healing complications, infection and dehiscence
at 7 days. Apgar score less than 7 at 1 minute
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Notes Mediolateral episiotomies. Epsiotomy rates were 30% for the restricted group and 80.6% for the
routine group

Risk of bias

Bias Authors’ judgement Support for judgement

Allocation Low risk A - Adequate
concealment
(selection
bias)

Dannecker 2004

Methods Random generation: not stated.

Allocation concealment: sealed opaque envelopes.

Participants 146 primiparous women. Gestation of > 34 weeks, with an uncomplicated pregnancy and a live
singleton fetus. Women were intending to have a vaginal delivery

Interventions Restrictive: try to avoid an episiotomy even if severe perineal trauma was judged to be imminent and
only do it for fetal indications.
Liberal: in addition to fetal indications use of episiotomy when a tear is judged to be imminent

Outcomes Reduction of episiotomies, increase of intact perinea and only minor perineal trauma, perineal pain in
the postpartum period, percentage change in overall anterior perineal trauma, difference of the PH of
the umbilical artery, percentage of umbilical artery PH less than 7.15, percentage of Apgar scores less
than 7 at 1 minute, maternal blood loss at delivery, percentage of severe perineal trauma

Notes Mediolateral episiotomies. Epsiotomy rates were 70% for restricted group and 79% for the routine
group
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Risk of bias

Bias Authors’ judgement Support for judgement

Allocation Low risk A - Adequate
concealment
(selection
bias)

Eltorkey 1994

Methods Random generation: not stated.

Allocation concealment: sealed opaque envelopes.

Participants 200 primigravid women with live, singleton fetus, cephalic presentation of at least 37 weeks of
gestational age, having a spontaneous vaginal delivery. Women were not suffering from any
important medical or psychiatric disorder

Interventions Elective group: the intention was to perform an episiotomy unless it was considered absolutely
unnecessary
Selective group: the intention was not to perform an episiotomy unless it was absolutely necessary
for maternal or fetal reasons

Outcomes First, second, third and fourth degree tears, anterior trauma, need for suturing, and neonatal
outcomes: Apgar score at 1 and 7 minutes, and stay in neonatal intensive care unit

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Notes Mediolateral episiotomies. Epsiotomy rate were 53% for the restricted group and 83% for the routine
group were

Risk of bias

Bias Authors’ judgement Support for judgement

Allocation Low risk A - Adequate
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concealment
(selection bias)

Harrison 1984

Methods Generation method of randomization not established.

Concealment allocation method not established.
’Allocated randomly’.

Participants 181 women primigravid, vaginal delivery, at least 16 years old, no less than 38 weeks’ gestational
age, not suffering from any important medical or psychiatric conditions or eclampsia

Interventions One group were not to undergo episiotomy unless it was considered to be medically essential by the
person in charge, that is the accoucheur could see that a woman was going to sustain a greater
damage or if the intact perineum was thought to be hindering the achievement of a safe normal or
operative delivery
Another group were to undergo mediolateral episiotomy.

Outcomes Severe maternal trauma. Any posterior perineal trauma. Need for suturing perineal trauma

Notes Mediolateral episiotomies. Epsiotomy rates were 7.6% for restricted group and 100% for the routine
group

Risk of bias

Bias Authors’ judgement Support for judgement

Allocation Unclear risk B - Unclear
concealment
(selection bias)
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House 1986

Methods Generation method of randomization not established.

Concealment method of allocation by envelopes.
Participants Number of participants not established. There is only information for 165 women available to follow
up but it lacks information about those women lost to follow up either because one of the authors was
not available, or because of the early discharge scheme. Women were at least 37 weeks’ gestational
age, cephalic presentation and vaginal delivery

Interventions In one group episiotomy was not performed specifically to prevent laceration
Another group were to receive standard current management whereby perineal damage was avoided
by control of the descent of the head and supporting the perineum at crowning. An episiotomy was
made if there was fetal distress, or for maternal reasons to shorten the 2nd stage such as severe
exhaustion, inability to complete expulsion or unwillingness to continue pushing. Episiotomy was
performed if the perineum appeared to be too tight or rigid to permit delivery without laceration, or if
a laceration appeared imminent

Outcomes Second degree tear. Third degree tear. Need for perineal suturing. Any perineal pain at 3 days.
Healing at 3 days. Tenderness at 3 days. Perineal infection at 3 days. Blood loss during delivery

Notes Mediolateral episiotomies. Epsiotomy rate for restricted group were 18% and for the routine group
were 69%

Risk of bias

Bias Authors’ judgement Support for judgement

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Allocation Low risk A - Adequate

concealment
(selection
bias)

Klein 1992
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Methods Generation method of randomization not established.

Concealment of allocation by opaque, sequentially numbered envelopes

Participants 1050 women enrolled at30to 34 weeks’ gestation, from which 703 were randomized. Randomization
took place if the women were at least 37 weeks’ gestation, medical conditions developing late in
pregnancy, fetal distress, caesarean deliveries and planned forceps. Parity 0, 1 or 2. Between the ages
of 18 and 40 years. Single fetus. English or French spoken. Medical or obstetrical low risk determined
by the physician

Interventions “Try to avoid an episiotomy”: the restricted episiotomy instruction

“Try to avoid a tear”: the liberal episiotomy instruction.

Outcomes Perineal trauma including first, second, third and fourth degree and sulcus tears. Perineal pain at 1, 2,
10 days. Dyspareunia. Urinary incontinence and perineal bulging. Time on resumption and pain of
sexual activity. Pelvic floor function. Admission to special care baby unit

Notes Midline episiotomies. Epsiotomy rates were 43.8% for restricted group and 65% for the routine group

Risk of bias

Bias Authors’ judgement Support for judgement

Allocation Low risk A - Adequate
concealment
(selection
bias)

Rodriguez 2008
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Methods Ralloc software (Boston College Department of Economics, Boston, MA) was used to create a
random sequence of numbers in blocks with 2, 4, and 6 size permutations

Participants 446 nulliparous women with pregnancies more than 28 weeks of gestation who had vaginal deliveries

Interventions Patients were assigned either to the routine episiotomy or the selective episiotomy group, depending
on the basis of the randomization sequence kept at the institution. Patients assigned to the selective
episiotomy group underwent the procedure only in cases of forceps delivery, fetal distress, or shoulder
dystocia or when the operator considered that a severe laceration was impending and could only be
avoided by performing an episiotomy. This decision was made by the treating physician. All the
patients in the routine episiotomy group underwent the procedure at the time the fetal head was
distending the introitus

Outcomes The primary outcome of severe laceration to perineal tissues was defined as a third-degree laceration
when the extent of the lesion included the external anal sphincter totally or partially, and fourth degree
laceration when the rectal mucosa was involved.

Notes Midline episiotomies. Epsiotomy rates were 24.3% for restricted group and 100% for the routine
group

Risk of bias

Bias Authors’ judgement Support for judgement

Allocation Low risk A - Adequate
concealment
(selection
bias)

Sleep 1984

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Methods Generation method of randomization not established.

Concealment of allocation by opaque sealed envelopes.

Participants 1000 women randomized with spontaneous vaginal deliveries, live singleton fetus, at least 37
completed weeks of gestational age, cephalic presentation
Europe PMC Funders Author Manuscripts

From the 1000 original women randomized in the original trial, 922 were available for follow up and
674 of them responded to a postal questionnaire which are the women included in the analysis

Interventions “Try to avoid episiotomy”: the intention should be to avoid an episiotomy and performing it only for
fetal indications (fetal bradycardia, tachycardia, or meconium stained liquor)
“Try to prevent a tear”: the intention being that episiotomy should be used more liberally to prevent
tears

Outcomes Severe maternal trauma: extension through the anal sphincter or to the rectal mucosa or to the upper
3rd of the vagina. Apgar score less than 7 at 1 minute. Severe or moderate perineal pain 10 days after
delivery. Admission to special care baby unit in first 10 days of life. Perineal discomfort 3 months
after delivery. No resumption of sexual intercourse 3 months after delivery
Any dyspareunia in 3 years. Any incontinence of urine at 3 years. Urinary incontinence severe to wear
a pad at 3 years

Notes Mediolateral episiotomies. Epsiotomy rates were 10.2% for restricted group and 51.4% for the routine
group

Risk of bias

Bias Authors’ judgement Support for judgement

Allocation Low risk A - Adequate
concealment
(selection
bias)

Characteristics of excluded studies [ordered by study ID]

Study Reason for exclusion

Coats 1980 The allocation was quasi random and prone to cause selection bias. It is described in the article
as, ”women who were admitted to the delivery suite were randomly allocated into two groups by the
Europe PMC Funders Author Manuscripts

last digit of their hospital numbers“. In addition, when the staff performed an incision which was
inappropriate to the treatment allocation, the woman was removed from the trial.” This withdrawal
of women as opposed to the principle of’ intention-to-treat analysis’ increases the risk of selection
bias

Detlefsen 1980 This study does not compare the restrictive use of episiotomy versus the routine use of episiotomy

Dong 2004 This study does not compare the restrictive use of episiotomy versus the routine use of episiotomy

Henriksen 1992 The allocation was quasi random. As explained in the article, “the deliveries were assisted by
midwives on duty when they arrived on the labour ward”. This method of allocation is very prone to
selection bias

Werner 1991 There is no reference about the method of randomization used. The effects are not shown in a
quantitative format making the data uninterpretable

Characteristics of ongoing studies [ordered by study ID]

Murphy 2006

Trial name or title Randomised controlled trial of restrictive versus routine use of episiotomy for instrumental
vaginal delivery: a multi-centre pilot study

Methods Randomised controlled trial. Random allocation to: [A] Restrictive use of episiotomy for
instrumental vaginal delivery. [B] Routine use of episiotomy for instrumental vaginal delivery

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Participants The study aims to recruit 200 women. Inclusion criteria: primigravid women in the third
trimester of pregnancy (>36 weeks) with a singleton cephalic pregnancy who are English
speakers and have no contra-indication to vaginal birth. Exclusion criteria: Women who are:
non-English speakers; who have contra-indication to vaginal birth; multiple pregnancy;
malpresentation; multiparous women as the rate ofinstrumental delivery is significantly lower in
these women making the effort of recruitment unjustified; women who have not given written
informed consent prior to the onset of labour
Europe PMC Funders Author Manuscripts

Interventions Random allocation to: [A] Restrictive use of episiotomy for instrumental vaginal delivery. [B]
Routine use of episiotomy for instrumental vaginal delivery

Outcomes Damage to the anal sphincter (third or fourth degree tears).

Starting date 01/09/2005

Contact information Miss B Strachan

Department of Obstetrics and Gynaecology
St Michael’s Hospital
Bristol
BS2 8EG
Telephone: 0117 928 5594
Fax: 0117 928 5180
E-mail: bryony.strachan@ubht.swest.nhs.uk

Notes

DATA AND ANALYSES

Comparison 1
Restrictive versus routine episiotomy (all)

Outcome or subgroup
No. of studies No. of participants Statistical method Effect size
title
2 Number of episiotomies 8 5441 Risk Ratio (M-H, Fixed, 0.38 [0.36, 0.40]
95% CI)
2.1 Midline 2 1143 Risk Ratio (M-H, Fixed, 0.46 [0.41, 0.52]
95% CI)
Europe PMC Funders Author Manuscripts

2.2 Mediolateral 6 4298 Risk Ratio (M-H, Fixed, 0.36 [0.33, 0.38]
95% CI)
4 Assisted delivery rate 6 4210 Risk Ratio (M-H, Fixed, 0.77 [0.56, 1.05]
95% CI)
4.1 Midline 2 1137 Risk Ratio (M-H, Fixed, 0.85 [0.50, 1.46]
95% CI)
4.2 Mediolateral 4 3073 Risk Ratio (M-H, Fixed, 0.72 [0.49, 1.07]
95% CI)
5 Severe vaginal/perineal 5 4838 Risk Ratio (M-H, Fixed, 0.92 [0.72, 1.18]
trauma 95% CI)
5.1 Midline 2 1143 Risk Ratio (M-H, Fixed, 0.78 [0.55, 1.10]
95% CI)
5.2 Mediolateral 3 3695 Risk Ratio (M-H, Fixed, 1.10 [0.77, 1.59]
95% CI)
8 Severe perineal trauma 7 4404 Risk Ratio (M-H, Fixed, 0.67 [0.49, 0.91]
95% CI)
8.1 Midline 2 1143 Risk Ratio (M-H, Fixed, 0.74 [0.51, 1.07]
95% CI)
8.2 Mediolateral 5 3261 Risk Ratio (M-H, Fixed, 0.55 [0.31, 0.96]
95% CI)
11 Any posterior perineal 4 2079 Risk Ratio (M-H, Fixed, 0.88 [0.84, 0.92]
trauma 95% CI)
11.1 Midline 1 698 Risk Ratio (M-H, Fixed, 0.92 [0.87, 0.99]
95% CI)

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Outcome or subgroup
No. of studies No. of participants Statistical method Effect size
title
11.2 Mediolateral 3 1381 Risk Ratio (M-H, Fixed, 0.85 [0.80, 0.91]
95% CI)
14 Any anterior trauma 6 4896 Risk Ratio (M-H, Fixed, 1.84 [1.61, 2.10]
95% CI)
Europe PMC Funders Author Manuscripts

14.1 Midline 2 1143 Risk Ratio (M-H, Fixed, 2.00 [1.45, 2.77]
95% CI)
14.2 Mediolateral 4 3753 Risk Ratio (M-H, Fixed, 1.80 [1.56, 2.09]
95% CI)
17 Need for suturing 5 4133 Risk Ratio (M-H, 0.71 [0.61, 0.81]
perineal trauma Random, 95% CI)
20 Estimated blood loss at 1 165 Mean Difference (IV, −58.0 [−107.57,
delivery Fixed, 95% CI) −8. 43]
21 Moderate/severe 1 165 Risk Ratio (M-H, Fixed, 0.71 [0.48, 1.05]
perineal pain at 3 days 95% CI)
22 Any perineal pain at 1 2422 Risk Ratio (M-H, Fixed, 0.72 [0.65, 0.81]
discharge 95% CI)
23 Any perineal pain at 10 1 885 Risk Ratio (M-H, Fixed, 1.00 [0.78, 1.27]
days 95% CI)
24 Moderate/severe 1 885 Risk Ratio (M-H, Fixed, 1.04 [0.67, 1.62]
perineal pain at 10 days 95% CI)
25 Use of oral analgesia at 1 885 Risk Ratio (M-H, Fixed, 1.47 [0.63, 3.40]
10 days 95% CI)
26 Any perineal pain at 3 1 895 Risk Ratio (M-H, Fixed, 0.98 [0.62, 1.55]
months 95% CI)
27 Moderate/severe 1 895 Risk Ratio (M-H, Fixed, 1.51 [0.65, 3.49]
perineal pain at 3 months 95% CI)
28 No attempt at 1 895 Risk Ratio (M-H, Fixed, 0.92 [0.61, 1.39]
intercourse in 3 months 95% CI)
29 Any dyspareunia within 1 895 Risk Ratio (M-H, Fixed, 1.02 [0.90, 1.16]
3 months 95% CI)
Europe PMC Funders Author Manuscripts

30 Dyspareunia at 3 1 895 Risk Ratio (M-H, Fixed, 1.22 [0.94, 1.59]

months 95% CI)
31 Ever suffering 1 674 Risk Ratio (M-H, Fixed, 1.21 [0.84, 1.75]
dyspareunia in 3 years 95% CI)
32 Perineal haematoma at 1 2296 Risk Ratio (M-H, Fixed, 0.96 [0.65, 1.42]
discharge 95% CI)
33 Healing complications 1 1119 Risk Ratio (M-H, Fixed, 0.69 [0.56, 0.85]
at 7 days 95% CI)
34 Perineal wound 1 1118 Risk Ratio (M-H, Fixed, 0.48 [0.30, 0.75]
dehiscence at 7 days 95% CI)
35 Perineal infection 2 1298 Risk Ratio (M-H, Fixed, 1.02 [0.48, 2.16]
95% CI)
36 Perineal bulging at 3 1 667 Risk Ratio (M-H, Fixed, 0.84 [0.50, 1.40]
months -Midline 95% CI)
37 Urinary incontinence 2 1569 Risk Ratio (M-H, Fixed, 0.98 [0.79, 1.20]
within 3-7 months 95% CI)
37.1 Midline 1 674 Risk Ratio (M-H, Fixed, 0.95 [0.68, 1.32]
95% CI)
37.2 Mediolateral 1 895 Risk Ratio (M-H, Fixed, 1.00 [0.76, 1.30]
95% CI)
38 Any urinary 1 674 Risk Ratio (M-H, Fixed, 0.95 [0.77, 1.16]
incontinence at 3 years 95% CI)

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Outcome or subgroup
No. of studies No. of participants Statistical method Effect size
title
39 Pad wearing for urinary 1 674 Risk Ratio (M-H, Fixed, 1.16 [0.71, 1.89]
incontinence 95% CI)
40 Apgar score less than 7 4 3908 Risk Ratio (M-H, Fixed, 1.04 [0.76, 1.43]
at 1 minute 95% CI)
Europe PMC Funders Author Manuscripts

41 Admission to special 3 1898 Risk Ratio (M-H, Fixed, 0.74 [0.46, 1.19]
care baby unit 95% CI)
41.1 Midline 1 698 Risk Ratio (M-H, Fixed, 0.0 [0.0, 0.0]
95% CI)
41.2 Mediolateral 2 1200 Risk Ratio (M-H, Fixed, 0.74 [0.46, 1.19]
95% CI)
42 Anorectal incontinence 0 0 Odds Ratio (M-H, Fixed, 0.0 [0.0, 0.0]
at 7 months 95% CI)

Comparison 2
Restrictive versus routine (primiparae)

Outcome or subgroup
No. of studies No. of participants Statistical method Effect size
title
1 Number of 8 3364 Risk Ratio (M-H, Fixed, 95% 0.41 [0.38, 0.44]
episiotomies CI)
1.1 Midline 2 801 Risk Ratio (M-H, Fixed, 95% 0.43 [0.37, 0.48]
CI)
1.2 Mediolateral 6 2563 Risk Ratio (M-H, Fixed, 95% 0.40 [0.37, 0.44]
CI)
2 Severe vaginal/perineal 5 2541 Risk Ratio (M-H, Fixed, 95% 0.82 [0.60, 1.12]
trauma CI)
2.1 Midline 2 801 Risk Ratio (M-H, Fixed, 95% 0.79 [0.56, 1.11]
CI)
Europe PMC Funders Author Manuscripts

2.2 Mediolateral 3 1740 Risk Ratio (M-H, Fixed, 95% 0.96 [0.45, 2.07]
CI)
3 Severe perineal trauma 7 2944 Risk Ratio (M-H, Fixed, 95% 0.68 [0.49, 0.94]
CI)
3.1 Midline 2 801 Risk Ratio (M-H, Fixed, 95% 0.75 [0.52, 1.08]
CI)
3.2 Mediolateral 5 2143 Risk Ratio (M-H, Fixed, 95% 0.53 [0.28, 1.01]
CI)
4 Any posterior trauma 4 1157 Risk Ratio (M-H, Fixed, 95% 0.86 [0.82, 0.91]
CI)
4.1 Midline 1 356 Risk Ratio (M-H, Fixed, 95% 0.99 [0.93, 1.05]
CI)
4.2 Mediolateral 3 801 Risk Ratio (M-H, Fixed, 95% 0.80 [0.75, 0.87]
CI)
5 Any anterior trauma 5 1530 Risk Ratio (M-H, Fixed, 95% 1.52 [1.24, 1.86]
CI)
5.1 Midline 2 801 Risk Ratio (M-H, Fixed, 95% 2.26 [1.51, 3.38]
CI)
5.2 Mediolateral 3 729 Risk Ratio (M-H, Fixed, 95% 1.27 [1.00, 1.60]
CI)
6 Need for suturing 5 2441 Risk Ratio (M-H, Fixed, 95% 0.73 [0.70, 0.76]
perineal trauma CI)

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Outcome or subgroup
No. of studies No. of participants Statistical method Effect size
title
6.2 Mediolateral 5 2441 Risk Ratio (M-H, Fixed, 95% 0.73 [0.70, 0.76]
CI)
Europe PMC Funders Author Manuscripts

Comparison 3
Restrictive versus routine episiotomy (multiparae)

Outcome or subgroup
No. of studies No. of participants Statistical method Effect size
title
1 Number of 4 2040 Risk Ratio (M-H, Fixed, 95% 0.27 [0.23, 0.31]
episiotomies CI)
1.1 Midline 1 342 Risk Ratio (M-H, Fixed, 95% 0.65 [0.50, 0.86]
CI)
1.2 Mediolateral 3 1698 Risk Ratio (M-H, Fixed, 95% 0.20 [0.17, 0.24]
CI)
2 Severe vaginal/perineal 3 1973 Risk Ratio (M-H, Fixed, 95% 1.14 [0.52, 2.48]
trauma CI)
2.1 Midline 1 342 Risk Ratio (M-H, Fixed, 95% 0.94 [0.19, 4.61]
CI)
2.2 Mediolateral 2 1631 Risk Ratio (M-H, Fixed, 95% 1.21 [0.49, 2.96]
CI)
3 Severe perineal trauma 3 1460 Risk Ratio (M-H, Fixed, 95% 0.71 [0.28, 1.82]
CI)
3.1 Midline 1 342 Risk Ratio (M-H, Fixed, 95% 0.94 [0.19, 4.61]
CI)
3.2 Mediolateral 2 1118 Risk Ratio (M-H, Fixed, 95% 0.61 [0.19, 1.97]
CI)
4 Any posterior perineal 2 922 Risk Ratio (M-H, Fixed, 95% 0.91 [0.83, 0.99]
trauma CI)
Europe PMC Funders Author Manuscripts

4.1 Midline 1 342 Risk Ratio (M-H, Fixed, 95% 0.86 [0.76, 0.97]
CI)
4.2 Mediolateral 1 580 Risk Ratio (M-H, Fixed, 95% 0.94 [0.83, 1.05]
CI)
5 Any anterior trauma 2 922 Risk Ratio (M-H, Fixed, 95% 1.61 [1.19, 2.18]
CI)
5.1 Midline 1 342 Risk Ratio (M-H, Fixed, 95% 1.57 [0.91, 2.71]
CI)
5.2 Mediolateral 1 580 Risk Ratio (M-H, Fixed, 95% 1.63 [1.13, 2.35]
CI)
6 Need for suturing 3 1692 Risk Ratio (M-H, Fixed, 95% 0.78 [0.72, 0.83]
perineal trauma CI)
6.1 Mediolateral 3 1692 Risk Ratio (M-H, Fixed, 95% 0.78 [0.72, 0.83]
CI)

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Analysis 1.2
Comparison 1 Restrictive versus routine episiotomy
(all), Outcome 2 Number of episiotomies.
Review: Episiotomy for vaginal birth
Europe PMC Funders Author Manuscripts

Comparison: 1 Restrictive versus routine episiotomy (all)

Outcome: 2 Number of episiotomies
Europe PMC Funders Author Manuscripts

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Analysis 1.4
Comparison 1 Restrictive versus routine episiotomy
(all), Outcome 4 Assisted delivery rate.
Review: Episiotomy for vaginal birth
Europe PMC Funders Author Manuscripts

Comparison: 1 Restrictive versus routine episiotomy (all)

Outcome: 4 Assisted delivery rate
Europe PMC Funders Author Manuscripts

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Analysis 1.5
Comparison 1 Restrictive versus routine episiotomy
(all), Outcome 5 Severe vaginal/perineal trauma.
Review: Episiotomy for vaginal birth
Europe PMC Funders Author Manuscripts

Comparison: 1 Restrictive versus routine episiotomy (all)

Outcome: 5 Severe vaginal/perineal trauma
Europe PMC Funders Author Manuscripts

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Analysis 1.8
Comparison 1 Restrictive versus routine episiotomy
(all), Outcome 8 Severe perineal trauma.
Review: Episiotomy for vaginal birth
Europe PMC Funders Author Manuscripts

Comparison: 1 Restrictive versus routine episiotomy (all)

Outcome: 8 Severe perineal trauma
Europe PMC Funders Author Manuscripts

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Analysis 1.11
Comparison 1 Restrictive versus routine episiotomy
(all), Outcome 11 Any posterior perineal trauma.
Review: Episiotomy for vaginal birth
Europe PMC Funders Author Manuscripts

Comparison: 1 Restrictive versus routine episiotomy (all)

Outcome: 11 Any posterior perineal trauma
Europe PMC Funders Author Manuscripts

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Analysis 1.14
Comparison 1 Restrictive versus routine episiotomy
(all), Outcome 14 Any anterior trauma.
Review: Episiotomy for vaginal birth
Europe PMC Funders Author Manuscripts

Comparison: 1 Restrictive versus routine episiotomy (all)

Outcome: 14 Any anterior trauma
Europe PMC Funders Author Manuscripts

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Analysis 1.17
Comparison 1 Restrictive versus routine episiotomy
(all), Outcome 17 Need for suturing perineal trauma.
Review: Episiotomy for vaginal birth
Europe PMC Funders Author Manuscripts

Comparison: 1 Restrictive versus routine episiotomy (all)

Outcome: 17 Need for suturing perineal trauma

Analysis 1.20
Comparison 1 Restrictive versus routine episiotomy
(all), Outcome 20 Estimated blood loss at delivery.
Europe PMC Funders Author Manuscripts

Review: Episiotomy for vaginal birth

Comparison: 1 Restrictive versus routine episiotomy (all)
Outcome: 20 Estimated blood loss at delivery

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Analysis 1.21
Comparison 1 Restrictive versus routine episiotomy
(all), Outcome 21 Moderate/severe perineal pain at 3
days.
Europe PMC Funders Author Manuscripts

Review: Episiotomy for vaginal birth

Comparison: 1 Restrictive versus routine episiotomy (all)
Outcome: 21 Moderate/severe perineal pain at 3 days

Analysis 1.22
Comparison 1 Restrictive versus routine episiotomy
(all), Outcome 22 Any perineal pain at discharge.
Review: Episiotomy for vaginal birth
Comparison: 1 Restrictive versus routine episiotomy (all)
Outcome: 22 Any perineal pain at discharge
Europe PMC Funders Author Manuscripts

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Analysis 1.23
Comparison 1 Restrictive versus routine episiotomy
(all), Outcome 23 Any perineal pain at 10 days.
Review: Episiotomy for vaginal birth
Europe PMC Funders Author Manuscripts

Comparison: 1 Restrictive versus routine episiotomy (all)

Outcome: 23 Any perineal pain at 10 days

Analysis 1.24
Comparison 1 Restrictive versus routine episiotomy
(all), Outcome 24 Moderate/severe perineal pain at 10
days.
Review: Episiotomy for vaginal birth
Comparison: 1 Restrictive versus routine episiotomy (all)
Outcome: 24 Moderate/severe perineal pain at 10 days
Europe PMC Funders Author Manuscripts

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Analysis 1.25
Comparison 1 Restrictive versus routine episiotomy
(all), Outcome 25 Use of oral analgesia at 10 days.
Review: Episiotomy for vaginal birth
Europe PMC Funders Author Manuscripts

Comparison: 1 Restrictive versus routine episiotomy (all)

Outcome: 25 Use of oral analgesia at 10 days

Analysis 1.26
Comparison 1 Restrictive versus routine episiotomy
(all), Outcome 26 Any perineal pain at 3 months.
Review: Episiotomy for vaginal birth
Comparison: 1 Restrictive versus routine episiotomy (all)
Outcome: 26 Any perineal pain at 3 months
Europe PMC Funders Author Manuscripts

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Analysis 1.27
Comparison 1 Restrictive versus routine episiotomy
(all), Outcome 27 Moderate/severe perineal pain at 3
months.
Europe PMC Funders Author Manuscripts

Review: Episiotomy for vaginal birth

Comparison: 1 Restrictive versus routine episiotomy (all)
Outcome: 27 Moderate/severe perineal pain at 3 months

Analysis 1.28
Comparison 1 Restrictive versus routine episiotomy
(all), Outcome 28 No attempt at intercourse in 3
months.
Review: Episiotomy for vaginal birth
Comparison: 1 Restrictive versus routine episiotomy (all)
Europe PMC Funders Author Manuscripts

Outcome: 28 No attempt at intercourse in 3 months

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Analysis 1.29
Comparison 1 Restrictive versus routine episiotomy
(all), Outcome 29 Any dyspareunia within 3 months.
Review: Episiotomy for vaginal birth
Europe PMC Funders Author Manuscripts

Comparison: 1 Restrictive versus routine episiotomy (all)

Outcome: 29 Any dyspareunia within 3 months

Analysis 1.30
Comparison 1 Restrictive versus routine episiotomy
(all), Outcome 30 Dyspareunia at 3 months.
Review: Episiotomy for vaginal birth
Comparison: 1 Restrictive versus routine episiotomy (all)
Outcome: 30 Dyspareunia at 3 months
Europe PMC Funders Author Manuscripts

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Analysis 1.31
Comparison 1 Restrictive versus routine episiotomy
(all), Outcome 31 Ever suffering dyspareunia in 3 years.
Review: Episiotomy for vaginal birth
Europe PMC Funders Author Manuscripts

Comparison: 1 Restrictive versus routine episiotomy (all)

Outcome: 31 Ever suffering dyspareunia in 3 years

Analysis 1.32
Comparison 1 Restrictive versus routine episiotomy
(all), Outcome 32 Perineal haematoma at discharge.
Review: Episiotomy for vaginal birth
Comparison: 1 Restrictive versus routine episiotomy (all)
Outcome: 32 Perineal haematoma at discharge
Europe PMC Funders Author Manuscripts

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Analysis 1.33
Comparison 1 Restrictive versus routine episiotomy
(all), Outcome 33 Healing complications at 7 days.
Review: Episiotomy for vaginal birth
Europe PMC Funders Author Manuscripts

Comparison: 1 Restrictive versus routine episiotomy (all)

Outcome: 33 Healing complications at 7 days

Analysis 1.34
Comparison 1 Restrictive versus routine episiotomy
(all), Outcome 34 Perineal wound dehiscence at 7 days.
Review: Episiotomy for vaginal birth
Comparison: 1 Restrictive versus routine episiotomy (all)
Outcome: 34 Perineal wound dehiscence at 7 days
Europe PMC Funders Author Manuscripts

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Analysis 1.35
Comparison 1 Restrictive versus routine episiotomy
(all), Outcome 35 Perineal infection.
Review: Episiotomy for vaginal birth
Europe PMC Funders Author Manuscripts

Comparison: 1 Restrictive versus routine episiotomy (all)

Outcome: 35 Perineal infection

Analysis 1.36
Comparison 1 Restrictive versus routine episiotomy
(all), Outcome 36 Perineal bulging at 3 months -
Midline.
Review: Episiotomy for vaginal birth
Comparison: 1 Restrictive versus routine episiotomy (all)
Outcome: 36 Perineal bulging at 3 months - Midline
Europe PMC Funders Author Manuscripts

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Analysis 1.37
Comparison 1 Restrictive versus routine episiotomy
(all), Outcome 37 Urinary incontinence within 3-7
months.
Europe PMC Funders Author Manuscripts

Review: Episiotomy for vaginal birth

Comparison: 1 Restrictive versus routine episiotomy (all)
Outcome: 37 Urinary incontinence within 3-7 months
Europe PMC Funders Author Manuscripts

Analysis 1.38
Comparison 1 Restrictive versus routine episiotomy
(all), Outcome 38 Any urinary incontinence at 3 years.
Review: Episiotomy for vaginal birth
Comparison: 1 Restrictive versus routine episiotomy (all)
Outcome: 38 Any urinary incontinence at 3 years

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Analysis 1.39
Comparison 1 Restrictive versus routine episiotomy
(all), Outcome 39 Pad wearing for urinary incontinence.
Review: Episiotomy for vaginal birth
Europe PMC Funders Author Manuscripts

Comparison: 1 Restrictive versus routine episiotomy (all)

Outcome: 39 Pad wearing for urinary incontinence

Analysis 1.40
Comparison 1 Restrictive versus routine episiotomy
(all), Outcome 40 Apgar score less than 7 at 1 minute.
Review: Episiotomy for vaginal birth
Comparison: 1 Restrictive versus routine episiotomy (all)
Outcome: 40 Apgar score less than 7 at 1 minute
Europe PMC Funders Author Manuscripts

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Analysis 1.41
Comparison 1 Restrictive versus routine episiotomy
(all), Outcome 41 Admission to special care baby unit.
Review: Episiotomy for vaginal birth
Europe PMC Funders Author Manuscripts

Comparison: 1 Restrictive versus routine episiotomy (all)

Outcome: 41 Admission to special care baby unit
Europe PMC Funders Author Manuscripts

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Analysis 2.1
Comparison 2 Restrictive versus routine (primiparae),
Outcome 1 Number of episiotomies.
Review: Episiotomy for vaginal birth
Europe PMC Funders Author Manuscripts

Comparison: 2 Restrictive versus routine (primiparae)

Outcome: 1 Number of episiotomies
Europe PMC Funders Author Manuscripts

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Analysis 2.2
Comparison 2 Restrictive versus routine (primiparae),
Outcome 2 Severe vaginal/perineal trauma.
Review: Episiotomy for vaginal birth
Europe PMC Funders Author Manuscripts

Comparison: 2 Restrictive versus routine (primiparae)

Outcome: 2 Severe vaginal/perineal trauma
Europe PMC Funders Author Manuscripts

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Analysis 2.3
Comparison 2 Restrictive versus routine (primiparae),
Outcome 3 Severe perineal trauma.
Review: Episiotomy for vaginal birth
Europe PMC Funders Author Manuscripts

Comparison: 2 Restrictive versus routine (primiparae)

Outcome: 3 Severe perineal trauma
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 Carroli and Mignini Page 39

Analysis 2.4
Comparison 2 Restrictive versus routine (primiparae),
Outcome 4 Any posterior trauma.
Review: Episiotomy for vaginal birth
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Comparison: 2 Restrictive versus routine (primiparae)

Outcome: 4 Any posterior trauma
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Analysis 2.5
Comparison 2 Restrictive versus routine (primiparae),
Outcome 5 Any anterior trauma.
Review: Episiotomy for vaginal birth
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Comparison: 2 Restrictive versus routine (primiparae)

Outcome: 5 Any anterior trauma
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Analysis 2.6
Comparison 2 Restrictive versus routine (primiparae),
Outcome 6 Need for suturing perineal trauma.
Review: Episiotomy for vaginal birth
Europe PMC Funders Author Manuscripts

Comparison: 2 Restrictive versus routine (primiparae)

Outcome: 6 Need for suturing perineal trauma
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Analysis 3.1
Comparison 3 Restrictive versus routine episiotomy
(multiparae), Outcome 1 Number of episiotomies.
Review: Episiotomy for vaginal birth
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Comparison: 3 Restrictive versus routine episiotomy (multiparae)

Outcome: 1 Number of episiotomies
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Analysis 3.2
Comparison 3 Restrictive versus routine episiotomy
(multiparae), Outcome 2 Severe vaginal/perineal
trauma.
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Review: Episiotomy for vaginal birth

Comparison: 3 Restrictive versus routine episiotomy (multiparae)
Outcome: 2 Severe vaginal/perineal trauma
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Analysis 3.3
Comparison 3 Restrictive versus routine episiotomy
(multiparae), Outcome 3 Severe perineal trauma.
Review: Episiotomy for vaginal birth
Europe PMC Funders Author Manuscripts

Comparison: 3 Restrictive versus routine episiotomy (multiparae)

Outcome: 3 Severe perineal trauma
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Analysis 3.4
Comparison 3 Restrictive versus routine episiotomy
(multiparae), Outcome 4 Any posterior perineal
trauma.
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Review: Episiotomy for vaginal birth

Comparison: 3 Restrictive versus routine episiotomy (multiparae)
Outcome: 4 Any posterior perineal trauma
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Analysis 3.5
Comparison 3 Restrictive versus routine episiotomy
(multiparae), Outcome 5 Any anterior trauma.
Review: Episiotomy for vaginal birth
Europe PMC Funders Author Manuscripts

Comparison: 3 Restrictive versus routine episiotomy (multiparae)

Outcome: 5 Any anterior trauma
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Analysis 3.6
Comparison 3 Restrictive versus routine episiotomy
(multiparae), Outcome 6 Need for suturing perineal
trauma.
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Review: Episiotomy for vaginal birth

Comparison: 3 Restrictive versus routine episiotomy (multiparae)
Outcome: 6 Need for suturing perineal trauma

FEEDBACK

Preston, September 2001

Summary
Europe PMC Funders Author Manuscripts

Results—The relative risks reported in the results section have been calculated using a
fixed effects analysis. There is significant heterogeneity in the outcomes for suturing and
perineal trauma. Use of the fixed effects approach ignores this variability between studies,
producing artificially narrow confidence intervals. For example, the relative risk for ‘need
for suturing perineal trauma’ changes from 0.74 (0.71,0.77) to 0.71(0.61,0.81) with a
random effects model, and that for ‘any anterior trauma’ changes from 1.79 (1.55,2.07) to
1.48 (0.99,2.21). [Summary of comment from Carol Preston, September 2001.]

Reply—In cases of heterogeneity among the results of the studies, it is clearly of interest to
determine the causes by conducting subgroup analyses or meta-regression on the basis of
biological characteristics of the population, use of different interventions, methodological
quality of the studies, etc, to find the source of heterogeneity. Trying to find the source of
heterogeneity, we performed beforehand a sensitivity analysis stratifying by parity. When
the heterogeneity were not readily explained by this sensitivity analysis, we used a random-
effects model. A random-effects meta-analysis model involves an assumption that the
effects being estimated in the different studies are not identical, but follow similar
distribution. However, one needs to be careful in interpreting these results as, the relative

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 Carroli and Mignini Page 48

risk summary for the random-effects model tend to show a larger treatment effect than the
fixed-effect model while not eliminating the heterogeneity itself (Villar 2001).

Contributors—Guillermo Carroli, Luciano Mignini.

Verdurmen, 1 October 2012

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Summary
This important and well-performed review assesses the effects of restrictive use of
episiotomy compared with routine episiotomy during vaginal birth. We would like to have
more information on several important definitions, used in this review. It is known that there
are several strong indications for the use of an episiotomy, such as fetal distress, breech
delivery and assisted delivery. We can presume that with “restricted use of episiotomy” the
review authors mean that there was no episiotomy used, unless there was such a strong
indication for an episiotomy in that specific case. We wonder what the exact indications
were in this specific review. To prevent confusion, we think it is necessary to have a clear
description of what is meant by a “restrictive use of episiotomy” policy in this Cochrane
review.

The exact definitions of “anterior perineal trauma” and “posterior perineal trauma” are
described properly under the subheading “description of the condition”. In addition, the
various degrees of spontaneous ruptures are well-defined. However, the terms “severe
vaginal/perineal trauma” (outcome 5) and “severe perineal trauma” (outcome 8) are not well
described. We can assume involvement of the anal sphincter complex (third and fourth
degree ruptures) is defined as severe trauma. Unfortunately, this is not described in the
background text, although it is of great importance to interpret the outcomes of the review
correctly.
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Similarly, the exact definitions of Outcomes 21, 24 and 27 (Moderate/severe perineal pain in
3 days; - 10 days; -3 months) are not clear. The methods used in the individual trials to
assess the degree of experienced pain, for example the standardized visual analogue score,
are not described. In Outcome 33 (Healing complications at 7 days), there is no specification
of these complications and/or symptoms involved with healing complications. Therefore, it
is not possible for the reader to determine how serious these complications were.

In conclusion, we think that this review would gain strength if the above mentioned
definitions are added to the description of the data.

[Comments submitted by KMJ Verdurmen and PJ van Runnard Heimel, September 2012.]

Reply
The authors for this review are currently updating the review and will consider these
recommendations when preparing their update.

Contributors
Guillermo Carroli

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 Carroli and Mignini Page 49

WHAT’S NEW
Last assessed as up-to-date: 28 July 2008.
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Date Event Description

1 October 2012 Feedback has been incorporated Feedback 2 added.

HISTORY
Protocol first published: Issue 2, 1997

Review first published: Issue 2, 1997

Date Event Description

18 January 2012 Amended Contact details updated.

28 July 2008 New citation required but New author.

conclusions have not changed

31 March 2008 New search has been performed New search conducted; two new studies included (Dannecker
2004; Rodriguez 2008), two excluded (Detlefsen 1980; Dong
2004) and one new ongoing study identified (Murphy 2006).

31 January 2008 Feedback has been incorporated Response to feedback from Carol Preston added.

3 October 2001 Feedback has been incorporated Received from Carol Preston, September 2001.

DIFFERENCES BETWEEN PROTOCOL AND REVIEW

Review methodology section was updated (Higgins 2006).
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References to studies included in this review

*Indicates the major publication for the study

Argentine 1993 {published data only} . Argentine Episiotomy Trial Collaborative Group. Routine
vs selective episiotomy: a randomised controlled trial. Lancet. 1993; 42:1517–8.
Dannecker 2004 {published data only} . Dannecker C, Hillemanns P, Strauss A, Hasbargen U,
Hepp H, Anthuber C. Episiotomy and perineal tears presumed to be imminent: randomized
controlled trial. Acta Obstetricia et Gynecologica Scandinavica. 2004; 83(4):364–8. [PubMed:
15005784] Dannecker C, Hillemanns P, Strauss A, Hasbargen U, Hepp H, Anthuber C.
Episiotomy and perineal tears presumed to be imminent: the influence on the urethral pressure
profile, analmanometric and other pelvic floor findings - follow up study of a randomized
controlled trial. Acta Obstetricia et Gynecologica Scandinavica. 2005; 84:65–71. [PubMed:
15603570]
Eltorkey 1994 {published data only} . Eltorkey MM, Al Nuaim MA, Kurdi AM, Sabagh TO,
Clarke F. Episiotomy, elective or selective: a report of a random allocation trial. Journal of
Obstetrics and Gynaecology. 1994; 14:317–20.
Harrison 1984 {published data only} . Harrison RF, Brennan M, North PM, Reed JV, Wickham
EA. Is routine episiotomy necessary? BMJ. 1984; 288:1971–5. [PubMed: 6428627]
House 1986 {published data only} . House MJ, Cario G, Jones MH. Episiotomy and the perineum:
a random controlled trial. Journal of Obstetrics and Gynaecology. 1986; 7:107–10.

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Klein 1992 {published data only} . Klein, M.; Gauthier, R.; Jorgensen, S.; North, B.; Robbins, J.;
Kaczorowski, J., et al. The McGill/University of Montreal multicentre episiotomy trial
preliminary results. Innovations in Perinatal Care; Proceedings of the 9th Birth Conference; San
Francisco, USA. 1990; Nov 11-13. p. 44-55.1990 Klein MC, Gauthier RJ, Jorgensen SH,
Robbins JM, Kaczorowski J, Johnson B, et al. Does episiotomy prevent perineal trauma and
pelvic floor relaxation? [Forebygger episiotomi perineal trauma och forsvagning av
backenbotten?]. Jordemodern. 1993; 106(10):375–7. [PubMed: 8276683] Klein MC, Gauthier
Europe PMC Funders Author Manuscripts

RJ, Jorgensen SH, Robbins JM, Kaczorowski J, Johnson B, et al. Does episiotomy prevent
perineal trauma and pelvic floor relaxation? Online Journal of Current Clinical Trials. 1992 Vol.
Doc No 10:[6019 words; 65 paragraphs] . Klein MC, Gauthier RJ, Robbins JM, Kaczorowski J,
Jorgensen SH, Franco ED, et al. Relationship of episiotomy to perineal trauma and morbidity,
sexual dysfunction and pelvic floor relaxation. American Journal of Obstetrics and Gynecology.
1994; 171:591–8. [PubMed: 8092203] Klein MC, Kaczorowsky J, Robbins JM, Gauthier RJ,
Jorgensen SH, Joshi AK. Physicians’ beliefs and behaviour during a randomized controlled trial
of episiotomy: consequences for women in their care. Canadian Medical Association Journal.
1995; 153:769–79. [PubMed: 7664230]
Rodriguez 2008 {published data only} . Rodriguez A, Arenas EA, Osorio AL, Mendez O, Zuleta
JJ. Selective vs routine midline episiotomy for the prevention of third- or fourth-degree
lacerations in nulliparous women. American Journal of Obstetrics and Gynecology. 2008;
198(3):285.e1–285.e4. [PubMed: 18221925]
Sleep 1984 {published data only} . Sleep J, Grant AM. West Berkshire perineal management trial:
three year follow up. BMJ. 1987; 295:749–51. [PubMed: 3119022] Sleep, J.; Grant, AM.;
Garcia, J.; Elbourne, D.; Spencer, J.; Chalmers, I. The Reading episiotomy trial: a randomised
trial comparing two policies for managing the perineum during spontaneous vaginal delivery;
Proceedings of 23rd British Congress of Obstetrics and Gynaecology; Birmingham, UK. 1983;
Jul 12-15. p. 241983 Sleep J, Grant AM, Garcia J, Elbourne DR, Spencer JAD, Chalmers I. West
Berkshire perineal management trial. BMJ. 1984; 289:587–90. [PubMed: 6432201]

References to studies excluded from this review

Coats 1980 {published data only} . Coats PM, Chan KK, Wilkins M, Beard RJ. A comparison
between midline and mediolateral episiotomies. British Journal of Obstetrics and Gynaecology.
1980; 87:408–12. [PubMed: 7387941]
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Detlefsen 1980 {published data only} . Detlefsen GU, Vinther S, Larsen P, Schroeder E. Median
and mediolateral episiotomy [Median og mediolateral episiotomi]. Ugeskrift for Laeger. 1980;
142(47):3114–6. [PubMed: 7003882]
Dong 2004 {published data only} . Dong LQ, Li HL, Song ZL. Clinical study and application of
the improved episiotomy incision and anesthesia method in the vaginal deliveries. Journal of Qilu
Nursing. 2004; 10(1):1–3.
Henriksen 1992 {published data only} . Henriksen T, Beck KM, Hedegaard M, Secher NJ.
Episiotomy and perineal lesions in spontaneous vaginal deliveries. British Journal of Obstetrics
and Gynaecology. 1992; 99:950–4. [PubMed: 1477014] Henriksen TB, Bek KM, Hedegaard M,
Secher NJ. Episiotomy and perineal lesions in spontaneous vaginal delivery [Episiotomi og
perineale laesioner ved spontane vaginale fodsler]. Ugeskrift for Laeger. 1994; 156(21):3176–9.
[PubMed: 8066836]
Werner 1991 {published data only} . Werner, Ch; Schuler, W.; Meskendahl, I. Midline episiotomy
versus medio-lateral episiotomy - a randomized prospective study; Proceedings of 13th World
Congress of Gynaecology and Obstetrics (FIGO) (Book 1); Singapore. 1991; Sep 15-20. p.
331991

References to ongoing studies

Murphy 2006 {published data only} . Murphy, DJ. Randomised controlled trial of restrictive
versus routine use of episiotomy for instrumental vaginal delivery - a multi-centre pilot study.
National Research Register; [accessed 6 July 2006]

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Additional references
Aldridge 1935. Aldridge AN, Watson P. Analysis of end results of labor in primiparas after
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Gynecology. 1935; 30:554–65.
Borghi 2002. Borghi J, Fox-Rushby J, Bergel E, Abalos E, Hutton G, Carroli G. The cost-effectiveness
of routine versus restrictive episiotomy in Argentina. American Journal of Obstetrics and
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Gynecology. 2002; 186:221–8. [PubMed: 11854639]

Buekens 1985. Buekens P, Lagasse R, Dramaix M, Wollast E. Episiotomy and third degree tears.
British Journal of Obstetrics and Gynaecology. 1985; 92:820–3. [PubMed: 4027204]
Chalmers 1989. Chalmers, I.; Hetherington, J.; Elbourne, D.; Keirse, MJNC.; Enkin, M. Materials and
methods used in synthesizing evidence to evaluate the effects of care during pregnancy and
childbirth. In: Chalmers, I.; Enkin, MWE.; Keirse, MJNC., editors. Effective care in pregnancy
and childbirth. Oxford University Press; Oxford: 1989. p. 39-65.
Cunningham 1993. Cunningham, FG. Conduct of normal labor and delivery. In: Cunningham, FG.;
MacDonald, PC.; Gant, NF.; Leveno, KJ.; Gilstrap, LC., III, editors. Williams obstetrics. 19th
Edition. Appleton and Lange; Norwalk, CT: 1993. p. 371-93.
Fernando 2006. Fernando R, Sultan AH, Kettle C, Thakar R, Radley S. Methods of repair for obstetric
anal sphincter injury. Cochrane Database of Systematic Reviews. 2006; (3) DOI:
10.1002/14651858.
Fernando 2007. Fernando, RJ.; Williams, AA.; Adams, EJ. The management of third or fourth degree
perineal tears. RCOG; London: 2007. RCOG Green-top guidelines. No 29
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Journal of Obstetrics and Gynecology. 1955; 70:800–7. [PubMed: 13258672]
Graham 2005. Graham ID, Carroli G, Davies C, Medves JM. Episiotomy rates around the world: an
update. Birth. 2005; 32:219–23. [PubMed: 16128977]
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Journal. 1861; 7(313):21.
Higgins 2006. Higgins, JPT.; Green, S., editors. The Cochrane Library. John Wiley & Sons, Ltd.;
Chichester, UK: 2006. Cochrane Handbook for Systematic Reviews of Interventions 4.2.6
[updated September 2006].
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and rectovaginal fistula. Obstetrical & Gynecological Survey. 1994; 49:803–8. [PubMed:
7885655]
Kettle 2007. Kettle C, Hills RK, Ismail KMK. Continuous versus interrupted sutures for repair of
episiotomy or second degree tears. Cochrane Database of Systematic Reviews. 2007; (4) DOI:
10.1002/14651858.CD000947.pub2.
Lede 1991. Lede R, Moreno M, Belizan JM. Reflections on the routine indications for episiotomy
[Reflexiones acerca de la indicacion rutinaria de la episiotomia]. Sinopsis Obstétrico-
Ginecológica. 1991; 38:161–6.
Lede 1996. Lede R, Belizan JM, Carroli G. Is routine use of episiotomy justified? American Journal of
Obstetrics and Gynecology. 1996; 174:1399–402. [PubMed: 9065102]
Mascarenhas 1992. Mascarenhas T, Eliot BW, Mackenzie IZ. A comparison of perinatal outcome,
antenatal and intrapartum care between England and Wales and France. British Journal of
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Thacker 1983. Thacker SB, Banta HD. Benefits and risks of episiotomy: an interpretative review of the
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Villar 2001. Villar J, Mackey ME, Carroli G, Donner A. Meta-analyses in systematic reviews of
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References to other published versions of this review

Hay-Smith 1995a. Hay-Smith, J.; The Cochrane Collaboration. Liberal use of episiotomy for
Europe PMC Funders Author Manuscripts

spontaneous vaginal delivery. In: Enkin, MW.; Keirse, MJNC.; Renfrew, MJ.; Neilson, JP.;
Crowther, CA., editors. The Cochrane Pregnancy and Childbirth Database. Update Software;
Oxford: 1995. [database on disk and CD ROM] Issue 2 Pregnancy and Childbirth Module
revised 05 May 1994
Hay-Smith 1995b. Hay-Smith, J.; The Cochrane Collaboration. Midline vs mediolateral episiotomy.
In: Enkin, MW.; Keirse, MJNC.; Renfrew, MJ.; Neilson, JP.; Crowther, CA., editors. The
Cochrane Pregnancy and Childbirth Database. Update Software; Oxford: 1995. [database on disk
and CD ROM] Issue 2 Pregnancy and Childbirth Modulerevised 26 January 1994
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PLAIN LANGUAGE SUMMARY

Episiotomy for vaginal birth
Vaginal tears can occur during childbirth, most often at the vaginal opening as the baby’s
head passes through, especially if the baby descends quickly. Tears can involve the
Europe PMC Funders Author Manuscripts

perineal skin or extend to the muscles and the anal sphincter and anus. The midwife or
obstetrician may decide to make a surgical cut to the perineum with scissors or scalpel
(episiotomy) to make the baby’s birth easier and prevent severe tears that can be difficult
to repair. The cut is repaired with stitches (sutures). Some childbirth facilities have a
policy of routine episiotomy.

The review authors searched the medical literature for randomised controlled trials that
compared episiotomy as needed (restrictive) compared with routine episiotomy to
determine the possible benefits and harms for mother and baby. They identified eight
trials involving more than 5000 women. For women randomly allocated to routine
episiotomy 75.10% actually had an episiotomy whereas with a restrictive episiotomy
policy 28.40% had an episiotomy. Restrictive episiotomy policies appeared to give a
number of benefits compared with using routine episiotomy. Women experienced less
severe perineal trauma, less posterior perineal trauma, less suturing and fewer healing
complications at seven days (reducing the risks by from 12% to 31%); with no difference
in occurrence of pain, urinary incontinence, painful sex or severe vaginal/perineal trauma
after birth. Overall, women experienced more anterior perineal damage with restrictive
episiotomy. Both restrictive compared with routine mediolateral episiotomy and
restrictive compared with midline episiotomy showed similar results to the overall
comparison with the limited data on episiotomy techniques available from the present
trials.
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