Episiotomy
Episiotomy
Carroli G, Mignini L
This is a reprint of a Cochrane review, prepared and maintained by The Cochrane Collaboration and published in The Cochrane Library
2009, Issue 3
[Link]
TABLE OF CONTENTS
HEADER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
ABSTRACT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
PLAIN LANGUAGE SUMMARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
BACKGROUND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
OBJECTIVES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
METHODS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
RESULTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
DISCUSSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
AUTHORS CONCLUSIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
ACKNOWLEDGEMENTS
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
CHARACTERISTICS OF STUDIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
DATA AND ANALYSES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Analysis 1.2. Comparison 1 Restrictive versus routine episiotomy (all), Outcome 2 Number of episiotomies. . . .
Analysis 1.4. Comparison 1 Restrictive versus routine episiotomy (all), Outcome 4 Assisted delivery rate. . . . .
Analysis 1.5. Comparison 1 Restrictive versus routine episiotomy (all), Outcome 5 Severe vaginal/perineal trauma. .
Analysis 1.8. Comparison 1 Restrictive versus routine episiotomy (all), Outcome 8 Severe perineal trauma. . . . .
Analysis 1.11. Comparison 1 Restrictive versus routine episiotomy (all), Outcome 11 Any posterior perineal trauma.
Analysis 1.14. Comparison 1 Restrictive versus routine episiotomy (all), Outcome 14 Any anterior trauma. . . . .
Analysis 1.17. 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.
Analysis 1.21. 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.
Analysis 1.23. 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. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Analysis 1.25. 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.
Analysis 1.27. 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. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Analysis 1.29. 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. . .
Analysis 1.31. 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.
Analysis 1.33. 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. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Analysis 1.35. 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.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Analysis 1.37. Comparison 1 Restrictive versus routine episiotomy (all), Outcome 37 Urinary incontinence within 3-7
months. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Analysis 1.38. Comparison 1 Restrictive versus routine episiotomy (all), Outcome 38 Any urinary incontinence at 3
years. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Analysis 1.39. 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.
Episiotomy for vaginal birth (Review)
Copyright 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
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Analysis 1.41. Comparison 1 Restrictive versus routine episiotomy (all), Outcome 41 Admission to special care baby unit.
Analysis 2.1. Comparison 2 Restrictive versus routine (primiparae), Outcome 1 Number of episiotomies. . . . .
Analysis 2.2. Comparison 2 Restrictive versus routine (primiparae), Outcome 2 Severe vaginal/perineal trauma. . .
Analysis 2.3. Comparison 2 Restrictive versus routine (primiparae), Outcome 3 Severe perineal trauma. . . . . .
Analysis 2.4. Comparison 2 Restrictive versus routine (primiparae), Outcome 4 Any posterior trauma. . . . . .
Analysis 2.5. Comparison 2 Restrictive versus routine (primiparae), Outcome 5 Any anterior trauma. . . . . . .
Analysis 2.6. Comparison 2 Restrictive versus routine (primiparae), Outcome 6 Need for suturing perineal trauma. .
Analysis 3.1. Comparison 3 Restrictive versus routine episiotomy (multiparae), Outcome 1 Number of episiotomies.
Analysis 3.2. Comparison 3 Restrictive versus routine episiotomy (multiparae), Outcome 2 Severe vaginal/perineal
trauma. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Analysis 3.3. Comparison 3 Restrictive versus routine episiotomy (multiparae), Outcome 3 Severe perineal trauma. .
Analysis 3.4. Comparison 3 Restrictive versus routine episiotomy (multiparae), Outcome 4 Any posterior perineal
trauma. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Analysis 3.5. Comparison 3 Restrictive versus routine episiotomy (multiparae), Outcome 5 Any anterior trauma. . .
Analysis 3.6. Comparison 3 Restrictive versus routine episiotomy (multiparae), Outcome 6 Need for suturing perineal
trauma. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
FEEDBACK . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
WHATS NEW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
HISTORY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
CONTRIBUTIONS OF AUTHORS . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
DECLARATIONS OF INTEREST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
SOURCES OF SUPPORT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
DIFFERENCES BETWEEN PROTOCOL AND REVIEW . . . . . . . . . . . . . . . . . . . . .
INDEX TERMS
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[Intervention Review]
Contact address: Guillermo Carroli, Centro Rosarino de Estudios Perinatales, Pueyrredon 985, Rosario, Santa Fe, 2000, Argentina.
gcarroli@[Link]. (Editorial group: Cochrane Pregnancy and Childbirth Group.)
Cochrane Database of Systematic Reviews, Issue 3, 2009 (Status in this issue: Unchanged)
Copyright 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
DOI: 10.1002/14651858.CD000081.pub2
This version first published online: 21 January 2009 in Issue 1, 2009.
Last assessed as up-to-date: 27 July 2008. (Help document - Dates and Statuses explained)
This record should be cited as: Carroli G, Mignini L. Episiotomy for vaginal birth. Cochrane Database of Systematic Reviews 2009,
Issue 1. Art. No.: CD000081. DOI: 10.1002/14651858.CD000081.pub2.
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 strategy
We searched the Cochrane Pregnancy and Childbirth Groups 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.
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
Episiotomy for vaginal birth (Review)
Copyright 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Restrictive episiotomy policies appear to have a number of benefits compared to policies based on routine episiotomy. There is less
posterior perineal trauma, less 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.
BACKGROUND
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.
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
These include:
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.
We searched the Cochrane Pregnancy and Childbirth Groups Trials Register by contacting the Trials Search Co-ordinator (March
2008).
The Cochrane Pregnancy and Childbirth Groups 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 (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.
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.
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
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
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
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.
Effects of interventions
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 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.
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 routine midline. Until further evidence is available,
the choice of technique should be that with which the accoucheur
is most familiar.
ACKNOWLEDGEMENTS
Jean Hay-Smith was the author of previous published version of
this review See Other published versions of this review.
Jos M Belizn 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 the Cochrane Pregnancy and Childbirth Review
Groups 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.
REFERENCES
Additional references
Aldridge 1935
Aldridge AN, Watson P. Analysis of end results of labor in primiparas
after spontaneous versus prophylactic methods of delivery. American
Journal of Obstetrics and Gynecology 1935;30:55465.
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 Gynecology 2002;186:
2218.
Buekens 1985
Buekens P, Lagasse R, Dramaix M, Wollast E. Episiotomy and third
degree tears. British Journal of Obstetrics and Gynaecology 1985;92:
8203.
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 editor(s). Effective care in pregnancy and
childbirth. Oxford: Oxford University Press, 1989:3965.
Cunningham 1993
Cunningham FG. Conduct of normal labor and delivery. In: Cunningham FG, MacDonald PC, Gant NF, Leveno KJ, Gilstrap LC III
editor(s). Williams obstetrics. 19th Edition. Norwalk, CT: Appleton
and Lange, 1993:37193.
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, Issue 3. [DOI: 10.1002/14651858]
Fernando 2007
Fernando RJ, Williams AA, Adams EJ. The management of third or
fourth degree perineal tears. RCOG Green-top guidelines. No 29. London: RCOG, 2007.
Gainey 1955
Gainey NL. Postpartum observation of pelvis tissue damage: further
studies. American Journal of Obstetrics and Gynecology 1955;70:800
7.
Graham 2005
Graham ID, Carroli G, Davies C, Medves JM. Episiotomy rates
around the world: an update. Birth 2005;32:21923.
Hamilton 1861
Hamilton G. Classical observations and suggestions in obstetrics.
Edinburgh Medical Journal 1861;7(313):21.
Higgins 2006
Higgins JPT, Green S, editors. Cochrane Handbook for Systematic
Reviews of Interventions 4.2.6 [updated September 2006]. In: The
Cochrane Library, Issue 4, 2006. Chichester, UK: John Wiley &
Sons, Ltd.
Homsi 1994
Homsi R, Daikoku NH, Littlejohn J, Wheeless CR Jr. Episiotomy;
risks of dehiscence and rectovaginal fistula. Obstetrical & Gynecological Survey 1994;49:8038.
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, Issue 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 Obsttrico-Ginecolgica 1991;38:1616.
Lede 1996
Lede R, Belizan JM, Carroli G. Is routine use of episiotomy justified?.
American Journal of Obstetrics and Gynecology 1996;174:1399402.
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 Obstetrics and Gynaecology 1992;99:
9558.
Ould 1741
Ould F. A treatise of midwifery. London: J Buckland, 1741:1456.
RevMan 2008
The Cochrane Collaboration. Review Manager (RevMan). 5.0.
Copenhagen: The Nordic Cochrane Centre: The Cochrane Collaboration, 2008.
Shiono 1990
Shiono P, Klebanoff MA, Carey JC. Midline episiotomies: more
harm than good?. Obstetrics & Gynecology 1990;75:76570.
Thacker 1983
Thacker SB, Banta HD. Benefits and risks of episiotomy: an interpretative review of the english language literature, 1860-1980. Obstetrical & Gynecological Survey 1983;38:32238.
Villar 2001
Villar J, Mackey ME, Carroli G, Donner A. Meta-analyses in systematic reviews of randomized controlled trials in perinatal medicine:
comparison of fixed and random effects models. Statistics in Medicine
2001;20(23):363547.
CHARACTERISTICS OF STUDIES
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.
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 hospitals 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.
Notes
Mediolateral episiotomies. Epsiotomy rates were 30% for the restricted group and 80.6% for the routine
group.
Risk of bias
Item
Authors judgement
Description
Allocation concealment?
Yes
A - Adequate
Dannecker 2004
Methods
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
Dannecker 2004
(Continued)
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.
Risk of bias
Item
Authors judgement
Description
Allocation concealment?
Yes
A - Adequate
Eltorkey 1994
Methods
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.
Notes
Mediolateral episiotomies. Epsiotomy rate were 53% for the restricted group and 83% for the routine
group were.
Risk of bias
Item
Authors judgement
Description
Allocation concealment?
Yes
A - Adequate
Harrison 1984
Methods
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Harrison 1984
(Continued)
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
Item
Authors judgement
Description
Allocation concealment?
Unclear
B - Unclear
House 1986
Methods
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
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
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House 1986
(Continued)
Item
Authors judgement
Description
Allocation concealment?
Yes
A - Adequate
Klein 1992
Methods
Participants
1050 women enrolled at 30 to 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
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
Item
Authors judgement
Description
Allocation concealment?
Yes
A - Adequate
Rodriguez 2008
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.
12
Rodriguez 2008
(Continued)
Outcomes
Notes
Midline episiotomies. Epsiotomy rates were 24.3% for restricted group and 100% for the routine group.
Risk of bias
Item
Authors judgement
Description
Allocation concealment?
Yes
A - Adequate
Sleep 1984
Methods
Participants
1000 women randomized with spontaneous vaginal deliveries, live singleton fetus, at least 37 completed
weeks of gestational age, cephalic presentation.
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
Item
Authors judgement
Description
13
Sleep 1984
(Continued)
Allocation concealment?
Yes
A - Adequate
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 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-totreat 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.
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.
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 of instrumental 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.
14
Murphy 2006
(Continued)
Interventions
Random allocation to: [A] Restrictive use of episiotomy for instrumental vaginal delivery. [B] Routine use of
episiotomy for instrumental vaginal delivery.
Outcomes
Starting date
01/09/2005
Contact information
Miss B Strachan
Department of Obstetrics and Gynaecology
St Michaels Hospital
Bristol
BS2 8EG
Telephone: 0117 928 5594
Fax: 0117 928 5180
E-mail: [Link]@[Link]
Notes
15
No. of
studies
No. of
participants
2 Number of episiotomies
2.1 Midline
2.2 Mediolateral
4 Assisted delivery rate
4.1 Midline
4.2 Mediolateral
5 Severe vaginal/perineal trauma
5.1 Midline
5.2 Mediolateral
8 Severe perineal trauma
8.1 Midline
8.2 Mediolateral
11 Any posterior perineal trauma
11.1 Midline
11.2 Mediolateral
14 Any anterior trauma
14.1 Midline
14.2 Mediolateral
17 Need for suturing perineal
trauma
20 Estimated blood loss at delivery
8
2
6
6
2
4
5
2
3
7
2
5
4
1
3
6
2
4
5
5441
1143
4298
4210
1137
3073
4838
1143
3695
4404
1143
3261
2079
698
1381
4896
1143
3753
4133
165
165
1
1
1
2422
885
885
1
1
1
885
895
895
895
895
1
1
895
674
2296
1119
Statistical method
Effect size
16
1118
2
1
1298
667
1569
1
1
1
674
895
674
674
3908
1898
1
2
0
698
1200
0
Not estimable
0.74 [0.46, 1.19]
Not estimable
No. of
studies
No. of
participants
8
2
6
5
2
3
7
2
5
4
1
3
5
2
3
5
3364
801
2563
2541
801
1740
2944
801
2143
1157
356
801
1530
801
729
2441
2441
Statistical method
Effect size
17
No. of
studies
No. of
participants
4
1
3
3
1
2
3
1
2
2
1
1
2
1
1
3
2040
342
1698
1973
342
1631
1460
342
1118
922
342
580
922
342
580
1692
1692
Statistical method
Effect size
18
Analysis 1.2. Comparison 1 Restrictive versus routine episiotomy (all), Outcome 2 Number of episiotomies.
Review:
Study or subgroup
Restricted episiotomy
Routine episiotomy
n/N
Risk Ratio
n/N
Weight
M-H,Fixed,95% CI
Risk Ratio
M-H,Fixed,95% CI
1 Midline
Klein 1992
153/349
227/349
11.1 %
54/222
223/223
10.9 %
571
572
22.0 %
392/1308
1046/1298
51.4 %
49/70
60/76
2.8 %
Eltorkey 1994
53/100
83/100
4.1 %
Harrison 1984
7/92
89/89
4.4 %
House 1986
17/94
49/71
2.7 %
Sleep 1984
51/498
258/502
12.6 %
2162
2136
78.0 %
2708
100.0 %
Rodriguez 2008
2733
0.002
0.1
Favours Restricted
10
500
Favours Routine
19
Analysis 1.4. Comparison 1 Restrictive versus routine episiotomy (all), Outcome 4 Assisted delivery rate.
Review:
Study or subgroup
Restricted episiotomy
Routine episiotomy
n/N
Risk Ratio
n/N
Weight
M-H,Fixed,95% CI
Risk Ratio
M-H,Fixed,95% CI
1 Midline
Klein 1992
20/346
23/346
27.5 %
3/222
4/223
4.8 %
568
569
32.3 %
24/1302
32/1297
38.4 %
4/49
9/60
9.7 %
Eltorkey 1994
4/100
5/100
6.0 %
House 1986
10/94
10/71
13.6 %
1545
1528
67.7 %
2097
100.0 %
Rodriguez 2008
2113
0.1 0.2
0.5
Favours Restrictive
10
Favours Routine
20
Analysis 1.5. Comparison 1 Restrictive versus routine episiotomy (all), Outcome 5 Severe vaginal/perineal
trauma.
Review:
Study or subgroup
Restricted episiotomy
Routine episiotomy
n/N
Risk Ratio
n/N
Weight
M-H,Fixed,95% CI
Risk Ratio
M-H,Fixed,95% CI
1 Midline
Klein 1992
30/349
29/349
24.2 %
Rodriguez 2008
22/222
38/223
31.6 %
571
572
55.8 %
53/1308
47/1278
39.6 %
2/49
5/60
3.7 %
4/498
1/502
0.8 %
1855
1840
44.2 %
2412
100.0 %
2426
0.1 0.2
0.5
Favours Restricted
10
Favours Routine
21
Analysis 1.8. Comparison 1 Restrictive versus routine episiotomy (all), Outcome 8 Severe perineal trauma.
Review:
Study or subgroup
Restricted episiotomy
n/N
Routine episiotomy
Risk Ratio
n/N
Risk Ratio
M-H,Fixed,95% CI
M-H,Fixed,95% CI
1 Midline
Klein 1992
30/349
29/349
Rodriguez 2008
15/222
32/223
571
572
15/1308
19/1298
2/49
5/60
Eltorkey 1994
0/100
0/100
Harrison 1984
0/92
5/89
House 1986
0/94
3/71
1643
1618
2190
2214
0.005
0.1
Favours Restricted
10
200
Favours Routine
22
Analysis 1.11. Comparison 1 Restrictive versus routine episiotomy (all), Outcome 11 Any posterior perineal
trauma.
Review:
Study or subgroup
Restricted episiotomy
Routine episiotomy
n/N
Risk Ratio
n/N
Weight
M-H,Fixed,95% CI
Risk Ratio
M-H,Fixed,95% CI
1 Midline
Klein 1992
282/349
305/349
35.9 %
349
349
35.9 %
60/100
75/100
8.8 %
Harrison 1984
73/92
89/89
10.7 %
329/498
380/502
44.6 %
690
691
64.1 %
1040
100.0 %
Sleep 1984
1039
0.1 0.2
0.5
Favours Restricted
10
Favours Routine
23
Analysis 1.14. Comparison 1 Restrictive versus routine episiotomy (all), Outcome 14 Any anterior trauma.
Review:
Study or subgroup
Restricted episiotomy
Routine episiotomy
n/N
Risk Ratio
n/N
Weight
M-H,Fixed,95% CI
Risk Ratio
M-H,Fixed,95% CI
1 Midline
Klein 1992
52/349
37/349
13.5 %
Rodriguez 2008
46/222
12/223
4.4 %
571
572
17.8 %
230/1197
101/1247
36.0 %
27/49
25/60
8.2 %
12/100
18/100
6.5 %
131/498
87/502
31.5 %
1844
1909
82.2 %
2481
100.0 %
2415
0.1 0.2
0.5
Favours Restricted
10
Favours Routine
24
Analysis 1.17. Comparison 1 Restrictive versus routine episiotomy (all), Outcome 17 Need for suturing
perineal trauma.
Review:
Study or subgroup
Restricted episiotomy
Routine episiotomy
n/N
Argentine 1993
n/N
Risk Ratio
Weight
M-H,Random,95% CI
Risk Ratio
M-H,Random,95% CI
817/1296
1138/1291
24.2 %
Eltorkey 1994
62/100
86/100
18.2 %
Harrison 1984
50/92
89/89
17.4 %
House 1986
54/94
63/71
17.1 %
344/498
392/502
23.2 %
2080
2053
100.0 %
Sleep 1984
0.1 0.2
0.5
Favours Restricted
10
Favours Routine
Analysis 1.20. Comparison 1 Restrictive versus routine episiotomy (all), Outcome 20 Estimated blood loss
at delivery.
Review:
Study or subgroup
Restricted episiotomy
N
House 1986
Routine episiotomy
Mean(SD)
94
94
214 (162)
Mean Difference
Mean(SD)
71
Weight
IV,Fixed,95% CI
Mean Difference
IV,Fixed,95% CI
272 (160)
100.0 %
71
-10
-5
Favours Restricted
10
Favours Routine
25
Analysis 1.21. Comparison 1 Restrictive versus routine episiotomy (all), Outcome 21 Moderate/severe
perineal pain at 3 days.
Review:
Study or subgroup
Restricted episiotomy
Routine episiotomy
n/N
Risk Ratio
n/N
House 1986
Weight
M-H,Fixed,95% CI
Risk Ratio
M-H,Fixed,95% CI
30/94
32/71
100.0 %
94
71
100.0 %
0.1 0.2
0.5
Favours Restricted
10
Favours Routine
Analysis 1.22. Comparison 1 Restrictive versus routine episiotomy (all), Outcome 22 Any perineal pain at
discharge.
Review:
Study or subgroup
Restricted episiotomy
n/N
Argentine 1993
Routine episiotomy
Risk Ratio
n/N
Weight
M-H,Fixed,95% CI
Risk Ratio
M-H,Fixed,95% CI
371/1207
516/1215
100.0 %
1207
1215
100.0 %
0.1 0.2
0.5
Favours Restricted
10
Favours Routine
26
Analysis 1.23. Comparison 1 Restrictive versus routine episiotomy (all), Outcome 23 Any perineal pain at
10 days.
Review:
Study or subgroup
Restricted episiotomy
Routine episiotomy
n/N
Sleep 1984
Risk Ratio
n/N
Weight
M-H,Fixed,95% CI
Risk Ratio
M-H,Fixed,95% CI
99/439
101/446
100.0 %
439
446
100.0 %
0.1 0.2
0.5
Favours Restricted
10
Favours Routine
Analysis 1.24. Comparison 1 Restrictive versus routine episiotomy (all), Outcome 24 Moderate/severe
perineal pain at 10 days.
Review:
Study or subgroup
Restricted episiotomy
Routine episiotomy
n/N
Sleep 1984
Risk Ratio
n/N
Weight
M-H,Fixed,95% CI
Risk Ratio
M-H,Fixed,95% CI
37/439
36/446
100.0 %
439
446
100.0 %
0.1 0.2
0.5
Favours Restricted
10
Favours Routine
27
Analysis 1.25. Comparison 1 Restrictive versus routine episiotomy (all), Outcome 25 Use of oral analgesia
at 10 days.
Review:
Study or subgroup
Restricted episiotomy
Routine episiotomy
n/N
Sleep 1984
Risk Ratio
n/N
Weight
M-H,Fixed,95% CI
Risk Ratio
M-H,Fixed,95% CI
13/439
9/446
100.0 %
439
446
100.0 %
0.1 0.2
0.5
Favours Restricted
10
Favours Routine
Analysis 1.26. Comparison 1 Restrictive versus routine episiotomy (all), Outcome 26 Any perineal pain at 3
months.
Review:
Study or subgroup
Restricted episiotomy
Routine episiotomy
n/N
Sleep 1984
Risk Ratio
n/N
Weight
M-H,Fixed,95% CI
Risk Ratio
M-H,Fixed,95% CI
33/438
35/457
100.0 %
438
457
100.0 %
0.1 0.2
0.5
Favours Restricted
10
Favours Routine
28
Analysis 1.27. Comparison 1 Restrictive versus routine episiotomy (all), Outcome 27 Moderate/severe
perineal pain at 3 months.
Review:
Study or subgroup
Restricted episiotomy
Routine episiotomy
n/N
Sleep 1984
Risk Ratio
n/N
Weight
M-H,Fixed,95% CI
Risk Ratio
M-H,Fixed,95% CI
13/438
9/457
100.0 %
438
457
100.0 %
0.1 0.2
0.5
Favours Restricted
10
Favours Routine
Analysis 1.28. Comparison 1 Restrictive versus routine episiotomy (all), Outcome 28 No attempt at
intercourse in 3 months.
Review:
Study or subgroup
Restricted episiotomy
Routine episiotomy
n/N
Sleep 1984
Risk Ratio
n/N
Weight
M-H,Fixed,95% CI
Risk Ratio
M-H,Fixed,95% CI
39/438
44/457
100.0 %
438
457
100.0 %
0.1 0.2
0.5
Favours Restricted
10
Favours Routine
29
Analysis 1.29. Comparison 1 Restrictive versus routine episiotomy (all), Outcome 29 Any dyspareunia
within 3 months.
Review:
Study or subgroup
Restricted episiotomy
Routine episiotomy
n/N
Sleep 1984
Risk Ratio
n/N
Weight
M-H,Fixed,95% CI
Risk Ratio
M-H,Fixed,95% CI
228/438
233/457
100.0 %
438
457
100.0 %
0.1 0.2
0.5
Favours Restricted
10
Favours Routine
Analysis 1.30. Comparison 1 Restrictive versus routine episiotomy (all), Outcome 30 Dyspareunia at 3
months.
Review:
Study or subgroup
Restricted episiotomy
Routine episiotomy
n/N
Sleep 1984
Risk Ratio
n/N
Weight
M-H,Fixed,95% CI
Risk Ratio
M-H,Fixed,95% CI
96/438
82/457
100.0 %
438
457
100.0 %
0.1 0.2
0.5
Favours Restricted
10
Favours Routine
30
Analysis 1.31. Comparison 1 Restrictive versus routine episiotomy (all), Outcome 31 Ever suffering
dyspareunia in 3 years.
Review:
Study or subgroup
Restricted episiotomy
Routine episiotomy
n/N
Sleep 1984
Risk Ratio
n/N
Weight
M-H,Fixed,95% CI
Risk Ratio
M-H,Fixed,95% CI
52/329
45/345
100.0 %
329
345
100.0 %
0.1 0.2
0.5
Favours Restricted
10
Favours Routine
Analysis 1.32. Comparison 1 Restrictive versus routine episiotomy (all), Outcome 32 Perineal haematoma
at discharge.
Review:
Study or subgroup
Restricted episiotomy
Routine episiotomy
n/N
Argentine 1993
Risk Ratio
n/N
Weight
M-H,Fixed,95% CI
Risk Ratio
M-H,Fixed,95% CI
47/1148
49/1148
100.0 %
1148
1148
100.0 %
0.1 0.2
0.5
Favours Restricted
10
Favours Routine
31
Analysis 1.33. Comparison 1 Restrictive versus routine episiotomy (all), Outcome 33 Healing complications
at 7 days.
Review:
Study or subgroup
Restricted episiotomy
Routine episiotomy
n/N
Argentine 1993
Risk Ratio
n/N
Weight
M-H,Fixed,95% CI
Risk Ratio
M-H,Fixed,95% CI
114/555
168/564
100.0 %
555
564
100.0 %
0.1 0.2
0.5
Favours Restricted
10
Favours Routine
Analysis 1.34. Comparison 1 Restrictive versus routine episiotomy (all), Outcome 34 Perineal wound
dehiscence at 7 days.
Review:
Study or subgroup
Restricted episiotomy
Routine episiotomy
n/N
Argentine 1993
Risk Ratio
n/N
Weight
M-H,Fixed,95% CI
Risk Ratio
M-H,Fixed,95% CI
25/557
53/561
100.0 %
557
561
100.0 %
0.1 0.2
0.5
Favours Restricted
10
Favours Routine
32
Analysis 1.35. Comparison 1 Restrictive versus routine episiotomy (all), Outcome 35 Perineal infection.
Review:
Study or subgroup
Restricted episiotomy
Routine episiotomy
n/N
Argentine 1993
House 1986
Risk Ratio
n/N
Weight
M-H,Fixed,95% CI
Risk Ratio
M-H,Fixed,95% CI
9/555
10/578
74.1 %
5/94
3/71
25.9 %
649
649
100.0 %
0.1 0.2
0.5
Favours Restricted
10
Favours Routine
Analysis 1.36. Comparison 1 Restrictive versus routine episiotomy (all), Outcome 36 Perineal bulging at 3
months - Midline.
Review:
Study or subgroup
Restricted episiotomy
Routine episiotomy
n/N
Klein 1992
Risk Ratio
n/N
Weight
M-H,Fixed,95% CI
Risk Ratio
M-H,Fixed,95% CI
24/332
29/335
100.0 %
332
335
100.0 %
0.1 0.2
0.5
Favours Restricted
10
Favours Routine
33
Analysis 1.37. Comparison 1 Restrictive versus routine episiotomy (all), Outcome 37 Urinary incontinence
within 3-7 months.
Review:
Study or subgroup
Restricted episiotomy
Routine episiotomy
n/N
Risk Ratio
n/N
Weight
M-H,Fixed,95% CI
Risk Ratio
M-H,Fixed,95% CI
1 Midline
Klein 1992
57/337
60/337
41.3 %
337
337
41.3 %
83/438
87/457
58.7 %
438
457
58.7 %
794
100.0 %
775
0.1 0.2
0.5
Favours Restricted
10
Favours Routine
34
Analysis 1.38. Comparison 1 Restrictive versus routine episiotomy (all), Outcome 38 Any urinary
incontinence at 3 years.
Review:
Study or subgroup
Restricted episiotomy
Routine episiotomy
n/N
Sleep 1984
Risk Ratio
n/N
Weight
M-H,Fixed,95% CI
Risk Ratio
M-H,Fixed,95% CI
112/329
124/345
100.0 %
329
345
100.0 %
0.1 0.2
0.5
Favours Restricted
10
Favours Routine
Analysis 1.39. Comparison 1 Restrictive versus routine episiotomy (all), Outcome 39 Pad wearing for
urinary incontinence.
Review:
Study or subgroup
Restricted episiotomy
Routine episiotomy
n/N
Sleep 1984
Risk Ratio
n/N
Weight
M-H,Fixed,95% CI
Risk Ratio
M-H,Fixed,95% CI
31/329
28/345
100.0 %
329
345
100.0 %
0.1 0.2
0.5
Favours Restricted
10
Favours Routine
35
Analysis 1.40. Comparison 1 Restrictive versus routine episiotomy (all), Outcome 40 Apgar score less than
7 at 1 minute.
Review:
Study or subgroup
Restricted episiotomy
Routine episiotomy
n/N
Argentine 1993
Risk Ratio
n/N
Weight
M-H,Fixed,95% CI
Risk Ratio
M-H,Fixed,95% CI
43/1306
39/1293
54.9 %
3/49
7/60
8.8 %
1/100
3/100
4.2 %
27/498
23/502
32.1 %
1953
1955
100.0 %
Dannecker 2004
Eltorkey 1994
Sleep 1984
0.1 0.2
0.5
Favours Restricted
10
Favours Routine
36
Analysis 1.41. Comparison 1 Restrictive versus routine episiotomy (all), Outcome 41 Admission to special
care baby unit.
Review:
Study or subgroup
Restricted episiotomy
n/N
Routine episiotomy
Risk Ratio
n/N
Risk Ratio
M-H,Fixed,95% CI
M-H,Fixed,95% CI
1 Midline
Klein 1992
0/349
0/349
349
349
0/100
0/100
28/498
38/502
598
602
951
947
0.1 0.2
0.5
Favours Restricted
10
Favours Routine
37
Analysis 2.1. Comparison 2 Restrictive versus routine (primiparae), Outcome 1 Number of episiotomies.
Review:
Study or subgroup
Restrictive
Routine
n/N
Risk Ratio
n/N
Weight
M-H,Fixed,95% CI
Risk Ratio
M-H,Fixed,95% CI
1 Midline
Klein 1992
99/173
149/183
9.9 %
Rodriguez 2008
54/222
223/223
15.2 %
395
406
25.1 %
307/777
706/778
48.1 %
20/49
46/60
2.8 %
Eltorkey 1994
53/100
83/100
5.7 %
Harrison 1984
7/92
89/89
6.2 %
House 1986
16/50
38/48
2.6 %
Sleep 1984
36/201
147/219
9.6 %
1269
1294
74.9 %
1700
100.0 %
1664
0.01
0.1
Favours Restricted
10
100
Favours Routine
38
Analysis 2.2. Comparison 2 Restrictive versus routine (primiparae), Outcome 2 Severe vaginal/perineal
trauma.
Review:
Study or subgroup
Restrictive
Routine
Risk Ratio
Weight
M-H,Fixed,95% CI
Risk Ratio
n/N
n/N
M-H,Fixed,95% CI
Klein 1992
27/173
26/183
33.1 %
Rodriguez 2008
22/222
38/223
49.7 %
395
406
82.8 %
1 Midline
9/531
8/520
10.6 %
Dannecker 2004
2/49
5/60
5.9 %
1/297
0/283
0.7 %
877
863
17.2 %
1269
100.0 %
Sleep 1984
1272
0.01
0.1
Favours Restricted
10
100
Favours Routine
39
Analysis 2.3. Comparison 2 Restrictive versus routine (primiparae), Outcome 3 Severe perineal trauma.
Review:
Study or subgroup
Restrictive
Routine
Risk Ratio
Risk Ratio
n/N
n/N
M-H,Fixed,95% CI
M-H,Fixed,95% CI
Klein 1992
27/173
26/183
Rodriguez 2008
15/222
32/223
395
406
11/777
14/778
2/49
5/60
Eltorkey 1994
0/100
0/100
Harrison 1984
0/92
5/89
House 1986
0/50
2/48
1068
1075
1481
1 Midline
1463
0.01
0.1
Favours Restricted
10
100
Favours Routine
40
Analysis 2.4. Comparison 2 Restrictive versus routine (primiparae), Outcome 4 Any posterior trauma.
Review:
Study or subgroup
Restrictive
Routine
n/N
Risk Ratio
n/N
Weight
M-H,Fixed,95% CI
Risk Ratio
M-H,Fixed,95% CI
1 Midline
Klein 1992
160/173
171/183
32.5 %
173
183
32.5 %
60/100
75/100
14.7 %
Harrison 1984
73/92
89/89
17.8 %
139/201
187/219
35.0 %
393
408
67.5 %
591
100.0 %
Sleep 1984
566
0.01
0.1
Favours Restricted
10
100
Favours Routine
41
Analysis 2.5. Comparison 2 Restrictive versus routine (primiparae), Outcome 5 Any anterior trauma.
Review:
Study or subgroup
Restrictive
Routine
Risk Ratio
Weight
M-H,Fixed,95% CI
Risk Ratio
n/N
n/N
M-H,Fixed,95% CI
Klein 1992
22/173
19/183
15.7 %
Rodriguez 2008
46/222
12/223
10.2 %
395
406
25.8 %
27/49
25/60
19.1 %
Eltorkey 1994
12/100
18/100
15.3 %
Sleep 1984
66/201
49/219
39.8 %
350
379
74.2 %
785
100.0 %
1 Midline
745
0.01
0.1
Favours Restricted
10
100
Favours Routine
42
Analysis 2.6. Comparison 2 Restrictive versus routine (primiparae), Outcome 6 Need for suturing perineal
trauma.
Review:
Study or subgroup
Restrictive
Routine
n/N
Risk Ratio
n/N
Weight
M-H,Fixed,95% CI
Risk Ratio
M-H,Fixed,95% CI
2 Mediolateral
Argentine 1993
522/769
722/773
63.7 %
Eltorkey 1994
62/100
86/100
7.6 %
Harrison 1984
50/92
89/89
8.0 %
House 1986
34/50
46/48
4.2 %
149/201
195/219
16.5 %
1212
1229
100.0 %
Sleep 1984
0.01
0.1
Favours Restricted
10
100
Favours Routine
43
Analysis 3.1. Comparison 3 Restrictive versus routine episiotomy (multiparae), Outcome 1 Number of
episiotomies.
Review:
Study or subgroup
Restrictive
Routine
Risk Ratio
Weight
M-H,Fixed,95% CI
Risk Ratio
n/N
n/N
M-H,Fixed,95% CI
54/176
78/166
13.9 %
176
166
13.9 %
87/531
367/520
64.0 %
1/44
11/23
2.5 %
15/297
111/283
19.6 %
872
826
86.1 %
992
100.0 %
1 Midline
Klein 1992
1048
0.01
0.1
Favours Restricted
10
100
Favours Routine
44
Analysis 3.2. Comparison 3 Restrictive versus routine episiotomy (multiparae), Outcome 2 Severe
vaginal/perineal trauma.
Review:
Study or subgroup
Restrictive
n/N
Routine
Risk Ratio
n/N
Weight
M-H,Fixed,95% CI
Risk Ratio
M-H,Fixed,95% CI
1 Midline
Klein 1992
3/176
3/166
26.4 %
176
166
26.4 %
9/531
8/520
69.2 %
Sleep 1984
1/297
0/283
4.4 %
828
803
73.6 %
969
100.0 %
1004
0.01
0.1
Favours Restricted
10
100
Favours Routine
45
Analysis 3.3. Comparison 3 Restrictive versus routine episiotomy (multiparae), Outcome 3 Severe perineal
trauma.
Review:
Study or subgroup
Restrictive
n/N
Routine
Risk Ratio
n/N
Weight
M-H,Fixed,95% CI
Risk Ratio
M-H,Fixed,95% CI
1 Midline
Klein 1992
3/176
3/166
30.6 %
176
166
30.6 %
4/531
5/520
50.0 %
0/44
1/23
19.4 %
575
543
69.4 %
709
100.0 %
751
0.01
0.1
Favours Restricted
10
100
Favours Routine
46
Analysis 3.4. Comparison 3 Restrictive versus routine episiotomy (multiparae), Outcome 4 Any posterior
perineal trauma.
Review:
Study or subgroup
Restrictive
n/N
Routine
Risk Ratio
n/N
Weight
M-H,Fixed,95% CI
Risk Ratio
M-H,Fixed,95% CI
1 Midline
Klein 1992
122/176
134/166
41.1 %
176
166
41.1 %
190/297
193/283
58.9 %
297
283
58.9 %
449
100.0 %
473
0.01
0.1
Favours Restricted
10
100
Favours Routine
47
Analysis 3.5. Comparison 3 Restrictive versus routine episiotomy (multiparae), Outcome 5 Any anterior
trauma.
Review:
Study or subgroup
Restrictive
Routine
Risk Ratio
Weight
M-H,Fixed,95% CI
Risk Ratio
n/N
n/N
M-H,Fixed,95% CI
30/176
18/166
32.3 %
176
166
32.3 %
65/297
38/283
67.7 %
297
283
67.7 %
449
100.0 %
1 Midline
Klein 1992
473
0.01
0.1
Favours Restricted
10
100
Favours Routine
48
Analysis 3.6. Comparison 3 Restrictive versus routine episiotomy (multiparae), Outcome 6 Need for
suturing perineal trauma.
Review:
Study or subgroup
Restrictive
n/N
Routine
Risk Ratio
n/N
Weight
M-H,Fixed,95% CI
Risk Ratio
M-H,Fixed,95% CI
1 Mediolateral
Argentine 1993
House 1986
Sleep 1984
295/527
416/518
65.4 %
20/44
17/23
3.5 %
196/297
195/283
31.1 %
868
824
100.0 %
0.01
0.1
Favours Restricted
10
100
Favours Routine
FEEDBACK
Preston, September 2001
Summary
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).
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 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
Summary of comment from Carol Preston, September 2001
49
WHATS NEW
Last assessed as up-to-date: 27 July 2008.
28 July 2008
New citation required but conclusions have not changed New author.
31 March 2008
31 January 2008
HISTORY
Protocol first published: Issue 2, 1997
Review first published: Issue 2, 1997
3 October 2001
CONTRIBUTIONS OF AUTHORS
To be completed.
DECLARATIONS OF INTEREST
Guillermo Carroli is the author of one of the studies included in this review.
SOURCES OF SUPPORT
Internal sources
Human Reproduction, World Health Organization, Switzerland.
Centro Rosarino de Estudios Perinatales, Rosario, Argentina.
Secretaria de Salud Publica, Municipalidad de Rosario, Argentina.
50
External sources
No sources of support supplied
INDEX TERMS
Medical Subject Headings (MeSH)
Episiotomy
[adverse effects; methods; standards]; Parturition; Perineum [ injuries; surgery]; Randomized Controlled Trials as Topic
51