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. 2011 Apr 11;2011:1401.

Perineal care

Chris Kettle 1,#, Julie Frohlich 2,#
PMCID: PMC3275301  PMID: 21481287

Abstract

Introduction

Over 85% of women having a vaginal birth suffer some perineal trauma. Spontaneous tears requiring suturing are estimated to occur in at least a third of women in the UK and US, with anal sphincter tears in 0.5% to 7% of women. Perineal trauma can lead to long-term physical and psychological problems.

Methods and outcomes

We conducted a systematic review and aimed to answer the following clinical questions: What are the effects of intrapartum surgical and non-surgical interventions on rates of perineal trauma? What are the effects of different methods and materials for primary repair of first- and second-degree tears and episiotomies? What are the effects of different methods and materials for primary repair of obstetric anal sphincter injuries (third- and fourth-degree tears)? We searched: Medline, Embase, The Cochrane Library, and other important databases up to March 2010 (Clinical Evidence reviews are updated periodically, please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).

Results

We found 38 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.

Conclusions

In this systematic review we present information relating to the effectiveness and safety of the following interventions: active pushing, spontaneous pushing, and sustained breath-holding (Valsalva) method of pushing; continuous support during labour; conventional suturing; different methods and materials for primary repair of obstetric anal sphincter injuries; episiotomies (midline and mediolateral incisions); epidural analgesia; forceps; methods of delivery ("hands-on" method, "hands poised"); water births; non-suturing of muscle and skin (or perineal skin alone); passive descent in the second stage of labour; positions (supine or lithotomy positions, upright position during delivery); restrictive or routine use of episiotomy; sutures (absorbable synthetic sutures, catgut sutures, continuous sutures, interrupted sutures); and vacuum extraction.

Key Points

Over 85% of women having a vaginal birth suffer some perineal trauma.

  • Spontaneous tears requiring suturing are estimated to occur in at least one third of women in the UK and US, with anal sphincter tears in 0.5% to 7% of women.

  • Risk factors include first vaginal delivery, large or malpositioned baby, older or white mother, abnormal collagen synthesis, poor nutritional state, and forceps delivery.

Perineal trauma can lead to long-term physical and psychological problems.

  • Up to 10% of women continue to have long-term perineal pain; up to 25% will have dyspareunia or urinary problems, and up to 10% will report faecal incontinence.

Restricting routine use of episiotomy reduces the risk of posterior perineal trauma.

  • Using episiotomies only when there are clear maternal or fetal indications increases the likelihood of maintaining an intact perineum, and does not increase the risk of third-degree tears.

We don't know whether pain or wound dehiscence are less likely to occur with midline episiotomy compared with mediolateral incision.

  • Midline incisions may be more likely to result in severe tears, although we can't be sure about this.

Instrumental delivery increases the risk of perineal trauma.

  • The risk of instrumental delivery is increased after epidural analgesia. Vacuum extraction reduces the rate of severe perineal trauma compared with forceps delivery, but increases the risk of cephalhaematoma and retinal haemorrhage in the newborn.

Continuous support during labour reduces the rate of assisted vaginal births, and thus the rate of perineal trauma.

The "hands-poised" delivery method is associated with lower rates of episiotomy, but increased rates of short-term pain and manual removal of the placenta. Likewise, an upright position during delivery is associated with lower rates of episiotomy, but no significant difference in overall rates of perineal trauma.

Non-suturing of first- and second-degree tears (perineal skin and muscles) may be associated with reduced wound healing up to 3 months after birth. However, leaving the perineal skin alone unsutured (vagina and perineal muscles sutured) reduces dyspareunia and may reduce pain at up to 3 months.

Absorbable synthetic sutures for repair of first- and second-degree tears and episiotomies are less likely to result in long-term pain than catgut sutures. Rapidly absorbed synthetic sutures reduce the need for suture removal. Continuous sutures reduce short-term pain.

Early primary overlap repair for third- and fourth-degree anal sphincter tears seems to be associated with lower risks for faecal urgency and anal incontinence symptoms than end-to-end approximation.

We don't know whether immersion in water during the first or second stage of labour has any effect on rates of perineal trauma or whether passive descent is better than active pushing.

It is unclear whether the sustained breath holding (Valsalva) method is more effective at reducing rates of perineal trauma compared with exhalatory or spontaneous pushing.

About this condition

Definition

Perineal trauma is any damage to the genitalia during childbirth that occurs spontaneously or intentionally by surgical incision (episiotomy). 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.Spontaneous tears are defined as first degree when they involve the perineal skin only; second-degree tears involve the perineal muscles and skin; third-degree tears involve the anal sphincter complex (classified as 3a where <50% of the external anal sphincter is torn; 3b where >50% of the external anal sphincter is torn; 3c where the internal and external anal sphincter is torn); fourth-degree tears involve the anal sphincter complex and anal epithelium.

Incidence/ Prevalence

Over 85% of women having a vaginal birth sustain some form of perineal trauma, and 60% to 70% receive stitches — equivalent to approximately 400,000 women a year in the UK in 1997. There are wide variations in rates of episiotomy: 8% in the Netherlands, 99% in east European countries, 13% in England, and 25% in the US. Sutured spontaneous tears are reported in about one third of women in the US and the UK, but this is probably an underestimate because of inconsistencies in both reporting and classification of perineal trauma. The incidence of anal sphincter tears varies between 0.5% in the UK, 2.5% in Denmark, and 7% in Canada.

Aetiology/ Risk factors

Perineal trauma occurs during spontaneous or assisted vaginal delivery, and is usually more extensive after the first vaginal delivery. Associated risk factors also include increased fetal size, mode of delivery, and malpresentation and malposition of the fetus. Other maternal factors that may increase the extent and degree of trauma are ethnicity (white women are probably at greater risk than black women), older age, abnormal collagen synthesis, and poor nutritional state. Clinicians' practices or preferences in terms of intrapartum interventions may influence the severity and rate of perineal trauma (e.g., use of ventouse v forceps).

Prognosis

Perineal trauma affects women's physical, psychological, and social wellbeing in the immediate postnatal period as well as in the long term. It can also disrupt breastfeeding, family life, and sexual relations. In the UK, about 23% to 42% of women continue to have pain and discomfort for 10 to 12 days postpartum, and 7% to 10% of women continue to have long-term pain (3–18 months after delivery); 23% of women experience superficial dyspareunia at 3 months; 3% to 10% report faecal incontinence; and up to 24% have urinary problems. Complications depend on the severity of perineal trauma, and on the effectiveness of treatment.

Aims of intervention

To reduce the rate and severity of trauma; to improve the short- and long-term maternal morbidity associated with perineal injury and repair.

Outcomes

Incidence and severity of perineal trauma; rates of episiotomy, assisted vaginal delivery (indirectly associated with an increased risk of episiotomy and perineal trauma, especially with forceps delivery); psychological trauma; short- and long-term perineal pain; blood loss; infection; wound dehiscence; superficial dyspareunia; urinary incontinence or retention; faecal incontinence; quality of life; adverse effects of treatment.

Methods

Clinical Evidence search and appraisal March 2010. The following databases were used to identify studies for this systematic review: Medline 1966 to March 2010, Embase 1980 to March 2010, and The Cochrane Database of Systematic Reviews 2010, Issue 2 (1966 to date of issue). An additional search within The Cochrane Library was carried out for the Database of Abstracts of Reviews of Effects (DARE) and Health Technology Assessment (HTA). We also searched for retractions of studies included in the review. Abstracts of the studies retrieved from the initial search were assessed by an information specialist. Selected studies were then sent to the contributor for additional assessment, using predetermined criteria to identify relevant studies. Study design criteria for inclusion in this review were: published systematic reviews of RCTs and RCTs in any language, at least single blinded, and containing >20 individuals of whom >80% were followed up. There was no minimum length of follow-up required to include studies. We excluded all studies described as "open", "open label", or not blinded unless blinding was impossible. We included systematic reviews of RCTs and RCTs where harms of an included intervention were studied applying the same study design criteria for inclusion as we did for benefits. In addition we use a regular surveillance protocol to capture harms alerts from organisations such as the FDA and the MHRA, which are added to the reviews as required. To aid readability of the numerical data in our reviews, we round many percentages to the nearest whole number. Readers should be aware of this when relating percentages to summary statistics such as relative risks (RRs) and odds ratios (ORs). We have performed a GRADE evaluation of the quality of evidence for interventions included in this review (see table). The categorisation of the quality of the evidence (high, moderate, low, or very low) reflects the quality of evidence available for our chosen outcomes in our defined populations of interest. These categorisations are not necessarily a reflection of the overall methodological quality of any individual study, because the Clinical Evidence population and outcome of choice may represent only a small subset of the total outcomes reported, and population included, in any individual trial. For further details of how we perform the GRADE evaluation and the scoring system we use, please see our website (www.clinicalevidence.com).

Table.

GRADE Evaluation of interventions for Perineal care.

Important outcomes Adverse effects, Perineal trauma
Studies (Participants) Outcome Comparison Type of evidence Quality Consistency Directness Effect size GRADE Comment
What are the effects of intrapartum surgical interventions on rates of perineal trauma?
at least 8 (at least 5006) Perineal trauma Restrictive versus routine use of episiotomy 4 0 –1 0 0 Moderate Consistency point deducted for conflicting results
1 (at least 407) Perineal trauma Midline versus mediolateral episiotomy incision 4 –3 0 0 0 Very low Quality points deducted for quasi-randomisation, incomplete reporting of results, and no intention-to-treat analysis.
19 (at least 6162) Perineal trauma Epidural analgesia versus other forms of analgesia or no analgesia 4 –2 0 0 0 Low Quality points deducted for weak methods and use of surrogate outcome (instrumental deliveries)
1 (1912) Adverse effects Epidural analgesia versus other forms of analgesia or no analgesia 4 –2 0 0 0 Low Quality points deducted for weak methods and unclear clinical relevance of outcome
11 (3799) Perineal trauma Vacuum extraction versus forceps delivery 4 –2 0 0 0 Low Quality points deducted for inclusion of quasi-randomised RCTs and lack of blinding
at least 11 (at least 3431) Adverse effects Vacuum extraction versus forceps delivery 4 –2 0 0 0 Low Quality points deducted for inclusion of quasi-randomised RCTs and lack of blinding
What are the effects of intrapartum non-surgical interventions on rates of perineal trauma?
at least 15 (at least 13,357) Perineal trauma Continuous support during labour versus usual care 4 –2 0 0 0 Low Quality points deducted for support intervention varying between trials and use of surrogate outcome (instrumental deliveries)
18 (5506) Perineal trauma Upright position versus supine or lithotomy positions during delivery 4 –3 0 0 0 Very low Quality points deducted for exclusion of participants after randomisation, diversity of interventions, and crossover between groups
11 (4542) Adverse effects Upright position versus supine or lithotomy positions during delivery 4 –3 0 0 0 Very low Quality points deducted for exclusion of participants after randomisation, diversity of interventions, and crossover between groups
1 (252) Perineal trauma Passive descent versus active pushing in the second stage of labour 4 –2 0 0 0 Low Quality points deducted for incomplete reporting of results and use of surrogate outcome (instrumental deliveries)
3 (438) Perineal trauma Sustained breath holding (Valsalva) method of pushing versus exhalatory or spontaneous pushing 4 –3 0 0 0 Very low Quality points deducted for incomplete reporting, including unpublished trials, and inclusion of non-RCT data
2 (6632) Perineal trauma "Hands-poised" versus "hands-on" method of delivery 4 –2 0 0 0 Low Quality points deducted for quasi-randomisation and missing data
1 (5471) Adverse effects "Hands-poised" versus "hands-on" method of delivery 4 0 0 0 0 High
at least 5 (at least 2401) Perineal trauma Water births versus no immersion in water 4 –3 0 0 0 Very low Quality points deducted for different interventions of water immersion in RCTs, crossover between groups, and poor methods
What are the effects of different methods and materials for primary repair of first- and second-degree tears and episiotomies?
2 (2594) Perineal trauma Non-suturing of perineal skin versus conventional suturing in first- and second-degree tears and episiotomies 4 –1 –1 0 0 Low Quality point deducted for no intention-to-treat analysis. Consistency point deducted for conflicting results
2 (2594) Adverse effects Non-suturing of perineal skin versus conventional suturing in first- and second-degree tears and episiotomies 4 –1 –1 0 0 Low Quality point deducted for no intention-to-treat analysis. Consistency point deducted for conflicting results
2 (152) Perineal trauma Non-suturing of muscle and skin versus conventional suturing in first- and second-degree perineal tears 4 –3 0 0 0 Very low Quality points deducted for sparse data, incomplete reporting of results, and unclear outcome measurement
2 (152) Adverse effects Non-suturing of muscle and skin versus conventional suturing in first- and second-degree perineal tears 4 –3 –1 0 0 Very low Quality points deducted for sparse data, incomplete reporting of results, and unclear outcome measurement. Consistency point deducted for conflicting results
11 (at least 5172) Perineal trauma Absorbable synthetic sutures versus catgut sutures 4 –3 –1 0 0 Very low Quality points deducted for incomplete reporting of results, no blinding in some RCTs, and incomplete recruiting in 1 RCT. Consistency point deducted for conflicting results
2 (1811) Perineal trauma Different types of absorbable synthetic suture versus each other 4 0 0 –1 0 Moderate Directness point deducted for use of restrictive outcome measure
at least 6 (at least 3527) Perineal trauma Continuous versus interrupted sutures for repair of all layers or only perineal skin (analysed as a group) 4 0 –1 0 0 Moderate Consistency point deducted for different results at different time points
at least 7 (at least 3289) Perineal trauma Continuous versus interrupted sutures for repair of all layers 4 0 –1 0 0 Moderate Consistency point deducted for conflicting results
What are the effects of different methods and materials for primary repair of obstetric anal sphincter injuries (third- and fourth-degree tears)?
3 (279) Perineal trauma Different methods for primary repair versus each other 4 –1 –1 0 0 Low Quality point deducted for heterogeneity of outcome measurement. Consistency point deducted for different results for different outcomes
1 (112) Perineal trauma Different materials for primary repair versus each other 4 –2 0 –1 0 Very low Quality points deducted for sparse data and methodological weakness. Directness point deducted for composite outcome
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We initially allocate 4 points to evidence from RCTs, and 2 points to evidence from observational studies. To attain the final GRADE score for a given comparison, points are deducted or added from this initial score based on preset criteria relating to the categories of quality, directness, consistency, and effect size. Quality: based on issues affecting methodological rigour (e.g., incomplete reporting of results, quasi-randomisation, sparse data [<200 people in the analysis]). Consistency: based on similarity of results across studies. Directness: based on generalisability of population or outcomes. Effect size: based on magnitude of effect as measured by statistics such as relative risk, odds ratio, or hazard ratio.

Glossary

Continuous support during labour

The presence of a companion (lay person or healthcare worker) who provides continuous social support for the woman during the intrapartum period; social support may include advice, information, assistance, or emotional support.

End-to-end technique

for primary repair of third-degree obstetric anal sphincter tears involves the torn ends of the external anal sphincter being juxtaposed with interrupted sutures.

Gardosi cushion

An obstetric aid used during the second stage of labour, which allows most of the woman's weight to rest on her thighs instead of her feet, while being in a squatting position.

High-quality evidence

Further research is very unlikely to change our confidence in the estimate of effect.

Low-quality evidence

Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.

Moderate-quality evidence

Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.

Overlap technique

for primary repair of third-degree obstetric anal sphincter tears involves the torn ends of the external anal sphincter being overlapped and sutured with interrupted stitches.

Passive fetal descent

An alternative method of bearing down, involving a period of rest to allow passive descent of the fetus before active pushing.

Very low-quality evidence

Any estimate of effect is very uncertain.

Disclaimer

The information contained in this publication is intended for medical professionals. Categories presented in Clinical Evidence indicate a judgement about the strength of the evidence available to our contributors prior to publication and the relevant importance of benefit and harms. We rely on our contributors to confirm the accuracy of the information presented and to adhere to describe accepted practices. Readers should be aware that professionals in the field may have different opinions. Because of this and regular advances in medical research we strongly recommend that readers' independently verify specified treatments and drugs including manufacturers' guidance. Also, the categories do not indicate whether a particular treatment is generally appropriate or whether it is suitable for a particular individual. Ultimately it is the readers' responsibility to make their own professional judgements, so to appropriately advise and treat their patients. To the fullest extent permitted by law, BMJ Publishing Group Limited and its editors are not responsible for any losses, injury or damage caused to any person or property (including under contract, by negligence, products liability or otherwise) whether they be direct or indirect, special, incidental or consequential, resulting from the application of the information in this publication.

Contributor Information

Dr Chris Kettle, University Hospital of North Staffordshire (NHS Trust) and Staffordshire University, Stoke-on-Trent, UK.

Dr Julie Frohlich, St Thomas' Hospital, London, UK.

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BMJ Clin Evid. 2011 Apr 11;2011:1401.

Restrictive versus routine use of episiotomy

Summary

Restricting routine use of episiotomy reduces the risk of posterior perineal trauma.

Using episiotomies only when there are clear maternal or fetal indications increases the likelihood of maintaining an intact perineum, and does not increase the risk of third-degree tears.

Benefits and harms

Restrictive versus routine use of episiotomy:

We found one systematic review (search date 2008, 8 RCTs, 5441 women, see further information on studies) one additional RCT, and one subsequent RCT comparing restricted versus routine episiotomy.

Perineal trauma

Restrictive use of episiotomy compared with routine use of episiotomy Restrictive use of episiotomy seems more effective at reducing the proportion of women with posterior perineal trauma, perineal pain at discharge, healing complications, and the need for suturing, but we don't know whether it is more effective at reducing severe vaginal and perineal trauma, dyspareunia, or urinary incontinence at 3 months. Restrictive use of episiotomy seems less effective at reducing rates of anterior perineal trauma (which carries minimal morbidity) (moderate-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Perineal trauma

Systematic review		 2079 women
4 RCTs in this analysis		 Proportion of women with posterior perineal trauma
744/1039 (72%) with restricted use of episiotomy
849/1040 (82%) with routine use of episiotomy
RR 0.88
95% CI 0.84 to 0.92
NNT 10
95% CI 8 to 16 		Small effect size restricted use

Systematic review		 4404 women
7 RCTs in this analysis		 Proportion of women with severe perineal trauma
62/2214 (3%) with restricted use of episiotomy
93/2190 (4%) with routine use of episiotomy
RR 0.67
95% CI 0.49 to 0.91 		Small effect size restricted use

Systematic review		 4838 women
5 RCTs in this analysis		 Proportion of women with severe vaginal and perineal trauma
111/2426 (4.6%) with restricted use of episiotomy
120/2412 (5.0%) with routine use of episiotomy
RR 0.92
95% CI 0.72 to 1.18 		Not significant

RCT		 402 women, in Spain Proportion of women with first- and second-degree tears
60/200 (30%) with selective use of episiotomies at operative vaginal delivery
27/202 (13%) with routine use of episiotomies at operative vaginal delivery
RR 1.552
95% CI 1.287 to 1.872 		Small effect size routine use

RCT		 200 women, in Scotland and England Proportion of women with anal sphincter tears
11/101 (11%) with restrictive use of episiotomies at operative vaginal delivery
8/99 (8%) with routine use of episiotomies at operative vaginal delivery
OR (routine use v restrictive use) 0.72
95% CI 0.28 to 1.87 		Not significant

Systematic review		 4896 women
6 RCTs in this analysis		 Proportion of women with anterior trauma
498/2415 (21%) with restricted use of episiotomy
280/2481 (11%) with routine use of episiotomy
RR 1.84
95% CI 1.61 to 2.10 		Small effect size routine use

RCT		 402 women, in Spain Proportion of women with anterior perineal trauma
23/200 (12%) with selective use of episiotomies at operative vaginal delivery
15/202 (7%) with routine use of episiotomies at operative vaginal delivery
RR 1.245
95% CI 0.943 to 1.643 		Not significant
Perineal pain

Systematic review		 2422 women
Data from 1 RCT		 Proportion of women with perineal pain at discharge from hospital
371/1207 (31%) with restricted use of episiotomy
516/1215 (42%) with routine use of episiotomy
RR 0.72
95% CI 0.65 to 0.81
NNT 9
95% CI 7 to 12 		Small effect size restricted use
Suturing

Systematic review		 4133 women
5 RCTs in this analysis		 Proportion of women with suturing
1327/2080 (64%) with restricted use of episiotomy
1768/2053 (86%) with routine use of episiotomy
RR 0.74
95% CI 0.71 to 0.77
NNT 4
95% CI 4 to 5 		Small effect size restricted use
Healing complications

Systematic review		 1119 women
Data from 1 RCT		 Proportion of women with healing complications
114/555 (21%) with restricted use of episiotomy
168/564 (30%) with routine use of episiotomy
RR 0.69
95% CI 0.56 to 0.85
NNT 11
95% CI 7 to 23 		Small effect size restricted use
Primary postpartum haemorrhage

RCT		 200 women, in Scotland and England Proportion of women with primary postpartum haemorrhage
27/101 (27%) with restrictive use of episiotomies at operative vaginal delivery
36/99 (36%) with routine use of episiotomies at operative vaginal delivery
OR (routine use v restrictive use) 1.57
95% CI 0.86 to 2.86 		Not significant
Dyspareunia

Systematic review		 895 women
Data from 1 RCT		 Proportion of women with dyspareunia within 3 months
96/438 (22%) with restricted use of episiotomy
82/457 (18%) with routine use of episiotomy
RR 1.22
95% CI 0.94 to 1.59 		Not significant

Systematic review		 674 women
Data from 1 RCT		 Proportion of women with dyspareunia in the next 3 years
52/329 (16%) with restricted use of episiotomy
45/345 (13%) with routine use of episiotomy
RR 1.21
95% CI 0.84 to 1.75 		Not significant
Urinary incontinence

Systematic review		 1569 women
2 RCTs in this analysis		 Proportion of women with urinary incontinence 3 months
140/775 (18%) with restricted use of episiotomy
147/794 (19%) with routine use of episiotomy
RR 0.98
95% CI 0.79 to 1.20 		Not significant
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Adverse effects

No data from the following reference on this outcome.

Further information on studies

The systematic review reported that 2035/2708 (75%) women in the routine episiotomy group had an episiotomy compared with 776/2733 (28%) women in the restricted group. The types of episiotomy performed were mediolateral in 6 of the trials and midline in two of the trials, and the rate of episiotomy varied between studies for the intervention and control groups. The method of randomisation was not clear in one trial. The trials varied in quality, performed intention-to-treat analysis, and took place in the UK, Canada, Argentina, and Germany.

Comment

Clinical guide:

There is strong evidence of benefit for restricted use of episiotomy compared with routine episiotomy.

Substantive changes

Restrictive versus routine use of episiotomy New evidence added. Categorisation unchanged (Beneficial).

BMJ Clin Evid. 2011 Apr 11;2011:1401.

Midline versus mediolateral episiotomy incision

Summary

Midline incisions may be more likely to result in severe tears, although we can't be sure about this.

We don't know whether pain or wound dehiscence are less likely to occur with midline episiotomy compared with mediolateral incision.

Benefits and harms

Midline versus mediolateral episiotomy incision:

We found no systematic review comparing mediolateral versus midline episiotomy incisions but found one quasi-randomised trial. See comment for further information on third- and fourth-degree tears from observational studies.

Perineal trauma

Midline episiotomy incision compared with mediolateral episiotomy incision Midline episiotomy incision may be less effective at decreasing the proportion of women with third- or fourth-degree tears (very low-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Perineal trauma

Pseudo-randomised trial		 407 primigravidas, 24% withdrawals Proportion of women with third- or fourth-degree tears
39/163 (24%) with midline episiotomies
22/244 (9%) with mediolateral episiotomies
RR 2.7
95% CI 1.6 to 4.3
NNH 6
95% CI 4 to 13
Results must be interpreted with caution, as the study limitations compromise their validity; see further information on studies 		Moderate effect size mediolateral episiotomies
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Adverse effects

No data from the following reference on this outcome.

Further information on studies

The trial had an increased risk of selection bias because of quasi-random treatment allocation, and because analysis was not by intention to treat. The trial found no evidence of a difference in perineal pain or wound dehiscence. Women who had midline episiotomy had significantly less perineal bruising, and resumed sexual intercourse earlier.

Comment

Two retrospective cohort studies, including 5376 primiparous and 341 multiparous women, also found that midline episiotomies were associated with a 4-fold increased risk of third- and fourth-degree tears after allowing for multiple confounders (CI not reported). We found one abstract (no detailed data, no description of treatment allocation method) that we excluded as it did not meet Clinical Evidence inclusion criteria.

Clinical guide:

It is claimed that midline incision is easier to repair, and is associated with less blood loss, better healing, less pain, and earlier resumption of sexual intercourse. We found no reliable evidence to support these claims.

Substantive changes

No new evidence

BMJ Clin Evid. 2011 Apr 11;2011:1401.

Epidural analgesia

Summary

The risk of instrumental delivery is increased after epidural analgesia. Instrumental delivery increases the risk of perineal trauma.

Benefits and harms

Epidural analgesia versus other forms of analgesia or no analgesia:

We found one systematic review (search date 2005, 21 RCTs, 6664 women; see further information on studies) comparing epidural analgesia versus other forms of analgesia or no analgesia in labour.

Perineal trauma

Compared with non-epidural analgesia Epidural analgesia may be less effective at decreasing the proportion of women with instrumental delivery (instrumental deliveries are associated with an increased risk of perineal trauma) and may increase rates of urinary retention (low-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Perineal trauma

RCT		 369 women
In review 		Proportion of women with perineal trauma requiring suturing
141/184 (77%) with epidural analgesia
135/185 (73%) with non-epidural analgesia
RR (fixed) 1.05
95% CI 0.93 to 1.18 		Not significant
Instrumental delivery

Systematic review		 6162 women
17 RCTs in this analysis		 Proportion of women with instrumental delivery
587/3044 (19%) with epidural analgesia
442/3118 (14%) with non-epidural analgesia
RR (fixed) 1.38
95% CI 1.24 to 1.53 		Small effect size non-epidural analgesia
Urinary retention

Systematic review		 283 women
3 RCTs in this analysis		 Proportion of women with urinary retention
27/126 (21%) with epidural analgesia
1/157 (1%) with non-epidural analgesia
RR (fixed) 17.05
95% CI 4.82 to 60.39 		Large effect size non-epidural analgesia
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Adverse effects

Compared with non-epidural analgesia Epidural analgesia may be less effective at decreasing the proportion of women with maternal fever (defined as a temperature above 38 °C) (low-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Adverse effects

Systematic review		 1912 women
3 RCTs in this analysis		 Proportion of women with fever (defined as a temperature above 38 °C)
205/956 (21%) with epidural analgesia
56/956 (6%) with non-epidural analgesia
RR (fixed) 3.67
95% CI 2.77 to 4.86 		Moderate effect size non-epidural analgesia
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Further information on studies

The quality of the trials was variable, in that information regarding the randomisation process was clearly described in only 16 of the trials included in the review.

Comment

Clinical guide:

There is fairly strong evidence that epidural analgesia increases the risk of instrumental delivery compared with non-epidural analgesia or no analgesia in labour (this is a confounding effect, in that instrumental deliveries are associated with an increased risk of perineal trauma).

Substantive changes

No new evidence

BMJ Clin Evid. 2011 Apr 11;2011:1401.

Vacuum extraction versus forceps

Summary

Vacuum extraction reduces the rate of severe perineal trauma compared with forceps delivery, but increases the risk of cephalhaematoma and retinal haemorrhage in the newborn.

Benefits and harms

Vacuum extraction versus forceps delivery:

We found one systematic review (search date 1999, 10 RCTs, comparing vacuum extraction versus forceps delivery, 2885 women; see further information on studies) and three subsequent RCTs (carried out in teaching hospitals in Mexico, Sri Lanka, and Ireland).

Perineal trauma

Vacuum extraction compared with forceps delivery Vacuum extraction may be more effective at decreasing the proportion of women with severe perineal injury, severe perineal pain at 24 hours, and altered faecal continence at 3 months (low-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Perineal trauma

Systematic review		 2582 women
7 RCTs in this analysis		 Proportion of women with severe perineal injury
127/1296 (10%) with vacuum extraction
261/1286 (20%) with forceps delivery
RR 0.46
95% CI 0.38 to 0.56
NNT 10
95% CI 8 to 12 		Moderate effect size vacuum extraction

RCT		 442 women undergoing instrumental delivery in the second stage Proportion of women with severe perineal trauma
2/204 (1.0%) with vacuum extraction
4/238 (1.7%) with forceps
RR 0.58
95% CI 0.19 to 3.15 		Not significant

RCT
3-armed trial 		210 women Proportion of women with severe perineal trauma
2/70 (3%) with vacuum extractor
4/70 (6%) with forceps
RR 0.50
95% CI 0.10 to 2.64 		Not significant

RCT		 130 primiparous women (in whom an instrumental delivery was indicated) Proportion of women with third-degree tears
5/69 (7%) with vacuum assistance
10/61 (16%) with forceps
RR 0.44
95% CI 0.16 to 1.22 		Not significant
Perineal pain

Systematic review		 495 women
Data from 1 RCT		 Proportion of women with severe perineal pain at 24 hours
21/247 (9%) with vacuum extraction
37/248 (15%) with forceps delivery
RR 0.57
95% CI 0.34 to 0.94
NNT 16
95% CI 10 to 119 		Small effect size vacuum extraction
Faecal incontinence

RCT		 130 primiparous women (in whom an instrumental delivery was indicated) Proportion of women complaining of altered faecal continence at 3 months after birth
23/69 (33%) with vacuum assistance
36/61 (59%) with forceps
RR 0.35
95% CI 0.17 to 0.71
Intention-to-treat analysis 		Moderate effect size vacuum assistance
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Adverse effects

Vacuum extraction compared with forceps delivery Vacuum extraction may be less effective at decreasing the proportion of babies with cephalhaematoma or retinal haemorrhage, or at decreasing the proportion of failed deliveries with the selected instrument (low-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Cephalhaematoma

Systematic review		 1966 women
6 RCTs in this analysis		 Proportion of babies with cephalhaematoma
98/995 (10%) with vacuum extraction
40/971 (4%) with forceps delivery
RR 2.34
95% CI 1.64 to 3.35
NNH 17
95% CI 10 to 35 		Moderate effect size forceps

RCT		 442 women undergoing instrumental delivery in the second stage Proportion of babies with cephalhaematoma
12/204 (6%) with vacuum extraction
2/238 (1%) with forceps
RR 7.00
95% CI 1.59 to 30.91 		Large effect size forceps

RCT
3-armed trial 		210 women Proportion of babies with cephalhaematoma
6/70 (9%) with vacuum extractor
2/70 (3%) with forceps
RR 3.0
95% CI 0.63 to 14.36 		Not significant
Retinal haemorrhage

Systematic review		 445 women
5 RCTs in this analysis		 Proportion of babies with retinal haemorrhage
109/224 (49%) with vacuum extraction
74/221 (34%) with forceps delivery
RR 1.46
95% CI 1.17 to 1.83
NNH 7
95% CI 4 to 17 		Small effect size forceps
Delivery failure

Systematic review		 2849 women
9 RCTs in this analysis		 Rates of failed delivery with selected instrument
166/1436 (12%) with vacuum extraction
102/1413 (7%) with forceps delivery
RR 1.60
95% CI 1.27 to 2.02
NNH 23
95% CI 14 to 51 		Small effect size forceps
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No data from the following reference on this outcome.

Further information on studies

The RCTs identified by the review varied in quality regarding treatment allocation, with some using quasi-randomisation. None of the trials attempted to "blind" the allocated intervention during the postnatal assessments. The trials took place in different countries (UK, US, South Africa, Denmark, Sweden, and Greece), and the procedures in the studies were comparable to everyday practice when an assisted delivery is required. Although some studies were performed in teaching hospitals, they were pragmatic, with wide inclusion criteria. The evidence is likely to be generalisable.

The RCT failed to achieve adequate power to detect a 20% difference between vacuum and forceps in morbidity.

Comment

Clinical guide:

There is strong evidence that vacuum extraction reduces the rate of severe perineal trauma compared with forceps deliveries.

Substantive changes

No new evidence

BMJ Clin Evid. 2011 Apr 11;2011:1401.

Continuous support during labour

Summary

Continuous support during labour reduces the rate of assisted vaginal births, and thus the rate of perineal trauma.

Benefits and harms

Continuous support during labour versus usual care:

We found one systematic review (search date 2007, 16 RCTs, at least 13,391 women) comparing continuous one-to-one intrapartum support from a professional nurse, midwife, or lay person versus usual care (see further information on studies).

Perineal trauma

Compared with usual care Continuous support during labour may be more effective at decreasing the proportion of women with assisted (vacuum extraction or forceps) vaginal birth (instrumental deliveries are associated with an increased risk of perineal trauma). We don't know whether continuous support during labour is more effective at reducing perineal trauma (defined as episiotomy or laceration requiring suturing) (low-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Perineal trauma

Systematic review		 7328 women
2 RCTs in this analysis		 Proportion of women with perineal trauma (defined as episiotomy or laceration requiring suturing)
1996/3663 (54%) with continuous support
2026/3665 (55%) with usual care
RR 0.99
95% CI 0.95 to 1.03 		Not significant
Assisted birth

Systematic review		 13,357 women
15 RCTs in this analysis		 Rates of assisted vaginal birth (vacuum extraction or forceps)
1052/6644 (16%) with continuous support
1181/6713 (18%) with usual care
RR 0.89
95% CI 0.82 to 0.96 		Small effect size continuous support
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Adverse effects

No data from the following reference on this outcome.

Further information on studies

The RCTs were of reasonable quality, with one trial using a central computerised randomisation service for treatment allocation, 13 using sealed opaque envelopes, and two using methods that were centrally controlled but not concealed. Although the experimental intervention was always described as one-to-one support, the experience, relationship to the labouring woman, timing, and duration of support varied among trials. The pragmatic trials took place in different countries (Australia, Belgium, Botswana, Canada, Finland, France, Greece, Guatemala, Mexico, South Africa, and the US). The trials in the review examined a wide range of outcomes, but none revealed harmful effects.

Comment

Clinical guide:

There is some evidence of benefit of continuous support during labour compared with usual care, in terms of reducing the rate of assisted vaginal birth. However, the overall rates of perineal trauma were not reduced.

Substantive changes

Continuous support during labour New evidence added. Categorisation unchanged (Beneficial).

BMJ Clin Evid. 2011 Apr 11;2011:1401.

Upright position during delivery

Summary

An upright position during delivery is associated with lower rates of episiotomy, but no significant difference in overall rates of perineal trauma.

Benefits and harms

Upright position versus supine or lithotomy positions during delivery:

We found one systematic review (search date 2005, 19 RCTs, 5764 women) comparing any upright position for delivery (birthing chairs, stools, Gardosi cushion, and squatting) versus supine or lithotomy positions (see further information on studies).

Perineal trauma

Compared with delivery in the supine or lithotomy positions The upright position for delivery may be more effective at reducing the proportion of women with episiotomies and assisted vaginal deliveries, but not third- and fourth-degree tears. The upright position for delivery may be less effective at decreasing the proportion of women with second-degree tears (very low-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Episiotomy

Systematic review		 4081 women
12 RCTs in this analysis		 Proportion of women with episiotomy
742/2039 (36%) with upright position
870/2042 (43%) with supine or lithotomy positions
RR 0.84
95% CI 0.79 to 0.91
NNH 17
95% CI 12 to 35 		Small effect size upright position
Second-degree tears

Systematic review		 4492 women
11 RCTs in this analysis		 Proportion of women with second-degree tears
405/2225 (18%) with upright position
352/2267 (16%) with supine or lithotomy positions
RR 1.23
95% CI 1.09 to 1.39
NNH 40
95% CI 20 to 57 		Small effect size supine or lithotomy positions
Third- and fourth-degree tears

Systematic review		 1478 women
4 RCTs in this analysis		 Proportion of women with third- and fourth-degree tears
5/719 (0.7%) with upright position
6/759 (0.8%) with supine or lithotomy positions
RR 0.91
95% CI 0.31 to 2.68 		Not significant
Assisted delivery

Systematic review		 5506 women
18 RCTs in this analysis		 Rates of assisted vaginal delivery
277/2737 (10%) with upright position
326/2769 (12%) with supine or lithotomy positions
RR 0.84
95% CI 0.73 to 0.98 		Small effect size upright position
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Adverse effects

Compared with delivery in the supine or lithotomy positions The upright position for delivery may be less effective at decreasing the proportion of women with blood loss estimated at >500 mL (very low-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Blood loss

Systematic review		 4542 women
11 RCTs in this analysis		 Proportion of women with blood loss >500 mL
160/2256 (7%) with upright position
96/2286 (4%) with supine or lithotomy position
RR 1.68
95% CI 1.32 to 2.15
NNH 36
95% CI 21 to 82 		Small effect size supine or lithotomy position

Systematic review		 1747 women
2 RCTs in this analysis		 Proportion of women with blood transfusion
14/891 (2%) with upright position
8/856 (1%) with supine or lithotomy position
RR 1.66
95% CI 0.70 to 3.94 		Not significant
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Further information on studies

The results of this review should be interpreted with caution because of the variable qualities of the trials, and diversity of the treatment interventions. The reviewers state that the main outcome measures may have been affected as a result of exclusion of participants from some of the trials after randomisation, and several women allocated to deliver in the upright position had difficulty complying.

Comment

Clinical guide:

There is very weak evidence of benefit that any upright position for delivery reduces episiotomies compared with supine or lithotomy positions. Further well-designed trials should be undertaken, with particular attention given to methodological and clinical heterogeneity, observer bias, intention-to-treat analyses, and standardised objective measurements of blood loss.

Substantive changes

No new evidence

BMJ Clin Evid. 2011 Apr 11;2011:1401.

Passive descent in the second stage of labour

Summary

We don't know whether passive fetal descent in the second stage of labour reduces instrumental delivery or perineal laceration.

Benefits and harms

Passive descent versus active pushing in the second stage of labour:

We found one RCT, which compared passive fetal descent versus active pushing from the start of the second stage of labour.

Perineal trauma

Compared with active pushing We don't know whether passive fetal descent in the second stage of labour is more effective at reducing the proportion of women with instrumental delivery (instrumental deliveries are associated with an increased risk of perineal trauma) or perineal laceration (low-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Perineal trauma

RCT		 312 women with epidural anaesthesia randomised; 252 women completed protocol
Subgroup analysis		 Proportion of women with perineal laceration
47% with passive fetal descent
46% with active pushing from the start of the second stage of labour
Absolute numbers not reported
P = 0.94 		Not significant

RCT		 312 women with epidural anaesthesia randomised; 252 women completed protocol
Subgroup analysis		 Proportion of women with perineal laceration
36% with passive fetal descent
33% with active pushing from the start of the second stage of labour
Absolute numbers not reported
P = 0.73 		Not significant
Instrumental delivery

RCT		 312 women with epidural anaesthesia randomised; 252 women completed protocol
Subgroup analysis		 Rate of instrumental delivery
23% with passive fetal descent
30% with active pushing from the start of the second stage of labour
Absolute numbers not reported
P = 0.36 		Not significant

RCT		 312 women with epidural anaesthesia randomised; 252 women completed protocol
Subgroup analysis		 Rate of instrumental delivery
3% with passive fetal descent
13% with active pushing from the start of the second stage of labour
Absolute numbers not reported
P = 0.078 		Not significant
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Adverse effects

No data from the following reference on this outcome.

Further information on studies

None.

Comment

There is weak evidence of benefit for passive fetal descent compared with immediate active pushing.

It is unclear whether the rate of adverse perineal outcomes is affected by different types of bearing down during the second stage of labour.

Substantive changes

No new evidence

BMJ Clin Evid. 2011 Apr 11;2011:1401.

Sustained breath holding (Valsalva) method of pushing in the second stage of labour

Summary

It is unclear whether the sustained breath holding (Valsalva) method is more effective at reducing rates of perineal trauma compared with exhalatory or spontaneous pushing.

Benefits and harms

Sustained breath holding (Valsalva) method of pushing versus exhalatory or spontaneous pushing:

We found one systematic review and one subsequent RCT. The systematic review (search date 1993, 5 trials, of which 2 were known to be RCTs, 471 women) compared bearing down by sustained breath holding (Valsalva) versus exhalatory or spontaneous pushing (see further information on studies).

Perineal trauma

Compared with exhalatory or spontaneous pushing in the second stage of labour We don't know whether the sustained breath holding (Valsalva) method is more effective than exhalatory or spontaneous pushing at reducing the rate of perineal trauma in general or of perineal trauma requiring suturing (very low-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Episiotomy

RCT		 100 women Proportion of women with episiotomy
29/50 (58%) with Valsalva pushing technique
39/50 (78%) with spontaneous pushing
P = 0.167 		Not significant
Second-degree tears

RCT		 100 women Proportion of women with second-degree perineal tears with episiotomy
6/50 (12%) with Valsalva pushing technique
4/50 (8%) with spontaneous pushing
Reported as not significant
P value not reported 		Not significant
Perineal trauma requiring suturing

Systematic review		 338 women
2 RCTs in this analysis		 Proportion of women with perineal trauma requiring suturing
57/172 (33%) with sustained Valsalva
66/166 (40%) with exhalatory bearing down
RR 0.83
95% CI 0.61 to 1.10 		Not significant
Postpartum haemorrhage

RCT		 100 women Postpartum haemorrhage
with Valsalva pushing technique
with spontaneous pushing
Absolute results not reported
P >0.05 		Not significant
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Adverse effects

No data from the following reference on this outcome.

Further information on studies

The review included published and unpublished trials. Three of the trials were small and of poor quality. Two of these trials found reduced rates of perineal trauma with spontaneous bearing down, but this was not supported by data from the two subsequent, more robust controlled trials.The systematic review has now been withdrawn from the online version of The Cochrane Library, but it is still available in previous issues on CD.

Comment

Clinical guide:

There is weak evidence of benefit for sustained breath holding (Valsalva) compared with spontaneous exhalatory methods of pushing during the second stage of labour.

It is unclear whether the rate of adverse perineal outcomes is affected by different types of bearing down during the second stage of labour.

Substantive changes

Sustained breath holding (Valsalva) method of pushing in the second stage of labour New evidence added. Categorisation unchanged (Unknown effectiveness), as there remains insufficient evidence to judge the effects of this intervention.

BMJ Clin Evid. 2011 Apr 11;2011:1401.

"Hands-poised" versus "hands-on" method of delivery

Summary

The "hands-poised" delivery method is associated with lower rates of episiotomy, but increased rates of short-term pain and manual removal of the placenta.

Benefits and harms

"Hands-poised" versus "hands-on" method of delivery:

We found no systematic review. We found one randomised and one quasi-randomised trial comparing the "hands-poised" versus the "hands-on" method of delivery.

Perineal trauma

"Hands-poised" method of delivery compared with "hands-on" method of delivery The "hands-poised" method of delivery may be more effective at reducing the proportion of women with episiotomy, but not at reducing perineal trauma requiring suturing, or the occurrence of third- and fourth-degree tears. The "hands-poised" method may be less effective than the "hands-on" method at reducing the proportion of women with perineal pain at 10 days (low-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Episiotomy

RCT		 5471 women Proportion of women with episiotomy
280/2740 (10%) with "hands-poised" method
351/2731 (13%) with "hands-on" method
RR 0.79
95% CI 0.65 to 0.96
NNT 38
95% CI 23 to 106 		Small effect size "hands-poised" method

Pseudo-randomised trial		 1161 women Proportion of women with episiotomy
51/502 (10%) with "hands-poised" method
103/574 (18%) with "hands-on" method
RR 0.57
95% CI 0.41 to 0.78 		Small effect size "hands-poised" method
First- or second-degree tears

Pseudo-randomised trial		 1161 women Proportion of women with first- and second-degree perineal trauma
175/502 (35%) with "hands-poised" method
171/574 (30%) with "hands-on" method
RR 1.17
95% CI 0.98 to 1.39 		Not significant
Third- or fourth-degree tears

RCT		 5471 women Proportion of women with third- and fourth-degree tears
40/2740 (1.5%) with "hands-poised" method
31/2731 (1.2%) with "hands-on" method
RR 1.3
95% CI 0.81 to 2.05 		Not significant

Pseudo-randomised trial		 1161 women Proportion of women with third-degree tears
5/502 (1%) with "hands-poised" method
16/574 (3%) with "hands-on" method
RR 0.36
95% CI 0.13 to 0.97 		Moderate effect size "hands-poised" method
Suturing

RCT		 5471 women Proportion of women with perineal trauma requiring suturing
1636/2740 (60%) with "hands-poised" method
1605/2731 (59%) with "hands-on" method
RR 1.02
95% CI 0.97 to 1.06 		Not significant
Perineal pain

RCT		 5471 women Proportion of women with perineal pain 10 days after delivery
910/2669 (34%) with "hands-poised" method
823/2647 (31%) with "hands-on" method
RR 1.10
95% CI 1.02 to 1.19
NNH 33
95% CI 18 to 212 		Small effect size "hands-on" method
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Adverse effects

"Hands-poised" method of delivery compared with "hands-on" method of delivery The "hands-poised" method of delivery is less effective at reducing the proportion of women who require manual removal of the placenta (high-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Manual removal of the placenta

RCT		 5471 women Proportion of women with manual removal of the placenta
71/2740 (2.6%) with "hands-poised" method
42/2731 (1.5%) with "hands-on" method
RR 1.69
95% CI 1.16 to 2.46
NNH 95
95% CI 45 to 417 		Small effect size "hands-on" method
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No data from the following reference on this outcome.

Further information on studies

The RCT was a large, robust, multicentre, pragmatic trial carried out in the UK and the results are likely to be generalisable.

The quasi-randomised trial was carried out in the University Hospital of Vienna, and used alternate allocation based on the date of delivery (even days allocated to "hands-on", and odd days to "hands-poised"). Data were missing for 45 women in the "hands-poised" group, and for 40 in the "hands-on" group.

Comment

The two RCTs showed no difference in benefit between the "hands-poised" method of delivery compared with the "hands-on" method regarding risk of perineal trauma.

Substantive changes

No new evidence

BMJ Clin Evid. 2011 Apr 11;2011:1401.

Water births

Summary

We don't know whether immersion in water during the first or second stage of labour has any effect on rates of perineal trauma.

Benefits and harms

Water births versus no immersion in water:

We found one systematic review (search date 2008, 11 RCTs, 3146 women; see further information on studies) comparing immersion in water versus no immersion during the first or second stage of labour.

Perineal trauma

Compared with no immersion in water during the first or second stage of labour We don't know whether immersion in water is more effective at reducing the proportion of women with episiotomies, second-degree tears, or third- or fourth-degree tears (very low-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Episiotomy

Systematic review		 1272 women
5 RCTs in this analysis		 Proportion of women with episiotomy first stage of labour
207/644 (32%) with immersion
219/628 (35%) with no immersion
OR 0.89
95% CI 0.70 to 1.13 		Not significant

Systematic review		 179 women
2 RCTs in this analysis		 Proportion of women with episiotomy second stage of labour only
12/100 (12%) with immersion
10/79 (13%) with no immersion
OR 0.70
95% CI 0.27 to 1.80 		Not significant
Second-degree tears

Systematic review		 179 women
2 RCTs in this analysis		 Proportion of women with second-degree tears second stage of labour only
21/100 (21%) with immersion
14/79 (18%) with no immersion
OR 1.26
95% CI 0.59 to 2.27 		Not significant

Systematic review		 1286 women
5 RCTs in this analysis		 Proportion of women with second-degree tears first stage of labour
110/658 (17%) with immersion
112/628 (18%) with no immersion
OR 0.93
95% CI 0.69 to 1.25 		Not significant
Third- or fourth-degree tears

Systematic review		 60 women
Data from 1 RCT		 Proportion of women with third-degree tears second stage of labour only
1/40 (3%) with immersion
0/20 (0%) with no immersion
OR 1.56
95% CI 0.06 to 39.95 		Not significant

Systematic review		 2401 women
5 RCTs in this analysis		 Proportion of women with third- and fourth-degree tears first stage of labour
40/1202 (3%) with immersion
29/1199 (2%) with no immersion
OR 1.38
95% CI 0.85 to 2.23 		Not significant
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Adverse effects

No data from the following reference on this outcome.

Further information on studies

Eight of the RCTs included in the review involved immersion in water during the first stage of labour only, one RCT involved immersion during the first and the second stages of labour, one RCT compared early versus late immersion in the first stage of labour, and another RCT involved women in the second stage of labour. The review included published and unpublished trials. The quality of the RCTs was variable, and there was diversity in the definitions of water immersion, which makes the comparison of outcomes across RCTs difficult to carry out. There were also differences in the type and size of pools used, depth of water, and if the water was still or moving (e.g., whirlpool, jacuzzi). In addition, there were differences with compliance to treatment allocation. One of the RCTs reported that 183/396 (46%) women allocated to water immersion did not actually use water, another RCT reported that of the 40 women allocated to use water, only 24 used the pool. Four other RCTs reported some crossover between groups, while a fifth RCT did not provide information on crossover.

Comment

The review found no evidence of harmful effects. However, the results should be interpreted with caution, as the small sample sizes, as well as the impossibility of blinding to the intervention, limit the validity and reliability of the trials.

Clinical guide:

There is insufficient evidence of benefit or harm to support or not to support a woman's decision to give birth in water. The RCTs included in the systematic review were of variable methodological quality and used small sample sizes. Therefore there is a high risk of bias, which may limit the reliability and validity of the findings.

Further investigation is needed regarding the effects of immersion in water compared with no immersion during the second stage of labour, as currently there is lack of clear evidence.

Substantive changes

Water births New evidence added. Categorisation unchanged (Unknown effectiveness), as RCTs found were of variable methodological quality and used small sample sizes, which make it difficult to judge the effects of this intervention.

BMJ Clin Evid. 2011 Apr 11;2011:1401.

Non-suturing of perineal skin alone in first- and second-degree tears and episiotomies

Summary

Leaving the perineal skin alone unsutured (vagina and perineal muscles sutured) reduces dyspareunia and may reduce pain at up to 3 months.

Benefits and harms

Non-suturing of perineal skin versus conventional suturing in first- and second-degree tears and episiotomies:

We found two RCTs that compared leaving the perineal skin unsutured but apposed (the vagina and perineal muscle were sutured) versus a conventional repair in which all three layers were sutured.

Perineal trauma

Non-suturing of perineal skin alone in first- and second-degree tears and episiotomies compared with conventional repair Leaving the perineal skin unsutured but apposed (with the vagina and perineal muscles sutured) may be more effective than conventional repair (in which all three layers are sutured), in women with first- and second-degree tears or episiotomies, at decreasing the proportion of women with superficial dyspareunia at 3 months, but not at reducing pain (low-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Perineal pain

RCT		 1780 primiparous and multiparous women with first- and second-degree tears or episiotomies after spontaneous or assisted vaginal delivery in a single UK centre Proportion of women reporting perineal pain at 10 days after birth
221/886 (25%) with perineal skin unsutured
244/885 (28%) with perineal skin sutured
RR 0.91
95% CI 0.77 to 1.06 		Not significant

RCT		 823 women who sustained a second-degree tear or episiotomy; see further information on studies Proportion of women with perineal pain at 48 hours
237/417 (57%) with perineal skin unsutured
265/406 (65%) with perineal skin sutured
RR 0.87
95% CI 0.78 to 0.97 		Small effect size perineal skin unsutured

RCT		 823 women who sustained a second-degree tear or episiotomy; see further information on studies Proportion of women with perineal pain 14 days
93/417 (22%) with perineal skin unsutured
117/406 (29%) with perineal skin sutured
RR 0.77
95% CI 0.61 to 0.98 		Small effect size perineal skin unsutured

RCT		 823 women who sustained a second-degree tear or episiotomy; see further information on studies Proportion of women with perineal pain 6 weeks
41/417 (10%) with perineal skin unsutured
62/406 (15%) with perineal skin sutured
RR 0.64
95% CI 0.44 to 0.93 		Small effect size perineal skin unsutured

RCT		 823 women who sustained a second-degree tear or episiotomy; see further information on studies Proportion of women with perineal pain 3 months after delivery
4/417 (1%) with perineal skin unsutured
21/406 (5%) with perineal skin sutured
RR 0.19
95% CI 0.06 to 0.54 		Large effect size perineal skin unsutured
Dyspareunia

RCT		 1780 primiparous and multiparous women with first- and second-degree tears or episiotomies after spontaneous or assisted vaginal delivery in a single UK centre Proportion of women with superficial dyspareunia at 3 months after birth
128/828 (16%) with perineal skin unsutured
162/836 (19%) with perineal skin sutured
RR 0.80
95% CI 0.64 to 0.99
NNT 26
95% CI 14 to 345 		Small effect size perineal skin unsutured

RCT		 823 women who sustained a second-degree tear or episiotomy; see further information on studies Proportion of women with superficial dyspareunia 3 months after birth
26/417 (6%) with perineal skin unsutured
49/406 (12%) with perineal skin sutured
RR 0.52
95% CI 0.33 to 0.81 		Small effect size perineal skin unsutured
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Adverse effects

Non-suturing of perineal skin alone in first- and second-degree tears and episiotomies compared with conventional repair Leaving the perineal skin unsutured but apposed may be less effective at decreasing the proportion of women with a gaping wound at 48 hours and at 10 days, but not at 14 days (low-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Wound gaping/wound breakdown

RCT		 1780 primiparous and multiparous women with first- and second-degree tears or episiotomies after spontaneous or assisted vaginal delivery in a single UK centre Rates of wound gaping 48 hours
203/885 (23%) with perineal skin unsutured but apposed
40/889 (4%) with perineal skin sutured
RR 5.10
95% CI 3.68 to 7.06 		Large effect size perineal skin sutured

RCT		 1780 primiparous and multiparous women with first- and second-degree tears or episiotomies after spontaneous or assisted vaginal delivery in a single UK centre Rates of wound gaping 10 days
227/886 (26%) with perineal skin unsutured but apposed
145/885 (16%) with perineal skin sutured
RR 1.56
95% CI 1.30 to 1.88 		Small effect size perineal skin sutured

RCT		 823 women who sustained a second-degree tear or episiotomy; see further information on studies Rates of wound gaping 48 hours
107/417 (26%) with perineal skin unsutured but apposed
21/406 (5%) with perineal skin sutured
RR 4.96
95% CI 3.17 to 7.76 		Moderate effect size perineal skin sutured

RCT		 823 women who sustained a second-degree tear or episiotomy; see further information on studies Rates of wound gaping 14 days after birth
86/417 (21%) with perineal skin unsutured but apposed
67/406 (17%) with perineal skin sutured
RR 1.25
95% CI 0.94 to 1.67
Longer-term results were not reported in the RCT 		Not significant

RCT		 823 women who sustained a second-degree tear or episiotomy; see further information on studies Rates of wound breakdown 14 days
13/417 (3%) with perineal skin unsutured but apposed
10/406 (2%) with perineal skin sutured
RR 1.27
95% CI 0.56 to 2.85 		Not significant
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Further information on studies

The two RCTs were pragmatic studies, and the results are likely to be generalisable.

The second RCT was a multicentre trial conducted in Nigeria. Initially, 1077 women were recruited into the trial, but only 823 of these responded up to 3 months after birth and were included in the analysis.

Comment

Clinical guide:

There is some evidence of benefit associated with leaving the perineal skin unsutured compared with skin sutured in terms of reducing pain and dyspareunia. However, practitioners must be aware that there is an increased risk of wound gaping with non-suturing.

Substantive changes

No new evidence

BMJ Clin Evid. 2011 Apr 11;2011:1401.

Non-suturing of muscle and skin in first- and second-degree tears

Summary

Non-suturing of first- and second-degree tears (perineal skin and muscles) may be associated with reduced wound healing up to 3 months after birth.

Benefits and harms

Non-suturing of muscle and skin versus conventional suturing in first- and second-degree perineal tears:

We found no systematic review. We found two small RCTs comparing non-suturing versus suturing of first- and second-degree tears.

Perineal trauma

Compared with suturing of first- and second-degree tears We don't know whether non-suturing of muscle and skin in first- and second-degree perineal tears is more effective at reducing the proportion of women with "burning sensation" (not further defined) or with soreness at 2 to 3 days after birth, or at reducing pain scores at 10 days or 6 weeks (very low-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Perineal pain

RCT		 78 women in Sweden Proportion of women with burning sensation at 2 to 3 days after birth
9/40 (23%) with non-suturing of first- and second-degree tears
4/38 (11%) with suturing of first- and second-degree tears
RR 0.47
95% CI 0.16 to 1.39
Results should be interpreted with caution because of study limitations; see further information on studies 		Not significant

RCT		 78 women in Sweden Proportion of women with soreness at 2 to 3 days after birth
3/40 (8%) with non-suturing of first- and second-degree tears
1/38 (3%) with suturing of first- and second-degree tears
RR 0.35
95% CI 0.04 to 3.23
Results should be interpreted with caution because of study limitations; see further information on studies 		Not significant

RCT		 74 primiparous women in Scotland McGill pain scores at 10 days
with non-suturing of first- and second-degree tears
with suturing of first- and second-degree tears
Absolute results not reported
P = 0.8 		Not significant

RCT		 74 primiparous women in Scotland McGill pain scores at 6 weeks
with non-suturing of first- and second-degree tears
with suturing of first- and second-degree tears
Absolute results not reported
P = 0.8 		Not significant
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Adverse effects

Compared with suturing of first- and second-degree tears Non-suturing of muscle and skin in first- and second-degree perineal tears may be less effective at reducing the proportion of women with an open tear at 6 weeks after birth, but not at reducing "healing" (not further defined; not clear how assessed) at 2 to 3 days and at 8 weeks after birth (very low-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Wound gaping/non-healing

RCT		 74 primiparous women in Scotland Proportion of women with a closed tear 6 weeks after delivery
16/36 (44%) with non-suturing of first- and second-degree tears
26/31 (84%) with suturing of first- and second-degree tears
RR 0.53
95% CI 0.36 to 0.79 		Small effect size sutured

RCT		 78 women in Sweden Healing at 2 to 3 days after birth
with non-suturing of first- and second-degree tears
with suturing of first- and second-degree tears
Absolute results not reported
Results should be interpreted with caution, because of study limitations; see further information on studies 		Not significant

RCT		 78 women in Sweden Healing at 8 weeks after birth
with non-suturing of first- and second-degree tears
with suturing of first- and second-degree tears
Absolute results not reported
Results should be interpreted with caution, because of study limitations; see further information on studies 		Not significant
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Further information on studies

Results from the first small RCT should be interpreted with caution, because the study limitations compromise the validity of the results. It is unclear how healing was defined and assessed, and the study had an insufficient sample size to detect clinically important differences. This is suggested by the broad confidence intervals in the presence of a large difference in rates between the study groups.

The RCT was of reasonable methodological quality and used sealed opaque envelopes to allocate treatment. It was acknowledged that it was impossible to blind assessors to the allocated treatment, and that this might have biased results.

Comment

Clinical guide:

There is limited evidence regarding the benefits and harms of leaving perineal muscle and skin unsutured (first- and second-degree tears). Practitioners must be cautious about leaving this type of trauma unsutured unless it is the explicit wish of the woman.

Substantive changes

No new evidence

BMJ Clin Evid. 2011 Apr 11;2011:1401.

Absorbable sutures in first- and second-degree tears

Summary

Absorbable synthetic sutures for repair of first- and second-degree tears and episiotomies are less likely to result in long-term pain than catgut sutures.

Benefits and harms

Absorbable synthetic sutures versus catgut sutures:

We found one systematic review (search date 1999, 8 RCTs, 3681 primiparous and multiparous women; the RCTs varied in quality and in operator skills and training, and were conducted in Europe and the US), and three subsequent RCTs (carried out in Australia, the US, and Canada).

Perineal trauma

Compared with catgut sutures Absorbable synthetic sutures may be more effective at reducing the proportion of women with perineal pain at up to 10 days, but not at 3 months or 6 months. Absorbable synthetic sutures may be more effective at reducing analgesic use between 48 hours and 10 days; however, results were conflicting between different trials. We don't know whether absorbable synthetic sutures are more effective at reducing the proportion of women with dyspareunia (very low-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Perineal pain/analgaesic use

Systematic review		 2044 women
3 RCTs in this analysis		 Proportion of women with perineal pain up to 10 days
232/1024 (23%) with absorbable synthetic sutures
298/1020 (29%) with catgut sutures
RR 0.78
95% CI 0.67 to 0.90 		Small effect size absorbable synthetic sutures

Systematic review		 2129 women
2 RCTs in this analysis		 Proportion of women with perineal pain 3 months
92/1061 (9%) with absorbable synthetic sutures
112/1068 (11%) with catgut sutures
RR 0.86
95% CI 0.64 to 1.08 		Not significant

RCT		 391 women who sustained a first- or second-degree tear or episiotomy after a spontaneous vaginal delivery Proportion of women with perineal pain 3 days
112/187 (60%) with absorbable synthetic (standard polyglactin 910 or polyglycolic acid)
124/188 (66%) with catgut suture material
RR 0.91
95% CI 0.78 to 1.06
RCT may have lacked power to detect clinically important effects 		Not significant

RCT		 391 women who sustained a first- or second-degree tear or episiotomy after a spontaneous vaginal delivery Proportion of women with perineal pain 3 months
17/167 (10%) with absorbable synthetic (standard polyglactin 910 or polyglycolic acid)
14/174 (8%) with catgut suture material
RR 1.26
95% CI 0.64 to 2.48 		Not significant

RCT		 391 women who sustained a first- or second-degree tear or episiotomy after a spontaneous vaginal delivery Proportion of women with perineal pain 6 months
9/158 (6%) with absorbable synthetic (standard polyglactin 910 or polyglycolic acid)
5/159 (3%) with catgut suture material
RR 1.81
95% CI 0.62 to 5.28 		Not significant

Systematic review		 2820 women
5 RCTs in this analysis		 Proportion of women with analgesic use up to 10 days
262/1422 (18%) with absorbable synthetic sutures
338/1398 (24%) with catgut sutures
RR 0.74
95% CI 0.65 to 0.85
NNT 18
95% CI 13 to 35 		Small effect size absorbable synthetic sutures

RCT		 908 women with sustained perineal laceration or episiotomy Proportion of women requiring analgesia 24 to 48 hours following birth
375/459 (82%) with fast-absorbing synthetic (rapidly absorbed polyglactin 910)
383/449 (85%) with chromic catgut suture material
P = 0.14 		Not significant

RCT		 908 women with sustained perineal laceration or episiotomy Proportion of women requiring analgesia 10 to 14 days following birth
81/430 (19%) with fast-absorbing synthetic (rapidly absorbed polyglactin 910)
88/416 (21%) with chromic catgut suture material
Difference reported as not significant
P value and CI not reported 		Not significant

RCT
3-armed trial 		192 women (repair of second-degree perineal lacerations or uncomplicated episiotomy [median or mediolateral]) McGill pain scores at 48 hours
with fast-absorbing polyglactin 910
with standard polyglactin 910
with chromic catgut suture material
Absolute results not reported
Reported no significant difference among all 3 groups
P = 0.25 		Not significant

RCT
3-armed trial 		192 women (repair of second-degree perineal lacerations or uncomplicated episiotomy [median or mediolateral]) McGill pain scores 6 weeks
with fast-absorbing polyglactin 910
with standard polyglactin 910
with chromic catgut suture material
Absolute results not reported
Reported no significant difference among all 3 groups
P = 0.68 		Not significant

RCT
3-armed trial 		192 women (repair of second-degree perineal lacerations or uncomplicated episiotomy [median or mediolateral]) McGill pain scores 3 months
with fast-absorbing polyglactin 910
with standard polyglactin 910
with chromic catgut suture material
Absolute results not reported
Reported no significant difference among all 3 groups
P = 0.40 		Not significant

RCT
3-armed trial 		192 women (repair of second-degree perineal lacerations or uncomplicated episiotomy [median or mediolateral]) Median use of analgesia up to 48 hours
with fast-absorbing polyglactin 910
with standard polyglactin 910
Absolute results not reported
P <0.5 		Effect size not calculated fast-absorbing polyglactin 910
Dyspareunia

Systematic review		 2175 women
3 RCTs in this analysis		 Proportion of women with dyspareunia 3 months
171/1086 (16%) with absorbable synthetic sutures
180/1089 (17%) with catgut sutures
RR 0.95
95% CI 0.79 to 1.15 		Not significant

RCT		 793 women
In review 		Proportion of women with dyspareunia 12 months after birth
30/395 (8%) with absorbable synthetic sutures
51/398 (13%) with catgut sutures
RR 0.59
95% CI 0.39 to 0.91
NNT 20
95% CI 11 to 106 		Small effect size absorbable synthetic sutures

RCT		 391 women who sustained a first- or second-degree tear or episiotomy after a spontaneous vaginal delivery Proportion of women with dyspareunia 3 months
35/132 (27%) with absorbable synthetic (standard polyglactin 910 or polyglycolic acid)
27/144 (19%) with catgut suture material
RR 1.41
95% CI 0.91 to 2.20 		Not significant

RCT		 391 women who sustained a first- or second-degree tear or episiotomy after a spontaneous vaginal delivery Proportion of women with dyspareunia 6 months
24/148 (16%) with absorbable synthetic (standard polyglactin 910 or polyglycolic acid)
19/147 (13%) with catgut suture material
RR 1.25
95% CI 0.72 to 2.19 		Not significant

RCT
3-armed trial 		192 women (repair of second-degree perineal lacerations or uncomplicated episiotomy [median or mediolateral]) Dyspareunia 6 weeks postpartum
with fast-absorbing polyglactin 910
with chromic catgut suture material
Absolute results not reported
P <0.05 		Effect size not calculated fast-absorbing polyglactin 910

RCT
3-armed trial 		192 women (repair of second-degree perineal lacerations or uncomplicated episiotomy [median or mediolateral]) Dyspareunia 3 months
with fast-absorbing polyglactin 910
with standard polyglactin 910
with chromic catgut suture material
Absolute results not reported
Reported no significant difference among all 3 groups
P = 0.84 		Not significant
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Adverse effects

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Adverse effects

Systematic review		 2129 women
2 RCTs in this analysis		 Proportion of women with suture removal up to 3 months after birth
191/1061 (18%) with absorbable synthetic sutures
108/1068 (10%) with catgut sutures
RR 1.78
95% CI 1.44 to 2.20
NNH 13
95% CI 8 to 22 		Small effect size catgut sutures

RCT		 391 women who sustained a first- or second-degree tear or episiotomy after a spontaneous vaginal delivery Proportion of women reporting problems at 6 weeks
8/184 (4%) with absorbable synthetic (standard polyglactin 910 or polyglycolic acid)
3/184 (2%) with catgut suture material
OR 2.61
95% CI 0.59 to 12.41 		Not significant
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No data from the following reference on this outcome.

Different types of absorbable synthetic suture versus each other:

We found no systematic review. We found three RCTs comparing rapidly absorbed polyglactin 910 versus standard polyglactin 910. The first RCT did not report data in a format suitable for inclusion here (153 women in Northern Ireland).

Perineal trauma

Different types of absorbable synthetic suture compared with each other Rapidly absorbed polyglactin 910 may be more effective than standard polyglactin 910 at reducing the proportion of women with pain on walking at 2 weeks (moderate-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Perineal pain

RCT		 308 primiparous women in Denmark Proportion of women with perineal pain on walking 2 weeks postpartum
46/138 (33%) with rapidly absorbed polyglactin 910
65/134 (49%) with standard polyglactin 910
RR 0.69
95% CI 0.51 to 0.92 		Small effect size rapidly absorbed polyglactin 910

RCT		 1542 women in the UK Proportion of women with perineal pain on walking 2 weeks postpartum
259/769 (34%) with rapidly absorbed polyglactin 910
314/770 (41%) with standard polyglactin 910
RR 0.83
95% CI 0.73 to 0.94 		Small effect size rapidly absorbed polyglactin 910
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Adverse effects

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Suture removal

RCT		 1542 women in the UK Suture removal rates 3 months postpartum
22/769 (3%) with rapidly absorbed polyglactin 910
98/770 (13%) with standard polyglactin 910
RR 0.23
95% CI 0.14 to 0.35 		Moderate effect size rapidly absorbed polyglactin 910
Open in a new tab

No data from the following reference on this outcome.

Further information on studies

The systematic review reported that it was not possible to "blind" outcome assessment because of the obvious differences in methods and materials used. Most of the trials included in the review used "intention to treat" as the method of analysis.

The RCT used sealed opaque envelopes for treatment allocation, and analysis was by intention to treat. It was not possible to blind operators to allocated treatments because of obvious differences in suture materials. Follow-up was by face-to-face interview until participants were discharged from hospital, and then by telephone interview. The RCT was powered to detect a reduction in short-term pain from 60% to 45%.

The RCT used sealed opaque envelopes for treatment allocation, and analysis was by intention to treat. It would not have been possible to blind participants, operators, or assessors to treatment allocation because of the obvious differences in appearance and handling of suture materials. The RCT also reported results from 6 to 8 weeks of follow-up, but we have not included these, as the follow-up rate was low (175/459 [35%] with fast absorbing v 134/449 [30%] with chromic catgut). The RCT was powered to show an 8% difference in vaginal or uterine pain between groups at 24 to 48 hours; the study did not assess perineal pain or carry out a power calculation based on analgesia use.

The RCT used sealed opaque envelopes for treatment allocation, and analysis was by intention to treat. The women were not informed of the suture material used by the operator. The research nurse who evaluated pain scores at 36 to 48 hours following the suturing was also blinded to the suture type. The short form of the McGill Pain Questionnaire was used to measure perineal pain. The RCT originally planned to recruit 1200 women, but after 6 months the study was stopped when 192 women had been randomised because chromic catgut suture material was withdrawn from the hospital for reasons not related to the trial.

The RCT also compared continuous versus interrupted sutures for all layers (see continuous sutures). Suture materials were produced by the manufacturers in an identical form in order to "blind" allocated treatments from the participants, operators, and assessors. It was a large, robust trial, and its results are likely to be generalisable.

The RCTs found no significant difference between rapidly absorbed and standard absorbable sutures in overall perineal pain, pain on sitting, or dyspareunia.

Comment

Clinical guide:

There is strong evidence of benefit associated with absorbable synthetic suture material compared with catgut. The benefit is even greater if fast-absorbing polyglactin 910 suture material is used.

Substantive changes

No new evidence

BMJ Clin Evid. 2011 Apr 11;2011:1401.

Continuous sutures in second-degree tears and episiotomies

Summary

Continuous sutures reduce short-term pain.

Benefits and harms

Continuous versus interrupted sutures for repair of all layers or only perineal skin (analysed as a group):

We found one systematic review (search date 2007, 7 RCTs, 3822 primiparous and multiparous women) comparing continuous versus interrupted sutures for repair of episiotomy or second-degree tears.

Perineal trauma

Continuous sutures for perineal repair of all layers or only perineal skin (analysed together as a group) compared with interrupted sutures Continuous sutures for repair seem more effective at reducing the proportion of women with pain at 10 days, but we don't know whether they are more effective at 3 months (moderate-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Perineal pain

Systematic review		 3527 women
6 RCTs in this analysis		 Proportion of women with perineal pain 10 days
568/1758 (32%) with continuous sutures (for closure of all layers or only perineal skin)
818/1769 (46%) with interrupted sutures (for closure of perineal muscle with interrupted transcutaneous stitches to close the skin)
RR 0.70
95% CI 0.64 to 0.76 		Small effect size continuous sutures (for closure of all layers or only perineal skin)

Systematic review		 2408 women
2 RCTs in this analysis		 Proportion of women with perineal pain 3 months
128/1216 (11%) with continuous sutures (for closure of all layers or only perineal skin)
146/1192 (12%) with interrupted sutures
RR 0.86
95% CI 0.69 to 1.07 		Not significant
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Adverse effects

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Suture removal

Systematic review		 2650 women
3 RCTs in this analysis		 Proportion of women with suture removal 3 months
145/1334 (11%) with continuous sutures (for closure of all layers or only perineal skin)
262/1316 (20%) with interrupted sutures
RR 0.54
95% CI 0.45 to 0.65 		Small effect size continuous sutures (for closure of all layers or only perineal skin)
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Continuous versus interrupted sutures for repair of all layers:

We found one systematic review (search date 2007, 7 RCTs, 3822 primiparous and multiparous women) comparing continuous versus interrupted sutures for repair of episiotomy or second-degree tears. The review presented subgroup analyses based on whether the continuous group used continuous suture techniques for all layers (including vagina, perineal muscles, and skin) or perineal skin only. We found two subsequent RCTs (carried out in Denmark and Spain).

Perineal trauma

Continuous sutures for perineal repair of all layers compared with interrupted sutures Continuous sutures for repair of all layers seem more effective at reducing pain at 10 days or dyspareunia at 3 months, but we don't know whether they are more effective at reducing dyspareunia in the longer term (moderate-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Perineal pain

Systematic review		 2459 women
4 RCTs in this analysis		 Proportion of women with perineal pain 10 days
432/1231 (35%) with continuous sutures (for repair of all layers)
660/1228 (54%) with interrupted sutures
RR 0.65
95% CI 0.60 to 0.71 		Small effect size continuous sutures (for repair of all layers)

RCT		 400 primiparous women with a second-degree tear or episiotomy Proportion of women with perineal pain 10 days
65/198 (33%) with continuous suture technique for all layers (vagina, perineal muscles, and skin)
72/197 (37%) with interrupted inverted stitches to close perineal muscles and skin (the inverted interrupted skin sutures were placed in the subcutaneous layer and not transcutaneously through the skin)
RR 0.90
95% CI 0.68 to 1.18
Intention-to-treat (ITT) analysis 		Not significant

RCT		 445 primiparous women with a second-degree tear or episiotomy Proportion of women with perineal pain 2 days
109/222 (49%) with continuous non-locking suture for all layers (vagina, perineal muscles, and skin were closed with a continuous suture)
113/221 (51%) with continuous locking stitch to close the vagina plus interrupted stitches to close the perineal muscles and skin (transcutaneously)
RR 1.08
95% CI 0.74 to 1.57
ITT analysis 		Not significant

RCT		 445 primiparous women with a second-degree tear or episiotomy Proportion of women with pain 10 days
42/216 (19%) with continuous non-locking suture for all layers (vagina, perineal muscles, and skin were closed with a continuous suture)
41/217 (18%) with continuous locking stitch to close the vagina plus interrupted stitches to close the perineal muscles and skin (transcutaneously)
RR 0.96
95% CI 0.59 to 1.55
ITT analysis 		Not significant

RCT		 445 primiparous women with a second-degree tear or episiotomy Proportion of women with perineal pain 3 months
6/215 (3%) with continuous non-locking suture for all layers (vagina, perineal muscles, and skin were closed with a continuous suture)
4/207 (2%) with continuous locking stitch to close the vagina plus interrupted stitches to close the perineal muscles and skin (transcutaneously)
RR 0.68
95% CI 0.19 to 2.46
ITT analysis 		Not significant
Dyspareunia

Systematic review		 2149 women
5 RCTs in this analysis		 Proportion of women with dyspareunia 3 months
196/1078 (18%) with continuous sutures (for repair of all layers)
235/1071 (22%) with interrupted sutures
RR 0.83
95% CI 0.70 to 0.98 		Small effect size continuous sutures (for repair of all layers)

RCT		 400 primiparous women with a second-degree tear or episiotomy Proportion of women with dyspareunia 6 months
47/198 (24%) with continuous suture technique for all layers (vagina, perineal muscles, and skin)
58/197 (29%) with interrupted inverted stitches to close perineal muscles and skin (the inverted interrupted skin sutures were placed in the subcutaneous layer and not transcutaneously through the skin)
RR 0.81
95% CI 0.58 to 1.12
ITT analysis 		Not significant
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Adverse effects

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Suture removal

RCT		 400 primiparous women with a second-degree tear or episiotomy Proportion of women with suture removal 6 months
25/198 (13%) with continuous suture technique for all layers (vagina, perineal muscles, and skin)
21/197 (11%) with interrupted inverted stitches to close perineal muscles and skin (the inverted interrupted skin sutures were placed in the subcutaneous layer and not transcutaneously through the skin)
RR 1.18
95% CI 0.69 to 2.04 		Not significant

RCT		 445 primiparous women with a second-degree tear or episiotomy Proportion of women with necessary suture removal 3 months
25/223 (11%) with continuous non-locking suture for all layers (vagina, perineal muscles, and skin were closed with a continuous suture)
28/222 (13%) with continuous locking stitch to close the vagina plus interrupted stitches to close the perineal muscles and skin (transcutaneously)
RR 0.84
95% CI 0.47 to 1.50 		Not significant

RCT		 445 primiparous women with a second-degree tear or episiotomy Risk of complications
with continuous non-locking suture for all layers (vagina, perineal muscles, and skin were closed with a continuous suture)
with continuous locking stitch to close the vagina plus interrupted stitches to close the perineal muscles and skin (transcutaneously)
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No data from the following reference on this outcome.

Further information on studies

The RCTs were heterogeneous in respect of operator skill and were conducted in Europe and the UK.

The RCT reported that the continuous technique was quicker to perform.

The RCT reported that the continuous technique was quicker to perform and used less suture material.

Comment

Clinical guide:

There is strong evidence of benefit when using a continuous subcuticular suture for perineal skin closure, and the benefit is increased if the continuous technique is used to repair all layers (vagina, perineal muscles, and skin) compared with methods using interrupted stitches to close perineal muscles with trancutaneous interrupted stitches inserted for skin closure. The first subsequent RCT used vicryl rapide for both groups and the second RCT changed from vicryl rapide to standard vicryl part way through the study. The first subsequent RCT placed the inverted interrupted skin sutures in the subcutaneous layer (not transcutaneously through the skin) in the comparison group, which may have contributed to the non-significant difference in pain at 24 to 48 hours and 10 days following birth.

Substantive changes

Continuous sutures in second-degree tears and episiotomies New evidence added. Categorisation unchanged (Beneficial).

BMJ Clin Evid. 2011 Apr 11;2011:1401.

Different methods and materials for primary repair of obstetric anal sphincter injuries (third- and fourth-degree tears)

Summary

Early primary overlap repair for third- and fourth-degree anal sphincter tears seems to be associated with lower risks for faecal urgency and anal incontinence symptoms than end-to-end approximation.

Benefits and harms

Different methods for primary repair versus each other:

We found one systematic review (search date 2006, 3 RCTs, 279 primiparous and multiparous women) comparing overlap versus end-to-end approximation for primary repair of the external anal sphincter after childbirth (third-degree obstetric tears). The three included RCTs were of good methodological quality, but there was considerable heterogeneity in outcome measures, time points, and reported results.

Perineal trauma

Different methods for primary repair compared with each other The overlap technique for primary repair of the external anal sphincter (third-degree tears) may be more effective than end-to-end approximation at reducing faecal urgency and anal incontinence scores at 12 months, but not at reducing faecal urgency, faecal incontinence, or perineal pain at 3 months (low-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Perineal pain

Systematic review		 172 women
2 RCTs in this analysis		 Proportion of women with perineal pain 3 months postpartum
22/84 (26%) with overlap approximation for primary repair of the external anal sphincter after childbirth (third-degree obstetric tears)
27/88 (31%) with end-to-end approximation for primary repair of the external anal sphincter after childbirth (third-degree obstetric tears)
RR 0.85
95% CI 0.54 to 1.34 		Not significant
Faecal urgency or incontinence

Systematic review		 172 women
2 RCTs in this analysis		 Proportion of women with faecal urgency 3 months postpartum
20/84 (24%) with overlap approximation for primary repair of the external anal sphincter after childbirth (third-degree obstetric tears)
31/88 (35%) with end-to-end approximation for primary repair of the external anal sphincter after childbirth (third-degree obstetric tears)
RR 0.68
95% CI 0.42 to 1.09 		Not significant

Systematic review		 52 women
Data from 1 RCT		 Proportion of women with faecal urgency 12 months
1/27 (4%) with overlap approximation for primary repair of the external anal sphincter after childbirth (third-degree obstetric tears)
8/25 (32%) with end-to-end approximation for primary repair of the external anal sphincter after childbirth (third-degree obstetric tears)
RR 0.12
95% CI 0.02 to 0.86 		Large effect size overlap approximation

Systematic review		 60 women
Data from 1 RCT		 Proportion of women with faecal incontinence 3 months postpartum
2/29 (7%) with overlap approximation for primary repair of the external anal sphincter after childbirth (third-degree obstetric tears)
9/31 (29%) with end-to-end approximation for primary repair of the external anal sphincter after childbirth (third-degree obstetric tears)
RR 0.24
95% CI 0.06 to 1.01 		Not significant

Systematic review		 52 women
Data from 1 RCT		 Anal incontinence scores 12 months
0.74 with overlap approximation for primary repair of the external anal sphincter after childbirth (third-degree obstetric tears)
2.44 with end-to-end approximation for primary repair of the external anal sphincter after childbirth (third-degree obstetric tears)
Weighted mean difference –1.70
95% CI –3.03 to –0.37 		Effect size not calculated overlap approximation
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Adverse effects

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Adverse effects

RCT		 112 women
In review 		Proportion of women with residual full-thickness defect in the external anal sphincter ultrasound 3 months postpartum
34/55 (62%) with overlap approximation for primary repair of the external anal sphincter after childbirth (third-degree obstetric tears)
40/57 (70%) with end-to-end approximation for primary repair of the external anal sphincter after childbirth (third-degree obstetric tears)
RR 0.88
95% CI 0.67 to 1.15 		Not significant
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Different materials for primary repair versus each other:

We found one RCT (112 women), which had a factorial 2×2 design, comparing PDS 3/0 versus coated vicryl 2/0 and also overlap versus end-to-end approximation for primary repair of the external anal sphincter.

Perineal trauma

Different materials for primary repair compared with each other We don't know how effective PDS 3/0 and coated vicryl 2/0 are, compared with each other, at reducing suture material related morbidity (including suture migration and/or dyspareunia) at 6 weeks after childbirth (very low-quality evidence).

Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Perineal trauma

RCT		 112 women Proportion of women with suture material related morbidity (including suture migration and/or dyspareunia) 6 weeks after childbirth
10/50 (20%) with PDS 3/0 for primary repair of the external anal sphincter
9/53 (17%) with coated vicryl 2/0 for primary repair of the external anal sphincter
RR 0.8
95% CI 0.4 to 1.9
P = 0.18 		Not significant
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Adverse effects

No data from the following reference on this outcome.

Further information on studies

This RCT, also identified by the systematic review,was small and had a low event rate, therefore the results must be interpreted with caution.

Comment

Clinical guide:

There is weak evidence of benefit associated with the overlap technique for primary repair of the external anal sphincter compared with the end-to-end method.

Substantive changes

Different methods and materials for primary repair of obstetric anal sphincter injuries (third- and fourth-degree tears) New evidence added. Categorisation unchanged (Unknown effectiveness), as we found insufficient evidence to assess the effects of different materials for primary repair versus each other.

Articles from BMJ Clinical Evidence are provided here courtesy of BMJ Publishing Group

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