Abstract
Introduction
More than 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. 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 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 November 2013 (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 33 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: conventional suturing; different methods and materials for primary repair of obstetric anal sphincter injuries; non-suturing of muscle and skin (or perineal skin alone); and sutures (absorbable synthetic sutures, catgut sutures, continuous sutures, interrupted sutures).
Key Points
More than 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.
Risk factors for severe perineal trauma include first vaginal delivery, large or malpositioned baby, older mother, abnormal collagen synthesis, and forceps delivery.
Perineal trauma can lead to long-term physical and psychological problems such as long-term perineal pain, dyspareunia or urinary problems, and faecal incontinence.
Non-suturing of all layers in first- and second-degree tears (perineal skin and muscles) may be associated with reduced wound healing at 6 weeks after birth. However, leaving the perineal skin alone unsutured (vagina and perineal muscles sutured) reduces dyspareunia and may reduce perineal pain at 14 days to 6 weeks after delivery.
Perineal gaping may be more likely for up to 3 months after delivery, when the skin is left unsutured; although, further studies are required. There is no evidence about longer-term outcomes when the skin is left unsutured.
Absorbable synthetic sutures for repair of first- and second-degree tears and episiotomies may be less likely to result in perineal pain and dyspareunia than catgut sutures. Rapidly absorbed synthetic sutures reduce the need for suture removal. Continuous sutures reduce short-term pain and analgesic use.
We don’t know how primary overlap repair for third- and fourth-degree anal sphincter tears and end-to-end approximation compare with each other at reducing perineal pain or faecal urgency or incontinence.
Clinical context
General background
More than 85% of women having a vaginal birth suffer some degree of perineal trauma. It is estimated that at least one third of women in the UK and US require perineal suturing following birth. Perineal trauma can lead to long-term physical and psychological problems for women. This review looks at the effects of different methods and materials for primary repair of perineal trauma in all classifications including obstetric anal sphincter injury (OASI).
Focus of the review
To increase the likelihood of a good outcome following repair of perineal trauma sustained during vaginal birth, clinicians must ensure that the suturing techniques they employ, and the materials they use, are supported by the best available evidence. We reviewed the effects and different methods and materials for the primary repair of first- and second-degree tears and episiotomies, the trauma most often sustained during vaginal birth. We also reviewed the effects of different methods and materials for primary repair of OASI (third- and fourth-degree tears), the trauma most likely to have longer-term consequences for women both physically and psychologically.
Comments on evidence
We found no high-quality evidence in any of the areas reviewed. With regard to perineal trauma and adverse effects, we found moderate-quality evidence when comparing different types of absorbable synthetic suture materials; however, there was some statistical heterogeneity between studies. We also found moderate-quality evidence with regard to continuous versus interrupted sutures for perineal repair; again, there was statistical heterogeneity between studies and the results were analysed at different time points. The remaining studies were assessed as being of low- or of very low-quality using a GRADE evaluation.
Search and appraisal summary
The update literature search for this review was carried out from the date of the last search (March 2010) to November 2013. For more information on the electronic databases searched and criteria applied during assessment of studies for potential relevance to the review, please see the Methods section. Searching of electronic databases retrieved 100 studies. After deduplication and removal of conference abstracts, 37 records were screened for inclusion in the review. Appraisal of titles and abstracts led to the exclusion of 27 studies and the further review of 10 full publications. Of the 10 full articles evaluated, two systematic reviews and five RCTs were added at this update.
Additional information
Given that perineal trauma sustained during vaginal birth is so prevalent, it is disappointing that there is a lack of high-quality evidence concerning primary repair.
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
More than 85% of women having a vaginal birth sustain some form of perineal trauma, and 60% to 70% receive stitches. In England from 2012 to 2013, perineal tears during delivery were reported in 42% of deliveries for women aged 15 to 24 years, and 31% of deliveries for women aged 40 to 49 years. There are wide variations in rates of episiotomy: 8% in the Netherlands, 14% in England, and 50% 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 1% in Finland, 2% in the UK, and 17% in the US. The incidence of obstetric anal sphincter injuries in primiparous women in the UK is reported to have risen to 6% over the past decade.
Aetiology/ Risk factors
Perineal trauma occurs during spontaneous or assisted vaginal delivery, and is usually more extensive with the first vaginal delivery. Associated risk factors also include bigger baby, mode of delivery (especially forceps), and malpresentation and malposition of the fetus, position of the mother during birth (especially birthing stools), and prolonged pushing. Other maternal factors that may increase the extent and degree of trauma are ethnicity (Asian women in the UK have been shown to be at greater risk of obstetric anal sphincter injury), age older than 25 years, abnormal collagen synthesis, poor nutritional state, and higher socio-economic status. 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 or ‘hands-on’ v ‘hands-off’).
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: 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.
Methods
BMJ Clinical Evidence search and appraisal November 2013. The following databases were used to identify studies for this systematic review: Medline 1966 to November 2013, Embase 1980 to November 2013, and The Cochrane Database of Systematic Reviews 2013, issue 10 (1966 to date of issue). Additional searches were carried out in the Database of Abstracts of Reviews of Effects (DARE) and Health Technology Assessment (HTA) database. We also searched for retractions of studies included in the review. Titles and abstracts identified by the initial search, run by an information specialist, were assessed against predefined criteria by an evidence scanner. Full texts for potentially relevant studies were then assessed against predefined criteria by an evidence analyst. Studies selected for inclusion were discussed with an expert contributor. All data relevant to the review were then extracted by an evidence analyst. Study design criteria for inclusion in this review were: published RCTs and systematic reviews of RCTs in the English language, at least single-blinded, and containing more than 20 individuals of whom more than 80% were followed up. There was no minimum length of follow-up. We excluded all studies described as 'open', 'open label', or not blinded unless blinding was impossible. We included RCTs and systematic reviews of 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 different methods and materials for primary repair of first- and second-degree tears and episiotomies? | |||||||||
| 2 (2857) | Perineal trauma | Vagina and perineal muscle sutured but perineal skin left unsutured in first- and second-degree tears and episiotomies versus conventional suturing | 4 | –1 | –1 | 0 | 0 | Low | Quality point deducted for no intention-to-treat analysis; consistency point deducted for statistical heterogeneity between RCTs |
| 2 (2594) | Adverse effects | Vagina and perineal muscle sutured but perineal skin left unsutured in first- and second-degree tears and episiotomies versus conventional suturing | 4 | –1 | –1 | 0 | 0 | Low | Quality point deducted for no intention-to-treat analysis in one study; consistency point deducted for statistical heterogeneity between RCTs |
| 2 (152) | Perineal trauma | Non-suturing of all layers in first- and second-degree tears versus conventional suturing | 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 all layers in first- and second-degree tears versus conventional suturing | 4 | –3 | 0 | 0 | 0 | Very low | Quality points deducted for sparse data, incomplete reporting of results, and unclear outcome measurement |
| 12 (5472) | 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 one RCT; consistency point deducted for statistical heterogeneity between RCTs |
| 5 (2711) | Adverse effects | Absorbable synthetic sutures versus catgut sutures | 4 | –1 | –1 | 0 | 0 | Low | Quality point deducted for incomplete reporting of results of one RCT; consistency point deducted for statistical heterogeneity between RCTs |
| 5 (2182) | Perineal trauma | Different types of absorbable synthetic suture versus each other | 4 | 0 | 0 | –1 | 0 | Moderate | Directness point deducted for clinical heterogeneity |
| 3 (1967) | Adverse effects | Different types of absorbable synthetic suture versus each other | 4 | 0 | 0 | –1 | 0 | Moderate | Directness point deducted for clinical heterogeneity between RCTs |
| 11 (at least 4231) | 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 statistical heterogeneity |
| At least 7 (at least 3457) | Adverse effects | 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 significant heterogeneity |
| at least 7 (at least 3289) | Perineal trauma | Continuous versus interrupted sutures for repair of all layers | 4 | –1 | –1 | 0 | 0 | Low | Quality point deducted for weak methodology; consistency point deducted for statistical heterogeneity between RCTs |
| 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 weak methods; 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 |
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
- 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.
- 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.
- 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 Julie Frohlich, St Thomas' Hospital, London, UK.
Christine Kettle, Faculty of Health Sciences, Staffordshire University, Stoke-on-Trent, UK.
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