Perineal damage, such as perineal tears or as a result of an episiotomy (surgical incision), occurs quite often during childbirth. The issue of suturing perineal tears versus leaving them to heal spontaneously has been reviewed by Elharmeel 2011 and associates. The authors concluded that, at present there is insufficient evidence to suggest that one method is superior to an other with regard to healing of perineal damage and recovery in the early or late postnatal periods. Hence, they recommended that decisions regarding suturing should depend on women's wishes, the extent of trauma and the clinical judgment of the medical professional involved (Elharmeel 2011). Traditionally, perineal tears involving the muscles, or as a result of an episiotomy are repaired by suturing. Current evidence states that repair should be performed with fast absorbable suture material using continuous suturing techniques for all layers, as this results in a reduction in postnatal short- and long-term pain (Kettle 2010; Kettle 2012). However, some authors suggest the use of alternative methods for perineal wound closure (e.g. adhesive materials for the repair of perineal skin) in an attempt to reduce the risk of postnatal wound complications and perineal pain and to facilitate healing (Bowen 2002; Mota 2009; Rogerson 2000). The issue of alternative wound closure has not been addressed by the above authors. Therefore, in this review, we plan to compare the outcomes of childbirth-related perineal trauma repair using traditional sutures versus alternative wound closure techniques.
Description of the condition
Around 85% of women who have a vaginal delivery will sustain perineal trauma, which occurs either spontaneously or as a consequence of an episiotomy, and three-quarters of women will require suturing to facilitate healing of the disrupted tissue (McCandlish 1998).
Persistent perineal pain is one of the most commonly experienced health problems associated with vaginal birth (Brown 1998; Glazener 1997). It is a symptom highly related to perineal trauma and can impact on a woman’s physical and psychological well-being as well as her relationship with her baby and family (Sleep 1991).Studies investigating maternal morbidity have reported that for some women, perineal pain persists well beyond the postnatal period (Brown 1998; Glazener 1997). In the UK, childbirth-related perineal trauma is sub-divided into the following four types according to the tissues and structures involved.
First degree: injury to perineal skin only.
Second degree: injury to perineum involving perineal muscles but not involving the anal sphincter.
Third degree: injury to perineum involving the anal sphincter complex:
- 3a: less than 50% of the external anal sphincter (EAS) thickness torn;
- 3b: more than 50% of EAS thickness torn;
- 3c: both EAS and internal anal sphincter (IAS) torn.
Fourth degree: injury to perineum involving the anal sphincter complex (EAS and IAS) and anal epithelium (Sultan 1999).
Episiotomy is a surgical incision performed by the accoucheur to expedite the delivery of the baby or prevent significant tears. This procedure is done with scissors or scalpel and requires repair by suturing (Thacker 1983).
Description of the intervention
Second degree vaginal tears and episiotomies need to be repaired in order to restore the anatomy of the damaged area, accelerate the healing process and reduce bleeding, pain, and the risk of infection. A Cochrane systematic review showed that the use of absorbable synthetic material is associated with less perineal pain and less requirement for analgesia (Kettle 2010). A large randomised controlled trial (RCT) involving 1542 women compared the continuous and interrupted techniques for episiotomy and second degree perineal repair and reported a significant improvement in perineal pain with the continuous technique (Kettle 2002). More recently, a Cochrane review of seven RCTs reported that the use of continuous suturing techniques for all layers was associated with less short-term pain compared to the traditional interrupted method (Kettle 2012). Therefore, there is high-level evidence recommending the use of fast absorbable suture material for the repair of second degree perineal trauma and episiotomy using the continuous technique whenever feasible (NICE 2007). However, there are considerable variations in suture materials and techniques used for repairing perineal trauma in current clinical practice, despite guidelines and evidence to support best practice (Bick 2012).
None of the above reviewers have addressed the issue of the use of alternative wound closure techniques for the repair of episiotomy or second degree perineal tears following childbirth.
Some clinicians advocate the use of alternative wound closure techniques to treat perineal trauma in an attempt to reduce discomfort, risk of wound infection and achieve better cosmetic results. An example of alternative wound closure techniques is the use of adhesive materials. Wound closure with adhesives has been widely used, especially in paediatric surgery (Mestieri 2012), ophthalmology and sports medicine for many years. The main component of currently available medical adhesive materials is cyanoacrylate and its different derivatives. All of the medical glues and adhesives have minimal histotoxicity and do not cause significant allergic reaction. The perineum was always an area considered unsuitable for the use of adhesive materials due to the increase in moisture associated with this area (Bruns 2000). However, recently there have been several studies comparing the use of adhesive materials for perineal skin closure with traditional subcutaneous sutures. Outcomes of these studies included a shorter duration of repair when adhesives were used but a similar rate of complications and pain (Mota 2009). Some studies found that there was a significant reduction in postnatal pain (Adoni 1991; Bowen 2002), and others showed that the method of perineal skin repair is quicker and less painful (Rogerson 2000) when compared with conventional suturing. There are no studies describing use of staples on the perineum.
How the intervention might work
The benefits of surgical repair of episiotomy or second degree tears are well established and as reported by Kettle 2002; Kettle 2010; and Kettle 2012, the continuous suturing technique with synthetic fast absorbable sutures leads to a significant reduction in postnatal pain.
In an attempt to further reduce postnatal perineal pain, discomfort and wound complications, researchers have explored the possibility of using alternative wound closure techniques (e.g. adhesive material) compared with suturing for perineal skin closure. Some authors reported that alternative methods of perineal wound closure particularly for perineal skin are feasible, easier and quicker to use ( Bowen 2002; Mota 2009; Rogerson 2000).
Why it is important to do this review
This review aims to evaluate the available evidence regarding the clinical effectiveness of alternative methods used for repair of episiotomy or second degree perineal tear versus traditional suturing techniques.
None of the previous systematic reviews (Elharmeel 2011; Kettle 2010; Kettle 2012) addressed the use of alternative methods for surgical wound closure in combination with sutures or on their own. Therefore, by addressing this issue, the review will complement the currently available evidence in relation to the surgical management of perineal trauma following childbirth.
To assess the impact of suturing versus alternative methods/techniques for the repair of episiotomies or second degree perineal tears on the incidence of short- and long-term postpartum morbidity.
Comparisons will be made in the following categories.
- Standard suturing technique versus alternative wound closure techniques for all layers (vagina mucosa, muscles and perineal skin).
- Standard suturing technique versus alternative wound closure techniques for perineal skin closure only.
Criteria for considering studies for this review
Types of studies
Any adequate randomised controlled trial that compares one or more of the following techniques.
- Traditional suturing technique versus alternative closure techniques for perineal skin repair in episiotomy or second degree tears.
- Traditional suturing technique versus alternative wound closure techniques for all layers in episiotomy or second degree tears.
We are planning to include cluster-randomised trials but in order to minimise the risk of bias, we do not intend to include quasi-randomised controlled trials. We will include abstracts of trial reports if they have sufficient information on the study design and outcome data, but we will contact authors in order to get any missing relevant data. In this way we will ensure that study has not been published yet.
Types of participants
All women who have sustained a second degree tear or episiotomy during spontaneous or assisted vaginal birth.
Types of interventions
The main comparison is closure of the perineal skin after episiotomy or second degree vaginal tear using standard suturing versus alternative wound closure techniques.
Other comparisons will included the following.
- Repair of the vaginal mucosa after episiotomy or second degree vaginal tear using standard suturing versus alternative wound closure techniques.
- Repair of perineal muscles after episiotomy or second degree vaginal tear using standard suturing versus alternative wound closure techniques.
- Repair of all layers (vaginal mucosa, muscles and skin) after episiotomy or second degree vaginal tear using standard suturing versus alternative wound closure techniques.
Types of outcome measures
Maternal outcomes assessed will include the following.
In this review we will evaluate outcomes that have been previously addressed in perineal repair reviews. These will include the following.
Short-term postpartum outcome (up to two weeks postnatal)
- Perineal pain up to day 10 postnatal.
- Requirement for analgesia in the previous 24 hours, defined as a need for administration of pain killers via different routes (oral, intravenous, intramuscular, subcutaneous, transdermal) to allow women to tolerate pain or discomfort associated with perineal trauma.
- Perineal pain at three and six months postnatal.
- Wound infection.
- Wound breakdown.
- Wound haematoma.
- Need for re-suturing (six to eight weeks).
- Dyspareunia (pain on intercourse) at three and six months postnatal.
- Scar release/excision.
- Incontinence (urinary, faecal).
- Maternal satisfaction with repair.
Search methods for identification of studies
We will contact the Trials Search Co-ordinator to search the Cochrane Pregnancy and Childbirth Group’s Trials Register.
The Cochrane Pregnancy and Childbirth Group’s Trials Register is maintained by the Trials Search Co-ordinator and contains trials identified from:
- monthly searches of the Cochrane Central Register of Controlled Trials (CENTRAL);
- weekly searches of MEDLINE;
- weekly searches of EMBASE;
- handsearches of 30 journals and the proceedings of major conferences;
- weekly current awareness alerts for a further 44 journals plus monthly BioMed Central email alerts.
Details of the search strategies for CENTRAL, MEDLINE and EMBASE, the list of handsearched journals and conference proceedings, and the list of journals reviewed via the current awareness service can be found in the ‘Specialized Register’ section within the editorial information about the Cochrane Pregnancy and Childbirth Group.
Trials identified through the searching activities described above are each assigned to a review topic (or topics). The Trials Search Co-ordinator searches the register for each review using the topic list rather than keywords.
Searching other resources
In addition to the above, we intend to handsearch the list of references in selected trials to minimise the risk of missing studies that are relevant to this review.
We will not apply any language restrictions.
Data collection and analysis
Selection of studies
Two review authors will independently assess for inclusion all the potential studies we identify as a result of the search strategy. We will resolve any disagreement through third party discussion and consensus.
Data extraction and management
We will design a form to extract data. For eligible studies, at least two review authors will extract the data using the agreed form. We will resolve discrepancies through third party discussion and consensus. We will enter data into Review Manager software (RevMan 2011) and check for accuracy.
When information regarding any of the above is unclear, we will attempt to contact authors of the original reports to provide further details.
Assessment of risk of bias in included studies
Two review authors will independently assess risk of bias for each study using the criteria outlined in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011). We will resolve any disagreement by third party discussion and consensus.
(1) Random sequence generation (checking for possible selection bias)
We will describe for each included study the method used to generate the allocation sequence in sufficient detail to allow an assessment of whether it should produce comparable groups.
We will assess the method as:
- low risk of bias (any truly random process, e.g. random number table; computer random number generator);
- high risk of bias (any non-random process, e.g. odd or even date of birth; hospital or clinic record number);
- unclear risk of bias.
(2) Allocation concealment (checking for possible selection bias)
We will describe for each included study the method used to conceal allocation to interventions prior to assignment and will assess whether intervention allocation could have been foreseen in advance of, or during recruitment, or changed after assignment.
We will assess the methods as:
- low risk of bias (e.g. telephone or central randomisation; consecutively numbered sealed opaque envelopes);
- high risk of bias (open random allocation; unsealed or non-opaque envelopes, alternation; date of birth);
- unclear risk of bias.
(3.1) Blinding of participants and personnel (checking for possible performance bias)
We will describe for each included study the methods used, if any, to blind study participants and personnel from knowledge of which intervention a participant received. We will consider that studies are at low risk of bias if they were blinded, or if we judge that the lack of blinding would be unlikely to affect results. We will assess blinding separately for different outcomes or classes of outcomes.
We will assess the methods as:
- low, high or unclear risk of bias for participants;
- low, high or unclear risk of bias for personnel.
(3.2) Blinding of outcome assessment (checking for possible detection bias)
We will describe for each included study the methods used, if any, to blind outcome assessors from knowledge of which intervention a participant received. We will assess blinding separately for different outcomes or classes of outcomes.
We will assess methods used to blind outcome assessment as:
- low, high or unclear risk of bias.
(4) Incomplete outcome data (checking for possible attrition bias due to the amount, nature and handling of incomplete outcome data)
We will describe for each included study, and for each outcome or class of outcomes, the completeness of data including attrition and exclusions from the analysis. We will state whether attrition and exclusions were reported and the numbers included in the analysis at each stage (compared with the total randomised participants), reasons for attrition or exclusion where reported, and whether missing data were balanced across groups or were related to outcomes. Where sufficient information is reported, or can be supplied by the trial authors, we will re-include missing data in the analyses which we undertake.
We will assess methods as:
- low risk of bias (e.g. no missing outcome data; missing outcome data balanced across groups);
- high risk of bias (e.g. numbers or reasons for missing data imbalanced across groups; ‘as treated’ analysis done with substantial departure of intervention received from that assigned at randomisation);
- unclear risk of bias.
(5) Selective reporting (checking for reporting bias)
We will describe for each included study how we investigated the possibility of selective outcome reporting bias and what we found.
We will assess the methods as:
- low risk of bias (where it is clear that all of the study’s pre-specified outcomes and all expected outcomes of interest to the review have been reported);
- high risk of bias (where not all the study’s pre-specified outcomes have been reported; one or more reported primary outcomes were not pre-specified; outcomes of interest are reported incompletely and so cannot be used; study fails to include results of a key outcome that would have been expected to have been reported);
- unclear risk of bias.
(6) Other bias (checking for bias due to problems not covered by (1) to (5) above)
We will describe for each included study any important concerns we have about other possible sources of bias.
We will assess whether each study was free of other problems that could put it at risk of bias:
- low risk of other bias;
- high risk of other bias;
- unclear whether there is risk of other bias.
(7) Overall risk of bias
We will make explicit judgements about whether studies are at high risk of bias, according to the criteria given in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011).
Measures of treatment effect
For dichotomous data, we will present results as summary risk ratio with 95% confidence intervals.
For continuous data, we will use the mean difference if outcomes are measured in the same way between trials. We will use the standardised mean difference to combine trials that measure the same outcome, but use different methods.
Unit of analysis issues
We will include cluster-randomised trials in the analyses along with individually-randomised trials. We will adjust their standard errors using the methods described in the Cochrane Handbook for Systematic Reviews of Interventions using an estimate of the intra cluster correlation co-efficient (ICC) derived from the trial (if possible), from a similar trial or from a study of a similar population. If we use ICCs from other sources, we will report this and conduct sensitivity analyses to investigate the effect of variation in the ICC. If we identify both cluster-randomised trials and individually-randomised trials, we plan to synthesise the relevant information. We will consider it reasonable to combine the results from both if there is little heterogeneity between the study designs and the interaction between the effect of intervention and the choice of randomisation unit is considered to be unlikely.
We will also acknowledge heterogeneity in the randomisation unit and perform a subgroup analysis to investigate the effects of the randomisation unit.
Cross-over designs are not a valid study for the issue addressed by this review.
Other unit of analysis issues
Dealing with missing data
For included studies, we will note levels of attrition. We will explore the impact of including studies with high levels of missing data in the overall assessment of treatment effect by using sensitivity analysis.
For all outcomes, we will carry out analyses, as far as possible, on an intention-to-treat basis, i.e. we will attempt to include all participants randomised to each group in the analyses, and all participants will be analysed in the group to which they were allocated, regardless of whether or not they received the allocated intervention. The denominator for each outcome in each trial will be the number randomised minus any participants whose outcomes are known to be missing.
Assessment of heterogeneity
We will assess statistical heterogeneity in each meta-analysis using the T², I² and Chi² statistics. We will regard heterogeneity as substantial if the I² is greater than 30% and either the T² is greater than zero, or there is a low P value (less than 0.10) in the Chi² test for heterogeneity.
Assessment of reporting biases
If there are 10 or more studies in the meta-analysis we will investigate reporting biases (such as publication bias) using funnel plots. We will assess funnel plot asymmetry visually. If asymmetry is suggested by a visual assessment, we will perform exploratory analyses to investigate it.
We will carry out statistical analysis using the Review Manager software RevMan 2011. We will use fixed-effect meta-analysis for combining data where it is reasonable to assume that studies are estimating the same underlying treatment effect: i.e. where trials are examining the same intervention, and the trials’ populations and methods are judged sufficiently similar. If there is clinical heterogeneity sufficient to expect that the underlying treatment effects differ between trials, or if substantial statistical heterogeneity is detected, we will use random-effects meta-analysis to produce an overall summary if an average treatment effect across trials is considered clinically meaningful. The random-effects summary will be treated as the average range of possible treatment effects and we will discuss the clinical implications of treatment effects differing between trials. If the average treatment effect is not clinically meaningful, we will not combine trials.
If we use random-effects analyses, the results will be presented as the average treatment effect with 95% confidence intervals, and the estimates of T² and I².
Subgroup analysis and investigation of heterogeneity
If we identify substantial heterogeneity, we will investigate it using subgroup analyses and sensitivity analyses. We will consider whether an overall summary is meaningful, and if it is, use random-effects analysis to produce it. Depending on the size of identified studies and their inclusion/exclusion criteria, we will consider undertaking subgroup analyses for the management of episiotomies and spontaneous second degree perineal tears separately.
We plan to carry out the following subgroup analyses.
- Subgroup analysis by type of wound i.e. episiotomy versus spontaneous second degree tears.
- Singleton versus multiple pregnancies.
- Spontaneous onset of labour versus induction of labour.
- Spontaneous vaginal delivery versus instrumental delivery.
- Medical conditions that could affect wound healing such as diabetes versus no reported medical condition.
- Maternal age and weight.
Subgroup analysis will be restricted to the primary outcomes.
We will assess subgroup differences by interaction tests available within RevMan (RevMan 2011). We will report the results of subgroup analyses quoting the χ
Sensitivity analyses will be performed for aspects of the review that might affect the results, for example, where there is risk of bias associated with the quality of some of the included trials. We will consider carrying out sensitivity analysis to explore the effects of fixed-effect or random-effects analyses for outcomes with statistical heterogeneity and the effects of any assumptions made such as the value of the ICC used for cluster-randomised trials. Sensitivity analysis will be restricted to primary outcomes.
As part of the pre-publication editorial process, this protocol has been commented on by three peers (an editor and two referees who are external to the editorial team) and the Group's Statistical Adviser.
Contributions of authors
Professor Ismail (KI) and Fidan Israfilbayli (FI) prepared and registered the title. KI is a guarantor for the review.
KI, FI and Christine Kettle (CK) developed the protocol. Philip Toozs-Hobson (PTH) has reviewed the last version of the protocol.
Declarations of interest
Christine Kettle (CK) was the recipient of a fellowship from the Iolanthe Midwifery Research Trust 1996, which provided funding to enable her to carry out a randomised controlled trial of perineal repair following childbirth (Kettle 2002). The Iolanthe Midwifery Research Trust and Ethicon Ltd, UK (manufacturers of suture material) provided funding for employment of a part-time data management clerk for that trial.
CK and Khaled MK Ismail (KMKI) run perineal repair workshops both nationally and internationally and have developed an episiotomy and second-degree tear training model with Limbs & Things, UK.
Also some members of our team (KMKI, CK) are co-authors on the methods and materials Cochrane reviews for the repair of episiotomy and second degree tears.
KMKI and CK are involved in the following Cochrane reviews.
- Absorbable suture materials for primary repair of episiotomy and second degree tears (Kettle 2010)
- Continuous and interrupted suturing techniques for repair of episiotomy or second-degree tears (Kettle 2012)
- Secondary suturing compared to non-suturing for broken down perineal wounds following childbirth (Dudley 2011)
KMKI also involved in the following.
- Chinese herbal medicine for premenstrual syndrome (Jing 2009)
- Hypoglycaemic agents for pregnant women with polycystic ovarian syndrome (Ismail 2012)
CK also involved in the following.
- Methods of repair for obstetric anal sphincter injury (Fernando 2006)