Secondary suturing compared to non-suturing for broken down perineal wounds following childbirth

  • Review
  • Intervention

Authors


Abstract

Background

Each year approximately 350,000 women in the United Kingdom and millions more worldwide, experience perineal suturing following childbirth. The postpartum management of perineal trauma is a core component of routine maternity care. However, for those women whose perineal wound dehisces (breaks down), the management varies depending on individual practitioners preferences as there is limited scientific evidence and no clear guidelines to inform best practice. For most women the wound will be managed expectantly whereas, others may be offered secondary suturing.

Objectives

To evaluate the therapeutic effectiveness of secondary suturing of dehisced perineal wounds compared to non-suturing (healing by secondary intention, expectancy).

Search methods

We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 July 2013) and reference lists of retrieved studies.

Selection criteria

Randomised controlled trials of secondary suturing of dehisced perineal wounds (second-, third- or fourth-degree tear or episiotomy), following wound debridement and the removal of any remaining suture material within the first six weeks following childbirth compared with non-suturing.

Data collection and analysis

Three review authors independently assessed trials for inclusion. Two review authors independently assessed trial quality and extracted data. Data were checked for accuracy.

Main results

Two small studies of poor methodological quality including 52 women with a dehisced and/or infected episiotomy wound at point of entry have been included.

Only one small study presented data in relation to wound healing at less than four weeks, (the primary outcome measure for this review), although no reference was made to demonstrate how healing was measured. There was a trend to favour this outcome in the resuturing group, however, this difference was not statistically significant (risk ratio (RR) 1.69, 95% confidence interval (CI) 0.73 to 3.88, one study, 17 women).

Similarly, only one trial reported on rates of dyspareunia (a secondary outcome measure for this review) at two months and six months with no statistically significant difference between both groups; two months, (RR 0.44, 95% CI 0.18 to 1.11, one study, 26 women) and six months, (RR 0.39, 95% CI 0.04 to 3.87, one study 32 women). This trial also included data on the numbers of women who resumed sexual intercourse by two months and six months. Significantly more women in the secondary suturing group had resumed intercourse by two months (RR 1.78, 95% CI 1.10 to 2.89, one study, 35 women), although by six months there was no significant difference between the two groups (RR 1.08, 95% CI, 0.91 to 1.28).

Neither of the trials included data in relation to the following prespecified secondary outcome measures: pain at any time interval; the woman's satisfaction with the aesthetic results of the perineal wound; exclusive breastfeeding; maternal anxiety or depression.

Authors' conclusions

Based on this review, there is currently insufficient evidence available to either support or refute secondary suturing for the management of broken down perineal wounds following childbirth. There is an urgent need for a robust randomised controlled trial to evaluate fully the comparative effects of both treatment options.

Résumé scientifique

La suture secondaire par rapport à l'absence de suture pour la déhiscence des plaies périnéales après accouchement

Contexte

Chaqueannée, environ 350000 femmes au Royaume-Uni et des millions d'autres à travers le monde, ont une suture périnéale après leur accouchement. La prise en charge en postpartum des traumatismes du périnée est un composant clé de soins courants d'une maternité. Cependant, pour les femmes dont la plaie périnéale se rouvre, la prise en charge varie selon les préférences individuelles des professionnels de santé, car il n'existe que des preuves scientifiques limitées et aucune directive claire pour éclairer sur les meilleures pratiques. La la plupart des femmes auront une prise en charge expectative de leur plaie alors qu'une suture secondaire pourra être proposée à d'autres.

Objectifs

Évaluer l'efficacité thérapeutique de la suture secondaire des plaies périnéales déhiscentes par rapport à l'absence de suture (cicatrisation de seconde intention, expectative).

Stratégie de recherche documentaire

Nous avons effectué des recherches dans le registre des essais cliniques du groupe Cochrane sur la grossesse et la naissance (31 juillet 2013) et les références bibliographiques des études trouvées.

Critères de sélection

Les essais contrôlés randomisés relatifs à la suture secondaire des plaies périnéales déhiscentes (déchirure périnéale du second, troisième ou quatrième degré ou épisiotomie), après le débridement de la plaie et l'élimination de tout matériel de suture restant, effectuée dans les six premières semaines suivant l'accouchement par rapport à la non-suture.

Recueil et analyse des données

Trois auteurs de la revue ont indépendamment évalué les essais à inclure. Deux auteurs de la revue ont indépendamment évalué la qualité des essais et extrait les données. L'exactitude des données a été vérifiée.

Résultats principaux

Deux petites études de faible qualité méthodologique, ayant inclus 52 femmes présentant une plaie d'épisiotomie déhiscente et/ou infectée au point d'entrée ont été incluses dans la revue.

Une seule petite étude présentait des données en lien avec la cicatrisation des plaies à moins de quatre semaines (le critère de jugement principal de cette revue), bien qu'aucune référence n'a été faite sur la manière dont la cicatrisation avait été mesurée. Il y avait une tendance en faveur de ce critère de jugement dans le groupe resuturé, cependant, cette différence n'était pas statistiquement significative (risque relatif (RR) à 95% 1,69, intervalle de confiance (IC) à 95% 0,73 à 3,88, une étude, 17 femmes).

De même, un seul essai a rapporté des données sur les taux de dyspareunie (un critère de jugement secondaire pour cette revue) à deux mois et à six mois avec une absence de différence statistiquement significative entre les deux groupes; à deux mois, (RR 0,44, IC à 95% 0,18 à 1,11, une étude, 26 femmes) et à six mois, (RR 0,39, IC à 95% 0,04 à 3,87, une étude de 32 femmes). Cet essai avait également inclus des données sur le nombre de femmes ayant repris des rapports sexuels à deux mois et à six mois. De manière significative, plus de femmes dans le groupe de suture secondaire avaient repris des rapports sexuels à deux mois (RR de 1,78, IC à 95% 1,10 à 2,89, une étude, 35 femmes), bien qu'à six mois, il n'y avait aucune différence significative entre les deux groupes (RR 1,08, IC à 95% 0,91 à 1,28).

Aucun des essais navait inclus des données en lien avec les critères de jugement secondaires prédéfinis suivante: la douleur quelle qu'en soit la fréquence; la satisfaction de la femme relative aux résultats esthétiques de la plaie périnéale; l'allaitement au sein exclusif; l'anxiété ou la dépression maternelles.

Conclusions des auteurs

En ce basant sur cette revue, il n'existe actuellement pas suffisamment de preuves disponibles pour soutenir ou réfuter la suture secondaires pour la prise en charge des plaies périnéales déhiscentes après un accouchement. Il est urgent de réaliser un essai contrôlé randomisé robuste pour évaluer pleinement les effets comparatifs de ces deux options de traitement.

Plain language summary

Re-stitching broken down perineal (the area between the vagina and back passage) wounds compared with non-stitching

It is estimated that 350,000 women per year in the United Kingdom and millions more worldwide experience perineal stitches because of a childbirth-related natural tear or cut (episiotomy). Sometimes the perineal wound breaks down (opens up). This may be because it becomes infected, which could lead to systemic infection and sepsis. The current management of broken down wounds varies widely between individual health practitioners and hospitals. For most women the broken down perineal wound is left to heal naturally (managed expectantly). This is a slow process and it can take several weeks for the wound to heal completely resulting in persistent pain and discomfort at the perineal wound site, also possible urinary retention and defecation problems. The alternative is re-stitching. Due to the lack of research evidence, we do not know the best way to treat this type of complication. This review looked at randomised controlled trials of re-stitching broken down wounds compared with non-stitching. Two small studies were identified. One study, involving 17 women, showed a marginal tendency to improved healing in the women who were re-stitched, however, this evidence was not conclusive. In the other study involving 35 women, more women had resumed intercourse in the re-suturing group at two months. As the studies were small and of poor quality, it is not possible to draw conclusions about the best way to manage wound breakdown after childbirth. Therefore, there is an urgent need to conduct further studies to compare fully the benefits and risks of both treatments.

Résumé simplifié

Suturer de nouveau (resuturer) les plaies périnéales déhiscentes (rouvertes) par rapport à s'abstenir de suturer (la zone périnéale est située entre le vagin et l'anus)

Chaque année, on estime que 350 000 femmes au Royaume-Uni et des millions d'autres à travers le monde ont une suture périnéale en raison d'une déchirure naturelle ou d'une incision (épisiotomie) liées à l'accouchement. Parfois la plaie périnéale se rouvre. Cela peut être parce qu'elle s'infecte, ce qui pourrait entraîner une infection systémique et une septicémie. Le traitement actuel des plaies déhiscentes varie largement selon les pratiques des professionnels de santé et des hôpitaux. Pour la plupart des femmes, on laisse cicatriser naturellement la plaie déhiscente du périnée (prise en charge expectative). C'est un processus lent qui peut prendre plusieurs semaines pour atteindre la cicatrisation complète des plaies entraînant des douleurs persistantes et de la gêne au niveau du site de la plaie périnéale, une rétention urinaire et des problèmes de défécation sont également possibles. L'alternative est de suturer à nouveau (resuture). Étant donné l'absence de preuves issues de recherches, nous ne savons pas la meilleure manière de traiter ce type de complication. Cette revue a examiné les essais contrôlés randomisés portant sur une nouvelle suture (resuture) des plaies déhiscentes par rapport à l'absence de suture. Deux petites études ont été identifiées. Une étude, portant sur 17 femmes, a montré une tendance marginale à l'amélioration de la guérison chez les femmes qui ont été resuturées, cependant, ces preuves ne sont pas concluantes. Dans l'autre étude portant sur 35 femmes, davantage de femmes avaient repris des rapports sexuels à deux mois dans le groupe des resutures. Étant donné que les études étaient de petite taille et de qualité médiocre, il n'est pas possible de tirer des conclusions concernant la meilleure façon de prendre en charge une déhiscence de plaie après accouchement. Par conséquent, il est urgent de réaliser des études supplémentaires pour comparer de manière exhaustive les bénéfices et les risques des deux traitements.

Notes de traduction

Traduit par: French Cochrane Centre 15th December, 2013
Traduction financée par: Financeurs pour le Canada : Instituts de Recherche en Sant� du Canada, Minist�re de la Sant� et des Services Sociaux du Qu�bec, Fonds de recherche du Qu�bec-Sant� et Institut National d'Excellence en Sant� et en Services Sociaux; pour la France : Minist�re en charge de la Sant�

Background

Approximately 350,000 women in the United Kingdom every year undergo perineal repair following childbirth to facilitate healing of the trauma site (Kettle 2002; McCandlish 1998; RCOG 2004). Despite the large numbers of women undergoing perineal repair and given that the postpartum management of perineal trauma, including the prevention of wound infection and assessing wound healing, are core components of routine maternity care (Gould 2007; NICE 2006; Steen 2007), there is limited research evidence available on the management and consequences of perineal wound dehiscence (also referred to as wound breakdown). It is apparent that perineal wound dehiscence both nationally and worldwide has not been a high priority either in practice or research and therefore current management is unlikely to be based upon robust evidence. Due to the lack of evidence-based clinical guidelines, clinical practice varies widely between individual practitioners and institutions.

There are some suggestions that the early closure of dehisced perineal wounds should be attempted in order to maintain perineal integrity (ACOG 2006; Hankins 1990; Monberg 1987; Ramin 1992; Uygur 2004); however, most dehisced perineal wounds are left to heal naturally by secondary intention (expectant management). Healing by secondary intention is a process whereby the dehisced area fills with granulation tissue that gradually contracts to bring the wound edges together; unfortunately this is a slow process and can take several weeks for the wound to completely heal (Boyle 2006; Thomas 1990).

Perineal wound dehiscence, which is commonly reported to be associated with infection (Gould 2007; Ramin 1992; Tharpe 2008), may lead to major physical, psychological and social problems if left untreated. Although maternal mortality is extremely rare in developed countries, an infected perineal wound is a potential route for systemic infection whereby sepsis and septic shock may ensue (Lewis 2007; Rotas 2007). Indeed sepsis has for the first time been identified as the leading cause of maternal mortality in the UK. The Centre for Maternal and Child Enquiries (CMACE) recently published their eighth Report on Confidential Enquiries into Maternal Deaths (CMACE 2011). The report revealed that during the 2006 to 2008 triennium, sepsis resulted in 26 direct maternal deaths with three further deaths classified as ‘Late Direct Deaths’ (occurring more than six weeks after delivery). Seven women died from sepsis following a vaginal delivery, including one woman with an infected perineum following a second-degree tear. The report clearly illustrates how healthy women with an uncomplicated pregnancy and delivery can become critically ill and die in a very short time (CMACE 2011). Gallop 2002 in a retrospective case report analysis revealed the death of a young 25-year-old mother five days postnatal, who died as a consequence of an overwhelming sepsis with a necrotising fasciitis, associated with an infected episiotomy site.

The morbidity associated with perineal wound dehiscence, can and does pose a serious threat to the general well being and quality of life of the mother causing a protracted recovery period, persistent pain and discomfort at the perineal wound site, urinary retention and defecation problems. These complications can potentially have a negative impact on the woman's relationship with her baby and interfere with breastfeeding (Sleep 1991). Moreover, perineal scarring can lead to dyspareunia (painful sexual intercourse) and psychological and psychosexual issues problems from embarrassment and altered body image (Hankins 1990; Ramin 1992; Steen 2007; Uygur 2004; Williams 2006). Consequently, this may be detrimental to the woman’s relationship with her partner and other family members. Undoubtedly, the additional hospital appointments, delay in returning to work and corrective surgical procedures can be a source of financial burden both on the woman and the health service (Ganapathy 2008).

Perineal wound complications are feared by many pregnant and recently delivered women (Al-Mufti 1997; Bick 2010; Clements 2001). On occasions, some women are so traumatised by their experience of poor perineal management they request subsequent deliveries by caesarean section. Additionally, it is concerning that women who are pregnant for the first time are becoming increasingly worried about the consequences of perineal injury following childbirth and the associated morbidity. This may also be a contributing factor towards the increasing interest in elective caesarean section as a more ‘attractive’ alternative mode of delivery (Wagner 2000). Indeed, a survey conducted in 2001 reported that 31% of all women said they would prefer an elective caesarean section compared to vaginal delivery and astonishingly, 80% of these would prefer a caesarean section because of the fear of perineal damage (Clements 2001).    

A Delphi survey of a cohort of women who previously sustained a degree of perineal trauma demonstrated that the most important outcome for women is fear of perineal wound infection and wound healing both at one week and two to four weeks postnatal. These surveys were carried out in the UK and subsequently repeated in Brazil with comparable results (Perkins 2008).

Description of the condition

A dehisced perineal wound following a spontaneous second-, third- or fourth-degree tear or episiotomy.

Definition of a dehisced perineal wound

Separation of sutured perineal skin, vaginal mucosa or the underlying perineal muscles.

Incidence of dehisced perineal wounds

The precise incidence of childbirth-related perineal wound dehiscence remains unknown; figures of 0.1% to 4.6% have been reported, dependent upon the degree of the initial trauma (Goldaber 1993; Ramin 1994).

The current classification of perineal trauma was modified by Sultan in 1999 (Sultan 1999) and has been adopted by the Royal College of Obstetricians and Gynaecologists (RCOG 2007) and the International Consultation on Incontinence since 2002 (Koelbl 2009; Norton 2002).

Second-degree tear

Injury to the perineum involving perineal muscles but not the anal sphincter (RCOG 2007).

Episiotomy

A surgical incision of the perineum made by the midwife or obstetrician to increase the diameter of the vaginal outlet to facilitate the birth of the baby (Kettle 2012).

Third-degree tear

Injury to the perineum involving the anal sphincter complex (RCOG 2007).

3a: less than 50% of 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 tear

Injury to the perineum involving the anal sphincter complex (EAS and IAS) and anal epithelium.

Description of the intervention

Resuturing of the dehisced perineal wound compared with leaving the wound to heal by expectant management (secondary intention).

How the intervention might work

Traditionally, dehisced perineal wounds are managed expectantly, thereby allowing the wound to heal by secondary intention. This approach can result in a protracted period of significant morbidity for women. Therefore, some clinicians advocate secondary suturing and reported that early repair of perineal wound dehiscence is safe, effective and abolishes the prolonged period of disability and distress inherent with healing by secondary intention (Hankins 1990; Ramin 1992; Uygur 2004).

Why it is important to do this review

Currently there is wide variation in how practitioners manage perineal wound dehiscence. This variation is a result of the lack of robust evidence in support of any management strategy. Whilst mortality from perineal wound dehiscence is extremely rare, the impact of the morbidity associated with this complication is significant on women and their families. Therefore, we conducted this systematic review to evaluate the effectiveness of the management options offered to women who present with childbirth-related perineal wound dehiscence.

Objectives

The objective for this review was to evaluate the therapeutic effectiveness of secondary suturing of dehisced perineal wounds compared with non-suturing (healing by secondary intention).

Methods

Criteria for considering studies for this review

Types of studies

  • Randomised controlled trials investigating resuturing versus expectancy for dehisced perineal wounds (second-, third- and fourth-degree tears and episiotomy) following childbirth.

  • Non-randomised, quasi-randomised, cluster-randomised, and cross-over trial designs were excluded.

Types of participants

All women with a dehisced perineal wound following primary repair of a spontaneous second-, third- or fourth-degree tear or episiotomy within the first two weeks following childbirth.

Types of interventions

Any secondary suturing of dehisced perineal wounds (second-, third- or fourth-degree tear or episiotomy), following wound debridement and the removal of any remaining suture material within the first six weeks following childbirth compared with non-suturing.

All re-sutured perineal wounds were included irrespective of suture material.

Types of outcome measures

Primary outcomes
  • Perineal wound healing at six to eight weeks.

Secondary outcomes
  • Pain at six weeks, three months and six months.

  • Dyspareunia at three to six months.

  • Resumed intercourse within two months (non-prespecified outcome).

  • Resumed intercourse by six months (non-prespecified outcome).

  • Women's satisfaction with the aesthetic results of the perineal wound.

  • Rates of breastfeeding (at six weeks and at six months).

  • Rates of exclusive breastfeeding (at six weeks and six months).

  • Maternal depression.

  • Maternal anxiety.

Definition of wound healing

Wound healing is defined as the physiological processes by which the body both replaces and restores function to the damaged tissues (Flanagan 1996; Tortora G 1996).

Assessment of wound healing

Wound healing as described by the study investigator.

Search methods for identification of studies

Electronic searches

We contacted the Trials Search Co-ordinator to search the Cochrane Pregnancy and Childbirth Group’s Trials Register (31 July 2013). 

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

  1. monthly searches of the Cochrane Central Register of Controlled Trials (CENTRAL);

  2. weekly searches of MEDLINE;

  3. weekly searches of Embase;

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

  5. 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

We searched reference lists of retrieved studies, national and international guidelines and other publications identified when preparing this review.

We did not apply any language restrictions.

Data collection and analysis

Selection of studies

Three review authors (Lynn Dudley (LD), Christine Kettle (CK) and Khaled MK Ismail (KMKI)) independently assessed and selected trials for inclusion in this review. It was not possible to assess the relevance of the trials blinded because the authors’ names, institution, journal of publication and results were known when we applied the inclusion criteria. Disagreements were resolved by discussion until we reached a consensus. Reasons for exclusion of studies were documented.

Data extraction and management

We designed a data extraction form. For eligible studies, two review authors (LD and CK) independently extracted the data. Discrepancies were resolved by discussion or, if required, by consulting a third review author (KMKI). Data entry and analysis were undertaken using Review Manager software (RevMan 2011).

Assessment of risk of bias in included studies

Two review authors (LD and CK) independently assessed risk of bias for each study using the criteria outlined in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011). We resolved any disagreement by discussion or by involving the third review author (KMKI).

(1) Random sequence generation (checking for possible selection bias)

We 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 assessed 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 describe for each included study the method used to conceal allocation to interventions prior to assignment and assessed whether the intervention allocation could have been foreseen in advance of, or during recruitment, or changed after assignment.

We assessed 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.   

We tried to contact the trial authors for additional information regarding random sequence generation and treatment allocation concealment but were unsuccessful.

(3.1) Blinding of participants and personnel (checking for possible performance bias)

We 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 considered studies to be at low risk of bias if they were blinded, or if we judged that the lack of blinding would be unlikely to affect results. We assessed blinding separately for different outcomes or classes of outcomes.

We assessed 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 describe for each included study the methods used, if any, to blind outcome assessors from knowledge of which intervention a participant received. We assessed blinding separately for different outcomes or classes of outcomes.

We assessed the 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 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 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. 

We assessed 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 describe for each included study how we investigated the possibility of selective outcome reporting bias and what we found.

We assessed 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 describe for each included study any important concerns we have about other possible sources of bias.

We assessed 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 made explicit judgements about whether studies were at high risk of bias, according to the criteria given in the Handbook (Higgins 2011). With reference to (1) to (6) above, we assessed the likely magnitude and direction of the bias and whether we considered it was likely to impact on the findings. 

Measures of treatment effect

Dichotomous data

For dichotomous data, we presented the results as summary risk ratio with 95% confidence intervals. 

Continuous data

If we had found continuous data, we planned to use the mean difference if outcomes were measured in the same way between trials and the standardised mean difference to combine trials that measured the same outcome, but used different methods.  

Unit of analysis issues

We only included randomised controlled trials in which the participants were individually randomised into the clinical trials. We did not include cross-over trials or cluster-randomised trials in this review.

Dealing with missing data

For included studies, we noted levels of attrition. We planned to 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 carried out analyses, as far as possible, on an intention-to-treat basis, i.e. we attempted to include all participants randomised to each group in the analyses, and analysed all participants in the group to which they were allocated, regardless of whether or not they received the allocated intervention.

Assessment of heterogeneity

We assessed statistical heterogeneity in each meta-analysis using the T², I² and Chi² statistics. We regarded heterogeneity as substantial if the I² was greater than 30% and either the T² was greater than zero, or there was a low P value (less than 0.10) in the Chi² test for heterogeneity. 

Assessment of reporting biases

In this version of the review, we were not able to explore possible publication bias using funnel plots as only two small studies contributed data to the meta-analyses.

We did not have access to the study protocols for the two included studies, therefore, they have been assessed as unclear for reporting bias as we were not sure whether all pre-specified outcomes were reported in the published papers.

Data synthesis

We carried out statistical analysis using Review Manager software (RevMan 2011). We were unable to combine the two trials in a meta-analysis. If there are suitable studies in future updates of this review, we will use fixed-effect meta-analysis for combining data where it seems reasonable to assume that studies are estimating the same underlying treatment effect: that is where trials are examining the same intervention, and the trials' populations and methods are judged to be sufficiently similar. If we suspect 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, provided that an average treatment effect across trials is considered clinically meaningful. The random-effects summary gives an indication of the average range of possible treatment effects, and we will discuss the clinical implications of treatment effects differing between trials. If we do not think the average treatment effect is 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

Subgroup analysis and investigation of heterogeneity

If substantial heterogeneity had been identified, we planned to investigate it using subgroup analyses and sensitivity analyses (RevMan 2011). We would have considered whether an overall summary was meaningful, and if it was, used random-effects analysis to produce it, however, due to the lack of studies and insufficient data, we did not carry out any subgroup analyses. If necessary, subgroup analysis will be conducted in future updates.

Sensitivity analysis

As only two small studies were included in this review, we did not carry out a sensitivity analysis for the primary outcomes. If necessary, sensitivity analysis will be conducted in future updates to assess the risk of bias associated with the quality of the included trials.

Results

Description of studies

Results of the search

The search strategy identified seven reports in total (three from the Cochrane Pregnancy and Childbirth Group's Trials Register and four from other sources). See Figure 1.

Figure 1.

Study flow diagram.

Included studies

We included the two studies by Christensen 1994; Monberg 1987 involving 52 women with a dehisced and/or infected episiotomy wound at point of study entry.

Setttings

Both studies were conducted within individual hospital settings in Denmark over 24 months (Monberg 1987) and 31 months (Christensen 1994).

Participants

The sample size for both studies was small and ranged between 17 (Christensen 1994) and 35 (Monberg 1987); all women had received an episiotomy with primary repair of the perineal trauma. The mean number of days from delivery to the confirmation of perineal wound breakdown in the trial by Monberg 1987 was 4.8 to 5.5 for both the intervention and the control respectively. No data were provided by Christensen 1994 regarding time from delivery to confirmation of perineal wound breakdown.

Interventions

Both trials compared secondary suturing versus non-suturing. In Monberg 1987, all women presented with a broken down perineal wound referred to as 'ruptured episiotomy'. All 35 women were then allocated to either group A, the experimental intervention or group B spontaneous healing. In the experimental intervention group, women were treated with Clindamycine and secondary suturing referred to as 'primary re-suturing.' Clindamycine was administered two hours prior to suturing and continuously for five days (300 mg three times a day). In the spontaneous healing group, women were treated according to the routine management of the department, which was detailed as cleansing the wound with chlorine and saline.

In comparison, in Christensen 1994 17 women presented with an infected episiotomy wound, however six of the 17 women presented with a wound infection that required incision and drainage. The remaining 11 women had wound breakdown referred to as 'with rupture'. Women were allocated into two groups; either the experimental intervention of incision, curettage and suture, also described as 'primary suture,' under antibiotic cover (Clindaycine), or the conventional treatment of incision and drainage. Of the 11 women presenting with a wound infection and wound breakdown, seven were allocated to the experimental intervention and four were allocated to the conventional treatment. Of the six women who presented with wound infection but no wound breakdown, one woman was allocated to the experimental intervention and five allocated the conventional treatment.

Outcomes

Measurement of the initial episiotomy was provided in one study (Monberg 1987) but no reference was provided in relation to wound healing or how healing was assessed. Whereas, Christensen 1994 referred to outcome measures of both primary and secondary healing, detailed as less than four weeks for primary healing and greater than four weeks for secondary healing respectively.

One of the studies included in this review (Monberg 1987) reported figures on the resumption of sexual intercourse in both groups at two and six months (a non-prespecified outcome measure) and dyspareunia at two and six months. This study also referred to the continuation of lactation and although no actual figures were provided, lactation continued in both groups.

Both studies identified length of hospital in-patient times; Christensen 1994 revealing the total number of women discharged from hospital less than and more than 48 hours following the operative procedure and Monberg 1987 revealing the number of days following complications until discharge in both the intervention and control group.

Excluded studies

We excluded four studies from this review; in all cases the reason for exclusion was that they were not randomised controlled trials (Arona 1995; Hankins 1990; Ramin 1992; Uygur 2004).

Risk of bias in included studies

The methodological qualities of the two trials included in this systematic review did reveal some inconsistencies. It was not clear if antibiotics were used in the expectant management group in either of the studies. Traditionally, antibiotics are used during expectant management, however, if antibiotics were not used in the control arms, this co-intervention could be a serious source for bias particularly in the absence of blinding.

A risk of bias summary is provided in Figure 2.

Figure 2.

'Risk of bias' summary: review authors' judgements about each risk of bias item for each included study.

Allocation

Both Christensen 1994 and Monberg 1987 revealed that treatment was by randomisation however neither trial described the methods used.

Blinding

No details were provided by Christensen 1994 or Monberg 1987 in relation to blinding of the interventions to either the clinicians or the participants. However, blinding of the outcome assessments would not have been feasible in either trial due to the obvious differences in the treatment groups. The difficulties of blinding clinicians to treatment allocations can be a potential source of bias when assessing outcome measures, particularly when women are assessed by the researchers themselves. All women in the trial by Monberg 1987 were examined by one of the authors with further control if necessary by the general practitioner and/or in the outpatient clinic.

Incomplete outcome data

Attrition was low in the In the trial by Christensen 1994, 20 women were asked to participate; 17 women were randomised and three withdrew before being allocated to a treatment group. One participant was reported as being unable to attend for the four-week review appointment. Outcome data were reported for all women included in the trial with the exception of one participant who was allocated the conventional treatment.

There were missing outcome data in the trial by Monberg 1987 for dyspareunia, particularly at the two-month assessment; no details were provided in relation to the missing data. Data were however complete for resuming sexual intercourse.

Selective reporting

There is an unclear risk of reporting bias for both included trials (Christensen 1994; Monberg 1987). Lactation was reported to have continued in both the intervention and control groups by Monberg 1987, however, no reference was made to the length of time women continued to breast feed.

Other potential sources of bias

Only Monberg 1987 revealed the technique and material used for the secondary repair, Vicryl 2/0 intradermally and in the subcuticular layer.

Inclusion criteria was not specified in either study and only Christensen 1994 described exclusion criteria; Chrons disease, ulcerative colitis and immunosuppressive treatment.

Effects of interventions

We included two studies involving 52 women at point of trial entry.

Primary outcomes

Proportion of women with a healed perineal wound at six to eight weeks

Only the trial by Christensen 1994 presented data in a suitable format for inclusion in this analysis. Data were provided in relation to wound healing at less than four weeks although no reference was made on how healing was measured. This small trial demonstrated that there was a trend to reduced healing times in the secondary suturing group, however, this difference was not statistically significant, (risk ratio (RR) 1.69, 95% confidence interval (CI) 0.73 to 3.88, one study, 17 women; Analysis 1.1).

Secondary outcomes

Pain at six weeks, three months and six months

Neither of the trials included data in relation to pain at any time interval.

Resumption of sexual intercourse (non-prespecified outcome measure)

One of the trials included in this review (Monberg 1987), presented data on the resumption of sexual intercourse in both groups at two and six months. This was not an outcome prespecified in the protocol but one that the review authors felt was relevant to include in the analysis.

At two months, significantly more women in the secondary suturing group reported resuming sexual intercourse in comparison to the non-suturing group, (RR 1.78, 95% CI 1.10 to 2.89, one study, 35 women; Analysis 1.2). However there was no significant difference between groups at the six-month assessment. All women resumed intercourse by six months in the secondary suturing group and all but one woman resumed intercourse at six months in the non-suturing group, the last woman after six months, (RR 1.08, 95% CI, 0.91 to 1.28, one study, 35 women; Analysis 1.3).

Dyspareunia at three to six months

Only the trial by Monberg 1987 presented data relating to dyspareunia; assessed at two months and six months. At two and six months, dyspareunia was reported less frequently by women allocated to the secondary suturing group in comparison to women in the non-suturing group, however, these differences were not statistically significant , (at two months - RR 0.44, 95% CI 0.18 to 1.11, one study, 26 women; Analysis 1.4), (at six months - RR 0.39, 95% CI 0.04 to 3.87, one study, 32 women; Analysis 1.5).

Women's satisfaction with the aesthetic results of the perineal wound

Neither of the trials reported upon the woman's satisfaction with the aesthetic results of the perineal wound.

Rates of breastfeeding (at six weeks and at six months) and rates of exclusive breastfeeding (at six weeks and six months)

Only the trial by Monberg 1987 commented upon breastfeeding; no data were provided regarding rates of breastfeeding, although it was stated that lactation continued in both groups.

Maternal depression

Neither of the trials included data relating to maternal depression.

Maternal anxiety

Neither of the trials included data relating to maternal anxiety.

Discussion

The evidence from the two randomised controlled trials included in this review demonstrates that when compared with non-suturing of broken down perineal wounds, secondary suturing is a feasible alternative treatment option.

However we are unable to provide definitive evidence of benefits and risks associated with secondary suturing compared with non-suturing for broken down perineal wounds based on only two studies (Christensen 1994; Monberg 1987), particularly due to the methodological inconsistencies and outcome measures assessed. It was not clear if antibiotics were used in the expectant management group in either of the studies. Traditionally, antibiotics are used during expectant management, however, if antibiotics were not used in the control arms, this co-intervention could be a serious source for bias particularly in the absence of blinding.

The key issue is whether secondary suturing reduces the time taken to heal and only one study assessed this as an outcome measure (Christensen 1994). Secondary outcomes of pain; women's satisfaction with the aesthetic results of wound healing and maternal depression were not assessed as outcome measures by either study. Only Monberg 1987 assessed rates of dyspareunia at two months and six months.

Authors' conclusions

Implications for practice

There is insufficient evidence to assess the benefits and risks of secondary suturing for broken down perineal wounds compared with non-suturing. There is an urgent need for a robust randomised trial to fully evaluate the comparative effects of both treatment options.

Implications for research

The review has highlighted the following areas that need further evaluation to guide the future clinical management of broken down perineal wounds.

  • A robust randomised controlled trial to evaluate the effectiveness of secondary suturing compared with non-suturing for broken down perineal wounds, which addresses outcome measures that are important to women including pain, resuming sexual intercourse, dyspareunia, satisfaction with the aesthetic results of healing and the continuation of breastfeeding in both the short and long term.

  • Research into women's personal experiences of perineal wound breakdown and the impact of this complication of childbirth upon themselves as a new mother and that of their newborn and families.

Acknowledgements

The Pregnancy and Childbirth Group (Liverpool) for their assistance and support during the preparation of this systematic review.

As part of the pre-publication editorial process, this review 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.

The National Institute for Health Research (NIHR) is the largest single funder of the Cochrane Pregnancy and Childbirth Group. The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the NIHR, NHS or the Department of Health.

Data and analyses

Download statistical data

Comparison 1. Suturing versus non-suturing for perineal wound infection/breakdown
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Wound healing within 4 weeks117Risk Ratio (M-H, Fixed, 95% CI)1.69 [0.73, 3.88]
2 Resumed intercourse within 2 months135Risk Ratio (M-H, Fixed, 95% CI)1.78 [1.10, 2.89]
3 Resumed intercourse by 6 months135Risk Ratio (M-H, Fixed, 95% CI)1.08 [0.91, 1.28]
4 Dyspareunia at 2 months126Risk Ratio (M-H, Fixed, 95% CI)0.44 [0.18, 1.11]
5 Dyspareunia at 6 months132Risk Ratio (M-H, Fixed, 95% CI)0.39 [0.04, 3.87]
Analysis 1.1.

Comparison 1 Suturing versus non-suturing for perineal wound infection/breakdown, Outcome 1 Wound healing within 4 weeks.

Analysis 1.2.

Comparison 1 Suturing versus non-suturing for perineal wound infection/breakdown, Outcome 2 Resumed intercourse within 2 months.

Analysis 1.3.

Comparison 1 Suturing versus non-suturing for perineal wound infection/breakdown, Outcome 3 Resumed intercourse by 6 months.

Analysis 1.4.

Comparison 1 Suturing versus non-suturing for perineal wound infection/breakdown, Outcome 4 Dyspareunia at 2 months.

Analysis 1.5.

Comparison 1 Suturing versus non-suturing for perineal wound infection/breakdown, Outcome 5 Dyspareunia at 6 months.

Contributions of authors

Lynn Dudley (LD) and Christine Kettle (CK) conceived the original idea for the review. All three review authors LD, CK and Khaled MK Ismail (KMKI) critically appraised all papers for quality and eligibility independently. LD, CK and KMKI independently extracted the data and LD and KMKI entered the data onto the Review Manager software. All review authors agreed the final version of the review.

Declarations of interest

The authors of this review (LD, CK and KMKI) are conducting a randomised controlled trial 'The PREVIEW study' (perineal resuturing versus expectant management following vaginal delivery complicated by a dehisced wound) to evaluate the therapeutic effectiveness of resuturing dehisced perineal wounds versus healing by expectant management (secondary intention) (Dudley 2012). The contact person for this review is the Chief Investigator for the PREVIEW study. In the update of this review, two independent assessors who are not involved in the PREVIEW trial will conduct independent assessment of eligibility, risk of bias and data extraction for this trial.

Lynn Dudley is a recipient of a Doctoral Nursing Studentship award from the Smith and Nephew Foundation and Research Into Ageing (RIA) which has provided the funding for the trial and to prepare the Cochrane review. The Smith and Nephew Foundation and Research into Ageing do not have any financial interest in the conclusions of this review.

CK and KI run perineal repair workshops both nationally and internationally and have developed an episiotomy and second-degree tear training model with Limbs & Things, UK. They receive a very small royalty fee for input into the design of the model, which is administered by Keele University Office and Research enterprise and is used as part of their women's health research funds.

Sources of support

Internal sources

  • No sources of support supplied

External sources

  • Smith and Nephew Foundation and Research Into Ageing (RIA), UK.

    Lynn Dudley is a recipient of a Doctoral Nursing Studentship award from the Smith and Nephew Foundation and Research Into Ageing (RIA) which have provided the funding to prepare the Cochrane review.

Differences between protocol and review

Resuming sexual intercourse was a non-prespecified outcome measure in the protocol for this review; however, on reflection the authors felt that this was a relevant outcome measure to include for this review and subsequent updates.

Due to the lack of available studies and insufficient data relating to the prespecified outcomes, the authors were unable to carry out any subgroup analyses as planned. These will be conducted in future updates should more data become available.

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Christensen 1994

Methods

Participants were allocated into 2 treatment groups.

No methods of randomisation were provided.

No details were provided regarding how the randomisation sequence was generated.

Outcome assessment - no details provided.

20 women following vaginal delivery with an episiotomy wound were asked to participate and 17 women were randomised.

Participants

17 women were included in the study - no inclusion criteria specified.

11 women had wound infection and wound breakdown.

6 women had a wound infection but no wound breakdown.

Exclusion criteria - Chron's disease, ulcerative colitis, immunosuppressive treatment.

Interventions

Intervention group (n = 8) Incision, drainage, curettage and suture under antibiotic cover. No specific suture technique or material used detailed (referred to as 'primary suture').

7 of the 11 women with wound infection and wound breakdown were allocated the intervention group.

1 of the 6 women with wound infection but no wound breakdown was allocated the intervention group.

Control group (n = 9) Incision and drainage (conventional treatment, also described as 'open healing') compared with intervention.

4 of the 11 women with wound infection and wound breakdown were allocated the control group.

5 of the 6 women with wound infection but no wound breakdown were allocated the control group.

Outcomes

Included in the analysis:

Healing time.

Time spent in hospital (inpatient).

Recidivism (relapse/reoccurrence) of abscess.

Vaginal reconstructive surgery.

Notes

Setting - Odense University Hospital.

3 women who were approached for inclusion did not want to participate.

1 woman in the control group could not be contacted for assessment of wound healing.

Tables provided indicate an intention-to-treat analysis although not revealed in the paper.

There was no recidivism of abscess.

Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskNo details provided.
Allocation concealment (selection bias)Unclear riskNo details provided.
Incomplete outcome data (attrition bias)
All outcomes
Low risk

20 women were asked to participate in the study; 17 women were randomised, 3 withdrew before being allocated to a treatment group.

1 woman from the incision and drainage group was unable to attend the 4 week follow-up assessment.

Selective reporting (reporting bias)Unclear riskWe were not clear whether all pre-specified outcomes were reported in the published papers.
Other biasUnclear riskNot stated.
Blinding of participants and personnel (performance bias)
All outcomes
High risk

Participant: no details provided.

Clinician: no details provided.

Blinding of outcome assessment (detection bias)
All outcomes
High riskDue to the obvious differences in treatments, the women and outcome assessors could not be blinded to the allocated intervention.

Monberg 1987

Methods

Participants were randomised into 2 groups.

No methods of randomisation were provided.

No details regarding how the randomisation sequence was generated were provided.

35 participants with an infected and/or ruptured episiotomy were included.

Participants

35 participants (33 primipara) were randomised into 2 groups.

No exclusion criteria were provided.

Interventions

Intervention group A (n = 20) women had their episiotomy repaired (referred to as 'primary resuturing) and received Clindamycin 600 mg 2 hours prior to suturing and continuously for 5 days (300 mg 3 times a day).

Group B (n = 15) women were treated in accordance with the routine management of the department: cleaning the wound with chloramine and saline, resulting in spontaneous healing.

Outcomes

Included in the analysis:

Healing time.

Time spent in hospital (inpatient).

Recidivism (relapse/reoccurrence) of abscess.

Vaginal reconstructive surgery.

Notes

Setting - Hvidore Hospital, Copenhagan, Denmark.

Tables indicate intention-to-treat analysis although not stated in the paper.

All episiotomies examined for bacteria, unfortunately the authors reported that the results had been lost.

Method of repair described.

Lactation continued in both groups but length of times not provided.

No losses to follow-up reported.

Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskNo details provided.
Allocation concealment (selection bias)Unclear riskNo details provided.
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskDetails unclear in paper.
Selective reporting (reporting bias)Unclear riskWe were not clear whether all pre-specified outcomes were reported in the published papers.
Other biasUnclear riskNot stated.
Blinding of participants and personnel (performance bias)
All outcomes
High risk

Participant: no details provided.

Personnel: no details provided.

Blinding of outcome assessment (detection bias)
All outcomes
High riskDue to the obvious differences in treatments, the women and outcome assessors could not be blinded to the allocated intervention

Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion
Arona 1995Not a randomised trial. Case note review of 23 women who underwent early secondary repair of third- and fourth-degree perineal tears. 21 women had wound dehiscence following primary repair of a fourth-degree tear and 2 had wound dehiscence following primary repair of a third-degree tear. All repairs were successful with no subsequent wound dehiscence occurring.
Hankins 1990Not a randomised trial. Early repair of episiotomy dehiscence was performed in 22 women with a fourth degree tear and 4 with a third-degree tear and 5 with a mediolateral episiotomy. Most of the women (n = 27) 1 year post secondary repair demonstrated excellent anatomical results and the women reported complete continence and normal coital activity.
Ramin 1992Not a randomised trial. Case note review of 34 women who underwent early repair of episiotomy dehiscence. Clinical follow-up was reported in 29 cases, 5 women were lost to follow-up. Most of wounds were healed completely in 2-3 weeks; 2 women had subsequent wound dehiscence.
Uygur 2004Not a randomised trial. A retrospective case note review including 37 women with episiotomy dehiscence. 12 women with episiotomy dehiscence were allowed to heal by secondary intention and 25 women underwent early secondary repair. 3 women from the re-suturing group had superficial separation of the skin edges, whilst healing was complete in the remaining 22 women.

Characteristics of ongoing studies [ordered by study ID]

Dudley 2012

Trial name or titlePerineal resuturing versus expectant management following vaginal delivery complicated by a dehisced wound (PREVIEW).
MethodsPilot and feasibility randomised controlled trial designed to provide preliminary evidence of the effectiveness of re-suturing versus expectant management for dehisced perineal wounds following childbirth, and to feed into the design and feasibility of a larger definitive trial. 
ParticipantsPostnatal women referred to the perineal care clinics at the recruiting sites with dehisced perineal wound (spontaneous second-degree tear or episiotomy) that occurs within 2 weeks following childbirth.
InterventionsResuturing versus expectant management.
Outcomes

Primary outcome

The proportion of women with a healed perineal wound at 6-8 weeks from the trial entry.

Secondary outcomes

Pain at  2 and 6 weeks, 3 and 6 months following trial entry.

Dyspareunia  at 6 weeks, 3 and 6 months following trial entry.

Rates of breastfeeding at 6 weeks, 3 and 6 months following trial entry.

Woman’s satisfaction with aesthetic results of perineal wound at 6 weeks, 3 and 6 months following trial entry.

Starting dateJuly 25th 2011.
Contact informationLynn.dudley@uhns.nhs.uk
Notes12 women who have participated in the randomised controlled trial will also be interviewed to explore their physical and psychological experiences following perineal wound dehiscence; assess the acceptability of the research plan and ensure that all outcomes relevant to women are included in the definitive trial.

Ancillary