1 Introduction
Perineal trauma is the most common complication after childbirth, affecting approximately 90% of nulliparous and 69% of multiparous women [1]. Childbirth-related perineal trauma (CRPT) can impact all aspects of a woman’s life, with some women suffering long-lasting physical and psychological complications [2,3]. Poor management of wound complications after CRPT can further reduce quality of life and lead to worsening long-term outcomes, such as postnatal depression, chronic pain, dyspareunia and incontinence [4]. Despite this high prevalence and the potential for long-term consequences, there is a lack of research on this topic.
The exact incidence of wound infections after CRPT is unknown and varies significantly across the literature, with estimates between 0.1–23.6% [5]. Whilst clear guidelines exist for the postnatal care of women who have sustained obstetric anal sphincter injury (OASI), there is a lack of evidence based guidelines for the postnatal care of non-OASI trauma [6]. Clinicians express a lack of confidence in managing CRPT in the postnatal period and women report feeling dissatisfied with their postnatal care [7,8]. The recent governmental Birth Trauma Inquiry Report released in 2024 highlights this, and the need to ensure that improving care in the postnatal period is prioritised by policy-makers, clinicians and researchers [9].
Studies investigating the use of prophylactic antibiotics for perineal trauma have found antibiotics to be effective for preventing infection after assisted vaginal birth and OASI [10,11], with current guidelines therefore recommending antibiotic prophylaxis following either of these events [6,12]. Antibiotic prophylaxis is, however, not currently recommended following non-OASI perineal trauma after spontaneous vaginal birth [13]─ there is consequently a need to consider the use of prophylactic antibiotics in these circumstances, considering both the effectiveness in reducing complications and any potential harms.
This review forms part of the CHAPTER (Childbirth Associated Perineal Trauma) programme grant, which overall aims to improve the care of women who sustain CRPT. Other outputs of the CHAPTER programme include the development of a wound assessment tool and care pathways for women who have experienced perineal trauma. Here, we aim to assess the effectiveness of prophylactic antibiotics for the prevention of complications in all types of CRPT.
2 Materials and methods
2.1 Study design and registration
This forms a systematic review and meta-analysis of studies evaluating prophylactic antibiotics compared to no prophylactic antibiotics for women with CRPT. The review was performed in-line with PRISMA guidance, and the review protocol was published prospectively under the overarching PROSPERO for the series of reviews conducted across the CHAPTER project (CRD42023458738) [14,15]. The conclusions drawn have been discussed and refined with our patient and public advisory CHAPTER co-applicant.
2.2 Inclusion and exclusion criteria
Randomised controlled trials (RCTs), non-randomised interventional studies and observational studies were eligible for inclusion, where women with perineal trauma following vaginal birth received prophylactic antibiotics, compared to no antibiotics or a placebo. We chose to include observational studies in order to collate all the available evidence, as from scoping searches we were aware the existing evidence from RCTs was likely to be scarce─ this was particularly with the aim of including all different types of tear and antibiotic regimens, in different settings. Studies investigating all types of perineal trauma were eligible, including first- and second-degree tears, episiotomies and OASIs. We included trauma sustained following spontaneous or assisted vaginal birth. All types of antibiotics at different doses, routes of delivery and duration were included. Non-English studies were translated. Studies were excluded where the antibiotics were used only therapeutically, where CRPT was not sustained, or where data was not available for our outcomes of interest. Case studies, case series and case controlled studies were excluded. A summary of correspondence with study authors is included in Table A in S1 Appendix, and a table of excluded studies in Table B in S1 Appendix.
2.3 Outcomes
The primary outcome was perineal infection. Secondary outcomes included: wound dehiscence, pain, wound healing, urinary incontinence, faecal incontinence, dyspareunia, length of hospital stay, hospital readmission and maternal adverse reaction. Outcomes were defined as per the reports of the study author and where available these definitions were included in the study characteristics table. There is not an existing core outcome set for CRPT and therefore the list of outcomes chosen from outset were based on author consensus and from prior discussions with the CHAPTER patient advisory group.
2.4 Search strategy
A systematic literature search was undertaken using: Medline, Embase, CINAHL, Cochrane central register of controlled trials, Web of Science and Google Scholar, from inception to February 2024. A combination of medical subject headings (MeSH) and text words were used. An example of search terms used is included in Appendix A in S1 Appendix, which were adapted for each database searched.
2.5 Study selection and data extraction
Two reviewers independently reviewed titles and abstracts of the retrieved articles (HA, RM), with a third independent reviewer resolving any conflicts (VHM). This process was repeated for full text screening and data extraction. Covidence software was used for study screening. Data from the studies meeting the inclusion criteria was extracted onto a data entry form and then transferred onto an electronic spreadsheet.
2.6 Risk of bias assessment
Two review authors assessed risk of bias for each study (HA, RM) with conflicts solved by consensus. Risk of bias was assessed in line with guidance from the Cochrane Handbook for Systematic Reviews of Interventions, using the RoB2 tool for RCTs and ROBINS-I tool for observational studies [16,17]. Both tools were applied at the outcome level as per guidance [16,18,19].
2.7 Certainty of evidence
The GRADE approach [20] was used to assess the certainty of the included evidence from the meta-analyses based on RCTs only─ these analyses were deemed most appropriate to apply the GRADE framework to as the effectiveness of an intervention was being considered.
2.8 Data analysis
Data was synthesised using Review Manager 5.4 software. To assess dichotomous outcomes, risk ratios (RR) were calculated, with 95% confidence intervals. An absolute risk reduction (ARR) and number needed to treat (NNT) were calculated using standard formulas for the primary outcome [21]. For continuous outcomes, means and standard deviations were extracted. A random effects model was applied, as studies were conducted using different antibiotic protocols amongst different populations and at different time-points, so were likely to be estimating different underlying effects. To assess for statistical heterogeneity the I2 statistic was used. Where data was not available in primary studies, no assumptions or imputations were made and only available data was used for meta-analysis. Where there were three or more RCTs eligible for inclusion, we performed an RCT only analysis in addition to an overall analysis pooling both observational studies and RCTs. Subgroup analyses were planned for outcomes where meta-analysis was possible; by degree of tear, route of antibiotic administration, risk of bias judgement, type of antibiotic received and spontaneous/assisted vaginal birth.
2.9 Publication bias
Funnel plots were generated to assess for publication bias in meta-analyses. Egger’s regression test was used to quantitavely assess for funnel plot asymmetry where there were ≥10 studies in the analysis [22]. Funnel plots and Egger’s regression test were generated using R software (4.3.0) and RStudio.
3 Results
3.1 Included studies
Fourteen full-text studies were eligible for inclusion, which comprised eight RCTs and six observational studies (two prospective cohort studies, one retrospective cross sectional study, one prospective cross-sectional study, one quality improvement initiative [retrospective data collection], one cohort study with retrospective and prospective components), involving 8,878 women across nine countries [11,23–35](Fig 1). Four studies were conducted in the USA, three in India and one in each of; Iran, UK, Brazil, South Africa, Germany, Thailand and Turkey. Characteristics of included studies can be found in Table 1. We included data from one additional published abstract from the full-text by Propst et al., as it contained further outcome data not included in the full-text version [36]. Humphrey’s et al., a secondary analysis of the ANODE (Antibiotics in the Prevention of Infection after Operative Vaginal Delivery) RCT by Knight et al., was included, as we were able to derive the total number with perineal trauma from Humphreys et al., and the number with perineal wound infection from the primary ANODE trial [10,27]. Where Humphreys is cited in results, this refers to results from both published articles.
[Figure omitted. See PDF.]
[Figure omitted. See PDF.]
Study flow diagram illustrating the search and selection process generated using Covidence software (aligned to PRISMA 2020).
Studies used varying prophylactic antibiotic regimens. The most commonly used antibiotics were cefoxitin (four studies), co-amoxiclav (three studies) and cefazolin (three studies). Antibiotics were commenced at varying time points─ as detailed in Table 1, most commonly antibiotics were administered at the time of repair or after birth. There were varying definitions of perineal infection reported in the included studies (detailed in Table 1). Wound breakdown was included in the definition of perineal infection in five studies. Purulent discharge was also one of the most common signs included in definitions of perineal wound infection. The presence of infection was recorded at different time-points, ranging from 24 hours to three months postpartum.
3.2 Risk of bias
3.2.1 Randomised controlled trials.
Four studies were deemed to be at high risk of bias, two with some concerns and two low risk of bias. Fig A in S1 Appendix shows the overall quality of the RCTs split by the RoB2 tool domains. Domain two, bias due to deviations from intended interventions carried the highest risk of bias. There was a lack of blinding in several included RCTs.
3.2.2 Observational.
All six observational studies were deemed to be at critical or serious risk of bias. Fig B in S1 Appendix shows the overall quality of the observational studies split by the ROBINS-I tool domains. The ROBINS-I risk of bias tool determines bias by comparison of the observational interventional study to a fully randomised trial. As such, in domain one (risk of bias due to confounding), a study can only be classified as low risk of bias if the study is comparable to a well-performed randomised trial and therefore no studies were deemed at low risk of bias in this domain. Furthermore, the majority of outcome data used in this systematic review from observational studies was inherently not controllable and therefore a critical risk of bias was assigned for the first domain. Authors made the decision to still include these studies, whilst performing an RCT only sensitivity analyses. Whilst some studies presented baseline characteristics between intervention and no intervention groups, others did not present this data at all or in full.
3.3 GRADE assessment
Table C in S1 Appendix shows the Summary of Findings table. Overall the GRADE certainty of findings were low for both perineal infection and wound dehiscence. Several studies included in each analysis had a high or unclear risk of bias using the RoB2 and ROBINS-I tools. There were differences in the populations and interventions between the included studies, with Sebitloane et al. [28] solely including a HIV cohort, affecting the directness of the evidence. Varying antibiotic types, doses, durations and routes were utilised between studies. Heterogeneity was present in the wound dehiscence analysis, with some point estimates demonstrating an effect in the opposite direction.
3.4 Data analysis
For perineal wound infection, when observational studies and RCTs were pooled together, 12 studies were included in the analysis, involving 8,438 women (Fig 2) [11,24,25,27–35]. Overall, there was association with reduced rates of infection in those administered prophylactic antibiotics (RR 0.57, 95% CI 0.48 to 0.67, I2 = 0%). For perineal wound dehiscence when RCTs and observational studies were pooled together, nine studies were included, with 4,610 women [11,23,25,26,29,32–35]. Overall, there was an association with reduction in wound dehiscence events in the prophylactic antibiotic group compared to the placebo group (RR 0.60, 95% CI 0.36 to 0.99, I2 = 49%) (Fig 3).
[Figure omitted. See PDF.]
Forest plot to show the outcome of perineal wound infection for prophylactic antibiotics compared to no prophylactic antibiotics. Created using Revman. Abbreviations M-H = Mantel-Haenszel, CI = confidence interval.
[Figure omitted. See PDF.]
Forest plot to show the outcome of perineal wound dehiscence for prophylactic antibiotics compared to no prophylactic antibiotics. Created using Revman. Abbreviations M-H = Mantel-Haenszel, CI = confidence interval.
Data collected for the remaining secondary outcomes was solely descriptive as there was insufficient information for meta-analysis. Chandrababu et al. and Goodzari et al. measured wound healing using the REEDA (redness, oedema, ecchymosis and approximation) wound assessment tool, which scores each parameter on a scale of zero to three, with a higher score representing poorer wound healing and a total score from 15 subsequently calculated [23,26]. In the former study there was no statistically significant difference in the rate of wound healing between those receiving compared to not receiving antibiotics, when measured at the time of discharge [23]. Goodarzi et al. reported a mean REEDA score of 1.14 in the prophylactic antibiotics group versus 1.63 in the control group [26].
Tandon et al. reported the outcome of pain using both a visual analogue scale and in terms of the presence or absence of pain [29]. There was no significant difference in the presence or absence of pain between antibiotic and no antibiotic groups (p = 0.99), but there was a statistically significant difference between groups when pain was recorded using a visual analogue scale (p = 0.026).
The abstract by Propst et al. was the only study to report data for urinary and faecal incontinence [36]. It was reported immediately and at six to 12 months postpartum. There was no statistically significant difference in urinary or faecal incontinence between those receiving antibiotics versus no antibiotics immediately postpartum. This was consistent for urinary and faecal incontinence at six to 12 months postpartum where no significant differences were found [36]. For the outcome of length of hospital stay, Garala et al. found no statistically significant difference in those receiving compared to not receiving prophylactic antibiotics [24]. Goodarzi et al. found two cases of hospital readmission in the prophylactic antibiotics arm compared to none in the control arm (n = 70 in each arm) [26]. Goodarzi et al. was the only study to comment on maternal adverse reactions to antibiotics and there were no observed adverse reactions reported [26]. No included studies reported on dyspareunia.
3.5 Sensitivity and subgroup analyses
3.5.1 Sensitivity analyses.
The RCT only analysis for the outcome of perineal wound infection included six studies involving 3,968 women [11,24,27–29,35]. This showed a significant reduction in the risk of perineal infection with prophylactic antibiotics, across all types of tear (RR 0.51, 95% CI 0.42 to 0.62, I2 = 0%) (Fig 4). Calculation of the absolute risk for the RCT only analysis gave a reduction of 66 perineal infection events per 1000 women when prophylactic antibiotics were given compared to no prophylactic antibiotics. The NNT was 15. For the perineal wound dehiscence RCT only analysis, including five studies and 920 women, there was no statistically significant difference between risk in the prophylactic antibiotic versus placebo group (RR 0.77, 95% CI 0.37 to 1.58, I2 = 43%) (Fig 5) [11,23,26,29,35].
[Figure omitted. See PDF.]
Forest plot to show the outcome of perineal infection for prophylactic antibiotics compared to no prophylactic antibiotics for RCTs only. Created using Revman. Abbreviations M-H = Mantel-Haenszel, CI = confidence interval.
[Figure omitted. See PDF.]
Forest plot to show the outcome of wound dehiscence for prophylactic antibiotics compared to no prophylactic antibiotics for RCTs only. Created using Revman. Abbreviations M-H = Mantel-Haenszel, CI = confidence interval.
3.5.2 Subgroup analyses.
For the outcomes of infection and dehiscence in those receiving prophylactic antibiotics compared to no antibiotics, subgroup analysis was performed by type of tear, across observational studies and RCTs. For the outcome of infection in the first/second degree tear or episiotomy, episiotomy only, third/fourth degree tear and all types of perineal trauma (unable to separate by tear type) subgroups, results were RR 0.50, 95% CI 0.41–0.63, I2 = 0%; RR 0.57, 95% CI 0.36–0.91, I2 = 0%; RR 0.75, 95% CI 0.54–1.03, I2 = 0% and RR 0.51, 95% CI 0.25–1.02, I2 = 0% respectively (p = 0.25 for subgroup differences) (Fig 6). For the outcome of wound dehiscence, in the same tear subgroups respectively, results were RR 1.64, 95% CI 0.80–3.39, I2 = 0%; RR 0.39, 95% CI 0.19–0.80, I2 = 0%; RR 0.71, 95% CI 0.26–1.97, I2 = 59%; RR 0.38, 95% CI 0.20–0.69, I2 = 0% (p = 0.01 for subgroup differences) (Fig C in S1 Appendix).
[Figure omitted. See PDF.]
Forest plot to show the outcome of wound infection for prophylactic antibiotics compared to control where subgroups are split by type of perineal tear. Created using Revman. Abbreviations M-H = Mantel-Haenszel, CI = confidence interval.
We performed subgroup analyses investigating the effect of the route of administration of antibiotics on risk of perineal infection. There were two main routes of administration used in the included studies; intravenous and oral, and one study by Yilmaz et al. used a topical route [34]. Some studies administered antibiotics via a mixture of routes and others did not specify. For perineal wound infection, results for studies administering antibiotics intravenously, orally, topically or via mixed/unspecified routes were RR 0.52, 95% CI 0.43–0.63, I2 = 0%; RR 0.39, 95% CI 0.11–1.38, I2 = 0%; RR 0.48, 95% CI 0.24–0.95 [I2 not applicable]; RR 0.75, 95% CI 0.55–1.02, I2 = 0% respectively (p = 0.24 for subgroup differences) (Fig D in S1 Appendix). For perineal wound dehiscence, results for the same subgroups respectively were RR 0.39, 95% CI 0.14–1.15 [I2 not applicable]; RR 0.82, 95% CI 0.33–2.05, I2 = 49%; RR 0.25, 95% CI 0.07–0.87 [I2 not applicable] and RR 0.64, 95% CI 0.29–1.44, I2 = 56% (p = 0.43 for subgroup differences) (Fig E in S1 Appendix).
Subgroup analyses by risk of bias category were also performed to investigate whether the effect of antibiotics on perineal wound infection or wound dehiscence was altered by study quality. For perineal wound infection subgrouped by studies at high/critical/serious, some concerns and low risk of bias, results were RR 0.67, 95% CI 0.51–0.89, I2 = 0%; RR 0.76, 95% CI 0.39–1.46, I2 = N/A; RR 0.49, 95% CI 0.40–0.61, I2 = 0% (p = 0.14 for subgroup differences) (Fig F in S1 Appendix). For perineal wound dehiscence, for the same bias categories respectively, results were RR 0.53, 95% CI 0.31–0.88, I2 = 32%; RR 1.56, 95% CI 0.72–3.36, I2 = N/A; RR 0.39, 95% CI 0.14–1.15, I2 = N/A (p = 0.04 for subgroup differences) (Fig G in S1 Appendix).
Meta-analysis by type of antibiotic used was not possible as there were not sufficient studies using the same antibiotic. Many of the observational studies used several different types of antibiotics within their single dataset and it was not possible to separate the outcome data by antibiotic used. Type of antibiotic used in each study can be seen in Table 1. Similarly subgroup analysis by spontaneous/assisted vaginal birth was not possible, as there was insufficient data for analysis.
3.6 Publication bias
Funnel plots, generated for outcomes of infection and wound dehiscence can be found in Fig H and Fig I in S1 Appendix. Funnel plots suggest an absence of significant publication bias.
4 Discussion
4.1 Main findings
There is a reduction in perineal wound infection when prophylactic antibiotics are received, compared to placebo (absolute risk reduction 6.6% based on the RCT only analysis) across all types of tear. Subgroup analysis demonstrated a reduced risk of infection when prophylactic antibiotics were administered in the non-OASI groups. For the prevention of wound dehiscence, prophylactic antibiotics were not found to be superior to placebo or control in our RCT only analysis.
4.2 Context within previous research
The 2019 ANODE trial has provided clear evidence that antibiotics for assisted vaginal births are effective in preventing subsequent infections and therefore this has now been incorporated into guidelines and clinical practice [10]. Whilst our systematic review includes data from the ANODE trial, we also include studies where women underwent a spontaneous vaginal birth. Our results, whilst incorporating data from women with all types of CRPT and across all modes of vaginal birth and therefore not being directly comparable to ANODE, were overall in keeping with this robust and recent RCT.
In terms of existing systematic reviews on the subject, the Cochrane review investigating prophylactic antibiotics for episiotomy repair was published in 2017 [13]. Our systematic review includes the Neto 1990 RCT, which is the only trial included in the 2017 Cochrane review [35]. Based on the findings of the single, small RCT, the 2017 Cochrane review found that there was no clear difference between the groups who received antibiotics compared to those who did not. This trial is now 35-years-old and authors of the primary RCT used chloramphenicol as their prophylactic antibiotic─ this is clearly not an antibiotic that would be considered for this use in present settings. In our systematic review, we found a greater number of studies investigating the use of prophylactic antibiotics after episiotomy and therefore can build on evidence from this earlier Cochrane review. Furthermore, our subgroup analyses by type of tear suggested that prophylactic antibiotics for women who undergo episiotomy may be associated with a reduction in rates of wound infection and wound dehiscence. A further Cochrane review investigated prophylactic antibiotics for third and fourth degree tears and found one eligible RCT─ this trial suggested that prophylactic antibiotics were effective in preventing wound infection after OASI [11,37]. We found no additional RCTs focusing solely on women with OASI, however we were also able to draw on studies with observational design.
Our review must also be considered in the context of the recently published UK governmental Birth Trauma report, which highlights poor postnatal care as a significant contributor to trauma [9]. The devastating effects of perineal trauma are discussed in this report, stressing the urgency with which evidence-based improvements to care must be made. Our review therefore begins to unpick the existing evidence behind a simple intervention that may help to improve the lives of many women and their families.
4.3 Strengths and limitations
To our knowledge there is no existing up-to-date systematic review and meta-analysis which considers the use of prophylactic antibiotics amongst all types of CRPT. This work therefore begins to fill a notable gap in the evidence base, whilst additionally highlighting where further primary research is needed. A broad range of search terms were applied in relevant databases, producing a comprehensive analysis. The inclusion of non-English language studies and grey literature increases the number of studies on which conclusions can be drawn and improves the generalisability of our results. This review includes a larger number of studies in comparison to existing systematic reviews, meaning that our results provide increased breadth and depth to the subject area.
Notably, 10 of 14 included primary studies were determined to have a high, critical or serious risk of bias, which means our conclusions are based on studies which provide overall, less robust evidence. Whilst it is a strength that we included studies conducted across nine different countries, we found no studies eligible for inclusion conducted in low-income countries. This highlights a significant gap in the evidence base and we must ensure that future research considers the applicability and effectiveness of interventions in different healthcare settings.
Sebitloane et al. includes a HIV cohort, highlighting the use of antibiotics in particular groups who may be more likely to experience complications [28]. Inclusion of this trial must be considered when drawing conclusions, as these results may not be generalisable to the wider population. Many of the secondary outcomes were patient reported outcomes, with few eligible studies reporting them and therefore, due to scarcity of data, meta-analysis was not possible. These subjective outcomes were also increasingly likely to have been recorded and reported differently between studies. Additionally, the definitions of outcomes varied considerably across studies, with a lack of consistency in the definition of wound infection (see Table 1). The pooling of various antibiotic regimens used in the included studies, increases heterogeneity within our results, an additional limitation to this review.
A further important limitation to our systematic review is that whilst the inclusion of observational studies increased the available data for meta-analysis, only association can be demonstrated in these studies. We attempted to mitigate this by also performing analysis limited to RCTs only.
It is also important to note that due to both lack of reporting in primary studies and the inclusion of women who had undergone both assisted and spontaneous vaginal birth in the same study populations, we were not able to perform subgroup analysis by birth mode. As currently in the UK, women who undergo an assisted vaginal birth receive prophylactic antibiotics, it is important that we can ascertain the benefit of prophylactic antibiotics in those who experience spontaneous vaginal birth if an effect is truly there. Subgroup analysis by type of perineal trauma was also limited by reporting in primary studies, as the majority of studies included women with several different tear types (see Table 1) and results for each distinct type of tear were not completely separable. This therefore means that our subgroup analysis by perineal trauma type is restricted to more broad groups of perineal trauma and we are not able to draw any more granular conclusions.
4.4 Clinical implications and future research
Whilst our review demonstrates a reduction in perineal wound infections after antibiotics are received, when pooling data from all types of tear and from those with both assisted and normal vaginal births, there was scarce reporting of any potential harms in the included studies. In any future trials, we must ensure that consideration is given to minimising antibiotic excretion into breastmilk, through careful selection of the antibiotic type and duration of exposure. In terms of long-term risks to the infant, a recent large data-linkage study found no evidence of an increase in long-term health conditions such as asthma, eczma, autoimmune disease or neurodevelopmental issues in infants exposed to prophylactic antibiotics, administered prior to incision at caesarean section [38]. Whilst the data-linkage study investigated antibiotics given antenatally, prophylactic antibiotics for perineal trauma would likely result in less exposure to the infant, as administration would be postnatally.
One of the reasons it is hard to draw firm conclusions from our systematic review, is that a wide range of antibiotics were used, in some cases within the same study. Potential options for further investigation in a future trial are co-amoxiclav and the cephalosporin class of antibiotics. Both of these represent penicillin based antibiotics which can be associated with increasing resistance and Clostridium difficile infection and therefore this must be considered when balancing the risks and benefits [39].
There is also a need to consider the use of non-antibiotic interventions for reducing the risk of infection after perineal trauma. This includes maintaining a sterile field during repair of perineal trauma and ensuring sterile drapes and cleaning solution are utilised for repairs in every setting. Other interventions such as use of sanitary pads with antibacterial properties, require further investigation [40]. Prior to performing a further RCT, there is a need for development of a CRPT core outcome set, in order to ensure the outcomes captured are those most important to women and clinicians. Particularly notable in this review were the lack of widely used and validated wound assessment tools for healing of perineal trauma and the lack of standardised patient reported outcome measures. The wider CHAPTER project aims to develop these, so they are available for future trials. Additionally, further research should work to identify the characteristics of women at higher risk of CRPT complications, who would subsequently be likely to obtain the most benefit from intervention.
5 Conclusion
Although our meta-analysis demonstrates that prophylactic antibiotics significantly reduce the risk of perineal infection, there are not sufficient high-quality RCTs to adequately inform guideline change amongst women with first/second degree tears or episiotomies. The lack of consistency across primary research studies on the definition of perineal wound infection and the unavailability of outcome data for distinct tear types were important limitations to this review. Our findings highlight the need for further research, with a robust and sufficiently powered RCT amongst women with spontaneous vaginal births and non-OASI perineal trauma, required to provide a definitive answer. Any further trial involving antibiotics must also capture any potential maternal and infant harms from antibiotic administration and must consider the implications at a wider population level. As is evident from the recent Birth Trauma Report, improving postnatal care is imperative to improving women’s experiences of childbirth─ we must therefore ensure that any potential interventions to reduce complication rates after CRPT are fully investigated and that this remains a priority for researchers and clinicians.
Supporting information
S1 Appendix. Author correspondence, search terms, excluded studies, risk of bias, additional analyses.
https://doi.org/10.1371/journal.pone.0323267.s001
(DOCX)
S2 Appendix. Additional information.
https://doi.org/10.1371/journal.pone.0323267.s002
(XLSM)
S3 Appendix. Citations retrieved in searches.
https://doi.org/10.1371/journal.pone.0323267.s003
(XLSX)
S4 Appendix. PRISMA checklist.
https://doi.org/10.1371/journal.pone.0323267.s004
(DOCX)
Acknowledgments
We would like to thank Derick Yates and the team at the Birmingham Women’s Hospital library for their help in the search process and retrieving full-text articles. We would also like to thank the authors of the relevant research studies who kindly provided input where needed, so that we could include their data in this review.
^CHAPTER group: Laura Jones**- 1. Department of Applied Health Sciences, School of Health Sciences, College of Medicine and Health, University of Birmingham, United Kingdom
Laura Magill- 1. Department of Applied Health Sciences, School of Health Sciences, College of Medicine and Health, University of Birmingham, United Kingdom
Christine MacArthur- 1. Department of Applied Health Sciences, School of Health Sciences, College of Medicine and Health, University of Birmingham, United Kingdom
Sara Webb- 1. Royal College of Midwives, UK
John Maltby- 1. School of Psychology and Vision Sciences, University of Leicester, UK
Sarah Hillman- 1. Warwick Medical School, UK
Nicola J Adderley- 1. Department of Applied Health Sciences, School of Health Sciences, College of Medicine and Health, University of Birmingham, United Kingdom
2. National Institute for Health and Care Research (NIHR) Birmingham Biomedical Research Centre, UK
Alice Sitch- 1. Department of Applied Health Sciences, School of Health Sciences, College of Medicine and Health, University of Birmingham, United Kingdom 2. NIHR Birmingham Biomedical Research Centre, University Hospitals Birmingham NHS Foundation Trust and University of Birmingham, UK
Olalekan Lee Aiyegbusi- 1. Department of Applied Health Sciences, School of Health Sciences, College of Medicine and Health, University of Birmingham, United Kingdom
Marian Knight- 1. National Perinatal Epidemiology Unit, University of Oxford, UK
Krishnarajah Nirantharakumar- 1. Department of Applied Health Sciences, School of Health Sciences, College of Medicine and Health, University of Birmingham, United Kingdom
2. NIHR Birmingham Biomedical Research Centre, UK; 3. Health Data Research UK (HDRUK), London, UK
**lead author for group, email address: [email protected]
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* PubMed/NCBI
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* View Article
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* View Article
* Google Scholar
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* View Article
* PubMed/NCBI
* Google Scholar
26. 26. Goodarzi G, Rajabian S, Ahmadian M, Kalateh A. Comparing the incidence of episiotomy site infection in two groups of primiparas with and without taking prophylactic antibiotics after normal vaginal delivery referred to bent al-huda hospital in Bojnourd. J Obstet Gynecol Cancer Res. 2020;5(2):31–8.
* View Article
* Google Scholar
27. 27. Humphreys ABC, Linsell L, Knight M. Factors associated with infection after operative vaginal birth-a secondary analysis of a randomized controlled trial of prophylactic antibiotics for the prevention of infection following operative vaginal birth. Am J Obstet Gynecol. 2023;228(3):328.e1–328.e11. pmid:36027955
* View Article
* PubMed/NCBI
* Google Scholar
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* View Article
* PubMed/NCBI
* Google Scholar
29. 29. Tandon AN, Dalal AR. A Randomized, open-labelled, interventional study to evaluate the incidence of infection with or without use of prophylactic antibiotics in patients of episiotomy in a normal vaginal delivery. J Obstet Gynaecol India. 2018;68(4):294–9. pmid:30065545
* View Article
* PubMed/NCBI
* Google Scholar
30. 30. Cox CK, Bugosh MD, Fenner DE, Smith R, Swenson CW. Antibiotic use during repair of obstetrical anal sphincter injury: a quality improvement initiative. Int J Gynaecol Obstet. 2022;156(1):95–101. pmid:33507531
* View Article
* PubMed/NCBI
* Google Scholar
31. 31. Lewicky-Gaupp C, Leader-Cramer A, Johnson LL, Kenton K, Gossett DR. Wound complications after obstetric anal sphincter injuries. Obstet Gynecol. 2015;125(5):1088–93. pmid:25932836
* View Article
* PubMed/NCBI
* Google Scholar
32. 32. Propst K, Yao M, Hickman LC. Impact of peripartum antibiotics on wound complications in women with obstetric anal sphincter injury. Int J Gynaecol Obstet. 2023;161(2):491–8. pmid:36306399
* View Article
* PubMed/NCBI
* Google Scholar
33. 33. Thongtip N, Srilar A, Luengmettakul J. The incidence and associated factors of perineal wound infection following vaginal delivery in Charoenkrung Pracharak hospital, Bangkok, Thailand. Thai J Obstet Gynaecol. 2023;31:145–53.
* View Article
* Google Scholar
34. 34. Yılmaz E, Özdemir O, Demir MF, Tunç T, Soysal Ç, Vural Yılmaz Z. Could subcutaneous rifampicin administration be an effective approach for reducing episiotomy infections?. Eur Rev Med Pharmacol Sci. 2024;28(1):357–64. pmid:38235887
* View Article
* PubMed/NCBI
* Google Scholar
35. 35. Neto S GJ, de Andrade LF. Clinical evaluation of the chloramphenicol use as a prophylactic antibiotic in the vaginal delivery with episiotomy [Avaliacao clinica do emprego do cloranfenicol como antibiotico profilatico no parto normal com episiotomia]. Arq Catarin Med. 1990;19(2):97–102.
* View Article
* Google Scholar
36. 36. Propst K YM, Hickman L. Impact of intrapartum prophylactic antibiotics on bowel and bladder function in women with obstetric anal sphincter injury. Female Pelvic Med Reconstr Surg. 2022;28(6 Supplement 1):S194–5.
* View Article
* Google Scholar
37. 37. Buppasiri P, Lumbiganon P, Thinkhamrop J, Thinkhamrop B. Antibiotic prophylaxis for third- and fourth-degree perineal tear during vaginal birth. Cochrane Database Syst Rev. 2014;2014(10):CD005125. pmid:25289960
* View Article
* PubMed/NCBI
* Google Scholar
38. 38. Šumilo D, Nirantharakumar K, Willis BH, Rudge GM, Martin J, Gokhale K, et al. Long term impact of prophylactic antibiotic use before incision versus after cord clamping on children born by caesarean section: longitudinal study of UK electronic health records. BMJ. 2022;377:e069704. pmid:35580876
* View Article
* PubMed/NCBI
* Google Scholar
39. 39. Baur D, Gladstone BP, Burkert F, Carrara E, Foschi F, Döbele S, et al. Effect of antibiotic stewardship on the incidence of infection and colonisation with antibiotic-resistant bacteria and Clostridium difficile infection: a systematic review and meta-analysis. Lancet Infect Dis. 2017;17(9):990–1001. pmid:28629876
* View Article
* PubMed/NCBI
* Google Scholar
40. 40. Arendsen LP, Thakar R, Bassett P, Sultan AH. A double blind randomized controlled trial using copper impregnated maternity sanitary towels to reduce perineal wound infection. Midwifery. 2021;92:102858. pmid:33157498
* View Article
* PubMed/NCBI
* Google Scholar
Citation: Armstrong H, Whitehurst J, Morris RK, Hodgetts Morton V, Man R, on behalf of the CHAPTER group (2025) Antibiotic prophylaxis for childbirth-related perineal trauma: A systematic review and meta-analysis. PLoS One 20(5): e0323267. https://doi.org/10.1371/journal.pone.0323267
About the Authors:
Hannah Armstrong
Roles: Data curation, Formal analysis, Writing – original draft, Writing – review & editing
Affiliation: Department of Applied Health Sciences, School of Health Sciences, College of Medicine and Health, University of Birmingham, Edgbaston, Birmingham, United Kingdom,
Jane Whitehurst
Roles: Writing – review & editing
Affiliation: Applied Research Collaboration, West Midlands, United Kingdom,
R. Katie Morris
Roles: Funding acquisition, Supervision, Writing – review & editing
Affiliations: Department of Applied Health Sciences, School of Health Sciences, College of Medicine and Health, University of Birmingham, Edgbaston, Birmingham, United Kingdom,, Birmingham Women’s Hospital, Edgbaston, Birmingham, United Kingdom
ORICD: https://orcid.org/0000-0003-1247-429X
Victoria Hodgetts Morton
Roles: Conceptualization, Methodology, Supervision, Writing – review & editing
Affiliations: Department of Applied Health Sciences, School of Health Sciences, College of Medicine and Health, University of Birmingham, Edgbaston, Birmingham, United Kingdom,, Birmingham Women’s Hospital, Edgbaston, Birmingham, United Kingdom
Rebecca Man
Roles: Conceptualization, Data curation, Formal analysis, Methodology, Supervision, Writing – original draft, Writing – review & editing
E-mail: [email protected]
Affiliations: Department of Applied Health Sciences, School of Health Sciences, College of Medicine and Health, University of Birmingham, Edgbaston, Birmingham, United Kingdom,, Birmingham Women’s Hospital, Edgbaston, Birmingham, United Kingdom
ORICD: https://orcid.org/0000-0002-0983-7590
on behalf of the CHAPTER group
¶CHAPTER group members are provided in the Acknowledgements
[/RAW_REF_TEXT]
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11. Duggal N, Mercado C, Daniels K, Bujor A, Caughey AB, El-Sayed YY. Antibiotic prophylaxis for prevention of postpartum perineal wound complications: a randomized controlled trial. Obstet Gynecol. 2008;111(6):1268–73. pmid:18515507
12. RCOG. Assisted Vaginal Birth. Green top guideline No 26. [Cited 2025 March 24. ]. Available from: https://www.rcog.org.uk/guidance/browse-all-guidance/green-top-guidelines/assisted-vaginal-birth-green-top-guideline-no-26
13. Bonet M, Ota E, Chibueze CE, Oladapo OT. Antibiotic prophylaxis for episiotomy repair following vaginal birth. Cochrane Database Syst Rev. 2017;11(11):CD012136. pmid:29096053
14. Moher D, Liberati A, Tetzlaff J, Altman DG, PRISMA Group. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. PLoS Med. 2009;6(7):e1000097. pmid:19621072
15. A series of systematic reviews exploring childbirth related perineal trauma. PROSPERO 2024 [Cited 2025 March 24. ]. Available from: https://www.crd.york.ac.uk/PROSPERO/view/CRD42023458738
16. Sterne JA, Hernán MA, Reeves BC, Savović J, Berkman ND, Viswanathan M, et al. ROBINS-I: a tool for assessing risk of bias in non-randomised studies of interventions. BMJ. 2016;355:i4919. pmid:27733354
17. Cochrane. RoB2: a revised Cochrane risk-of-bias tool for randomized trials. [Cited 2025 March 24]. Available from: https://methods.cochrane.org/bias/resources/rob-2-revised-cochrane-risk-bias-tool-randomized-trials.
18. Sterne JAC, Savović J, Page MJ, Elbers RG, Blencowe NS, Boutron I, et al. RoB 2: a revised tool for assessing risk of bias in randomised trials. BMJ. 2019;366:l4898. pmid:31462531
19. Minozzi S, Gonzalez-Lorenzo M, Cinquini M, Berardinelli D, Cagnazzo C, Ciardullo S, et al. Adherence of systematic reviews to Cochrane RoB2 guidance was frequently poor: a meta epidemiological study. J Clin Epidemiol. 2022;152:47–55. pmid:36156301
20. Cochrane Training. Chapter 14: Completing ‘Summary of findings’ tables and grading the certainty of the evidence [Cited 2025 March 24]. Available from: https://training.cochrane.org/handbook/current/chapter-14.
21. BMJ Best Practice. Understanding statistics: risk [Cited 2025 March 24]. Available from: https://bestpractice.bmj.com/info/toolkit/learn-ebm/how-to-calculate-risk/.
22. Chapter 10: Addressing reporting biases. In: Higgins JPT, Churchill R, Chandler J, Cumpston MS editors. Cochrane handbook for systematic reviews of interventions version 5.2.0 (updated June 2017). Cochrane;2017 [Cited 2025 March 26]. Available from: https://training.cochrane.org/handbook.
23. Chandrababu A, Kumar S, Goli A. Antibiotic prophylaxis with episiotomy—Is it necessary?. MGM J Med Sci. 2019;6(1):19–21.
24. Garala N, Nambiar S. Prophylactic antibiotics in patients with episiotomy following normal vaginal delivery: a randomised clinical trial. Int J Reprod Contracept Obstet Gynecol. 2019;8(10):3846.
25. Gommesen D, Nohr EA, Drue HC, Qvist N, Rasch V. Obstetric perineal tears: risk factors, wound infection and dehiscence: a prospective cohort study. Arch Gynecol Obstet. 2019;300(1):67–77. pmid:31004221
26. Goodarzi G, Rajabian S, Ahmadian M, Kalateh A. Comparing the incidence of episiotomy site infection in two groups of primiparas with and without taking prophylactic antibiotics after normal vaginal delivery referred to bent al-huda hospital in Bojnourd. J Obstet Gynecol Cancer Res. 2020;5(2):31–8.
27. Humphreys ABC, Linsell L, Knight M. Factors associated with infection after operative vaginal birth-a secondary analysis of a randomized controlled trial of prophylactic antibiotics for the prevention of infection following operative vaginal birth. Am J Obstet Gynecol. 2023;228(3):328.e1–328.e11. pmid:36027955
28. Sebitloane HM, Moodley J, Esterhuizen TM. Prophylactic antibiotics for the prevention of postpartum infectious morbidity in women infected with human immunodeficiency virus: a randomized controlled trial. Am J Obstet Gynecol. 2008;198(2):189.e1–6. pmid:17997391
29. Tandon AN, Dalal AR. A Randomized, open-labelled, interventional study to evaluate the incidence of infection with or without use of prophylactic antibiotics in patients of episiotomy in a normal vaginal delivery. J Obstet Gynaecol India. 2018;68(4):294–9. pmid:30065545
30. Cox CK, Bugosh MD, Fenner DE, Smith R, Swenson CW. Antibiotic use during repair of obstetrical anal sphincter injury: a quality improvement initiative. Int J Gynaecol Obstet. 2022;156(1):95–101. pmid:33507531
31. Lewicky-Gaupp C, Leader-Cramer A, Johnson LL, Kenton K, Gossett DR. Wound complications after obstetric anal sphincter injuries. Obstet Gynecol. 2015;125(5):1088–93. pmid:25932836
32. Propst K, Yao M, Hickman LC. Impact of peripartum antibiotics on wound complications in women with obstetric anal sphincter injury. Int J Gynaecol Obstet. 2023;161(2):491–8. pmid:36306399
33. Thongtip N, Srilar A, Luengmettakul J. The incidence and associated factors of perineal wound infection following vaginal delivery in Charoenkrung Pracharak hospital, Bangkok, Thailand. Thai J Obstet Gynaecol. 2023;31:145–53.
34. Yılmaz E, Özdemir O, Demir MF, Tunç T, Soysal Ç, Vural Yılmaz Z. Could subcutaneous rifampicin administration be an effective approach for reducing episiotomy infections?. Eur Rev Med Pharmacol Sci. 2024;28(1):357–64. pmid:38235887
35. Neto S GJ, de Andrade LF. Clinical evaluation of the chloramphenicol use as a prophylactic antibiotic in the vaginal delivery with episiotomy [Avaliacao clinica do emprego do cloranfenicol como antibiotico profilatico no parto normal com episiotomia]. Arq Catarin Med. 1990;19(2):97–102.
36. Propst K YM, Hickman L. Impact of intrapartum prophylactic antibiotics on bowel and bladder function in women with obstetric anal sphincter injury. Female Pelvic Med Reconstr Surg. 2022;28(6 Supplement 1):S194–5.
37. Buppasiri P, Lumbiganon P, Thinkhamrop J, Thinkhamrop B. Antibiotic prophylaxis for third- and fourth-degree perineal tear during vaginal birth. Cochrane Database Syst Rev. 2014;2014(10):CD005125. pmid:25289960
38. Šumilo D, Nirantharakumar K, Willis BH, Rudge GM, Martin J, Gokhale K, et al. Long term impact of prophylactic antibiotic use before incision versus after cord clamping on children born by caesarean section: longitudinal study of UK electronic health records. BMJ. 2022;377:e069704. pmid:35580876
39. Baur D, Gladstone BP, Burkert F, Carrara E, Foschi F, Döbele S, et al. Effect of antibiotic stewardship on the incidence of infection and colonisation with antibiotic-resistant bacteria and Clostridium difficile infection: a systematic review and meta-analysis. Lancet Infect Dis. 2017;17(9):990–1001. pmid:28629876
40. Arendsen LP, Thakar R, Bassett P, Sultan AH. A double blind randomized controlled trial using copper impregnated maternity sanitary towels to reduce perineal wound infection. Midwifery. 2021;92:102858. pmid:33157498
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Abstract
Introduction
Childbirth-related perineal trauma affects the vast majority of women who give birth vaginally and subsequent complications such as wound infection occur frequently. Antibiotic prophylaxis is not currently recommended following first or second degree tears, or episiotomies. We aimed to evaluate the effectiveness of prophylactic antibiotics for preventing complications from perineal trauma across all types of childbirth-related perineal trauma.
Materials and methods
Databases were searched from inception to February 2024. Randomised controlled trials, non-randomised interventional studies and observational studies were eligible for inclusion where women experienced childbirth-related perineal trauma and received antibiotic prophylaxis or placebo, including any type of tear or episiotomy. The primary outcome was perineal wound infection. Results were combined into meta-analysis using a random effects model.
Results
14 studies were eligible for inclusion (eight randomised controlled trials, six observational) involving 8,878 women. Ten studies were deemed to have a high overall risk of bias. Overall the GRADE certainty of findings were low. Twelve studies were included in the analysis for perineal wound infection, involving 8,438 women. There was a reduced rate of perineal wound infection when prophylactic antibiotics were received (relative risk 0.57, 95% confidence interval 0.48 to 0.67). The subgroup analysis by type of tear demonstrated association with reduced risk of infection when prophylactic antibiotics were received, in the non-obstetric anal sphincter injuries combined subgroup (relative risk 0.50, 95% confidence interval 0.41–0.63) and the episiotomy only subgroup (relative risk 0.57, 95% confidence interval 0.36–0.91).
Conclusions
Prophylactic antibiotics are associated with a reduced risk of perineal wound infection. Despite these findings, there are not sufficient high-quality randomised controlled trials to adequately inform guideline change amongst women with first/second degree tears or episiotomies. We recommend that an adequately powered, robust, randomised controlled trial is needed amongst women with first/second degree tears or episiotomies after spontaneous birth.
You have requested "on-the-fly" machine translation of selected content from our databases. This functionality is provided solely for your convenience and is in no way intended to replace human translation. Show full disclaimer
Neither ProQuest nor its licensors make any representations or warranties with respect to the translations. The translations are automatically generated "AS IS" and "AS AVAILABLE" and are not retained in our systems. PROQUEST AND ITS LICENSORS SPECIFICALLY DISCLAIM ANY AND ALL EXPRESS OR IMPLIED WARRANTIES, INCLUDING WITHOUT LIMITATION, ANY WARRANTIES FOR AVAILABILITY, ACCURACY, TIMELINESS, COMPLETENESS, NON-INFRINGMENT, MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. Your use of the translations is subject to all use restrictions contained in your Electronic Products License Agreement and by using the translation functionality you agree to forgo any and all claims against ProQuest or its licensors for your use of the translation functionality and any output derived there from. Hide full disclaimer