Risk of infection and wound dehiscence after use of prophylactic antibiotics in episiotomy or second degree tear (REPAIR study): single centre, double blind, placebo-controlled randomised trial

1. Prophylactic antibiotics reduced the risk of clinically relevant wound complications but not overall wound complications in women with episiotomies and second-degree tears. 

Evidence Rating Level: 1 (Excellent)

Study Rundown:

Obstetric tears after vaginal delivery affect millions of women globally every year. Research on prevention and management of healing-related complications is lacking, particularly the role of prophylactic antibiotics in women with episiotomies and second-degree tears. This study thus examined the effect of prophylactic antibiotics on the risk of wound complications after episiotomy or second-degree tear regardless of mode of vaginal delivery. 

This single-centre, double blind, placebo-controlled randomised trial conducted in Denmark included women >18 years with second-degree tear or mediolateral episiotomy. Participants were randomized 1:1 to the treatment or placebo groups. During the first day postpartum, the treatment group received three doses of oral antibiotics, while the placebo group received three placebo tablets. The primary outcome was wound complications, and the secondary outcome was clinically relevant wound complications that required clinical follow-up due to the extent of dehiscence, severity of pain, or infection. Among the 433 participants included in the analysis, 218 were in the treatment group and 215 in the placebo group. There were no significant differences in overall wound complications between treatment and placebo groups. However, fewer clinically relevant wound complications occurred in the treatment group compared to the placebo group. For clinically relevant wound complications, the number needed to treat was 12. 

Overall, this study found no significant associations between prophylactic antibiotics and overall wound complications, although antibiotics reduced the risk of clinically relevant wound complications in women with episiotomies and second-degree tears. 

Click here to read the study in BMJ 

Relevant reading: Prophylactic antibiotics in the prevention of infection after operative vaginal delivery (ANODE): a multicentre randomised controlled trial

In-Depth [randomised controlled trial]:

This trial was conducted at a hospital in Denmark between March 2023 and January 2024 and included 442 women >18 years with second-degree tear or mediolateral episiotomy. Participants were randomized 1:1 to the treatment or placebo groups. During the first day postpartum, the treatment group received three doses of oral antibiotics (500 mg amoxicillin and 125 mg clavulanic acid) while the placebo group received three placebo tablets (calcium). The first dose was given within six hours postpartum, and then every eight hours. Clinical consultations were conducted four to 14 days postpartum. The primary outcome was wound complications (dehiscence > 5mm, wound infection with purulent discharge or abscess, or both). The secondary outcomes were clinically relevant wound complications that required clinical follow-up due to dehiscence >10mm, pain severity score > 5 on visual analogue scale or pain reported by the patient to have affected their daily life, or infection. 

In total, 433 participants completed follow-up, of which 218 were in the treatment group (mean [SD] age = 31 [4.6] years) and 215 in the placebo group (mean [SD] age = 32 [4.1] years). There were 109 (25%) women with wound complications reported, including 19 infections, and 55 (13%) with clinically relevant wound complications. There were no significant differences in overall wound complications between treatment and placebo groups (treatment 47/218, 22%; placebo 62/215, 29%; P=0.10). However, fewer clinically relevant wound complications occurred in the treatment group compared to the placebo group (19/218, 9% v 36/215, 17%; P=0.01), with a risk difference of −8.0% (95% CI −14.3% to −1.8%) and a relative risk of 0.52 (0.31 to 0.88). For clinically relevant wound complications, the number needed to treat was 12 (95% CI 7 to 56). No serious adverse reactions were reported. Overall, this study found no significant associations between prophylactic antibiotics and overall wound complications, although antibiotics reduced the risk of clinically relevant wound complications in women with episiotomies and second-degree tears. Some strengths of this study included a low drop-out rate, a short timeframe that reduced the risk of change in clinical practice, and the use of oral antibiotics, which the World Health Organization recognizes as a practical alternative to intravenous treatment. Limitations of this study included selection bias due to a single-center design that included only Danish-speaking women, which may have limited generalizability. Future studies should confirm this study’s findings in other populations.  

Image: PD

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