Prophylactic Antibiotic Reduces Risk of Infection by 56% Following Operative Vaginal Birth

A new study by investigators in the United Kingdom offers evidence to support the idea that a single dose of prophylactic antibiotic following operative vaginal birth may help prevent dangerous infections in new mothers.

Infections following childbirth are 1 of the leading causes of maternal mortality worldwide, according to the World Health Organization (WHO) and, although most women survive severe postnatal infections, there can be long-term health effects. A recent article published online in The Lancet explores the risk factors for maternal infections and details findings from the prophylactic antibiotics for the prevention of infection following operative delivery (ANODE) trial, which was conducted in the UK and sponsored by the University of Oxford.

“Without prophylaxis, an estimated 20-25% of women have an infection following caesarean birth, and up to 16% have an infection following operative vaginal birth,” the investigators write, noting that although strong evidence has contributed to recommendations for antibiotic prophylaxis for caesarean sections, there is far less research on the use of antibiotics following operative vaginal births, which include deliveries involving forceps or vacuum extraction. “Given the insufficient evidence of benefit of antibiotic prophylaxis after operative vaginal birth, we therefore did a randomized controlled trial to investigate whether a single dose of prophylactic amoxicillin and clavulanic acid was clinically and cost-effective for preventing confirmed or suspected maternal infection and other maternal outcomes.”

From March 13, 2016, to June 13, 2018, investigators enrolled women aged 16 years and older who had undergone operative vaginal birth at 36 weeks or greater gestation from 27 hospital obstetric units in the UK. Trial participants had no indication for ongoing prescription of antibiotics in the post-partum period and no contraindications to prophylactic amoxicillin and clavulanic acid. A total of 3420 women were included in the primary analysis, with 1715 in the amoxicillin and clavulanic acid group and 1705 in the placebo group. Among trial participants, 2234 (65%) had births by forceps and 1196 (35%) by vacuum extraction.

The study team found that women receiving a single dose of a prophylactic antibiotic had a 56% reduction in the risk of confirmed systemic infection on culture compared with women receiving placebo. Side effects were reported in only 1 participant in the placebo group who experienced a skin rash and 2 participants in the amoxicillin and clavulanic acid group who had allergic reactions. “At 6-weeks post-delivery, the proportions of women with perineal infection, perineal pain, use of pain relief for perineal pain, and need for additional perineal care and wound breakdown were significantly lower among women allocated to the amoxicillin and clavulanic acid group compared with the placebo group,” the investigators concluded. “Women allocated to the amoxicillin and clavulanic acid group were also significantly less likely to report that their perineum was ever too uncomfortable to feed their baby, or to report any primary care physician or home visits or any hospital outpatient visits.”

Upon further analysis, investigators found that each additional 100 doses of antibiotic used as prophylaxis can save 168 treatment doses, leading to a 17% overall reduction in antibiotic use with a policy of universal prophylaxis. The trial’s findings, according to the research team, indicate that there is an urgent need to change current clinical practice in women following operative vaginal birth to prevent maternal morbidity and a cause to update WHO guidelines for the prevention of maternal infection.