Prophylactic antibiotic beneficial for women undergoing operative vaginal delivery

Reference

Knight M, Chiocchia V, Partlett C, et al, for the ANODE collaborative group. Prophylactic antibiotics in the prevention of infection after an operative delivery (ANODE): a multicenter randomised trial. Lancet 2019;393(10189):2395-2403.

Synopsis

This large multicenter randomized controlled trial was undertaken in 27 centers in the United Kingdom to determine whether a single dose of intravenous amoxicillin with clavulanic acid given as soon after an operative vaginal delivery as possible (always within 6 hours) reduces infectious complications. Women were included if they were at least 16 years old and had operative vaginal delivery (forceps or vacuum) at 36 or more weeks' gestation. Women were excluded if they had intrapartum antibiotics therapy for an infection or any other indication after delivery, including repair of a third- or fourth-degree perineal tear, or if they were allergic to the antibiotic studied. Women were not excluded if they had intrapartum antibiotic prophylaxis for other reasons, such as prolonged rupture of membranes. There were 3427 women randomized to receive treatment; 7 women withdrew after allocation. Treatment with 1 g amoxicillin / 200 mg clavulanic acid was compared with 20 mL 0.9 % saline solution in a double-blinded fashion. The primary outcome was confirmed or suspected maternal infection within 6 weeks after birth, defined as a new prescription of antibiotics presumed to be for perineal wound or uterine infection, as well as other systemtic infection. Data for the primary outcome data were available for 94% of participating women. The primary outcome was significantly reduced among women who received prophylactic treatment (180/1619 [11%] vs 306/1606 [19%]; relative risk 0.58, 95% CI 0.49 - 0.69; P < 0.001; number needed to treat 13, 10 - 18). Four planned sensitivity analyses were consistent with the main analysis, including no differences based on whether the operative delivery was with forceps or vacuum. At 6 weeks after delivery, women assigned to the antibiotic group used fewer healthcare resources related to general practitioner visits, home visits, and hospital outpatient visits. Also at 6 weeks, postpartum outcomes, such as perineal pain and perineal wound breakdown, favored the treated group. Two women in the antibiotic treatment group had allergic reactions, one of which was considered to be a serious adverse event, but was not an anaphylactic reaction.