Current World Health Organization (WHO) guidelines do not recommend routine antibiotic prophylaxis for women undergoing operative vaginal birth — ie, with forceps or vacuum extraction — to reduce the risk for infection due to a lack of evidence of its efficacy. However, according to study results published in the Lancet, women who received a single prophylactic dose of amoxicillin and clavulanic acid following operative vaginal delivery were less likely to develop an infection compared with women who received saline.
Researchers conducted a blinded randomized controlled trial at 27 obstetric units in pregnant women age ≥16 years following operative vaginal birth at ≥36 weeks’ gestation. Women were randomly assigned (1:1) to receive either a 1-time intravenous dose of 1 g of amoxicillin and 200 mg of clavulanic acid as soon as possible following operative vaginal delivery (≤6 hours) or 20 mL of saline (placebo) within the same timeframe.
The primary outcome was confirmed or suspected maternal infection within 6 weeks of delivery, which was confirmed by a new prescription for antibiotics for presumed perineal wound-related infection, endometriosis or uterine infection, urinary tract infection with systemic manifestations, or other systemic infection. Secondary outcomes included systemic sepsis, surgical site infection, perineal pain, use of pain relief, hospital bed stay until discharge, as well as other maternal-related morbidities. All serious adverse events were reported within 24 hours of giving birth.
A total of 1715 women were included in the amoxicillin and clavulanic acid group and 1705 in the placebo group. Women allocated to the treatment group received amoxicillin and clavulanic acid at a median of 3.2 hours following delivery; women in the placebo group received saline at a median of 3.1 hours after giving birth. A smaller group of women in the treatment group developed a confirmed or suspected infection (11%) compared with women who were allocated to the placebo group (19%). The percentage of women with confirmed systemic infection on culture was reduced in the treatment group compared with the placebo group (0.6% vs 1.5%, respectively).
The number of women with secondary outcomes including perineal infection, pain, and use of pain relief was significantly lower in women in the treatment group compared with the placebo group. Adverse events were reported by 3 women: 1 in the placebo group and 2 in the treatment group.
“This trial shows benefit of a single dose of prophylactic antibiotic after operative vaginal birth and guidance from WHO and other national organisations should be changed to reflect this,” the investigators concluded.
Knight M, Chiocchia V, Partlett C, et al. Prophylactic antibiotics in the prevention of infection after operative vaginal delivery (ANODE): a multicentre randomised controlled trial [published online May 13, 2019]. Lancet. doi:10.1016/S0140-6736(19)30845-1