Azithromycin to Prevent Sepsis or Death in Women Planning a Vaginal Birth
Abstract
This Original Article from the A-PLUS Trial Group evaluates whether a single 2-g oral dose of azithromycin during labor reduces maternal and neonatal sepsis or death in women planning vaginal deliveries. In this multicountry, double-blind, placebo-controlled randomized trial across seven low- and middle-income countries, 29,278 women were enrolled. The azithromycin group had significantly lower incidence of maternal sepsis or death (1.6% vs. 2.4%) with a relative risk of 0.67. The reduction was primarily due to decreased maternal sepsis, while neonatal outcomes stillbirth, sepsis, or death showed no significant differences. Azithromycin reduced risks of endometritis, wound infections, and unscheduled visits, with no increase in adverse effects or antimicrobial resistance. The trial was stopped early due to clear maternal benefit, with findings supporting azithromycin prophylaxis during labor as a safe, effective strategy to reduce maternal infection.