Current Research: A randomized, placebo-controlled, parallel multicenter clinic trial to assess whether a single, prophylactic intrapartum oral dose of 2g azithromycin given to women in labor will reduce (1) maternal death or sepsis and (2) intrapartum/neonatal death or sepsis.
Maternal and neonatal infections are among the most frequent causes of maternal and neonatal deaths, and current antibiotic strategies have not been effective in preventing many of these deaths. There is evidence that treatment with an oral dose of 2 g azithromycin vs. placebo for women in labor reduced certain maternal and neonatal infections. However, it is unknown if this therapy reduces maternal and neonatal sepsis and mortality. The A-PLUS Trial (Azithromycin-Prevention in Labor Use Study) will assess the effect of a single oral 2 g dose of azithromycin given to women in labor on the prevention of maternal and neonatal deaths and infection. The trial will enroll 34,000 pregnant women at eight research sites in Latin America, South Asia, and sub-Saharan Africa who are in labor, ≥28 weeks gestational age with a live fetus pregnancy, and plan to deliver vaginally in a facility. The trial includes two primary hypotheses: (1) a single, prophylactic intrapartum oral dose of 2 g azithromycin given to women in labor will reduce maternal death or sepsis; (2) a single, prophylactic intrapartum oral dose of 2 g azithromycin given to women in labor will reduce intrapartum/neonatal death or sepsis. There will also be a sub-study to assess the effect of the intervention on antimicrobial resistance and microbiome diversity.