Azithromycin-Prevention in Labor Use Study (A-PLUS)

Brief summary

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. Recently, a randomized clinical trial conducted in a single site in The Gambia showed that treatment with oral dose of 2 g azithromycin vs. placebo for all women in labor reduced selected maternal and neonatal infections. However, it is unknown if this therapy reduces maternal and neonatal sepsis and mortality. The A-PLUS trial includes two primary hypotheses, a maternal hypothesis and a neonatal hypothesis. First, a single, prophylactic intrapartum oral dose of 2 g azithromycin given to women in labor will reduce maternal death or sepsis. Second, a single, prophylactic intrapartum oral dose of 2 g azithromycin given to women in labor will reduce intrapartum/neonatal death or sepsis.

Source: ClinicalTrials.gov (U.S. National Library of Medicine), data processed 2026-10-29T09:00:05; modifications: selected fields only; whitespace normalized; brief summary truncated to 2,000 characters. Not a U.S. Government endorsement.

Trial details

status

COMPLETED

phase

PHASE3

study type

INTERVENTIONAL

enrollment

58747

sponsor

NICHD Global Network for Women's and Children's Health

conditions

Maternal Death; Maternal Infections Affecting Fetus or Newborn; Neonatal SEPSIS; Maternal Sepsis During Labor; Neonatal Death; Postpartum Sepsis

interventions

DRUG: Azithromycin; DRUG: Placebo

start date

2020-09-01

start date type

ACTUAL

primary completion date

2022-09-30

has results

true

data source

ClinicalTrials.gov

data processed

2026-10-29T09:00:05

modifications

selected fields only; whitespace normalized; brief summary truncated to 2,000 characters