Azithromycin Prevention in Labor Use Study (A-Plus)

Overview

The Azithromycin Prevention in Labor Use Study (A-PLUS) assessed low-cost, sustainable interventions to improve maternal and child health. The study was conducted in partnership with the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) via its Global Network for Women's and Children's Health Research, which supports and conducts clinical trials in low- and middle-income countries by pairing foreign and U.S. investigators. Funding for the study was provided in part through a grant from the Bill & Melinda Gates Foundation to the FNIH.

A-PLUS researchers examined the safety and effectiveness of a single oral dose of intrapartum azithromycin compared to placebo (both in addition to standard of care) in reducing the risk of neonatal and maternal sepsis or death in laboring women. The results were positive, showing that azithromycin reduced the occurrence of sepsis and death by approximately a third.

As a next step, the A-PLUS investigators hope to enable a change to the current standard of care by adding this simple preventive intervention. This large study has great potential to inform and update the World Health Guidelines (WHO) to improve the outcomes of laboring mothers globally.

Goals

• Evaluate the role of a single oral dose of azithromycin (plus usual care) to prevent maternal death or peripartum sepsis and intrapartum/neonatal death or sepsis in laboring women as well as in a targeted sub-population of women at the highest risk for infection (i.e., because they have prolonged labor of 218 hours, and/or prolonged membrane rupture of 28 hours).
• Study whether a successful prophylaxis intervention significantly reduces the rate of infections and deaths, as well as the need for prolonged antibiotic therapy and associated costs of treating drug- resistant infections.

Scientific Publication

Tita A, Carlo W, McClure E, et al. Azithromycin to Prevent Sepsis or Death in Women Planning a Vaginal Birth. N Engl J Med. 2023;388:xxx-xxx.

Media

FNIH Press Release (February 9, 2023): The FNIH Announces Results of a New Study Published in the New England Journal of Medicine Showing a Single Dose of Azithromycin Reduced Maternal Sepsis by 35%  Read more

NICHD Press Release (February 9, 2023): Single-dose antibiotic prevents maternal sepsis and death. Read more

FNIH Announcement (June 3, 2020): FNIH Launches Project Testing Antibiotic to Prevent Infections in Mothers and Newborns Read more