Preventing Sepsis in Laboring Mothers Worldwide
Maternal and neonatal sepsis is one of the top three causes of maternal and newborn deaths globally. To address this pressing issue and urgent global need, the Azithromycin Prevention in Labor Use Study (A-PLUS) was conducted by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)’s Global Network for Women’s and Children’s Health Research and was co-funded by NICHD and the FNIH, with support to the FNIH provided by a grant from the Bill & Melinda Gates Foundation. The study assessed low-cost, sustainable interventions to improve maternal and child health in low- and middle-income countries.
After a rigorous process of training and pilot-testing, investigators examined the safety and effectiveness of a single oral dose of azithromycin administered during labor (compared to placebo) in reducing the risk of neonatal and maternal sepsis or death in laboring women. The results were very promising, suggesting that azithromycin can reduce the occurrence of maternal sepsis and death by approximately one-third.
“The A-PLUS study has remarkable potential to protect maternal health and represents a significant advancement, especially for women who cannot access modern obstetrical care.”Julie Gerberding, President and CEO, FNIH
“The A-PLUS study has remarkable potential to protect maternal health and represents a significant advancement, especially for women who cannot access modern obstetrical care,” explained Julie Gerberding, CEO, FNIH.
Following the study, investigators rapidly analyzed the quality of the data and results to enable open access to the findings in a timely manner. An abstract was submitted to the world’s premier pregnancy conference, the Society for Maternal-Fetal Medicine’s Annual Pregnancy Meeting (SMFM). The abstract was accepted and became the #1 late-breaking presentation at the conference in February 2023. The study investigators also submitted a manuscript to the New England Journal of Medicine (NEJM), which was accepted and published as the conference presentation was being delivered.
As a next step, the A-PLUS investigators will follow up with a subset of the mothers and infants to examine potential antimicrobial resistance at multiple points in time, up to a year after initial delivery, as a further safety measure. The study findings could result in a change to the current standard of care by adding this simple preventive intervention – an adjustment that could save millions of lives.