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NIH Record - 75th Anniversary - National Institutes of Health

Single-Dose Antibiotic Prevents Maternal Sepsis, Death

Pregnant woman stands with back to wall, cradling her baby bump.

In addition to a reduced risk of maternal sepsis and death after delivery, women who received azithromycin were less likely to develop endometritis (infection of the lining of the womb) and other infections.

Photo: Somnath Mahata/Shutterstock

A single oral dose of the antibiotic azithromycin can reduce the risk of postpartum sepsis and death among women who deliver vaginally by one-third, based on a large, NIH-funded multi-country clinical trial. 

Only 1.6% of women in the study who received azithromycin during labor developed sepsis or died within six weeks after delivery, compared to 2.4% of those who received placebo. Azithromycin did not reduce the risk of stillbirth, newborn sepsis or newborn death.

Results from the study, which enrolled more than 29,000 women in seven low- and middle-income countries, were published in the New England Journal of Medicine.

“These findings have the potential to change clinical practice by providing a safe, effective and low-cost approach to reduce the global burden of maternal sepsis and death,” said Dr. Diana Bianchi, director of NICHD, the primary funder of the trial. “We urgently need effective strategies to prevent pregnancy-related infections, which account for roughly 10% of maternal deaths worldwide.”

The trial, called A-PLUS, was co-funded by the Bill & Melinda Gates Foundation through a grant to the Foundation for the National Institutes of Health, a non-profit organization that manages multinational research projects implemented through alliances with public and private institutions in support of the NIH mission. NICHD’s Global Network for Women’s and Children’s Health Research conducted the study.

Sepsis—a life-threatening complication of bacterial and other infections—is a leading cause of maternal and newborn deaths worldwide, especially in low- and middle-income countries. Azithromycin, an inexpensive antibiotic effective against a broad range of bacteria, is known to reduce maternal infection when given intravenously during cesarean delivery. 

Launched in 2020, A-PLUS enrolled women at NICHD Global Network sites in Bangladesh, the Democratic Republic of the Congo, Guatemala, India, Kenya, Pakistan and Zambia. 

In addition to a reduced risk of maternal sepsis and death after delivery, women who received azithromycin were less likely to develop endometritis (infection of the lining of the womb) and other infections. They also had fewer hospital readmissions and unscheduled health care visits, compared to the placebo group.

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