Sepsis — a severe infection in the body that can lead to tissue damage, organ failure, and death — is among the top causes of maternal deaths worldwide, according to the World Health Organization (WHO).


It is a life-threatening emergency that is largely preventable with early diagnosis and treatment and may disproportionately affect pregnant people in low- and middle-income countries. WHO has identified reducing maternal deaths, including death from sepsis, as a top global health priority.

In a new study presented at the Society for Maternal-Fetal Medicine’s (SMFM) annual meeting, The Pregnancy Meeting™ — and published in the American Journal of Obstetrics & Gynecology   – researchers unveiled findings that suggest that a single dose of azithromycin given to women planning a vaginal delivery significantly reduced the risk of maternal death or sepsis.

The randomized control trial included 29,278 participants in eight sites of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Global Network for Women’s and Children’s Health Research in Africa (Democratic Republic of Congo, Kenya, and Zambia); Asia (Bangladesh, Pakistan,  and two sites in India); and Latin America (Guatemala).

Participants were randomized to receive either azithromycin — a popular, low-cost antibiotic used to treat a wide variety of bacterial infections and is on the WHO’s List of Essential Medicines — or a placebo. All participants were at least 28 weeks pregnant with a planned vaginal delivery at a healthcare facility.

Overall, 14,590 people received azithromycin and 14,688 received a placebo. All participants were followed for 42 days after delivery, ensuring alignment with the WHO’s definition of maternal mortality, which includes death during pregnancy and within 42 days following delivery.

Reduced risk

Researchers found that a single dose of azithromycin, given orally, reduced the risk of maternal death or sepsis by 33 percent in women who delivered vaginally. In addition, researchers discovered several secondary findings, including fewer hospital readmissions and emergency visits among patients who received azithromycin.

“International organizations identified severe maternal infections leading to death as a major global health problem, especially in developing counties, and there had been little progress over time,” says the study’s lead author Alan Thevenet N. Tita, MD, PhD, a maternal-fetal medicine subspecialist at the University of Alabama at Birmingham Marnix E. Heersink School of Medicine, where he holds several positions, including associate dean for Global and Women’s Health; Mary Heersink Endowed Chair of Global Health and Director of the Global Health Institute; and director of the university-wide interdisciplinary Center for Women’s Reproductive Health.

“We wanted to alleviate the burden of maternal infections in populations that give birth predominantly vaginally. Our research shows that just one dose of azithromycin may be a useful, low-cost intervention to reduce sepsis and attendant maternal deaths.”

The study was funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the Foundation for the National Institutes for Health (through a grant from the Gates Foundation).

The complete study is also being published simultaneously in the New England Journal of Medicine.