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RTI-supported clinical trial finds single-dose antibiotic significantly reduced the risk of maternal sepsis or death

Results suggest a low-cost approach to reduce maternal mortality in low- and middle-income countries 


RESEARCH TRIANGLE PARK, N.C. – RTI International, a nonprofit research institute, took part in a large multinational clinical trial that found 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.

Sepsis is a severe infection in the body that can lead to tissue damage, organ failure, and death and 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.

“Sepsis is a major global public health problem in low- and middle-income countries where women deliver babies predominantly vaginally,” said Elizabeth McClure, Ph.D., a perinatal epidemiologist in the Center for Clinical Research Network Coordination at RTI. “Our research shows that just one dose of azithromycin may be an effective, low-cost option to reduce sepsis and maternal deaths.”

The study, funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and the Foundation for the National Institutes for Health (through a grant from the Bill & Melinda Gates Foundation), enrolled more than 29,000 women in seven low- and middle-income countries in sub-Saharan Africa, south Asia and central America. 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 a placebo. Azithromycin did not reduce the risk of stillbirth, newborn sepsis or newborn death.

“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 Diana W. Bianchi, M.D., director of NICHD, which is part of the National Institutes of Health. “We urgently need effective strategies to prevent pregnancy-related infections, which account for roughly 10% of maternal deaths worldwide.”

Results of the study were published today in The New England Journal of Medicine and presented at the Society for Maternal-Fetal Medicine’s 43rd Annual Pregnancy Meeting.

About RTI International  
RTI International is an independent, nonprofit research institute dedicated to improving the human condition. Clients rely on us to answer questions that demand an objective and multidisciplinary approach — one that integrates expertise across the social and laboratory sciences, engineering and international development. We believe in the promise of science, and we are inspired every day to deliver on that promise for the good of people, communities and businesses around the world. For more information, visit www.rti.org.

About the Foundation for the National Institutes of Health
The Foundation for the National Institutes of Health (FNIH) connects the world’s leading public and private organizations to accelerate biomedical breakthroughs for patients, regardless of who they are, where they live, or what disease they have. Together with leading scientists and problem-solvers, and a successful track record of navigating complex problems, the FNIH accelerates new therapies, diagnostics, and potential cures; advances global health and equity in care; and celebrates and trains the next generation of scientists. Established by Congress in 1990 to support the mission of the NIH, the FNIH is a not-for-profit 501(c)(3) charitable organization. For more information about the FNIH, please visit fnih.org.