A UAB-UNC School of Medicine collaboration found that a single oral dose of the common antibiotic azithromycin reduced the risk of maternal sepsis or death by 33 percent in women who delivered vaginally. UNC School of Medicine study leads were Melissa Bauserman, MD, MPH, Carl Bose, MD, and Jackie Patterson, MD, MPH.
CHAPEL HILL, N.C. – Ten percent of maternal deaths are caused by infections that occur shortly before, during, or after delivery.
Maternal infections and sepsis, which is a serious complication of infections, are among the top five causes of maternal mortality worldwide. Maternal infection also increases the risk of neonatal sepsis, which accounts for 16 percent of newborn deaths.
A new study published today in the New England Journal of Medicine provides evidence that a single oral dose of azithromycin, a common antibiotic, reduced the risk of maternal sepsis or death by 33 percent in women who delivered vaginally. Published results were presented simultaneously at the Society for Maternal-Fetal Medicine’s annual meeting in San Francisco, California.
The Azithromycin Prevention in Labor Use Study, or A-PLUS trial, led by investigators from the University of Alabama at Birmingham’s Marnix E. Heersink School of Medicine and conducted in collaboration with the University of North Carolina School of Medicine, found that azithromycin given to patients planning vaginal delivery reduced maternal infections.
The trial was conducted in rural DRC by leaders from the UNC-Kinshasa School of Public Health research partnership, a twenty-year collaboration between the School of Public Health in Kinshasa, Democratic Republic of the Congo (DRC) and UNC. The collaboration, which includes UNC School of Medicine faculty members Melissa Bauserman, MD, MPH, Carl Bose, MD, and Jackie Patterson, MD, MPH, has resulted in high-quality research in the Democratic Republic of the Congo.
The trial was conducted at eight sites in seven low- and middle-income countries in Africa, Asia, and Latin America, with the UNC- Kinshasa School of Public Health site located in the Democratic Republic of the Congo. These sites are part of the Eunice Kennedy Shriver National Institute of Child Health and Human Development Global Network for Women and Children’s Health Research.
“We are proud that UNC could partner with the Kinshasa School of Public Health and the NICHD Global Network for Women’s and Children’s Health Research to find a low-cost, easily administered therapy that has been proven to reduce maternal sepsis and death in low-income countries,” said Dr. Bauserman, associate professor of neonatal-perinatal medicine in the UNC Department of Pediatrics, member of the UNC Children’s Research Institute, and Principal Investigator of the UNC-Kinshasa School of Public Health Research Site. “These types of interventions are critically needed to save the lives of women around the globe.”
From September 2020 to August 2022, more than 29,000 women were randomized to either an active or placebo group. Those in the active group were given a single 2-gram dose of azithromycin. Maternal sepsis or death, the study’s primary outcome, occurred in 1.6 percent of women in the active group versus 2.4 percent in the placebo group.
Additionally, rates of several secondary outcomes including specific maternal infections such as endometritis, wound infections and urine infections were lower in the azithromycin group.
While findings showed azithromycin reduced the risk of maternal sepsis or death, the intervention did not reduce the risk of sepsis or death in newborns. However, there were no adverse newborn effects.
“The A-PLUS Study is just one example of critical evidence produced by the UNC- KSPH Partnership,” said Dr. Patterson, assistant professor of neonatal-perinatal medicine in the UNC Department of Pediatrics and member of the UNC Children’s Research Institute. “Our research continues to focus on the study and implementation of interventions that improve women’s and children’s health in low-income settings.”
Funding for the trial was provided by The Eunice Kennedy Shriver National Institute of Child Health and Human Development and a grant from the Foundation for the National Institutes of Health through the Maternal, Newborn & Child Health Discovery & Tools initiative of The Bill and Melinda Gates Foundation.
Media contact: Kendall Daniels, Communications Specialist, UNC Health | UNC School of Medicine