Indiana and Kenyan Investigators Partner in Multi-Country Clinical Trial to Reduce Maternal Sepsis
Debbie Ungar Feb 23, 2023
A team from Indiana University School of Medicine and Moi University School of Medicine in Kenya led one of eight sites in seven countries contributing to the A-Plus study that showed that 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.
The Global Network for Women's and Children's Health Research conducted the trial with the results published this month in the New England Journal of Medicine.
Professor Fabian Esamai, MBChB, MMed, MPH, PhD, and Paul Nyongesa, MBChB, MMed (ObGy), PhD (ANT), from Moi University and Sherri Bucher, PhD, MA, and Osayame Ekhaguere, MBBS, MPH, MSc, from IU led the Kenya site which enrolled 3,673 mothers. Overall the study enrolled 29,000 mothers in Bangladesh, the Democratic Republic of the Congo, Guatemala, India, Kenya, Pakistan and Zambia. The original study design called for enrolling 34,000 mothers, but the clear maternal benefit resulted in the study concluding early.
“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 NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), in a press release about the study. “We urgently need effective strategies to prevent pregnancy-related infections, which account for roughly 10 percent of maternal deaths worldwide.” NICHD was the primary funder of the trial along with the Bill & Melinda Gates Foundation and the Foundation for the National Institutes of Health.
“The top three causes of maternal mortality are infections, hypertensive disorders and hemorrhage,” said Professor Esamai, professor of child health and pediatrics at Moi University. “If widely adopted and scaled-up, this simple intervention could potentially save thousands of lives of new mothers every year.”
“No baby should ever be left motherless, for lack of access to basic medications,” added Dr. Bucher, associate professor of pediatrics at IU. “Through this study and others like it, we know these interventions save lives, but moving from knowledge to implementation will be the next challenge.”
The study was led by the University of Alabama-Birmingham and their colleagues in Lusaka, Zambia. Each site in the Global Network is a collaboration between investigators in low- and middle-income countries and the U.S.
“Complex studies such as A-Plus are only possible through long-term, sustainable partnerships such as the relationship IU and Moi University have created through AMPATH Kenya and the Global Network,” said. Dr. Ekhaguere, assistant professor of pediatrics at IU School of Medicine.
The Global Network A-PLUS team is continuing a sub-study to explore patterns of antimicrobial resistance and potential changes to the maternal or neonatal microbiome to provide additional data to policymakers who will decide whether to recommend that administration of 2g of azithromycin during labor becomes standard of care in low- and middle-income countries. Determining the local patterns of antimicrobial resistance to azithromycin is important since such resistance would render its use for prophylaxis less effective.
Dr. Nyongesa, senior lecturer at Moi University, added appreciation for the mothers around the world who volunteered for the study. “The mothers who enrolled in the study are the true heroes and their contribution to our scientific knowledge will move us closer to our goal of lowering maternal and neonatal mortality globally.”
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