A single dose of a low-cost, generic, oral antibiotic called azithromycin, could prevent life threatening sepsis during child birth in up to 2 Million women per year a study shows.
In a randomized, placebo-controlled study published in the New global maternal health research on February 9th, 2023, researchers found that a single 2-g oral dose of azithromycin given during labor to women planning to deliver vaginally prevented maternal
sepsis by approximately 35%.
The study also found a lower risk of maternal endometritis (uterine infection), hospital readmission and unscheduled medical visits among women who received azithromycin.
Azithromycin is a cheap, generic antibiotic available in tablet form and suitable for room- temperature storage. Globally, the World Health Organization (WHO) estimates sepsis due to obstetric infection is the third most common cause of maternal mortality.
The study, called the Azithromycin Prophylaxis in Labor Use Study (A-PLUS), assigned 29,000 women who were in labor at 28 weeks’ gestation or more and who were planning a vaginal delivery.
They were randomised to receive either a single 2-g oral dose of azithromycin or placebo. The study sites were in Bangladesh, the Democratic Republic of Congo, Guatemala, India, Kenya, Pakistan, and Zambia. The incidence of maternal sepsis or death in the azithromycin group was at 1.6% compared to the placebo group at 2.4%.
“The A-PLUS study has remarkable potential to protect maternal health and represents a significant advancement, especially for women who cannot access modern obstetrical care,” said Julie Gerberding, CEO of the Foundation for the National Institutes of Health
However, during an interim analysis, the data and safety monitoring committee recommended stopping the trial for maternal benefit due to a significant beneficial effect in the treatment group.
“We saw such a significant reduction in the incidence of sepsis with azithromycin that we stopped enrolling new participants early to ensure that as many women as possible could benefit from our findings as soon as possible,” said Antoinette Tshefu Kitoto, Professor of Public Health at Kinshasa School of Public Health and International Principal Investigator of the UNC-Democratic Republic of the Congo site.
When a combination of sepsis and death was analyzed, there was a 33% reduction. “Sepsis is a leading cause of maternal death worldwide and there is urgent need for low- cost, effective interventions,” said Kitoto.
A-PLUS investigators will provide the World Health Organization (WHO) and other professional organizations with the results to inform their guidelines.
Researchers say the results are likely to be useful for informing national health policy and obstetrical practice in low and middle income settings around the world.