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Pregnant women considering vaginal deliveries had a lower risk of developing sepsis during childbirth if they were treated with a single dose of the antibiotic azithromycin, a multinational trial involving seven low- or middle-income countries showed.

In the trial, incidence of maternal sepsis or death was 1.6% for women who received azithromycin prophylaxis compared with 2.4% for those assigned to placebo (relative risk [RR] 0.67, 95% CI 0.56-0.79, P<0.001), reported Alan Tita, MD, PhD, of the University of Alabama at Birmingham, in a late-breaking presentation at the Society for Maternal-Fetal Medicine Annual Pregnancy Meeting.

For the study's co-primary endpoint -- incidence of stillbirth or neonatal death or sepsis -- findings were similar between treatment and placebo groups (10.5% vs 10.3%; RR 1.02, 95% CI 0.95-1.09, P=0.56).

The trial was stopped early for efficacy upon the recommendation of the data and safety monitoring board, Tita said. Results were published simultaneously in the .

"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 Bianchi, MD, director of the Eunice Kennedy Shriver National Institute of Child Health and Human Development, in a statement. "We urgently need effective strategies to prevent pregnancy-related infections, which account for roughly 10% of maternal deaths worldwide."

Sepsis is a leading cause of maternal and newborn deaths worldwide, especially in low- and middle-income countries. Azithromycin is inexpensive and known to reduce maternal infection when given intravenously during cesarean delivery. A study in Gambia showed that reduced infections in both women and newborns.

In the A-PLUS trial, sepsis appeared to drive the maternal primary outcome; it occurred in 1.5% of the azithromycin group and 2.3% of the placebo group (RR 0.65, 95% CI 0.55-0.77). Neonatal sepsis incidence was 9.8% and 9.6%, respectively (RR 1.03, 95% CI 0.96-1.10). Stillbirth occurred in 0.4% of both groups and neonatal death within 4 weeks after birth occurred in 1.5% of both groups.

"Maternal deaths were infrequent in both groups; findings were driven by the effects of azithromycin on maternal sepsis," Tita said. "The frequencies of selected maternal infections that cause sepsis (including endometritis, cesarean or perineal wound infections, and pyelonephritis) maternal readmissions, and unscheduled healthcare visits were consistent with the primary maternal results."

A-PLUS researchers randomly assigned 29,278 pregnant women in seven low- or middle-income countries in Asia, Africa, and Latin America who planned vaginal delivery to either a single dose of azithromycin (2 g) or placebo. Women were eligible if they were at least 28 weeks into their pregnancy.

Demographic characteristics were similar for the two groups. Median age was 24; about half the women had 7-12 years of formal schooling and 13% had college educations. About 43% of the women were giving birth for the first time. There were 99 multiple births among the azithromycin cohort and 95 in the placebo group. About 18.4% of the women had induced labor and 8.6% were judged to be at high risk for infection in each group, the researchers reported.

At least one maternal side effect was seen in 7.1% of the azithromycin group and 7.6% of the placebo group, but none were substantively more frequent in women who received azithromycin. Pyloric stenosis was diagnosed in eight infants in the azithromycin group and in three in the placebo group.

"This study was done in low- and middle-income countries and there is a question as to whether the results would be similar in higher-income countries such as the United States," noted Christina Penfield, MD, MPH, of New York University Grossman School of Medicine in New York City, who was not involved with the trial.

"I think we would have to do a similar study here to determine if routine prophylactic azithromycin is warranted for women having vaginal delivery in higher income populations," Penfield told MedPage Today. "We do provide routine prophylactic azithromycin for women undergoing cesarean deliveries based on the results of a reported a few years ago."