The risk of maternal sepsis or death was reduced significantly in women planning a vaginal birth when they received a single dose of azithromycin, researchers report. Newborn sepsis or death was not affected. The authors concluded, “The number of women who would need to be treated to prevent one case of maternal death or sepsis was 125; the same number would need to be treated to prevent one maternal sepsis event. In addition, apart from a potential greater benefit in Africa than in Asia, the benefit did not appear to vary according to subgroup, including risk status for infection.”
The multicountry, placebo-controlled, randomized trial included 29,278 women who were in labor at 28 weeks’ gestation or later and who were planning a vaginal delivery. Randomization to a single 2-g oral dose of azithromycin or placebo had these effects on 2 primary outcomes of a composite of maternal sepsis or death and a composite of stillbirth or neonatal death or sepsis: “The incidence of maternal sepsis or death was lower in the azithromycin group than in the placebo group (1.6% vs. 2.4%), with a relative risk of 0.67 (95% confidence interval [CI], 0.56 to 0.79; P <0.001), but the incidence of stillbirth or neonatal death or sepsis was similar (10.5% vs. 10.3%), with a relative risk of 1.02 (95% CI, 0.95 to 1.09; P = 0.56). The difference in the maternal primary outcome appeared to be driven mainly by the incidence of sepsis (1.5% in the azithromycin group and 2.3% in the placebo group), with a relative risk of 0.65 (95% CI, 0.55 to 0.77); the incidence of death from any cause was 0.1% in the two groups (relative risk, 1.23; 95% CI, 0.51 to 2.97). Neonatal sepsis occurred in 9.8% and 9.6% of the infants, respectively (relative risk, 1.03; 95% CI, 0.96 to 1.10). The incidence of stillbirth was 0.4% in the two groups (relative risk, 1.06; 95% CI, 0.74 to 1.53); neonatal death within 4 weeks after birth occurred in 1.5% in both groups (relative risk, 1.03; 95% CI, 0.86 to 1.24). Azithromycin was not associated with a higher incidence in adverse events.”
Editorial: “The focus on decreasing maternal and neonatal sepsis is a vital step toward improving maternal morbidity and mortality worldwide,” writes an editorialist. “However, far more is needed to address the regional and global inequities in pregnancy outcomes, including investments in health care infrastructure. Studies like the present one lead us closer to the international goals for improving maternal pregnancy outcomes. A single dose of azithromycin may prove to have a substantial effect on decreasing the incidence of maternal sepsis in women undergoing a vaginal delivery. More data that focus on antimicrobial resistance patterns over time are required before this strategy can be recommended universally.”