Effectiveness of intrapartum azithromycin to prevent infections in planned vaginal births in low-income and middle-income countries: a post-hoc analysis of data from a multicentre, randomised, double-blind, placebo-controlled trial.

Summary

In a post-hoc analysis of the large A-PLUS randomized trial, a single 2 g oral dose of azithromycin given intrapartum reduced maternal infections (4.0% vs 5.6%; RR 0.71, 95% CI 0.64–0.79) without increasing neonatal infections. Results were consistent across sites in low-resource settings and analyses were intention-to-treat.

Key Findings

• Maternal infection occurred in 4.0% with azithromycin vs 5.6% with placebo (RR 0.71, 95% CI 0.64–0.79, p<0.0001).
• No difference was observed in any neonatal infection between groups.
• Analysis used intention-to-treat and a Poisson model adjusted for site.

Clinical Implications

Consider a single 2 g oral azithromycin dose intrapartum for women planning vaginal delivery in low-resource settings to reduce maternal infections; implement with antimicrobial stewardship oversight and monitor for resistance and local epidemiology.

Limitations

• Post-hoc analysis; not a prespecified primary outcome of the original trial
• Follow-up time horizon for infection ascertainment not detailed in the abstract; antimicrobial resistance outcomes not assessed

Future Directions

Prospective implementation studies with resistance surveillance, cost-effectiveness within health systems, and evaluation in diverse settings including higher-resource facilities.