A-PLUS (post-hoc analysis)
Trial question
What is the role of intrapartum azithromycin in preventing infections in women planning vaginal delivery?
Study design
Multi-center
Double blinded
RCT
Population
29278 female patients.
Inclusion criteria: women in labor at ≥ 28 weeks of gestation who were planning a vaginal delivery.
Key exclusion criteria: non-emancipated minors; evidence of chorioamnionitis or other infection requiring antibiotic therapy at the time of eligibility; arrhythmia or known history of cardiomyopathy; allergy to azithromycin or other macrolides; receipt of azithromycin, erythromycin, or other macrolide in ≤ 3 days before randomization; planned Cesarean delivery.
Interventions
N=14590 azithromycin (a single intrapartum oral dose of 2 g).
N=14688 placebo (matching placebo).
Primary outcome
Any maternal infection
4%
5.6%
5.6 %
4.2 %
2.8 %
1.4 %
0.0 %
Azithromycin
Placebo
Significant
decrease ▼
NNT = 62
Significant decrease in any maternal infection (4% vs. 5.6%; RR 0.71, 95% CI 0.64 to 0.79).
Secondary outcomes
Significant decrease in maternal death or infection (4% vs. 5.7%; RR 0.72, 95% CI 0.64 to 0.8).
No significant difference in any neonatal infection (15.1% vs. 15%; RR 1.01, 95% CI 0.96 to 1.06).
No significant difference in stillbirth, death, or infection (15.7% vs. 15.7%; RR 1, 95% CI 0.95 to 1.06).
Conclusion
In women in labor at ≥ 28 weeks of gestation who were planning a vaginal delivery, azithromycin was superior to placebo with respect to any maternal infection.
Reference
Waldemar A Carlo, Alan T N Tita, Janet L Moore et al. 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. Lancet Glob Health. 2025 Apr;13(4):e689-e697.
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