A-PLUS
Trial question
What is the role of azithromycin in females planning a vaginal delivery?
Study design
Multi-center
Double blinded
RCT
Population
29278 female patients
Inclusion criteria: females who were in labor at ≥ 28 weeks of gestation and who were planning a vaginal delivery
Key exclusion criteria: women with infection warranting use of antibiotics; arrhythmia or known cardiomyopathy; allergy to azithromycin or other macrolide antibiotics or their use within 3 days; planned cesarean delivery, advanced stage of labor
Interventions
N=14590 azithromycin (a single 2 g oral dose)
N=14688 placebo (matching placebo)
Primary outcome
Rate of maternal sepsis or death within 6 weeks after birth
1.6
2.4
2.4 %
1.8 %
1.2 %
0.6 %
0.0 %
Azithromycin
Placebo
Significant decrease ▼
NNT = 125
Significant decrease in the rate of maternal sepsis or death within 6 weeks after birth (1.6% vs. 2.4%; RR 0.67, 95% CI 0.56 to 0.79)
Secondary outcomes
No significant difference in the rate of stillbirth or neonatal death or sepsis within 4 weeks of birth (10.5% vs. 10.3%; RR 1.02, 95% CI 0.95 to 1.09)
Borderline significant decrease in endometritis (1.3% vs. 2%; RR 0.66, 95% CI 0.55 to 0.79)
No significant difference in other infections in neonates (5.2% vs. 5.4%; RR 0.97, 95% CI 0.88 to 1.07)
Safety outcomes
No significant difference in adverse events.
Conclusion
In females who were in labor at ≥ 28 weeks of gestation and who were planning a vaginal delivery, azithromycin was superior to placebo with respect to the rate of maternal sepsis or death within 6 weeks after birth.
Reference
Alan T N Tita, Waldemar A Carlo, Elizabeth M McClure et al. Azithromycin to Prevent Sepsis or Death in Women Planning a Vaginal Birth. N Engl J Med. 2023 Mar 30;388(13):1161-1170.
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