6/27/23, 11:46 PM A-PLUS Pathway Feedback Search Clinical Topics Home Studies A PLUS A PLUS Trial question What is the role of azithromycin in women planning a vaginal delivery? Study design Multi-center Double blinded RCT Population 29278 female patients Inclusion criteria: women 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 2.4 % 2.4 1.8 % 1.6 1.2 % Significant decrease 0.6 % NNT = 125 0.0 % Azithromycin Placebo 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 https://web.pathway.md/studies/recQwHVUkJCqpuIe6 1/2 6/27/23, 11:46 PM A-PLUS Pathway 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 women 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. Open reference URL https://web.pathway.md/studies/recQwHVUkJCqpuIe6 2/2