6/28/23, 12:01 AM C/SOAP Pathway Feedback Search Clinical Topics Home Studies C/SOAP C/SOAP Disease Cesarean delivery Trial question What is the role of azithromycin-based extended-spectrum prophylaxis in women undergoing nonelective Cesarean delivery? Study design Multi-center Double blinded RCT Population 2013 female patients Inclusion criteria: women with a singleton pregnancy with a gestation of 24 weeks who were undergoing Cesarean delivery during labor or after membrane rupture Key exclusion criteria: known allergy to azithromycin; subsequent vaginal delivery; azithromycin use within 7 days before randomization; chorioamnionitis; fetal death or major congenital anomaly Interventions N=1019 azithromycin (500 mg intravenous azithromycin plus standard antibiotic prophylaxis) N=994 placebo (saline-based matching placebo plus standard antibiotic prophylaxis) Primary outcome Rate of composite of endometriosis, wound infection, or other infection occurring within 6 weeks 12.0 % 12 9.0 % 6.1 6.0 % Significant decrease 3.0 % NNT = 17 0.0 % https://web.pathway.md/studies/recWunbVG7QIU03R1 1/2 6/28/23, 12:01 AM C/SOAP Pathway Azithromycin Placebo Significant decrease in the rate of composite of endometriosis, wound infection, or other infection occurring within 6 weeks (6.1% vs. 12%; RR 0.51, 95% CI 0.38 to 0.68) Secondary outcomes No significant difference in neonatal death or complications (14.3% vs. 13.6%; RR 1.05, 95% CI 0.85 to 1.31) Significant decrease in postpartum fever (5% vs. 8.1%; RR 0.61, 95% CI 0.44 to 0.86) Significant decrease in postpartum readmission or unscheduled visit (8.1% vs. 12.4%; RR 0.66, 95% CI 0.51 to 0.86) Safety outcomes No significant difference in neonatal serious adverse events. Significant difference in maternal serious adverse events (1.5% vs. 2.9%). Conclusion In women with a singleton pregnancy with a gestation of 24 weeks who were undergoing Cesarean delivery during labor or after membrane rupture, azithromycin was superior to placebo with respect to the rate of composite of endometriosis, wound infection, or other infection occurring within 6 weeks. Reference Alan T N Tita, Jeff M Szychowski, Kim Boggess et al. Adjunctive Azithromycin Prophylaxis for Cesarean Delivery. N Engl J Med. 2016 Sep 29;375(13):1231-41. Open reference URL https://web.pathway.md/studies/recWunbVG7QIU03R1 2/2