C/SOAP
Trial question
What is the role of azithromycin-based extended-spectrum prophylaxis in females undergoing nonelective Cesarean delivery?
Study design
Multi-center
Double blinded
RCT
Population
2013 female patients.
Inclusion criteria: females 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 endometriosis, wound infection, or other infection occurring within 6 weeks
6.1%
12%
12.0 %
9.0 %
6.0 %
3.0 %
0.0 %
Azithromycin
Placebo
Significant
decrease ▼
NNT = 16
Significant decrease in the rate 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 females 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 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.
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