The Cesarean Section Optimal Antibiotic Prophylaxis (C/SOAP) study is a large pragmatic multi-center randomized clinical trial designed to evaluate the comparative effectiveness and safety of azithromycin-based extended-spectrum antibiotic prophylaxis (azithromycin plus standard narrow-spectrum cephalosporin) relative to standard single-agent cephalosporin (preferably prior to surgical incision) to prevent post-cesarean infection. Patients were randomly assigned to receive either azithromycin (at a dose of 500mg in 250 ml of saline, one time dose) or an identical-appearing saline placebo and the standard of care (cephazolin or clindamycin). The study found that extended-spectrum antibiotic prophylaxis regimen resulted in a statistically significantly lower rate of composite maternal morbidity (endometritis, would infection, or other post-cesarean infection) within 6 months of delivery compared to the standard antibiotic regimen (6.1% vs 12.0%). Two concurrent child follow-up studies are currently ongoing to evaluate childhood neurodevelopment and growth at 7-10 years of age.
- 14 sites
- 2013 participants randomized
- Parallel RCT
- NICHD funded, NCT: NCT01235546
- Clinicaltrials.gov website: https://clinicaltrials.gov/search?term=NCT01235546