Clinical Trial

Azithromycin Prophylaxis for PRElabor CEsarean DElivery Trial

Study acronym: PRECEDE
Recruiting Phase 3
View on ClinicalTrials.gov →
Summary
This is a phase-III multi-center double-blind randomized controlled trial of 8,000 individuals undergoing a scheduled or prelabor cesarean delivery who are randomized to either adjunctive azithromycin prophylaxis or to placebo. Both groups also will receive standard of care preoperative antibiotics (excluding azithromycin). The primary endpoint is a maternal infection composite defined as any one of the following up to 6 weeks postpartum: endometritis, wound infection, abscess, septic thrombosis, sepsis, pneumonia, pyelonephritis and breast infection.
Protocol Amendment History 10 amendments
This ClinicalTrials.gov record has been amended 10 times since 2024-09-17; most recent amendment 2026-04-03.
Status change: Not Yet Recruiting → Recruiting 2024-11-06
Trial Details
NCT Number NCT06605118
Lead Sponsor The George Washington University Biostatistics Center
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of Alabama at Birmingham
Conditions Obstetrical Complications, Labor and Delivery Complication, Cesarean Delivery
Enrollment 8,000 participants
Start Date 2024-11-06
Primary Completion 2027-11-30 (estimated)
Study Completion 2027-11-30 (estimated)
Updated on ClinicalTrials.gov 2026-04-09