Azithromycin Prophylaxis for PRElabor CEsarean DElivery Trial
NCT06605118
This study is recruiting at 14 US sites in 10 states, according to its ClinicalTrials.gov record last updated .
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.
Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov
Conditions studied
- Obstetrical Complications
- Labor and Delivery Complication
- Cesarean Delivery
Eligibility basics and study details
- Study type
- Interventional
- Phase
- Phase 3
- Ages
- Any age
- Sex
- Female
- Healthy volunteers
- Accepted
- Sponsor
- The George Washington University Biostatistics Center
- Last updated on ClinicalTrials.gov
- April 9, 2026
These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.
US recruiting sites
Alabama · 1
- University of Alabama - Birmingham · Birmingham, AL
California · 1
- Regents of the University of California San Francisco · San Francisco, CA
Illinois · 1
- Northwestern University · Chicago, IL
New York · 1
- Columbia University · New York, NY
North Carolina · 2
- University of North Carolina - Chapel Hill · Chapel Hill, NC
- Duke University · Durham, NC
Ohio · 2
- Case Western Reserve University · Cleveland, OH
- Ohio State University · Columbus, OH
Pennsylvania · 2
- Hospital of the University of Pennsylvania · Philadelphia, PA
- Magee Women's Hospital · Pittsburgh, PA
Rhode Island · 1
- Brown Univeristy · Providence, RI
Texas · 2
- Baylor College of Medicine · Houston, TX
- University of Texas - Houston · Houston, TX
Utah · 1
- University of Utah · Salt Lake City, UT
Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.