Condition: Obstetrical Complications · Labor and Delivery Complication · Cesarean Delivery · Sponsor: The George Washington University Biostatistics Center
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.
This description comes directly from the study's public registry record.
Rebecca G Clifton, PhD · 301-881-9260 · rclifton@bsc.gwu.edu
Steven Weiner, MS · weiner@bsc.gwu.edu
Always discuss trial participation with your own doctor first.
| University of Alabama - Birmingham | Birmingham, Alabama, United States | Recruiting |
| Regents of the University of California San Francisco | San Francisco, California, United States | Recruiting |
| Northwestern University | Chicago, Illinois, United States | Recruiting |
| Columbia University | New York, New York, United States | Recruiting |
| University of North Carolina - Chapel Hill | Chapel Hill, North Carolina, United States | Recruiting |
| Duke University | Durham, North Carolina, United States | Recruiting |
| Case Western Reserve University | Cleveland, Ohio, United States | Recruiting |
| Ohio State University | Columbus, Ohio, United States | Recruiting |
| Hospital of the University of Pennsylvania | Philadelphia, Pennsylvania, United States | Recruiting |
| Magee Women's Hospital | Pittsburgh, Pennsylvania, United States | Recruiting |
| Brown Univeristy | Providence, Rhode Island, United States | Recruiting |
| Baylor College of Medicine | Houston, Texas, United States | Recruiting |
+ 2 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT06605118