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NCT06605118 · ClinicalTrials.gov registry record · Phase 3
Azithromycin Prophylaxis for PRElabor CEsarean DElivery Trial
A Phase 3 study of Cesarean Delivery and Obstetrical Complications, sponsored by The George Washington University Biostatistics Center.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 8,000
- Enrollment target
- 14
- Study locations
NCT06605118: Recruiting Phase 3 study of Cesarean Delivery and Obstetrical Complications, sponsored by The George Washington University Biostatistics Center.
NCT06605118 is a Phase 3 study of Cesarean Delivery and Obstetrical Complications that is actively recruiting participants, run by The George Washington University Biostatistics Center. The registered enrollment target is 8,000 participants, above the 2,683-participant average among 10 other Cesarean Delivery trials with a reported enrollment target (198% higher). The trial reports 14 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06605118, a Phase 3 study of Cesarean Delivery and Obstetrical Complications, is actively recruiting participants, sponsored by The George Washington University Biostatistics Center.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 8,000 participants
- Enrollment target
- 14
- Study locations
Study 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.
Primary Outcome
a maternal infection composite defined as any one of the following: endometritis, wound infection, abdominal or pelvic abscess, septic pelvic thrombosis, sepsis, pneumonia, pyelonephritis and breast infection
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Azithromycin Injection
- DRUG Standard of Care Preoperative antibiotics
Study Locations (14)
North Carolina
- University of North Carolina - Chapel Hill - Chapel Hill
- Duke University - Durham
Ohio
- Case Western Reserve University - Cleveland
- Ohio State University - Columbus
Pennsylvania
- Hospital of the University of Pennsylvania - Philadelphia
- Magee Women's Hospital - Pittsburgh
Texas
- Baylor College of Medicine - Houston
- University of Texas - Houston - Houston
Alabama
- University of Alabama - Birmingham - Birmingham
California
- Regents of the University of California San Francisco - San Francisco
Illinois
- Northwestern University - Chicago
New York
- Columbia University - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8,000 participants |
| Start Date | 2024-11-06 |
| Est. Completion | 2027-11-30 |
| Phase | Phase 3 |
What NCT06605118 shows while recruiting
NCT06605118 is an interventional study that assigns participants to a tested intervention. Its 8,000 participants enrollment target places it among the larger protocols in the corpus, above the 2,683-participant average among 10 other Cesarean Delivery trials with a reported enrollment target (198% higher).
The record links to 3 conditions, with Cesarean Delivery appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT06605118 lists 14 locations in 10 states (North Carolina, Ohio, Pennsylvania).
Frequently Asked Questions
What is clinical trial NCT06605118 about?
NCT06605118 is a clinical study titled "Azithromycin Prophylaxis for PRElabor CEsarean DElivery Trial". 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 ...
What is the current status of trial NCT06605118?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 8,000 participants. The study started on 2024-11-06. Estimated completion is 2027-11-30.
What conditions does trial NCT06605118 study?
This clinical trial studies the following conditions: Cesarean Delivery, Obstetrical Complications, Labor and Delivery Complication.
What interventions are being tested in trial NCT06605118?
The interventions under investigation include: Placebo (DRUG), Azithromycin Injection (DRUG), Standard of Care Preoperative antibiotics (DRUG).
Who is sponsoring clinical trial NCT06605118?
This trial is sponsored by The George Washington University Biostatistics Center, which has 24 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06605118 being conducted?
This trial has 14 study locations across Alabama, California, Illinois, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Cesarean Delivery
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06605118's enrollment target sits among peer trials
8,000 2nd of 10 the highest of 10 other Cesarean Delivery trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cesarean Delivery trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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