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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06605118
The ClinicalTrials.gov registry entry for NCT06605118 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 8,000 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 2,683-participant average among 10 other Cesarean Delivery trials with a reported enrollment target (198% higher). The listed sponsor is The George Washington University Biostatistics Center, which has 24 total studies on file at ClinicalTrials.gov.
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 reports 14 study locations spanning 10 distinct geographic areas - top geographies include 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.
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