Actively Recruiting
Azithromycin Prophylaxis for PRElabor CEsarean DElivery Trial
Led by The George Washington University Biostatistics Center · Updated on 2026-04-09
8000
Participants Needed
14
Research Sites
159 weeks
Total Duration
On this page
Sponsors
T
The George Washington University Biostatistics Center
Lead Sponsor
E
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Azithromycin Prophylaxis for PRElabor CEsarean DElivery Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 23 weeks gestation based on ACOG dating criteria
- Scheduled or prelabor cesarean delivery
- Singleton or twin pregnancy
You will not qualify if you...
- Allergy or contraindication to azithromycin or macrolide antibiotics
- History of cholestatic jaundice or liver problems from azithromycin use
- Chorioamnionitis
- Ongoing bacterial infection needing antibiotics after delivery
- Premature rupture of membranes or active labor with cervical changes
- Fetal death or major known birth defects
- Azithromycin treatment within 7 days before delivery
- Planned antibiotic use after delivery for any reason
- Known structural heart disease or active cardiomyopathy with low ejection fraction (<40%)
- Known arrhythmia with QT prolongation or use of medications that prolong QT interval
- Unable or unwilling to consent (e.g., language barrier)
- Participation in another study affecting primary outcomes
- Previous participation in this trial during an earlier pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 14 locations
1
University of Alabama - Birmingham
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
Regents of the University of California San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
3
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
4
Columbia University
New York, New York, United States, 10032
Actively Recruiting
5
University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
6
Duke University
Durham, North Carolina, United States, 27710
Actively Recruiting
7
Case Western Reserve University
Cleveland, Ohio, United States, 44109
Actively Recruiting
8
Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
9
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
10
Magee Women's Hospital
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
11
Brown Univeristy
Providence, Rhode Island, United States, 02905
Actively Recruiting
12
Baylor College of Medicine
Houston, Texas, United States, 77030
Actively Recruiting
13
University of Texas - Houston
Houston, Texas, United States, 77030
Actively Recruiting
14
University of Utah
Salt Lake City, Utah, United States, 84132
Actively Recruiting
Research Team
R
Rebecca G Clifton, PhD
CONTACT
S
Steven Weiner, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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