Status:
RECRUITING
Azithromycin Prophylaxis for PRElabor CEsarean DElivery Trial
Lead Sponsor:
The George Washington University Biostatistics Center
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of Alabama at Birmingham
Conditions:
Obstetrical Complications
Labor and Delivery Complication
Eligibility:
FEMALE
Phase:
PHASE3
Brief 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...
Detailed Description
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 azithromycin prophylaxi...
Eligibility Criteria
Inclusion
- ≥ 23 weeks' gestation (ACOG dating criteria)
- Scheduled or prelabor cesarean delivery
- Singleton or twin gestation
Exclusion
- Allergy or contraindication to azithromycin or macrolide antibiotics, including those with a history of cholestatic jaundice/hepatic dysfunction associated with prior use of azithromycin
- Chorioamnionitis
- Bacterial infection (e.g., pyelonephritis) requiring ongoing antibiotic treatment after delivery
- Premature rupture of membranes (PROM) or labor (i.e., contractions with ongoing cervical change)
- Fetal demise or known major congenital anomaly
- Azithromycin treatment within 7 days
- Planned use of antimicrobial prophylaxis after delivery for any reason
- Known structural heart disease or active cardiomyopathy (current ejection fraction\<40%)
- Known arrhythmia with QT prolongation or taking scheduled medications known to prolong the QT interval such that it would preclude the use of azithromycin
- Refusal or unable to obtain consent (e.g., language barrier)
- Participating in another intervention study that influences the primary outcome in this study
- Participation in this trial in a previous pregnancy. Patients who were screened in a previous pregnancy, but not randomized, do not have to be excluded.
Key Trial Info
Start Date :
November 4 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2028
Estimated Enrollment :
8000 Patients enrolled
Trial Details
Trial ID
NCT06605118
Start Date
November 4 2024
End Date
March 31 2028
Last Update
April 24 2025
Active Locations (14)
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1
University of Alabama - Birmingham
Birmingham, Alabama, United States, 35233
2
Regents of the University of California San Francisco
San Francisco, California, United States, 94143
3
Northwestern University
Chicago, Illinois, United States, 60611
4
Columbia University
New York, New York, United States, 10032