Azithromycin Prophylaxis for PRElabor CEsarean DElivery Trial

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Obstetrical Complications, Labor and Delivery Complication, Cesarean Delivery

In brief

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.

Key facts

Study ID

NCT06605118

Run by

The George Washington University Biostatistics Center

People needed

8000

Starts

2024-11-06

Expected to finish

2027-11-30

Last updated by the study team

2026-04-09

Who can join

Age: any. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• ≥ 23 weeks' gestation (ACOG dating criteria)
• Scheduled or prelabor cesarean delivery
• Singleton or twin gestation

You may not qualify if…

• 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.

Where it is running

• University of Alabama - Birmingham — Birmingham, Alabama, United States (enrolling)
• Regents of the University of California San Francisco — San Francisco, California, United States (enrolling)
• Northwestern University — Chicago, Illinois, United States (enrolling)
• Columbia University — New York, New York, United States (enrolling)
• University of North Carolina - Chapel Hill — Chapel Hill, North Carolina, United States (enrolling)
• Duke University — Durham, North Carolina, United States (enrolling)
• Case Western Reserve University — Cleveland, Ohio, United States (enrolling)
• Ohio State University — Columbus, Ohio, United States (enrolling)
• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States (enrolling)
• Magee Women's Hospital — Pittsburgh, Pennsylvania, United States (enrolling)
• Brown Univeristy — Providence, Rhode Island, United States (enrolling)
• Baylor College of Medicine — Houston, Texas, United States (enrolling)
• University of Texas - Houston — Houston, Texas, United States (enrolling)
• University of Utah — Salt Lake City, Utah, United States (enrolling)

Full record on ClinicalTrials.gov

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