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Azithromycin Prophylaxis for PRElabor CEsarean DElivery Trial

RecruitingPhase 3Ages any - anyFemaleThe George Washington University Biostatistics Ce…
NCT06605118 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * ≥ 23 weeks' gestation (ACOG dating criteria) * Scheduled or prelabor cesarean delivery * Singleton or twin gestation Exclusion Criteria: * 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.
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What it tests

  • Azithromycin Injection
  • Placebo
  • Standard of Care Preoperative antibiotics
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Where

14 sites
University of Alabama - Birmingham
Birmingham, United States
Regents of the University of California San Francisco
San Francisco, United States
Northwestern University
Chicago, United States
Columbia University
New York, United States
University of North Carolina - Chapel Hill
Chapel Hill, United States
Duke University
Durham, United States
Case Western Reserve University
Cleveland, United States
Ohio State University
Columbus, United States

…and 6 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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