Azithromycin Prophylaxis for PRElabor CEsarean DElivery Trial
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
AgeNot listed
SponsorThe George Washington University Biostatistics Center
About this 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 (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.
Eligibility criteria
Qualifiers
≥ 23 weeks' gestation (ACOG dating criteria)
Scheduled or prelabor cesarean delivery
Singleton or twin gestation
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Azithromycin Injection
- Placebo
- Standard of Care Preoperative antibiotics
Treatment groups
8,000 Participants
are divided into 2 treatment groupsSponsors and collaborators
The George Washington University Biostatistics Center
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
University of Alabama at Birmingham
Collaborator
Source ClinicalTrials.gov