Azithromycin Prophylaxis for Prelabor Cesarean Delivery Trial
The George Washington University Biostatistics Center
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 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.
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 prophylaxis or to placebo. All participants will receive standard of care preoperative antibiotics. The primary objective is to evaluate in patients undergoing scheduled/prelabor cesarean if pre-incision adjunctive azithromycin prophylaxis reduces the risk of post-cesarean infections compared with placebo. Secondary objectives include 1) to assess the perinatal and maternal safety of pre-incision adjunctive…
Eligibility
- Age range
- Not specified
- Sex
- Female
- Healthy volunteers
- Yes
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 co…
Interventions
- DrugAzithromycin Injection
500mg azithromycin in 250 mL of normal saline
- DrugPlacebo
250 mL of normal saline
- DrugStandard of Care Preoperative antibiotics
standard of care preoperative antibiotics (excluding azithromycin) prior to incision
Locations (14)
- University of Alabama - BirminghamBirmingham, Alabama
- Regents of the University of California San FranciscoSan Francisco, California
- Northwestern UniversityChicago, Illinois
- Columbia UniversityNew York, New York
- University of North Carolina - Chapel HillChapel Hill, North Carolina
- Duke UniversityDurham, North Carolina