Azithromycin Prophylaxis for PRElabor CEsarean DElivery Trial
Azithromycin Prophylaxis for Prelabor Cesarean Delivery Trial
The George Washington University Biostatistics Center
8,000 participants
Nov 6, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria3
- ≥ 23 weeks' gestation (ACOG dating criteria)
- Scheduled or prelabor cesarean delivery
- Singleton or twin gestation
Exclusion Criteria12
- 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.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
500mg azithromycin in 250 mL of normal saline
250 mL of normal saline
standard of care preoperative antibiotics (excluding azithromycin) prior to incision
Locations(14)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06605118