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
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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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)
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NCT06605118