Azithromycin Prophylaxis for PRElabor CEsarean DElivery Trial

Brief 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.

Source: ClinicalTrials.gov (U.S. National Library of Medicine), data processed 2026-10-29T09:00:05; modifications: selected fields only; whitespace normalized; brief summary truncated to 2,000 characters. Not a U.S. Government endorsement.

Trial details

acronym

PRECEDE

status

RECRUITING

phase

PHASE3

study type

INTERVENTIONAL

enrollment

8000

sponsor

The George Washington University Biostatistics Center

conditions

Obstetrical Complications; Labor and Delivery Complication; Cesarean Delivery

interventions

DRUG: Azithromycin Injection; DRUG: Placebo; DRUG: Standard of Care Preoperative antibiotics

start date

2024-11-06

start date type

ACTUAL

primary completion date

2027-11-30

has results

false

data source

ClinicalTrials.gov

data processed

2026-10-29T09:00:05

modifications

selected fields only; whitespace normalized; brief summary truncated to 2,000 characters