# Azithromycin Prophylaxis for PRElabor CEsarean DElivery Trial

Clinical trial · The George Washington University Biostatistics Center

- Archive id: nct:NCT06605118
- Published: 2024-09-20
- Venue: ClinicalTrials.gov
- ClinicalTrials.gov: https://clinicaltrials.gov/study/NCT06605118
- Source URL: https://clinicaltrials.gov/study/NCT06605118
- Provenance: clinicaltrials

## Abstract

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.

_Abstract reproduced under 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._

## 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

Topics: [Infectious Disease, Vaccines & Antimicrobial Resistance](https://space-kitty.com/topics/infectious-disease-amr)

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