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Recruiting Phase 3 Interventional Accepts healthy volunteers

Azithromycin Prophylaxis for PRElabor CEsarean DElivery Trial

ClinicalTrials.gov ID: NCT06605118

Public ClinicalTrials.gov record NCT06605118. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 6, 2026, 9:50 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Azithromycin Prophylaxis for Prelabor Cesarean Delivery Trial

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT06605118
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 3
Enrollment
8,000 participants

Conditions and interventions

Eligibility (public fields only)

Age range
Not listed
Sex
Female
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Nov 5, 2024
Primary completion
Nov 29, 2027
Completion
Nov 29, 2027
Last update posted
Apr 8, 2026

2024 – 2027

United States locations

U.S. sites
14
U.S. states
10
U.S. cities
13
Facility City State ZIP Site status
University of Alabama - Birmingham Birmingham Alabama 35233 Recruiting
Regents of the University of California San Francisco San Francisco California 94143 Recruiting
Northwestern University Chicago Illinois 60611 Recruiting
Columbia University New York New York 10032 Recruiting
University of North Carolina - Chapel Hill Chapel Hill North Carolina 27599 Recruiting
Duke University Durham North Carolina 27710 Recruiting
Case Western Reserve University Cleveland Ohio 44109 Recruiting
Ohio State University Columbus Ohio 43210 Recruiting
Hospital of the University of Pennsylvania Philadelphia Pennsylvania 19104 Recruiting
Magee Women's Hospital Pittsburgh Pennsylvania 15213 Recruiting
Brown Univeristy Providence Rhode Island 02905 Recruiting
Baylor College of Medicine Houston Texas 77030 Recruiting
University of Texas - Houston Houston Texas 77030 Recruiting
University of Utah Salt Lake City Utah 84132 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT06605118, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Apr 8, 2026 · Synced Sep 6, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT06605118 live on ClinicalTrials.gov.

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