Clinical trialNCT06605118RecruitingPhase 3Interventional

Azithromycin Prophylaxis for PRElabor CEsarean DElivery Trial

SponsorThe George Washington University Biostatistics CenterEnrollment8,000Cesarean DeliveryLabor and Delivery ComplicationObstetrical Complications

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

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Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Alan T.N. Tita, MD PhD
University of Alabama at Birmingham
Study Chair
clinicaltrials.gov ↗
Kim Boggess, MD
University of North Carolina, Chapel Hill
Study Chair
clinicaltrials.gov ↗
Monica Longo, MD PhD
Eunice Kennedy Shriver NICHD
Study Director
clinicaltrials.gov ↗
Rebecca G Clifton, PhD
The George Washington University Biostatistics Center
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

14 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

University of Alabama - Birmingham
Birmingham, Alabama, United States
Alan TN Tita, MD
Recruiting
Regents of the University of California San Francisco
San Francisco, California, United States
Mary Norton, MD
Recruiting
Northwestern University
Chicago, Illinois, United States
Lynn Yee, MD
Recruiting
Columbia University
New York, New York, United States
Noelia Zork, MD
Recruiting
University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States
John M Thorp, MD
Recruiting
Duke University
Durham, North Carolina, United States
Brenna L Hughes, MD MS
Recruiting
Case Western Reserve University
Cleveland, Ohio, United States
Kelly Gibson, MD
Recruiting
Ohio State University
Columbus, Ohio, United States
Maged Costantine, MD
Recruiting
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Lorraine Dugoff, MD
Recruiting
Magee Women'S Hospital
Pittsburgh, Pennsylvania, United States
Hyagriv Simhan, MD, MS
Recruiting
Brown Univeristy
Providence, Rhode Island, United States
Dwight J Rouse, MD
Recruiting
Baylor College of Medicine
Houston, Texas, United States
Catherine Eppes, MD, MPH
Recruiting
University of Texas - Houston
Houston, Texas, United States
Hector Mendez-Figueroa, MD
Recruiting
University of Utah
Salt Lake City, Utah, United States
Torri Metz, MD
Recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Azithromycin →PlaceboStandard of Care Preoperative antibiotics

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 6 Nov 2024
Primary completion: 30 Nov 2027
Completion: 30 Nov 2027
Last update posted: 9 Apr 2026
Registered enrollment: 8,000
Registry id: NCT06605118

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.