Azithromycin Prophylaxis for PRElabor CEsarean DElivery Trial

PHASE3RecruitingINTERVENTIONAL
Enrollment

8,000

Participants

Timeline

Start Date

November 4, 2024

Primary Completion Date

November 30, 2027

Study Completion Date

March 31, 2028

Conditions
Obstetrical ComplicationsLabor and Delivery ComplicationCesarean Delivery
Interventions
DRUG

Azithromycin Injection

500mg azithromycin in 250 mL of normal saline

DRUG

Placebo

250 mL of normal saline

DRUG

Standard of Care Preoperative antibiotics

standard of care preoperative antibiotics (excluding azithromycin) prior to incision

Trial Locations (14)

10032

RECRUITING

Columbia University, New York

15213

RECRUITING

Magee Women's Hospital, Pittsburgh

19104

RECRUITING

Hospital of the University of Pennsylvania, Philadelphia

27599

RECRUITING

University of North Carolina - Chapel Hill, Chapel Hill

27710

RECRUITING

Duke University, Durham

35233

RECRUITING

University of Alabama - Birmingham, Birmingham

43210

RECRUITING

Ohio State University, Columbus

44109

RECRUITING

Case Western Reserve University, Cleveland

60611

RECRUITING

Northwestern University, Chicago

77030

RECRUITING

Baylor College of Medicine, Houston

RECRUITING

University of Texas - Houston, Houston

84132

RECRUITING

University of Utah, Salt Lake City

94143

RECRUITING

Regents of the University of California San Francisco, San Francisco

02905

RECRUITING

Brown Univeristy, Providence

All Listed Sponsors
collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

collaborator

University of Alabama at Birmingham

OTHER

lead

The George Washington University Biostatistics Center

OTHER