Study of Effectiveness and Safety of Azithromycin-based Extended-spectrum Prophylaxis to Prevent Post Cesarean Infection

NACompletedINTERVENTIONAL
Enrollment

2,013

Participants

Timeline

Start Date

May 31, 2011

Primary Completion Date

December 31, 2015

Study Completion Date

December 31, 2015

Conditions
EndometritisWound InfectionAbscessSurgical Site Infection
Interventions
DRUG

Azithromycin and standard of care

500 mg in 250 cc normal saline 1 time dose plus standard of care (cephazolin or clindamycin)

DRUG

Placebo and standard of care

250 cc normal saline, plus standard of care (cephazolin or clindamycin)

Trial Locations (9)

10032

Columbia University, New York

28801

Mission Hospital, Asheville

35233

University of Alabama at Birmingham, Birmingham

39216

University of Mississippi Medical Center, Jackson

70121

Ochsner Clinic Foundation, New Orleans

77225

University of Texas Health Science Center at Houston, Houston

84132

University of Utah, Salt Lake City

27599-7516

University of North Carolina, Chapel Hill

77555-0587

University of Texas Medical Branch, Galveston

Sponsors
All Listed Sponsors
collaborator

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

NIH

collaborator

University of Texas

OTHER

collaborator

University of North Carolina

OTHER

collaborator

Mission Hospital

UNKNOWN

collaborator

Ochsner Health System

OTHER

collaborator

The University of Texas Health Science Center, Houston

OTHER

collaborator

Columbia University

OTHER

collaborator

University of Utah

OTHER

collaborator

University of Mississippi Medical Center

OTHER

lead

Alan Tita

OTHER