Azithromycin Prophylaxis for PRElabor CEsarean DElivery Trial

Description

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.

Conditions

Obstetrical Complications, Labor and Delivery Complication, Cesarean Delivery

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Study Overview

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Study Details

Study overview

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.

Azithromycin Prophylaxis for Prelabor Cesarean Delivery Trial

Azithromycin Prophylaxis for PRElabor CEsarean DElivery Trial

Condition
Obstetrical Complications
Intervention / Treatment

-

Contacts and Locations

Birmingham

University of Alabama - Birmingham, Birmingham, Alabama, United States, 35233

San Francisco

Regents of the University of California San Francisco, San Francisco, California, United States, 94143

Chicago

Northwestern University, Chicago, Illinois, United States, 60611

New York

Columbia University, New York, New York, United States, 10032

Chapel Hill

University of North Carolina - Chapel Hill, Chapel Hill, North Carolina, United States, 27599

Durham

Duke University, Durham, North Carolina, United States, 27710

Cleveland

Case Western Reserve University, Cleveland, Ohio, United States, 44109

Columbus

Ohio State University, Columbus, Ohio, United States, 43210

Philadelphia

Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, United States, 19104

Pittsburgh

Magee Women's Hospital, Pittsburgh, Pennsylvania, United States, 15213

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * ≥ 23 weeks' gestation (ACOG dating criteria)
  • * Scheduled or prelabor cesarean delivery
  • * Singleton or twin gestation
  • * Allergy or contraindication to azithromycin or macrolide antibiotics, including those with a history of cholestatic jaundice/hepatic dysfunction associated with prior use of azithromycin
  • * Chorioamnionitis
  • * Bacterial infection (e.g., pyelonephritis) requiring ongoing antibiotic treatment after delivery
  • * Premature rupture of membranes (PROM) or labor (i.e., contractions with ongoing cervical change)
  • * Fetal demise or known major congenital anomaly
  • * Azithromycin treatment within 7 days
  • * Planned use of antimicrobial prophylaxis after delivery for any reason
  • * Known structural heart disease or active cardiomyopathy (current ejection fraction\<40%)
  • * Known arrhythmia with QT prolongation or taking scheduled medications known to prolong the QT interval such that it would preclude the use of azithromycin
  • * Refusal or unable to obtain consent (e.g., language barrier)
  • * Participating in another intervention study that influences the primary outcome in this study
  • * Participation in this trial in a previous pregnancy. Patients who were screened in a previous pregnancy, but not randomized, do not have to be excluded.

Ages Eligible for Study

to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

The George Washington University Biostatistics Center,

Alan T.N. Tita, MD PhD, STUDY_CHAIR, University of Alabama at Birmingham

Kim Boggess, MD, STUDY_CHAIR, University of North Carolina, Chapel Hill

Monica Longo, MD PhD, STUDY_DIRECTOR, Eunice Kennedy Shriver NICHD

Rebecca G Clifton, PhD, PRINCIPAL_INVESTIGATOR, The George Washington University Biostatistics Center

Study Record Dates

2028-03-31