RECRUITING

Azithromycin Prophylaxis for PRElabor CEsarean DElivery Trial

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Conditions

Obstetrical ComplicationsLabor and Delivery ComplicationCesarean Deliveryinfectionmaternal morbidityantibioticsprevention

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Azithromycin Prophylaxis for Prelabor Cesarean Delivery Trial

Quick Facts

Study Start:2024-11-04
Study Completion:2028-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06605118

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.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * ≥ 23 weeks' gestation (ACOG dating criteria)
  2. * Scheduled or prelabor cesarean delivery
  3. * Singleton or twin gestation
  1. * Allergy or contraindication to azithromycin or macrolide antibiotics, including those with a history of cholestatic jaundice/hepatic dysfunction associated with prior use of azithromycin
  2. * Chorioamnionitis
  3. * Bacterial infection (e.g., pyelonephritis) requiring ongoing antibiotic treatment after delivery
  4. * Premature rupture of membranes (PROM) or labor (i.e., contractions with ongoing cervical change)
  5. * Fetal demise or known major congenital anomaly
  6. * Azithromycin treatment within 7 days
  7. * Planned use of antimicrobial prophylaxis after delivery for any reason
  8. * Known structural heart disease or active cardiomyopathy (current ejection fraction\<40%)
  9. * Known arrhythmia with QT prolongation or taking scheduled medications known to prolong the QT interval such that it would preclude the use of azithromycin
  10. * Refusal or unable to obtain consent (e.g., language barrier)
  11. * Participating in another intervention study that influences the primary outcome in this study
  12. * 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.

Contacts and Locations

Study Contact

Rebecca G Clifton, PhD
CONTACT
301-881-9260
rclifton@bsc.gwu.edu
Steven Weiner, MS
CONTACT
weiner@bsc.gwu.edu

Principal Investigator

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 Locations (Sites)

University of Alabama - Birmingham
Birmingham, Alabama, 35233
United States
Regents of the University of California San Francisco
San Francisco, California, 94143
United States
Northwestern University
Chicago, Illinois, 60611
United States
Columbia University
New York, New York, 10032
United States
University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, 27599
United States
Duke University
Durham, North Carolina, 27710
United States
Case Western Reserve University
Cleveland, Ohio, 44109
United States
Ohio State University
Columbus, Ohio, 43210
United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
Magee Women's Hospital
Pittsburgh, Pennsylvania, 15213
United States
Brown Univeristy
Providence, Rhode Island, 02905
United States
Baylor College of Medicine
Houston, Texas, 77030
United States
University of Texas - Houston
Houston, Texas, 77030
United States
University of Utah
Salt Lake City, Utah, 84132
United States

Collaborators and Investigators

Sponsor: 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-04
Study Completion Date2028-03-31

Study Record Updates

Study Start Date2024-11-04
Study Completion Date2028-03-31

Terms related to this study

Keywords Provided by Researchers

  • cesarean delivery
  • infection
  • maternal morbidity
  • antibiotics
  • prevention

Additional Relevant MeSH Terms

  • Obstetrical Complications
  • Labor and Delivery Complication
  • Cesarean Delivery