Azithromycin Prophylaxis for PRElabor CEsarean DElivery Trial
NCT ID: NCT06605118
Last Updated: 2025-04-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
8000 participants
INTERVENTIONAL
2024-11-04
2028-03-31
Brief Summary
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Detailed Description
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Individuals will be randomized prior to the start of the cesarean to either 500mg of intravenous azithromycin or to placebo (normal saline). Maternal blood and cord blood will be collected on a subset of the population. Research staff will abstract maternal and neonatal outcomes following delivery and discharge from the hospital. A single maternal follow-up study visit at 6 weeks (4-8 weeks) postpartum will be scheduled to ascertain maternal and neonatal outcomes.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Azithromycin prophylaxis and standard of care preoperative antibiotics
500mg of intravenous azithromycin administered up to 1 hour prior to cesarean incision (or as soon as feasible after incision) and infused over one hour per FDA infusion recommendations for azithromycin. Additionally patients will received standard of care preoperative antibiotics (excluding azithromycin) prior to incision.
Azithromycin Injection
500mg azithromycin in 250 mL of normal saline
Standard of Care Preoperative antibiotics
standard of care preoperative antibiotics (excluding azithromycin) prior to incision
Placebo and standard of care preoperative antibiotics
Normal saline administered up to 1 hour prior to cesarean incision (or as soon as feasible after incision) and infused over one hour in addition to standard of care preoperative antibiotics (excluding azithromycin) prior to incision.
Placebo
250 mL of normal saline
Standard of Care Preoperative antibiotics
standard of care preoperative antibiotics (excluding azithromycin) prior to incision
Interventions
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Azithromycin Injection
500mg azithromycin in 250 mL of normal saline
Placebo
250 mL of normal saline
Standard of Care Preoperative antibiotics
standard of care preoperative antibiotics (excluding azithromycin) prior to incision
Eligibility Criteria
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Inclusion Criteria
* Scheduled or prelabor cesarean delivery
* Singleton or twin gestation
Exclusion Criteria
* 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.
FEMALE
Yes
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
University of Alabama at Birmingham
OTHER
The George Washington University Biostatistics Center
OTHER
Responsible Party
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Principal Investigators
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Alan T.N. Tita, MD PhD
Role: STUDY_CHAIR
University of Alabama at Birmingham
Kim Boggess, MD
Role: STUDY_CHAIR
University of North Carolina, Chapel Hill
Monica Longo, MD PhD
Role: STUDY_DIRECTOR
Eunice Kennedy Shriver NICHD
Rebecca G Clifton, PhD
Role: PRINCIPAL_INVESTIGATOR
The George Washington University Biostatistics Center
Locations
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University of Alabama - Birmingham
Birmingham, Alabama, United States
Regents of the University of California San Francisco
San Francisco, California, United States
Northwestern University
Chicago, Illinois, United States
Columbia University
New York, New York, United States
University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States
Duke University
Durham, North Carolina, United States
Case Western Reserve University
Cleveland, Ohio, United States
Ohio State University
Columbus, Ohio, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Magee Women's Hospital
Pittsburgh, Pennsylvania, United States
Brown Univeristy
Providence, Rhode Island, United States
Baylor College of Medicine
Houston, Texas, United States
University of Texas - Houston
Houston, Texas, United States
University of Utah
Salt Lake City, Utah, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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