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Search / Trial NCT06605118

Azithromycin Prophylaxis for PRElabor CEsarean DElivery Trial

Launched by THE GEORGE WASHINGTON UNIVERSITY BIOSTATISTICS CENTER · Sep 17, 2024

Trial Information

Current as of July 09, 2025

Recruiting

Keywords

Cesarean Delivery Infection Maternal Morbidity Antibiotics Prevention

ClinConnect Summary

The Azithromycin Prophylaxis for PRElabor CEsarean DElivery Trial is a clinical study aimed at understanding whether giving the antibiotic azithromycin before a scheduled cesarean delivery can help prevent infections in new mothers. The trial includes about 8,000 women who are at least 23 weeks pregnant and planning to have a cesarean delivery. Participants will receive either azithromycin or a placebo (which looks like the medication but has no effect) in addition to standard antibiotics usually given before surgery. Researchers will monitor the participants for up to six weeks after delivery to see if they develop any infections, such as wound infections or pneumonia.

To be eligible for this study, women must be expecting a single baby or twins and must be having a planned cesarean delivery. However, those with certain conditions, such as allergies to azithromycin or known infections requiring treatment, will not be able to participate. If you join this trial, you’ll receive care from your healthcare team, and you’ll be helping researchers learn more about how to reduce infection risks after cesarean deliveries. Your participation could contribute to improved health outcomes for future mothers.

Gender

FEMALE

Eligibility criteria

  • Inclusion Criteria:
  • ≥ 23 weeks' gestation (ACOG dating criteria)
  • Scheduled or prelabor cesarean delivery
  • Singleton or twin gestation
  • Exclusion Criteria:
  • 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.

About The George Washington University Biostatistics Center

The George Washington University Biostatistics Center is a leading research institution dedicated to advancing the field of biostatistics through innovative methodologies and rigorous scientific inquiry. As a prominent sponsor of clinical trials, the center specializes in the design, analysis, and interpretation of complex data in health-related research. With a commitment to enhancing public health outcomes, the Biostatistics Center collaborates with academic, governmental, and industry partners to foster evidence-based practices and promote the development of effective therapeutic interventions. Through its expertise, the center plays a vital role in ensuring the integrity and reliability of clinical research data, ultimately contributing to informed decision-making in healthcare.

Locations

Chicago, Illinois, United States

Philadelphia, Pennsylvania, United States

Houston, Texas, United States

Columbus, Ohio, United States

New York, New York, United States

Salt Lake City, Utah, United States

Durham, North Carolina, United States

Chapel Hill, North Carolina, United States

Houston, Texas, United States

Cleveland, Ohio, United States

Birmingham, Alabama, United States

Pittsburgh, Pennsylvania, United States

Providence, Rhode Island, United States

San Francisco, California, United States

Patients applied

0 patients applied

Trial Officials

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

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported