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RecruitingAccepts healthy volunteersPhase 3

Azithromycin Prophylaxis for PRElabor CEsarean DElivery Trial

The George Washington University Biostatistics Center · with Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of Alabama at Birmingham · NCT06605118

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Any age listed · Women only
Healthy volunteers
Accepted
Study type
Interventional · Phase 3
Target enrollment
8000
US sites recruiting
14
Study start
November 6, 2024
Record last updated
April 9, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Azithromycin Injection; Placebo; Standard of Care Preoperative antibiotics

Conditions: Obstetrical Complications; Labor and Delivery Complication; Cesarean Delivery

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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.

Recruiting US locations

  • University of Alabama - Birmingham

    Birmingham, AL 35233

    Site contact: Nancy Saxon, RN · 205-934-1616 · nbsaxon@uabmc.edu

  • Regents of the University of California San Francisco

    San Francisco, CA 94143

    Site contact: Natalie Oman, MPH · 206-718-4703 · natalie.oman@ucsf.edu

  • Northwestern University

    Chicago, IL 60611

    Site contact: Elizabeth Rangel, RN · elizabeth.rangel@northwestern.edu

  • Columbia University

    New York, NY 10032

    Site contact: Megan Loffredo, MD, CCRC · 203-722-1058 · ml4639@cumc.columbia.edu

  • University of North Carolina - Chapel Hill

    Chapel Hill, NC 27599

    Site contact: Kelly Clark, RN · 919-350-6117 · kelly_clark@med.unc.edu

  • Duke University

    Durham, NC 27710

    Site contact: Jennifer Ferrara, RNC MSN · 919-681-6176 · jennifer.ferrara@duke.edu

  • Case Western Reserve University

    Cleveland, OH 44109

    Site contact: Abigail Pierse, BS · 216-778-8443 · apierse@metrohealth.org

  • Ohio State University

    Columbus, OH 43210

    Site contact: Anna Bartholomew, RN, BSN · 614-685-3229 · anna.bartholomew@osumc.edu

  • Hospital of the University of Pennsylvania

    Philadelphia, PA 19104

    Site contact: Amee Feager, RN, BSN · 636-699-3433 · amee.feager@pennmedicine.upenn.edu

  • Magee Women's Hospital

    Pittsburgh, PA 15213

    Site contact: Jeanette Boyce, RN · 412-527-8118 · tessje@upmc.edu

  • Brown Univeristy

    Providence, RI 02905

    Site contact: Angelica DeMartino, RN, BSN · 401-274-1122 · amdemartino@wihri.org

  • Baylor College of Medicine

    Houston, TX 77030

    Site contact: Christina Reed, RN, NP · 832-826-7377 · christina.reed@bcm.edu

  • University of Texas - Houston

    Houston, TX 77030

    Site contact: Felecia Ortiz, RN · 713-500-6467 · felecia.ortiz@uth.tmc.edu

  • University of Utah

    Salt Lake City, UT 84132

    Site contact: Amber Sowles, RN · 801-585-5499 · amber.sowles@hsc.utah.edu

Study contacts (from the official record)

  • Rebecca G Clifton, PhD · 301-881-9260 · rclifton@bsc.gwu.edu
  • Steven Weiner, MS · weiner@bsc.gwu.edu
All pregnancy studies in Alabama →
Azithromycin Prophylaxis for PRElabor CEsarean DElivery Trial (NCT06605118) | Bored Studies