Using azithromycin to prevent infections after cesarean delivery
Azithromycin Prophylaxis for Prelabor Cesarean Delivery Trial
PHASE3 · The George Washington University Biostatistics Center · NCT06605118
This study is testing if giving azithromycin along with standard antibiotics can help prevent infections after cesarean deliveries for women and their babies.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 8000 (estimated) |
| Sex | Female |
| Sponsor | The George Washington University Biostatistics Center (other) |
| Locations | 14 sites (Birmingham, Alabama and 13 other locations) |
| Trial ID | NCT06605118 on ClinicalTrials.gov |
What this trial studies
This phase-III multi-center double-blind randomized controlled trial involves 8,000 individuals undergoing scheduled or prelabor cesarean deliveries. Participants will be randomized to receive either adjunctive azithromycin prophylaxis or a placebo, in addition to standard preoperative antibiotics. The primary goal is to determine if azithromycin reduces the risk of post-cesarean infections compared to placebo, while secondary objectives include assessing safety and resource use outcomes. Maternal and neonatal outcomes will be monitored up to six weeks postpartum.
Who should consider this trial
Good fit: Ideal candidates are pregnant individuals at or beyond 23 weeks' gestation scheduled for a cesarean delivery.
Not a fit: Patients with allergies to azithromycin, active infections requiring treatment, or those in labor prior to the cesarean will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of infections following cesarean deliveries, improving maternal health outcomes.
How similar studies have performed: Previous studies have shown promising results with antibiotic prophylaxis in surgical settings, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Birmingham, Alabama and 13 other locations
- University of Alabama - Birmingham — Birmingham, Alabama, United States (RECRUITING)
- Regents of the University of California San Francisco — San Francisco, California, United States (RECRUITING)
- Northwestern University — Chicago, Illinois, United States (RECRUITING)
- Columbia University — New York, New York, United States (RECRUITING)
- University of North Carolina - Chapel Hill — Chapel Hill, North Carolina, United States (RECRUITING)
- Duke University — Durham, North Carolina, United States (RECRUITING)
- Case Western Reserve University — Cleveland, Ohio, United States (RECRUITING)
- Ohio State University — Columbus, Ohio, United States (RECRUITING)
- Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States (RECRUITING)
- Magee Women's Hospital — Pittsburgh, Pennsylvania, United States (RECRUITING)
- Brown Univeristy — Providence, Rhode Island, United States (RECRUITING)
- Baylor College of Medicine — Houston, Texas, United States (RECRUITING)
- University of Texas - Houston — Houston, Texas, United States (RECRUITING)
- University of Utah — Salt Lake City, Utah, United States (RECRUITING)
Study contacts
- Principal investigator: Rebecca G Clifton, PhD — The George Washington University Biostatistics Center
- Study coordinator: Rebecca G Clifton, PhD
- Email: rclifton@bsc.gwu.edu
- Phone: 301-881-9260
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Obstetrical Complications, Labor and Delivery Complication, Cesarean Delivery, cesarean delivery, infection, maternal morbidity, antibiotics, prevention