Using azithromycin to prevent infections after cesarean delivery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Arm versus ankle mean arterial pressure during elective cesarean delivery

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.