Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING Phase 3

Azithromycin Prophylaxis for PRElabor CEsarean DElivery Trial

NCT06605118 · View on ClinicalTrials.gov ↗

Study Summary

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.

Interventions

  • DRUG Placebo
  • DRUG Azithromycin Injection
  • DRUG Standard of Care Preoperative antibiotics

Study Locations (14)

North Carolina

  • University of North Carolina - Chapel Hill — Chapel Hill
  • Duke University — Durham

Ohio

  • Case Western Reserve University — Cleveland
  • Ohio State University — Columbus

Pennsylvania

  • Hospital of the University of Pennsylvania — Philadelphia
  • Magee Women's Hospital — Pittsburgh

Texas

  • Baylor College of Medicine — Houston
  • University of Texas - Houston — Houston

Alabama

  • University of Alabama - Birmingham — Birmingham

California

  • Regents of the University of California San Francisco — San Francisco

Illinois

  • Northwestern University — Chicago

New York

  • Columbia University — New York

Trial Details

FieldValue
Enrollment Target 8,000 participants
Start Date 2024-11-06
Est. Completion 2027-11-30
Phase Phase 3

Interested in This Trial?

Always speak with your doctor before enrolling in a clinical trial.

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06605118

The ClinicalTrials.gov registry entry for NCT06605118 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 8,000 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The George Washington University Biostatistics Center, which has 7 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 3 conditions, with Cesarean Delivery appearing as the primary indexed condition, and to 3 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06605118 reports 14 study locations spanning 10 distinct geographic areas — top geographies include North Carolina, Ohio, Pennsylvania. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06605118 about?

NCT06605118 is a clinical study titled "Azithromycin Prophylaxis for PRElabor CEsarean DElivery Trial". 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 ...

What is the current status of trial NCT06605118?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 8,000 participants. The study started on 2024-11-06. Estimated completion is 2027-11-30.

What conditions does trial NCT06605118 study?

This clinical trial studies the following conditions: Cesarean Delivery, Obstetrical Complications, Labor and Delivery Complication. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06605118?

The interventions under investigation include: Placebo (DRUG), Azithromycin Injection (DRUG), Standard of Care Preoperative antibiotics (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06605118?

This trial is sponsored by The George Washington University Biostatistics Center, which has 7 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06605118 being conducted?

This trial has 14 study locations across Alabama, California, Illinois, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial