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Azithromycin for Cerclage Prophylaxis

NCT07608562 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-05-27

No results posted yet for this study

Summary

The primary goal is to assess the effectiveness in pregnancy prolongation utilizing azithromycin at the time of transvaginal cervical cerclage placement.

Conditions

  • Cervical Insufficiency

Interventions

DRUG

Azithromycin Placebo

normal saline placebo IV infusion prior to cerclage placement in the operating room or pre-operative area

DRUG

Azithromycin Prophylaxis

500 mg of IV azithromycin prior to cerclage placement in the operating room or pre-operative area.

DRUG

Cefazolin

All participants will receive standard of care cefazolin. First dose is to be given preoperatively, and the next two doses to be given 8 and 16 hours postoperatively. Participants weighing less than 100 kg will receive 2 g cefazolin, and those weighing 100 kg or more will receive 3 g cefazolin.

Sponsors & Collaborators

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Rachel Harrison, MD · advocate christ medical center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2028-06-30
Completion
2028-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07608562 on ClinicalTrials.gov