Azithromycin for Cerclage Prophylaxis

Part of paid clinical trials in Oak Lawn, Illinois.

Sponsor
Wake Forest University Health Sciences
Study ID
NCT07608562
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Cervical Insufficiency

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Azithromycin Prophylaxis — DRUG
    500 mg of IV azithromycin prior to cerclage placement in the operating room or pre-operative area.
  • Azithromycin Placebo — DRUG
    normal saline placebo IV infusion prior to cerclage placement in the operating room or pre-operative area
  • Cefazolin — DRUG
    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.

Study Details

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

Key Dates

Start date
Jun 30, 2026
Status verified
May 2026
Primary completion
Jun 30, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cerclage and Azithromycin Prophylaxis
    women at high risk for mid-trimester loss or early preterm birth who choose to undergo a cerclage as part of standard care recommendations
  • Active Comparator: Cerclage Without Azithromycin Prophylaxis
    women at high risk for mid-trimester loss or early preterm birth who choose to undergo a cerclage as part of standard care recommendations

Primary Outcome Measure

Latency from Cerclage to Delivery [ Time Frame: Up to Week 42 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Advocate Christ Medical CenterOak LawnIllinois60453
Rachel Harrison, MD
[email protected]
616-218-2892
Advocate Lutheran General HospitalPark RidgeIllinois60068-

Find similar trials in Oak Lawn, IL

By research site
Advocate Christ Medical Center· Oak Lawn, ILAdvocate Lutheran General Hospital· Park Ridge, IL

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