Recruiting
Phase 4

Azithromycin

Sponsor:

Wake Forest University Health Sciences

Code:

NCT07608562

Conditions

Cervical Insufficiency

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Azithromycin Prophylaxis

Azithromycin Placebo

Cefazolin

Progesterone

Study Details

Brief 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

Study ID

NCT07608562

Start date

Oct 15, 2026

Status verified date

Nov, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Singleton gestation at 16+0 to 23+6 weeks of gestational age at the time of enrollment
  • Indication for transvaginal cerclage placement
  • Intact amniotic membranes

Exclusion Criteria:

  • Evidence of active infection or chorioamnionitis at presentation
  • Preterm prelabor rupture of membranes (PPROM)
  • Multiple gestation
  • HIV positive status
  • Known severe allergy or contraindication to macrolide antibiotics (azithromycin or erythromycin)
  • Use of systemic antibiotics within the past 7 days (to avoid altered baseline vaginal microbiome)
  • Major fetal anomaly or known chromosomal abnormalities that significantly affect viability
  • Any maternal condition that would ethically preclude expectant management of pregnancy irrespective of cerclage

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

Azithromycin Prophylaxis

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

Azithromycin Placebo

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

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.

Progesterone

progesterone 200 mg nightly after cerclage placement until 36 weeks gestation

Primary outcome measure

  • Latency from Cerclage to Delivery [ Time Frame: Up to Week 42 ]
  • Gestational Age at Delivery [ Time Frame: Up to Week 42 ]

Central Contacts and Locations

Central contacts

Rachel Harrison, MD

616-218-2892rachel.harrison@aah.org

Locations

Advocate Christ Medical Center

Recruiting

Oak Lawn, Illinois, United States, 60453

Contacts

Rachel Harrison, MD

616-218-2892rachel.harrison@aah.org

Advocate Lutheran General Hospital

Recruiting

Park Ridge, Illinois, United States, 60068

Contacts

Rachel Harrison, MD

616-218-2892rachel.harrison@aah.org

More Information

Sponsor

Wake Forest University Health Sciences

Last update posted

Nov 12, 2026

Last verified

Nov, 2026

Keywords

  • short cervix
  • pregnancy prolongation
  • cerclage

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-13. This information was provided to ClinicalTrials.gov by Wake Forest University Health Sciences on 2026-11-12. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.