Azithromycin for Cerclage Prophylaxis

Starting soon · Phase 4 · Has a placebo group

Conditions studied: Cervical Insufficiency

In brief

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

Key facts

Study ID

NCT07608562

Run by

Wake Forest University Health Sciences

People needed

80

Starts

2026-08-01

Expected to finish

2028-12-01

Last updated by the study team

2026-07-23

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Advocate Christ Medical Center — Oak Lawn, Illinois, United States
• Advocate Lutheran General Hospital — Park Ridge, Illinois, United States

Full record on ClinicalTrials.gov

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