NCT06964373

Cervical Ripening Balloons for Same-Day Cervical Prep

Cervical Ripening Balloon for Same-Day Cervical Preparation for Second Trimester Termination

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: University of New Mexico · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn if a cervical ripening balloon (Foley balloon) works to prepare the cervix before same-day outpatient dilation and evacuation (D\&E). The main questions it aims to answer are: * Is cervical preparation with cervical ripening balloon for same-day outpatient D\&E non-inferior to cervical preparation with osmotic dilators? * How feasible and safe is cervical preparation with cervical ripening balloon for same-day outpatient D\&E? * How acceptable is cervical preparation with cervical ripening balloon for same-day outpatient D\&E? Participants will: * Have cervical preparation with cervical ripening balloon (experimental group) or osmotic dilators (usual care group) * Complete two surveys, one about the cervical preparation and one about the D\&E procedure

Conditions

• Dilation and Evacuation

Interventions

Type	Name	Description
DEVICE	Cervical Ripening Balloon	30 milliliter Foley balloon
DEVICE	Osmotic Dilators	Dilapan-S

Timeline

• Start date: 2025-04-08
• Primary completion: 2026-04-02
• Completion: 2026-07-31
• First posted: 2025-05-09
• Last updated: 2025-05-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study