Clinical Trial

Cervical Ripening Balloons for Same-Day Cervical Prep

Study acronym: CRB
Recruiting
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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
Protocol Amendment History 2 changes
notable Primary completion pushed: 2026-06-02 -> 2026-08-30 2026-07-07
minor Completion pushed: 2026-07-31 -> 2027-07-31 2026-07-07
Trial Details
NCT Number NCT06964373
Lead Sponsor University of New Mexico
Conditions Dilation and Evacuation
Enrollment 70 participants
Start Date 2025-04-08
Primary Completion 2026-08-30 (estimated)
Study Completion 2027-07-31 (estimated)
Updated on ClinicalTrials.gov 2026-07-06