NCT06964373NARecruiting

Cervical Ripening Balloons for Same-Day Cervical Prep

University of New Mexico

Start Date

4/8/2025

Completion Date

7/31/2027

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

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Individuals who desire outpatient dilation and evacuation (D\&E) * At least 18 years of age * Able and willing to consent * Gestational duration between 18 weeks 0 days and 19 weeks 6 days as determined by ultrasound * Able to read and understand English or Spanish * Able to obtain reliable post-procedure transportation * Able to observe fasting guidelines of 6 hours prior to the D\&E procedure Exclusion Criteria: * Medical conditions that require procedural management in the operating room * Preference for D\&E procedure in the operating room

Interventions

DEVICE

Cervical Ripening Balloon

DEVICE

Osmotic Dilators

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Conditions

Dilation and Evacuation

Locations

University of New Mexico

Albuquerque, New Mexico 87106

United States