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Cervical Ripening Balloons for Same-Day Cervical Prep
Cervical Ripening Balloon for Same-Day Cervical Preparation for Second Trimester Termination
Who can join
Ages 18 and older · Women
Full eligibility criteria
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
About the study
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
What is being tested
- Cervical Ripening Balloon (device)
- Osmotic Dilators (device)
Sponsor: University of New Mexico · Participants: 70 · Started: Apr 8, 2025
Contact the study team
Official record on ClinicalTrials.gov — NCT06964373
Locations in the U.S.
| New Mexico | University of New Mexico, Albuquerque |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.