Cervical Ripening Balloons for Same-Day Cervical Prep
Cervical Ripening Balloon for Same-Day Cervical Preparation for Second Trimester Termination
University of New Mexico
70 participants
Apr 8, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria7
- 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 Criteria2
- Medical conditions that require procedural management in the operating room
- Preference for D\&E procedure in the operating room
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Interventions
30 milliliter Foley balloon
Dilapan-S
Locations(1)
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NCT06964373