Cervical Ripening Balloons for Same-Day Cervical Prep

Part of paid clinical trials in Albuquerque, New Mexico.

Sponsor
University of New Mexico
Study ID
NCT06964373
Status
Recruiting
Apply to this trial

Conditions

  • Dilation and Evacuation

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cervical Ripening Balloon — DEVICE
    30 milliliter Foley balloon
  • Osmotic Dilators — DEVICE
    Dilapan-S

Study Details

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

Key Dates

Start date
Apr 8, 2025
Status verified
May 2026
Primary completion
Jun 2, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
70 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cervical Ripening Balloon
  • Active Comparator: Osmotic Dilators

Primary Outcome Measure

D&E procedure length (minutes) [ Time Frame: during procedure ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of New MexicoAlbuquerqueNew Mexico87106
Cervical Ripening Balloon Study Coordinator
[email protected]
505-205-4118

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By research site
University of New Mexico· Albuquerque, NM

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