Cervical Ripening Balloons for Same-Day Cervical Prep

Purpose

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

Condition

  • Dilation and Evacuation

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
Female
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Cervical Ripening Balloon
  • Device: Cervical Ripening Balloon
    30 milliliter Foley balloon
Active Comparator
Osmotic Dilators
  • Device: Osmotic Dilators
    Dilapan-S

Recruiting Locations

University of New Mexico
Albuquerque, New Mexico 87106
Contact:
Cervical Ripening Balloon Study Coordinator
505-205-4118
HSC-FamilyPlanningResearch@salud.unm.edu

More Details

NCT ID
NCT06964373
Status
Recruiting
Sponsor
University of New Mexico

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ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center