Cervical Ripening Balloons for Same-Day Cervical Prep

  • STATUS
    Recruiting
  • End date
    Jul 31, 2026
  • participants needed
    70
  • sponsor
    University of New Mexico
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Updated on 12 May 2025
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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

Details
Condition Dilation and Evacuation
Age 18years or above
Clinical Study IdentifierNCT06964373
SponsorUniversity of New Mexico
Last Modified on12 May 2025

Eligibility

 Yes No Not Sure

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
Clear my responses
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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