RecruitingNot ApplicableNCT06964373

Cervical Ripening Balloons for Same-Day Cervical Prep

Cervical Ripening Balloon for Same-Day Cervical Preparation for Second Trimester Termination


Sponsor

University of New Mexico

Enrollment

70 participants

Start Date

Apr 8, 2025

Study Type

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

Sex: FEMALEMin Age: 18 Years

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

DEVICECervical Ripening Balloon

30 milliliter Foley balloon

DEVICEOsmotic Dilators

Dilapan-S


Locations(1)

University of New Mexico

Albuquerque, New Mexico, United States

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NCT06964373


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