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Cervical Ripening Balloons for Same-Day Cervical Prep

RecruitingNAAges 18 Years - anyFemaleUniversity of New Mexico
NCT06964373 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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
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What it tests

  • Cervical Ripening Balloon
  • Osmotic Dilators
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Where

1 site
University of New Mexico
Albuquerque, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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