Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
70 participants
INTERVENTIONAL
2025-04-08
2026-07-31
Brief Summary
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* 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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cervical Ripening Balloon
Cervical Ripening Balloon
30 milliliter Foley balloon
Osmotic Dilators
Osmotic Dilators
Dilapan-S
Interventions
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Cervical Ripening Balloon
30 milliliter Foley balloon
Osmotic Dilators
Dilapan-S
Eligibility Criteria
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Inclusion Criteria
* 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
* Preference for D\&E procedure in the operating room
18 Years
FEMALE
No
Sponsors
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University of New Mexico
OTHER
Responsible Party
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Locations
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University of New Mexico
Albuquerque, New Mexico, United States
Countries
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Facility Contacts
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Other Identifiers
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24-493
Identifier Type: -
Identifier Source: org_study_id
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