Clinical trial NCT06964373: Cervical Ripening Balloons for Same-Day Cervical Prep
Official title: Cervical Ripening Balloon for Same-Day Cervical Preparation for Second Trimester Termination
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dilation and Evacuation
Lead sponsor: University of New Mexico
Sponsor class: OTHER
First posted: 2025-05-09
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 criteria: 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

Primary outcomes:
measure: D&E procedure length (minutes)
timeFrame: during procedure
Secondary outcomes:
measure: Starting dilation (French gauge)
timeFrame: during procedure
measure: Additional dilation (French gauge)
timeFrame: during procedure
measure: Estimated blood loss (milliliters)
timeFrame: during procedure
measure: Additional sedation medication administered
timeFrame: during procedure
measure: Pain (Visual Analog Scale)
timeFrame: during procedure
measure: Administration of uterotonic medications
timeFrame: during procedure
measure: Cervical laceration
timeFrame: during procedure
measure: Estimated blood loss > 500 milliliters
timeFrame: From enrollment to 24 hours after enrollment
measure: Hospital transfer
timeFrame: From enrollment to 24 hours after enrollment
measure: Feasibility of cervical preparation (physician-reported)
timeFrame: From enrollment to 24 hours after enrollment
measure: Likelihood to recommend cervical preparation (participant-reported)
timeFrame: From enrollment to 24 hours after enrollment
measure: Acceptability of cervical preparation (physician-reported)
timeFrame: From enrollment to 24 hours after enrollment
measure: Satisfaction with level of pain management (participant-reported)
timeFrame: From enrollment to 24 hours after enrollment
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
Study officials:
References: