Cervical Ripening Balloons for Same-Day Cervical Prep
- Conditions
- Dilation and Evacuation
- Registration Number
- NCT06964373
- Lead Sponsor
- University of New Mexico
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 70
- 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
- Medical conditions that require procedural management in the operating room
- Preference for D&E procedure in the operating room
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method D&E procedure length (minutes) during procedure From insertion of first instrument to removal of speculum
- Secondary Outcome Measures
Name Time Method Additional sedation medication administered during procedure yes/no
Administration of uterotonic medications during procedure yes/no
Cervical laceration during procedure yes/no
Estimated blood loss > 500 milliliters From enrollment to 24 hours after enrollment yes/no
Hospital transfer From enrollment to 24 hours after enrollment yes/no
Starting dilation (French gauge) during procedure Pratt dilator size in French gauge (sequential numbered instruments with size corresponding to diameter)
Additional dilation (French gauge) during procedure Pratt dilator size in French gauge (sequential numbered instruments with size corresponding to diameter)
Pain (Visual Analog Scale) during procedure 10 point visual analog scale with values from 0-10, with 0 being "No pain" and 10 being "Worst possible pain." Electronic slider measure so participants can specify up to 0.001 value.
Feasibility of cervical preparation (physician-reported) From enrollment to 24 hours after enrollment Yes/ No: "Is this type of cervical prep feasible for future patients" and qualitative free-text responses
Likelihood to recommend cervical preparation (participant-reported) From enrollment to 24 hours after enrollment Modified Likert scale: Very unlikely, Somewhat unlikely, Neither likely nor unlikely, Somewhat likely, Very likely
Acceptability of cervical preparation (physician-reported) From enrollment to 24 hours after enrollment Yes/ No: "Is this type of cervical prep acceptable for future patients" and qualitative free-text responses
Satisfaction with level of pain management (participant-reported) From enrollment to 24 hours after enrollment Yes/ No: "Are you satisfied with your level of pain management..." and qualitative free-text responses
Estimated blood loss (milliliters) during procedure Amount of blood loss, measured in milliliters throughout the procedure
Trial Locations
- Locations (1)
University of New Mexico
🇺🇸Albuquerque, New Mexico, United States
University of New Mexico🇺🇸Albuquerque, New Mexico, United States