Cervical Ripening Balloons for Same-Day Cervical Prep
CRB
Cervical Ripening Balloon for Same-Day Cervical Preparation for Second Trimester Termination
1 other identifier
interventional
70
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 7, 2025
CompletedStudy Start
First participant enrolled
April 8, 2025
CompletedFirst Posted
Study publicly available on registry
May 9, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 2, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 31, 2026
May 5, 2026
May 1, 2026
1.2 years
April 7, 2025
May 1, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
D&E procedure length (minutes)
From insertion of first instrument to removal of speculum
during procedure
Secondary Outcomes (13)
Starting dilation (French gauge)
during procedure
Additional dilation (French gauge)
during procedure
Estimated blood loss (milliliters)
during procedure
Additional sedation medication administered
during procedure
Pain (Visual Analog Scale)
during procedure
- +8 more secondary outcomes
Study Arms (2)
Cervical Ripening Balloon
EXPERIMENTALOsmotic Dilators
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Medical conditions that require procedural management in the operating room
- Preference for D\&E procedure in the operating room
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of New Mexico
Albuquerque, New Mexico, 87106, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 7, 2025
First Posted
May 9, 2025
Study Start
April 8, 2025
Primary Completion (Estimated)
June 2, 2026
Study Completion (Estimated)
July 31, 2026
Last Updated
May 5, 2026
Record last verified: 2026-05