Using cervical ripening balloons for outpatient dilation and evacuation
Official title: Cervical Ripening Balloon for Same-Day Cervical Preparation for Second Trimester Termination
Run by University of New Mexico · NCT06964373 · Data updated 2026-11-12
This study is testing if using cervical ripening balloons is as safe and acceptable as osmotic dilators for preparing women before a same-day outpatient dilation and evacuation procedure.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 70 (estimated) |
| Sponsor | University of New Mexico Academic / other |
| Locations | 1 site (Albuquerque, New Mexico) |
| Status | Recruiting |
| Started | April 8, 2025 |
| Main results expected | May 31, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | October 13, 2026 |
| Trial ID | NCT06964373 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals aged 18 and older who desire outpatient D&E and meet specific gestational criteria.
✕Probably not a fit
Patients with medical conditions requiring operating room management or those preferring D&E in the operating room may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial aims to evaluate the effectiveness of cervical ripening balloons compared to osmotic dilators for preparing the cervix before same-day outpatient dilation and evacuation (D&E). The study will assess whether the balloon method is non-inferior in terms of safety and feasibility, as well as patient acceptability. Participants will be randomly assigned to receive either the cervical ripening balloon or osmotic dilators and will complete surveys regarding their experiences. The goal is to improve outpatient D&E procedures for patients.
Why it matters
Potential benefit: If successful, this approach could provide a safer and more acceptable method for cervical preparation before outpatient D&E procedures.
How similar studies have gone: While this approach is being tested, similar studies using cervical ripening balloons have shown promise in other contexts, suggesting potential for success.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
University of New Mexico
Albuquerque, New Mexico, United States Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.