Using cervical ripening balloons for outpatient dilation and evacuation
Cervical Ripening Balloon for Same-Day Cervical Preparation for Second Trimester Termination
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of New Mexico Academic / other |
| Locations | 1 site (Albuquerque, New Mexico) |
| Trial ID | NCT06964373 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 18 and older who desire outpatient D&E and meet specific gestational criteria.
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.
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 performed: While this approach is being tested, similar studies using cervical ripening balloons have shown promise in other contexts, suggesting potential for success.
Eligibility criteria
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 this trial is running
Albuquerque, New Mexico
- University of New Mexico — Albuquerque, New Mexico, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.