Cervical Ripening Balloons for Same-Day Cervical Prep

Launched by UNIVERSITY OF NEW MEXICO · Apr 30, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a method to help prepare the cervix for a procedure called dilation and evacuation (D&E), which is done in an outpatient setting. Researchers want to find out if using a cervical ripening balloon, also known as a Foley balloon, is as effective and safe as the usual method, which involves using osmotic dilators. They are also interested in how acceptable this new method is for patients.

To be eligible for this trial, participants need to be at least 18 years old, able to understand English or Spanish, and looking for an outpatient D&E procedure. They should be between 18 to 19 weeks pregnant and able to arrange for transportation after the procedure. Participants will either receive the cervical balloon or the usual osmotic dilators and will complete two surveys to share their experiences. This trial is currently recruiting participants, and it aims to improve the care for women undergoing this procedure.

Gender

FEMALE

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