RCT of Cervical Ripening Double Ballon Catheter Prior to Dilation and Evacuation.

The purpose of this study is to determine whether the overnight use of an FDA-cleared CRDB catheter is superior to the use of overnight osmotic dilators as is standard of care cervical preparation for patients presenting for dilation and evacuation (D\&E). The CRDB catheter is an FDA cleared device for cervical dilation prior to labor induction at term. It has not been FDA cleared for cervical dilation in the second-trimester, however, will be used in a similar fashion to labor inductions at term. Our standard of care osmotic dilators (e.g., laminaria, Dilapan-S) are both FDA cleared for cervical dilation prior to labor induction at term or gynecologic procedures requiring cervical dilation.

NCT Number	NCT07200115
Lead Sponsor	Yale University
Conditions	Cervical Preparation Prior to Dilation and Evacuation
Enrollment	50 participants
Start Date	2025-12-03
Primary Completion	2027-09 (estimated)
Study Completion	2028-09 (estimated)
Updated on ClinicalTrials.gov	2026-02-05