Cervical Ripening Balloon for Same-Day Cervical Preparation for Second Trimester Termination

What this Trial Is About

This research aims to evaluate the use of a cervical ripening balloon (Foley balloon) to prepare the cervix before same-day outpatient dilation and evacuation (D&E) procedures in individuals between 18 weeks 0 days and 19 weeks 6 days of gestation. The study compares this method to the usual care of cervical preparation with osmotic dilators, focusing on whether the balloon method is not worse (non-inferior), as well as its feasibility, safety, and acceptability. Participants will be randomly assigned to receive either the cervical ripening balloon or osmotic dilators (Dilapan-S) for cervical preparation before the D&E procedure. The balloon used is a 30 milliliter Foley balloon. After the cervical preparation, participants will undergo the D&E procedure on the same day. Participants will also complete two surveys: one about their experience with the cervical preparation and another about the D&E procedure. During the study, researchers will measure the length of the D&E procedure as the primary outcome. They will also assess several secondary outcomes including starting and additional cervical dilation, estimated blood loss, pain levels, use of additional sedation or uterotonic medications, cervical lacerations, feasibility and acceptability of the cervical preparation, hospital transfer rates, and participant satisfaction with pain management. Follow-up will include monitoring from enrollment through 24 hours after the procedure to ensure safety and collect feedback.

Cervical Ripening Balloons for Same-Day Cervical Prep