Same-Day Cervical Preparation Prior to Second Trimester Dilation & Evacuation: A Noninferiority Randomized Control Trial Comparing Single-Balloon Catheter and Osmotic Dilators

What this Trial Is About

Researchers are evaluating two methods of cervical preparation before same-day Dilation & Evacuation (D&E) procedures in the second trimester. The study compares a single-balloon catheter method to osmotic dilators, focusing mainly on whether the catheter method is not worse than osmotic dilators in terms of the time needed for the D&E operation. Secondary goals include comparing dilation adequacy, same-day procedure completion, participant pain, satisfaction, and safety. Participants will be randomly assigned to one of two groups. One group will receive cervical dilation with a transcervical single-balloon catheter filled with 30cc of water or saline, which stays in place for about 3-4 hours before the procedure. The other group will have synthetic osmotic dilators placed in the cervix for 3-4 hours, during which the dilators expand. Both methods aim to prepare the cervix effectively for the D&E procedure. Participants will be monitored for operative time at the end of the procedure, which typically lasts about 20 minutes. Researchers will also assess participant pain every hour until the procedure, satisfaction after dilation, cervical dilation at the start of the procedure, and whether the surgery is completed the same day. The study includes follow-up for up to 12 months to evaluate these outcomes and safety. Total participation duration varies based on procedure and follow-up needs.

Cervical Preparation for Same-Day Dilation & Evacuation