Comparing Single-Balloon Catheter and Osmotic Dilators for Same-Day Cervical Preparation Before Second Trimester Dilation & Evacuation

What this Trial Is About

Researchers are evaluating two methods for preparing the cervix before same-day Dilation & Evacuation D&E procedures in the second trimester of pregnancy. The trial aims to show that using a single-balloon catheter is not worse than using osmotic dilators, focusing mainly on the time it takes to complete the D&E operation. Additional goals include comparing how well each method softens the cervix, the ability to complete the procedure on the same day, participant pain levels, satisfaction, and safety. Participants are randomly assigned to one of two groups. One group receives cervical dilation through a single-balloon catheter placed transcervically, which is filled with water or saline and left in place for about 3 to 4 hours or until it naturally falls out. The other group uses synthetic osmotic dilators that swell in the cervix over 3 to 4 hours to achieve dilation. Both devices are used shortly before the D&E procedure on the same day. During the study, participants will have their dilation adequacy and pain monitored hourly until the procedure, which typically lasts about 20 minutes. Satisfaction will be assessed after dilation, and the procedures completion on the same day will be tracked over a year. Participants must be able to provide informed consent and speak English or Spanish. Safety and procedural complications will be carefully observed throughout the trial, which follows participants from preparation through the D&E procedure.

Cervical Preparation for Same-Day Dilation & Evacuation