Comparing Foley Balloon and Misoprostol versus Laminaria for Cervical Preparation Before Second Trimester Surgical Abortion between 16 and 21 Weeks

What this Trial Is About

This research aims to evaluate the Foley Balloon technique combined with misoprostol for preparing the cervix before second trimester surgical abortion between 16 and 21 weeks gestational age. The study compares this method to the standard use of osmotic dilators Laminaria to assess if the Foley Balloon and misoprostol approach is not worse than the usual method. Additionally, the study will explore patient and provider satisfaction with both cervical preparation methods. Participants are randomly assigned to one of two groups. One group will receive a Foley Balloon catheter placed trans-cervically, inflated with saline, along with buccal misoprostol. The other group will have Laminaria devices placed in the cervix according to gestational age. Cervical preparation typically occurs on the first day, followed by dilation and evacuation D&E on the second day to complete the abortion procedure. Participants will undergo the cervical preparation procedure followed by D&E, with assessments including total procedure time, operative time, cervical dilation, complication rates, and pain levels. Satisfaction questionnaires will be completed by both patients and providers. The study spans the preparation and procedure days, with monitoring for safety and effectiveness outcomes. The total procedure time will be about 15-20 minutes during D&E completion, while complications and satisfaction are evaluated over 1-2 days.

Foley Balloon for Cervical Preparation Before Dilation and Evacuation