Clinical Trial

Foley Balloon for Cervical Preparation Before Dilation and Evacuation

Recruiting
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Summary
To evaluate the Foley Balloon technique for cervical preparation before second trimester surgical abortion between 16 and 21 weeks estimated gestational age in combination with misoprostol to prepare the cervix before dilation and evacuation (D\&E) instead of osmotic dilators (Laminaria). Specific Aim One: Assess definitively whether using a Foley Balloon and Misoprostol is non-inferior to osmotic dilators for cervical preparation before D\&E. Specific Aim Two: Evaluate patient satisfaction with the two methods of second trimester abortion. Specific Aim Three: Evaluate provider satisfaction with the two methods of second trimester abortion.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-02-25.
Trial Details
NCT Number NCT06850974
Lead Sponsor Stony Brook University
Conditions Abortion, Second Trimester, Abortion, Medical
Enrollment 102 participants
Start Date 2025-02-10
Primary Completion 2027-03 (estimated)
Study Completion 2027-03 (estimated)
Updated on ClinicalTrials.gov 2026-04-30