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Cervical Preparation for Same-Day Dilation & Evacuation
Sponsor: Boston Medical Center
Summary
This is a noninferiority randomized control trial of two cervical preparation methods prior to same-day Dilation \& Evacuation (D\&E). Cervical preparation is a process that softens and dilates the cervix prior to a procedure. The primary objective is to evidence noninferiority of cervical preparation using a single-balloon catheter method when compared to a group receiving osmotic dilators, specifically in D\&E operative time. Secondary objectives will compare the two methods for adequate dilation, ability to complete the operation in the same day, participant pain, satisfaction and safety.
Official title: Same-Day Cervical Preparation Prior to Second Trimester Dilation & Evacuation: A Noninferiority Randomized Control Trial Comparing Single-Balloon Catheter and Osmotic Dilators
Key Details
Gender
FEMALE
Age Range
16 Years - Any
Study Type
INTERVENTIONAL
Enrollment
32
Start Date
2025-06-12
Completion Date
2026-09
Last Updated
2025-06-26
Healthy Volunteers
Yes
Interventions
Transcervical single-balloon catheter
A single-balloon (Foley) catheter will be placed through the cervix and filled to 30cc of water or saline. The balloon will remain in the participant until their procedure, usually 3-4 hours, or earlier if it falls out on its own.
Synthetic osmotic dilators
Dilators will be maintained in the cervix between 3-4 hours, during which each dilator rod will swell several times its initial dried diameter.
Locations (1)
Boston Medical Center
Boston, Massachusetts, United States