Actively Recruiting
Cervical Preparation for Same-Day Dilation & Evacuation
Led by Boston Medical Center · Updated on 2025-06-26
32
Participants Needed
1
Research Sites
63 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Cervical Preparation for Same-Day Dilation & Evacuation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pregnant between 16 weeks 0 days and 18 weeks 6 days gestational age confirmed by ultrasound or certain last menstrual period
- Pursuing termination of pregnancy
- Able to provide informed consent
- English or Spanish speaking
- Carrying a single intrauterine pregnancy
You will not qualify if you...
- Allergy to betadine, aquacryl hydrogel, latex-free silicone single-balloon catheter, synthetic or natural osmotic dilators
- Fetal demise or known fetal anomaly
- Body mass index (BMI) greater than 45
- Incarceration or inability to give informed consent
- Planning to undergo cervical preparation overnight before next-day D&E
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Boston Medical Center
Boston, Massachusetts, United States, 02118
Actively Recruiting
Research Team
A
Anjanique Mariquit Lu, MD
CONTACT
A
Alana Martinusen, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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