Cervical Preparation for Same-Day Dilation & Evacuation
Same-Day Cervical Preparation Prior to Second Trimester Dilation & Evacuation: A Noninferiority Randomized Control Trial Comparing Single-Balloon Catheter and Osmotic Dilators
Boston Medical Center
32 participants
Jun 12, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria4
- Between 16 weeks 0 days - 18 weeks 6 days gestational age who are pursuing termination, based on reliable gestational age (defined as ultrasonography performed by a clinical provider, or a certain last menstrual period)
- Able to provide informed consent
- English- or Spanish-speaking
- Singleton intrauterine pregnancy
Exclusion Criteria5
- Allergy to betadine, aquacryl hydrogel, latex-free silicone single-balloon catheter, synthetic or natural osmotic dilators
- Fetal demise or known fetal anomaly
- BMI \>45
- Incarceration or other inability to give informed consent
- Decide to undergo cervical preparation overnight prior to next-day D\&E
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Interventions
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.
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)
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NCT06799052