NCT06799052NARecruitingAccepts Healthy Volunteers
Cervical Preparation for Same-Day Dilation & Evacuation
Boston Medical Center
Start Date
6/12/2025
Completion Date
12/1/2026
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 Criteria
Age Range: 16 years to No maximum
Inclusion Criteria:
* 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 Criteria:
* 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
Interventions
DEVICE
Transcervical single-balloon catheter
DEVICE
Synthetic osmotic dilators
Conditions
Abortion, Second TrimesterProcedural PainProcedural Complication
Locations
Boston Medical Center
Boston, Massachusetts 02118
United States