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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

Who can join

Ages 16 and older · Women · Healthy volunteers welcome

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

About the study

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.

What is being tested

• Transcervical single-balloon catheter (device)
• Synthetic osmotic dilators (device)

Sponsor: Boston Medical Center · Participants: 32 · Started: Jun 12, 2025

Contact the study team

• Anjanique Mariquit Lu, MD · Phone: 617 414 5716
• Alana Martinusen, MPH · Phone: 617 383 3500

Official record on ClinicalTrials.gov — NCT06799052

Locations in the U.S.

Conditions

• Procedural Pain
• Patient Satisfaction

From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.