Cervical Preparation for Same-Day Dilation & Evacuation

Recruiting now · Not applicable

Conditions studied: Abortion, Second Trimester, Procedural Pain, Procedural Complication

In brief

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.

Key facts

Study ID

NCT06799052

Run by

Boston Medical Center

People needed

32

Starts

2025-06-12

Expected to finish

2026-12-01

Last updated by the study team

2026-06-30

Who can join

Age: 16 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Boston Medical Center — Boston, Massachusetts, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.