Cervical Preparation for Same-Day Dilation & Evacuation

Boston Medical Center (BMC)

Status: Enrolling

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

Treatments: Device: Transcervical single-balloon catheter; Device: Synthetic osmotic dilators

Study type: Interventional

Funder types: Other

Identifiers

NCT06799052

H-45533

Details and patient eligibility

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.

Enrollment: 32 estimated patients

Sex: Female

Ages: 16+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

Transcervical single-balloon catheter group

Experimental group

Description:

Participants randomized to this arm will have cervical dilation done using a transcervical single-balloon catheter.

Treatment:

Device: Transcervical single-balloon catheter

Osmotic dilators group

Active Comparator group

Description:

Participants randomized to this arm will have cervical dilation done using osmotic dilators.

Treatment:

Device: Synthetic osmotic dilators