Cervical Preparation for Same-Day Dilation & Evacuation

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Boston Medical Center
Study ID
NCT06799052
Status
Recruiting
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Conditions

  • Abortion, Second Trimester
  • Procedural Complication
  • Procedural Pain

Eligibility Criteria

Sex
FEMALE
Age
16 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Transcervical single-balloon catheter — DEVICE
    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.
  • Synthetic osmotic dilators — DEVICE
    Dilators will be maintained in the cervix between 3-4 hours, during which each dilator rod will swell several times its initial dried diameter.

Study Details

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 Dates

Start date
Jun 12, 2025
Status verified
Jun 2025
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
32 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Transcervical single-balloon catheter group
    Participants randomized to this arm will have cervical dilation done using a transcervical single-balloon catheter.
  • Active Comparator: Osmotic dilators group
    Participants randomized to this arm will have cervical dilation done using osmotic dilators.

Primary Outcome Measure

Dilation & Evacuation (D&E) Operative time [ Time Frame: at end of procedure about 20 minutes ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Boston Medical CenterBostonMassachusetts02118
Anjanique M Lu, MD
[email protected]
617-414-5716
Pauline Yang, BS
[email protected]
617 414 5716

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By research site
Boston Medical Center· Boston, MA

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