Cervical Preparation for Same-Day Dilation & Evacuation

Purpose

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.

Conditions

  • Abortion, Second Trimester
  • Procedural Pain
  • Procedural Complication

Eligibility

Eligible Ages
Over 16 Years
Eligible Sex
Female
Accepts Healthy Volunteers
Yes

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
This is a noninferiority parallel randomized control trial of two cervical preparation methods prior to same-day D&E.
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Transcervical single-balloon catheter group 		Participants randomized to this arm will have cervical dilation done using a transcervical single-balloon catheter.
  • Device: Transcervical single-balloon catheter
    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.
    Other names:
    • Foley catheter
Active Comparator
Osmotic dilators group 		Participants randomized to this arm will have cervical dilation done using osmotic dilators.
  • Device: Synthetic osmotic dilators
    Dilators will be maintained in the cervix between 3-4 hours, during which each dilator rod will swell several times its initial dried diameter.
    Other names:
    • Dilapan-S, seaweed laminaria

Recruiting Locations

Boston Medical Center
Boston, Massachusetts 02118
Contact:
Anjanique M Lu, MD
617-414-5716
anjaniquemariquit.lu@bmc.org

More Details

Status
Recruiting
Sponsor
Boston Medical Center

Study Contact

Anjanique Mariquit Lu, MD
617 414 5716
anjaniquemariquit.lu@bmc.org