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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

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.