Recruiting

Single-Balloon Catheter vs. Osmotic Dilators

Sponsor:

Boston Medical Center

Code:

NCT06799052

Conditions

Abortion, Second Trimester

Procedural Pain

Procedural Complication

Eligibility Criteria

Sex: Female

Age: 16+

Healthy Volunteers: Accepted

Interventions

Transcervical single-balloon catheter

Synthetic osmotic dilators

Study Details

Brief summary:

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

Study ID

NCT06799052

Start date

Jun 12, 2025

Status verified date

Jun, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 16+

Healthy Volunteers: Accepted

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

Enrollment

32 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

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.

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Anjanique Mariquit Lu, MD

617 414 5716anjaniquemariquit.lu@bmc.org

Alana Martinusen, MPH

617 383 3500alana.martinusen@bmc.org

Locations

Boston Medical Center

Recruiting

Boston, Massachusetts, United States, 02118

Contacts

Anjanique M Lu, MD

617-414-5716anjaniquemariquit.lu@bmc.org

Pauline Yang, BS

617 414 5716yangp@bu.edu

More Information

Sponsor

Boston Medical Center

Last update posted

Jun 30, 2026

Last verified

Jun, 2026

Keywords

  • Cervical Dilation and Evacuation (D&E)
  • Transcervical single-balloon catheter
  • Osmotic dilators
  • Adequate dilation
  • Patient satisfaction

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Boston Medical Center on 2026-06-30.