Cervical Preparation for Same-Day Dilation & Evacuation

NCT06799052 | Recruiting FDA Device

• 1 other identifier: H-45533
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Dilation & Evacuation (D&E) Operative time

  the total duration in D\&E operative time measured in minutes. Operative start time will be marked as the time that the speculum is inserted for the first time. Operative end time will be marked as the time that the speculum is removed at the end of the case.

  at end of procedure about 20 minutes

Secondary Outcomes (5)

• Participant preoperative pain

  every hour until procedure, on average 3 hours

• Participant satisfaction

  after dilation, on average 3 hours

• Cervical dilation

  beginning of procedure, on average 3 hours

• Number of participants with adequate cervical dilation

  beginning of procedure, on average 3 hours

• Number of participants with surgery completed in the same day

  12 months

Study Arms (2)

Transcervical single-balloon catheter group

EXPERIMENTAL

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

Device: Transcervical single-balloon catheter

Osmotic dilators group

ACTIVE COMPARATOR

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

Device: Synthetic osmotic dilators

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.

Also known as: Foley catheter

Transcervical single-balloon catheter group

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.

Also known as: Dilapan-S, seaweed laminaria

Osmotic dilators group

Eligibility Criteria

• Age: 16 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Medical Center: lead

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

RECRUITING

MeSH Terms

Conditions

Pain, Procedural; Patient Satisfaction

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Anjanique Mariquit Lu, MD

  Boston Medical Center, Obstetrics and Gynecology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anjanique Mariquit Lu, MD

CONTACT

617 414 5716; anjaniquemariquit.lu@bmc.org

Alana Martinusen, MPH

CONTACT

617 383 3500; alana.martinusen@bmc.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a noninferiority parallel randomized control trial of two cervical preparation methods prior to same-day D\&E.

Study Record Dates

• First Submitted: January 23, 2025
• First Posted: January 29, 2025
• Study Start: June 12, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: June 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)