Cervical Preparation for Same-Day Dilation & Evacuation

Same-Day Cervical Preparation Prior to Second Trimester Dilation & Evacuation: A Noninferiority Randomized Control Trial Comparing Single-Balloon Catheter and Osmotic Dilators

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.

Study Overview

• Status: Recruiting
• Conditions: Procedural Complication; Procedural Pain; Abortion, Second Trimester
• Intervention / Treatment: Device: Transcervical single-balloon catheter; Device: Synthetic osmotic dilators

• Study Type: Interventional
• Enrollment (Estimated): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anjanique Mariquit Lu, MD; Phone Number: 617 414 5716; Email: anjaniquemariquit.lu@bmc.org
• Study Contact Backup: Name: Alana Martinusen, MPH; Phone Number: 617 383 3500; Email: alana.martinusen@bmc.org

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Recruiting
      • Boston Medical Center
      • Contact: Anjanique M Lu, MD; Phone Number: 617-414-5716; Email: anjaniquemariquit.lu@bmc.org
      • Contact: Pauline Yang, BS; Phone Number: 617 414 5716; Email: yangp@bu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant preoperative pain	Participant pain will be assessed via a 100 point visual analog scale immediately post-cervical preparation and at every hour interval until their D&E. Higher scores are associated with more pain.	every hour until procedure, on average 3 hours
Participant satisfaction	Participant satisfaction will be assessed with a 5-point Likert scale from very dissatisfied to very satisfied.	after dilation, on average 3 hours
Cervical dilation	Cervical dilation will be measured in millimeters at the beginning of the procedure by the surgeon.	beginning of procedure, on average 3 hours
Number of participants with adequate cervical dilation	Abstracted from the operative record, dilation will be considered adequate if no manual dilation is needed.	beginning of procedure, on average 3 hours
Number of participants with surgery completed in the same day	Abstracted from the electronic medical record, whether the surgery was completed in the same day as the dilation will be recorded as yes or no.	12 months

Collaborators and Investigators

• Sponsor: Boston Medical Center
• Investigators: Principal Investigator: Anjanique Mariquit Lu, MD, Boston Medical Center, Obstetrics and Gynecology

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: January 23, 2025
• First Submitted That Met QC Criteria: January 23, 2025
• First Posted (Actual): January 29, 2025

Study Record Updates

• Last Update Posted (Actual): June 26, 2025
• Last Update Submitted That Met QC Criteria: June 25, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Patient satisfaction; Osmotic dilators; Cervical Dilation and Evacuation (D&E); Transcervical single-balloon catheter; Adequate dilation
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathological Conditions, Anatomical; Pain, Procedural; Dilatation, Pathologic
• Other Study ID Numbers: H-45533

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No