RECRUITING

Cervical Preparation for Same-Day Dilation & Evacuation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-06-12
Study Completion:2026-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06799052

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:16 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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)
  2. * Able to provide informed consent
  3. * English- or Spanish-speaking
  4. * Singleton intrauterine pregnancy
  1. * Allergy to betadine, aquacryl hydrogel, latex-free silicone single-balloon catheter, synthetic or natural osmotic dilators
  2. * Fetal demise or known fetal anomaly
  3. * BMI \>45
  4. * Incarceration or other inability to give informed consent
  5. * Decide to undergo cervical preparation overnight prior to next-day D\&E

Contacts and Locations

Study Contact

Anjanique Mariquit Lu, MD
CONTACT
617 414 5716
anjaniquemariquit.lu@bmc.org
Alana Martinusen, MPH
CONTACT
617 383 3500
alana.martinusen@bmc.org

Principal Investigator

Anjanique Mariquit Lu, MD
PRINCIPAL_INVESTIGATOR
Boston Medical Center, Obstetrics and Gynecology

Study Locations (Sites)

Boston Medical Center
Boston, Massachusetts, 02118
United States

Collaborators and Investigators

Sponsor: Boston Medical Center

  • Anjanique Mariquit Lu, MD, PRINCIPAL_INVESTIGATOR, Boston Medical Center, Obstetrics and Gynecology

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-12
Study Completion Date2026-09

Study Record Updates

Study Start Date2025-06-12
Study Completion Date2026-09

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Abortion, Second Trimester
  • Procedural Pain
  • Procedural Complication