RECRUITING

Cervical Preparation for Same-Day Dilation & Evacuation

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.

Study Overview

Study Details

Study overview

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.

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

Cervical Preparation for Same-Day Dilation & Evacuation

Condition
Abortion, Second Trimester
Intervention / Treatment

-

Contacts and Locations

Boston

Boston Medical Center, Boston, Massachusetts, United States, 02118

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

16 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Boston Medical Center,

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

Study Record Dates

2026-09