Cervical Preparation for Same-Day Dilation & Evacuation

This study is looking at two ways to prepare the cervix (the lower part of the uterus) before a same-day Dilation & Evacuation (D&E) procedure. Cervical preparation helps soften and open the cervix. Researchers want to see if using a single-balloon catheter is as good as using synthetic osmotic dilators. They will compare how long the D&E procedure takes with each method. They will also look at how well the cervix opens, if the procedure can be completed the same day, how much pain you experience, your satisfaction, and safety. You may be able to join if you are a woman between 16 weeks and 18 weeks 6 days pregnant and are planning a termination. The study is currently enrolling 32 participants.

Study design
This is a randomized controlled trial, meaning participants will be assigned by chance to one of two groups. It plans to enroll 32 participants.
What's involved
You will have a cervical preparation method (either a single-balloon catheter or synthetic osmotic dilators) placed for 3-4 hours before your procedure. The D&E procedure itself takes about 20 minutes.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome, D&E operative time, is measured at the end of the procedure, about 20 minutes after it begins.

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NCT06799052

Cervical Preparation for Same-Day Dilation & Evacuation

Recruiting
NAAges 16+InterventionalTreatment
Boston Medical Center
~32 participants
Updated 2026-06-30 on ClinicalTrials.gov
What's tested:Transcervical single-balloon catheterSynthetic osmotic dilators

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Dilation & Evacuation (D&E) Operative time
Measured over at end of procedure about 20 minutes
Abortion, Second Trimester
Procedural Pain
Procedural Complication
1 sites across 1 states
Massachusetts1
  • Anjanique Mariquit Lu, MD · PRINCIPAL_INVESTIGATOR · Boston Medical Center, Obstetrics and Gynecology

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Eligibility criteria

Inclusion

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

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
  • Dilation & Evacuation (D&E) Operative timeat end of procedure about 20 minutes

    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.