Cervical Preparation for Same-Day Dilation & Evacuation
NCT ID: NCT06799052
Last Updated: 2025-06-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
32 participants
INTERVENTIONAL
2025-06-12
2026-09-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Transcervical single-balloon catheter group
Participants randomized to this arm will have cervical dilation done using a transcervical single-balloon catheter.
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.
Osmotic dilators group
Participants randomized to this arm will have cervical dilation done using osmotic dilators.
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.
Interventions
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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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Able to provide informed consent
* English- or Spanish-speaking
* Singleton intrauterine pregnancy
Exclusion Criteria
* 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
16 Years
FEMALE
Yes
Sponsors
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Boston Medical Center
OTHER
Responsible Party
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Principal Investigators
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Anjanique Mariquit Lu, MD
Role: PRINCIPAL_INVESTIGATOR
Boston Medical Center, Obstetrics and Gynecology
Locations
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Boston Medical Center
Boston, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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H-45533
Identifier Type: -
Identifier Source: org_study_id
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