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Cervical Preparation for Same-Day Dilation & Evacuation

Boston Medical Center · NCT06799052

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 16+ · Women only
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
32
US sites recruiting
1
Study start
June 12, 2025
Record last updated
June 30, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Transcervical single-balloon catheter; Synthetic osmotic dilators

Conditions: Abortion, Second Trimester; Procedural Pain; Procedural Complication

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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

Recruiting US locations

  • Boston Medical Center

    Boston, MA 02118

    Site contact: Anjanique M Lu, MD · 617-414-5716 · anjaniquemariquit.lu@bmc.org

Study contacts (from the official record)

  • Anjanique Mariquit Lu, MD · 617 414 5716 · anjaniquemariquit.lu@bmc.org
  • Alana Martinusen, MPH · 617 383 3500 · alana.martinusen@bmc.org
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Cervical Preparation for Same-Day Dilation & Evacuation (NCT06799052) | Bored Studies