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Cervical Preparation for Same-Day Dilation & Evacuation

RecruitingNAAges 16 Years - anyFemaleBoston Medical Center
NCT06799052 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Transcervical single-balloon catheter
  • Synthetic osmotic dilators
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Where

1 site
Boston Medical Center
Boston, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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