NCT06799052 Cervical Preparation for Same-Day Dilation & Evacuation
| NCT ID | NCT06799052 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Boston Medical Center |
| Condition | Abortion, Second Trimester |
| Study Type | INTERVENTIONAL |
| Enrollment | 32 participants |
| Start Date | 2025-06-12 |
| Primary Completion | 2026-09 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
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.
Eligibility 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