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Cervical Preparation for Same-Day Dilation & Evacuation

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary and study completion dates: Sep 2026 to Dec 2026v5
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jun 2025 to Jun 12, 2025
    • Site details revised
    v4
  3. Re-verified, no change to tracked fieldsv3
  4. Start date: Mar 2025 to Jun 2025
    • Primary and study completion dates: May 2026 to Sep 2026
    v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06799052
Lead Sponsor Boston Medical Center
Conditions
(from sponsor)		 Abortion, Second Trimester, Procedural Pain, Procedural Complication
Related terms Patient Satisfaction, Procedural Pain
Enrollment 32 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov