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Operative Hysteroscopy Versus Suction Curettage for Surgical Termination of Early Pregnancy Loss (Miscarriage)

StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. Minor Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date changed from estimate of Dec 2025 to Mar 30, 2025
    • Study completion date: Dec 2025 to Feb 2026
    • Site details revised
    v3
  2. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Apr 2024 to Apr 1, 2024
    • Study description shortened, about 13 words
    • Site details revised
    v2
  3. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Non-blinded prospective randomized study. 100 women diagnosed with early pregnancy loss up to 10 gestational weeks who opted for surgical management (after being offered the options of conservative management and medical treatment) will be recruited. Qualifying patients will sign an informed consent form and will be randomly assigned to the two arms of the study: 1. Surgical uterine evacuation by the traditional ultrasound-guided suction curettage (control group) 2. Surgical uterine evacuation by operative hysteroscopy using a tissue removal device (study group). The surgical procedure will be determined randomly by computer generated allocation. All surgical procedures will be performed under general anesthesia in an outpatient surgical suite. The operative time, operative blood loss and intraoperative complications will be recorded by the research team. Following the surgical procedure, the patients will be monitored and discharged home as per our department's day-surgery protocol. Immediate post-operative complications will be recorded until discharge. One week after the procedure, a telephone interview will be conducted to assess any procedure-related complications. A diagnostic hysteroscopy without anesthesia will be scheduled 6 weeks postoperatively to assess for retained products of conception and for intrauterine adhesions. The diagnostic hysteroscopy will be performed by a practitioner who will be blinded to the type of surgery performed. 6 months after the procedure, a telephone questionnaire will be conducted to assess for subsequent pregnancies.
Trial Details
NCT Number NCT06309927
Lead Sponsor Assaf-Harofeh Medical Center
Conditions
(from sponsor)
Early Pregnancy Loss, Intrauterine Adhesion
Related terms Abortion, Spontaneous, Gynatresia
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov