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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 45
Healthy Volunteers: f
View:

• Early pregnancy loss (miscarriage) up to 10 gestational weeks

• Able to give informed consent, and read/write in Hebrew

Locations
Other Locations
Israel
Shamir Medical Center
RECRUITING
Be’er Ya‘aqov
Contact Information
Primary
Noam Smorgick, MD
nsmorgik@shamir.gov.il
+972-8-9779000
Time Frame
Start Date: 2024-04-01
Estimated Completion Date: 2025-12
Participants
Target number of participants: 100
Treatments
Experimental: Operative hysteroscopy
Surgical evacuation of the uterine cavity by operative hysteroscopy (tissue removal device, Truclear Mini-Elite)
Active_comparator: Suction curettage
Surgical evacuation of the uterine cavity by ultrasound guided suction curettage
Related Therapeutic Areas
Sponsors
Leads: Assaf-Harofeh Medical Center

This content was sourced from clinicaltrials.gov