Status:
NOT_YET_RECRUITING
Use of Misoprostol in Hysteroscopic Myomectomy
Lead Sponsor:
Assuta Ashdod Hospital
Collaborating Sponsors:
Assuta Medical Center
Conditions:
Hysteroscopic Myomectomy
Eligibility:
FEMALE
20-55 years
Phase:
PHASE4
Brief Summary
Hysteroscopic myomectomy is typically suitable for myomas measuring under 4 cm in size. The utilization of misoprostol before the procedure can facilitate uterine access, decrease fluid absorption, an...
Detailed Description
Hysteroscopic myomectomy is a minimally invasive surgical procedure designed to remove uterine fibroids that are located within the uterine cavity. Traditionally, hysteroscopic myomectomy for large fi...
Eligibility Criteria
Inclusion
- women between the ags of 20 years- 55 years, inclusive
- undergoing hysteroscopic myomectomy
- submucosal fibroid less than 40 mm (type 0, 1 and 2)
- up to 2 submucosal fibroids
- patients are able to provide written informed consent
Exclusion
- post menopausal women
- inability to perform operative hysteroscopy under anesthesia in the past due to cervical stenosis
- previous PID or documented tubal occlusion
- positive BHCG test
- inability to consent due to cognitive or language barrier
- allergy to misoprostole
- severe COPD, asthma or cardiac disease
Key Trial Info
Start Date :
November 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06049745
Start Date
November 1 2023
End Date
October 1 2026
Last Update
September 22 2023
Active Locations (1)
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1
Assuta Ashdod University Hospital
Ashdod, Israel