Status:
RECRUITING
Prevention of HEMOrhagic Risk in Upper MYOmeCTomy by Use of Misoprostol.
Lead Sponsor:
University Hospital, Clermont-Ferrand
Conditions:
Myoma;Uterus
Myomectomy; Surgical Blood Loss
Eligibility:
FEMALE
18-43 years
Phase:
NA
Brief Summary
In France, uterine fibroids or leiomyomas are the most common benign tumour in women of childbearing age. In 30% of cases, fibroids are symptomatic (menorrhagia, anaemia, pain), in which case surgica...
Eligibility Criteria
Inclusion
- Patient aged 18 to 43
- Symptomatic myomas (bleeding, pain or infertility)
- Indication for laparoscopic myomectomy Fibroma ≤ 10cm or number ≤ to 4 fibroids
- Indication for myomectomy by laparotomy Fibroma \> 10cm, Number \> to 4 fibroids
- OTAU possible intraoperatively (Clip on uterine artery and tourniquet placement)
- Speak and understand French
- Affiliated with a social security scheme.
Exclusion
- History of major uterine surgery or myomectomy (excluding hysteroscopic myomectomy)
- Allergy to misoprostol and lactose
- Patients with hypersensitivity to misoprostol and/or other prostaglandins or to any of the product's excipients.
- Patients taking aspirin or anti-coagulants
- Patients with haemostasis disorders
- Malnourished patients
- Patients with hepatic or renal insufficiency
- Pregnancy, suspected ectopic pregnancy and breast-feeding women.
- Minors
- Guardianship, curatorship, deprived of liberty, safeguard of justice
Key Trial Info
Start Date :
March 12 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 17 2028
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06882824
Start Date
March 12 2025
End Date
April 17 2028
Last Update
September 24 2025
Active Locations (1)
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1
CHU Clermont-Ferrand
Clermont-Ferrand, Clermont-Ferrand, France, 63000