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Prevention of HEMOrhagic Risk in Upper MYOmeCTomy by Use of Misoprostol.

RecruitingNAAges 18 Years - 43 YearsFemaleUniversity Hospital, Clermont-Ferrand
NCT06882824 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 surgical management is indicated. This is known as myomectomy, and can be performed by hysteroscopy, laparoscopy (laparoscopy) or laparotomy, depending on the number, size and position of the fibroids. Intraoperative bleeding is the main surgical difficulty. For this reason, a number of studies have focused on ways of minimizing the risk of bleeding. A good surgical indication, prevention of anaemia (iron deficiency) and transient occlusion of the uterine arteries during surgery help to reduce this risk. There are also drugs available to reduce intraoperative bleeding, but few studies have been carried out to assess their real effectiveness. One such product is Misoprostol, commonly used in gynec

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Criteria: * 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
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What it tests

  • myomectomy with placebo
  • myomectomy with misoprostol
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Where

1 site
CHU Clermont-Ferrand
Clermont-Ferrand, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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