Preventing bleeding during myomectomy with misoprostol

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional trial at CHU Clermont-Ferrand compares misoprostol versus placebo given before myomectomy to reduce intraoperative blood loss. Eligible women are 18–43 with symptomatic fibroids and an indication for laparoscopic or open myomectomy according to size and number criteria in the protocol. Participants receive misoprostol or placebo perioperatively and investigators record surgical blood loss, hemoglobin change, and transfusion needs. Key exclusions include anticoagulant use, bleeding disorders, prior major uterine surgery, pregnancy or hypersensitivity to misoprostol.

Why it matters

Who can join: the full rules

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

Where it's running

• CHU Clermont-Ferrand
  Clermont-Ferrand, Clermont-Ferrand, France Recruiting

Study contacts

• Principal investigator: Anne-Sophie GREMEAU — University Hospital, Clermont-Ferrand
• Study coordinator: Lise LACLAUTRE
• Email: promo_internet_drci@chu-clermontferrand.fr
• Phone: +33473754963

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.