Preventing bleeding during myomectomy with misoprostol
Prevention of HEMOrhagic Risk in Upper MYOmeCTomy by Use of Misoprostol.
This will test whether giving misoprostol before myomectomy reduces surgical bleeding in women aged 18–43 having surgery for symptomatic uterine fibroids.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 43 Years |
| Sex | Female |
| Sponsor | University Hospital, Clermont-Ferrand Academic / other |
| Locations | 1 site (Clermont-Ferrand, Clermont-Ferrand) |
| Trial ID | NCT06882824 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Women aged 18–43 with symptomatic uterine fibroids scheduled for laparoscopic or open myomectomy who meet the protocol size/number criteria, speak French, and are covered by a French social security scheme.
Not a fit: Patients on anticoagulants, with haemostatic disorders, pregnancy or breastfeeding, prior major uterine surgery, hepatic or renal insufficiency, or allergy to misoprostol are excluded and unlikely to receive benefit from this intervention.
Why it matters
Potential benefit: If effective, misoprostol could lower intraoperative blood loss, reduce transfusion rates, and help patients recover faster after myomectomy.
How similar studies have performed: Small studies and clinical use of misoprostol for uterine contraction have suggested it may reduce surgical bleeding, but robust high-quality evidence is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Clermont-Ferrand, Clermont-Ferrand
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.