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Prevention of HEMOrhagic risk in upper MYOmeCTomy by use of Misoprostol.
EU CTIS ID: 2024-513617-13-00
What this study is testing
Evaluation of intraoperative blood loss during myomectomies with OTAU after administration of misoprostol 400μg PO (experimental group) versus placebo (control group) regardless of the type of surgery.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patient aged 18 to 43
- Symptomatic myomas (hemorrhages, pain or infertility)
- Indication for myomectomy by laparoscopy Fibroid ≤ 10cm or number ≤ 4 fibroids
- Indication for myomectomy by laparotomy Fibroid > 10cm, Number > 4 fibroids
- OTAU possible intraoperatively (Clip on uterine artery and Placement of a turnstile)
You likely can't join if
- History of major uterine surgery or myomectomy (excluding myomectomy by hysteroscopy)
- Allergy to misoprostol
- Patient on aspirin or anticoagulant
- Patients with a hemostasis disorder
- Patient with hypersensitivity to misoprostol and/or other prostaglandins or to any of the excipients of the product
- Malnourished patients
See the full eligibility criteria
- Patient aged 18 to 43
- Symptomatic myomas (hemorrhages, pain or infertility)
- Indication for myomectomy by laparoscopy Fibroid ≤ 10cm or number ≤ 4 fibroids
- Indication for myomectomy by laparotomy Fibroid > 10cm, Number > 4 fibroids
- OTAU possible intraoperatively (Clip on uterine artery and Placement of a turnstile)
- History of major uterine surgery or myomectomy (excluding myomectomy by hysteroscopy)
- Allergy to misoprostol
- Patient on aspirin or anticoagulant
- Patients with a hemostasis disorder
- Patient with hypersensitivity to misoprostol and/or other prostaglandins or to any of the excipients of the product
- Malnourished patients
- Patients with hepatic or renal impairment
- Pregnancy, suspected ectopic pregnancy and breastfeeding women.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.