Prevention trial for Myoma;Uterus
Official title Prevention of HEMOrhagic Risk in Upper MYOmeCTomy by Use of Misoprostol.
ClinicalTrials.gov ID: NCT06882824
What this study is testing
- What it's testing
- This study aims to find out if taking misoprostol before surgery reduces the amount of blood lost during a myomectomy (surgery to remove fibroids).
- Who it's for
- The study is looking for women who have uterine fibroids and are scheduled for surgery to remove them.
- What's involved
- Participants will take either a misoprostol pill or a placebo (a pill with no active medicine) before their surgery. During the operation, doctors will also temporarily block the blood flow to the uterus.
- Time commitment
- The study involves taking a pill before surgery and attending the scheduled surgical procedure.
You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 43, women only
You may be able to join if
- 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)
You likely can't join if
- 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
See the full eligibility 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.
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Clermont-Ferrand, Clermont-Ferrand, France
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, but 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 years to 43 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Clermont-Ferrand, Clermont-Ferrand, France. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.