RecruitingNAINTERVENTIONAL

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

This study, called HEMOMYOC, is investigating a way to reduce bleeding during an operation called a myomectomy. This surgery removes non-cancerous growths, called fibroids, from a woman's womb. Fibroids can cause problems like heavy periods and pain. A significant challenge during myomectomy is blood loss. Researchers are testing if a medication called misoprostol, which helps the womb contract, can help reduce bleeding when given before surgery. They will compare it to a dummy pill (placebo) to see if it makes a difference. The study also uses a technique during surgery to temporarily reduce blood flow to the womb. Misoprostol has been used for many years for other gynaecological conditions and is generally well-tolerated, with side effects usually limited to mild stomach upset. The aim is to find safer ways to perform this common surgery.

At a glance

Status

Recruiting

Phase

Sponsor

University Hospital, Clermont-Ferrand

Enrolment target

Start

12 Mar 2025

Estimated completion

17 Apr 2028

Myoma;Uterus Myomectomy; Surgical Blood Loss

What is this study about?

Many women experience non-cancerous growths in their womb called fibroids. While often harmless, they can sometimes cause uncomfortable symptoms like heavy bleeding, pain, or even fertility issues. When fibroids cause problems, doctors might recommend surgery to remove them, an operation known as a myomectomy. This can be done in different ways, like through a small cut (laparoscopy) or a larger one (laparotomy), depending on the fibroids' size and location.

One of the main challenges during a myomectomy is preventing too much blood loss. Doctors already use several methods to try and reduce bleeding during these operations, but they are always looking for better and safer ways. This study is exploring if a medicine called misoprostol can help. Misoprostol is a medication commonly used in women's health for its ability to make the womb contract, and it's generally considered safe and well-tolerated with few side effects, mainly mild digestive upset.

The HEMOMYOC study aims to see if giving misoprostol by mouth before a myomectomy, combined with a technique to temporarily reduce blood flow to the womb during surgery, can significantly reduce the amount of blood a woman loses. Researchers will compare patients who receive misoprostol to those who receive a placebo (a dummy pill with no active medicine) to understand its real benefits. The hope is that this combination could make myomectomy a safer procedure, regardless of the surgical approach used.

Key takeaways

This study investigates a way to reduce blood loss during fibroid removal surgery (myomectomy).
It tests a common medication called misoprostol, given before surgery, against a dummy pill.
The goal is to improve safety and recovery for women undergoing this type of operation.
Misoprostol is generally well-tolerated, with known mild side effects like stomach upset.
You would undergo your planned fibroid surgery with additional monitoring.
Participation could help future patients but offers no guaranteed personal benefit for you.

Who may be eligible?

This study is looking for women between 18 and 43 years old who have fibroids causing symptoms like bleeding, pain, or difficulty getting pregnant. You would be considered if your doctor has recommended a myomectomy to remove these fibroids.

The size or number of your fibroids slightly affects which type of surgery you might have been recommended for. If you're having laparoscopic surgery (keyhole surgery), your fibroids should be 10cm or smaller, or you should have 4 fibroids or fewer. If you're having laparotomy (open surgery), your fibroids might be larger than 10cm, or you might have more than 4 fibroids. It's also important that a specific method to temporarily reduce blood flow to your womb can be used during your surgery. You must also speak and understand French and be covered by a social security scheme.

However, you wouldn't be able to join if you've had major womb surgery or a myomectomy before (unless it was a very specific type done through the vagina). You also can't take part if you're allergic to misoprostol, similar medicines (prostaglandins), or any ingredients in the pill. Using blood-thinning medications like aspirin or anticoagulants, having blood clotting problems, being very undernourished, or having serious liver or kidney problems would also exclude you. Lastly, if you are pregnant, suspect you might be pregnant, breastfeeding, or are under 18 or under legal guardianship, you cannot participate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Am I a woman between 18 and 43 years old?
Do I have symptomatic fibroids that my doctor says need surgery?
Am I having either laparoscopic or open surgery for my fibroids?
Can I speak and understand French?
Am I not pregnant, breastfeeding, or taking blood-thinning medications?
Do I have no history of major womb surgery or allergies to misoprostol?

Answer every question to see your result.

What does participation involve?

If you decide to participate in this study, you will be given either misoprostol or a placebo (a dummy pill) to take before your myomectomy operation. During your surgery, doctors will also use a technique to temporarily reduce blood flow to your womb. The study involves your planned myomectomy, with specific procedures in place for monitoring and data collection. You will have regular medical check-ups and assessments before, during, and after the operation, similar to standard care, but with additional monitoring related to the study. The total duration of your participation would cover the period leading up to your surgery, the surgery itself, and a follow-up period to assess your recovery and any effects of the treatment. The exact number of visits and their timing will be explained in detail by the study team.

Potential risks and benefits

Taking part in this study may offer potential benefits, such as contributing to scientific understanding that could lead to improved surgical outcomes for women undergoing myomectomy in the future. For you personally, there is a chance that the medication being tested (misoprostol) could help reduce blood loss during your surgery, potentially leading to a smoother recovery, but this is not guaranteed as it is still being investigated. Potential risks include the known side effects of misoprostol, which are generally mild and include stomach upset, cramps, nausea, or vomiting. As with any medical procedure, there are also general risks associated with myomectomy surgery itself, which your doctor will discuss with you. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

CHU Clermont-Ferrand
Verified postcode
Clermont-Ferrand, France· Recruiting

Common questions

What are fibroids?

Fibroids are common non-cancerous growths that develop in the womb. They can cause symptoms like heavy periods, pain, or affect fertility.

What is a myomectomy?

A myomectomy is an operation to remove fibroids from the womb while keeping the womb intact.

What is misoprostol?

Misoprostol is a medicine that makes the womb contract. It's commonly used in women's health and has known mild side effects, mainly digestive.

Will I know if I'm getting the real medicine or a dummy pill?

No, this is a 'blinded' study, meaning neither you nor your doctors will know if you're receiving misoprostol or the placebo until after the study is complete, to ensure fair results.

What does 'transient occlusion of the uterine arteries' mean?

This is a technique used during surgery to temporarily reduce blood flow to the womb, helping to lessen bleeding during the operation.

How to find out more

Lise LACLAUTRE

promo_internet_drci@chu-clermontferrand.fr +33473754963 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.