Active not recruitingOBSERVATIONAL

Are Uterine Fibroids Pro-thrombotic?

This study aims to understand if womb fibroids, which are common growths in the womb, can make a person's blood more likely to clot. Researchers will compare blood samples from women with fibroids against those without, focusing on laboratory markers that show if the blood is more 'sticky'. Blood clots can be serious, and treating them in women with fibroids can be tricky because fibroids often cause heavy bleeding, which blood thinners can worsen. If fibroids are found to independently increase clotting risk, it could lead to better ways of identifying and helping many women, potentially reducing serious health problems and deaths. The study is particularly interested in cases where fibroids are the only apparent risk factor for clotting.

At a glance

Status

Active not recruiting

Sponsor

King's College Hospital NHS Trust

Enrolment target

105

Start

17 Oct 2022

Estimated completion

31 Dec 2024

Leiomyoma, Uterine Thrombosis

What is this study about?

This study is investigating a really important question: can womb fibroids, also known as uterine fibroids or leiomyomas, actually make your blood more likely to form clots? Fibroids are very common, affecting many women of childbearing age, and while they are usually harmless, they can cause symptoms like heavy periods. Blood clots, on the other hand, can be serious and sometimes life-threatening.

Doctors have noticed in some cases that women with fibroids also develop blood clots, even when they don't have other common risk factors for clotting. This study wants to find out if there's a direct link, or if fibroids themselves create conditions in the body that encourage clotting. This is especially important because blood thinners, which are used to treat clots, can make heavy periods from fibroids even worse, creating a difficult situation for patients and doctors.

If this study finds that fibroids do make blood more prone to clotting, it could change how doctors assess women with fibroids and help them identify those at higher risk of clots earlier. This could lead to new ways of managing their care, potentially preventing serious health problems and improving the lives of many women.

Key takeaways

The study investigates if womb fibroids increase blood clot risk.
It aims to identify if fibroids are an independent factor for clotting.
Compares blood samples from women with and without fibroids.
Could lead to improved risk assessment for women with fibroids.
Might reduce serious health problems and deaths related to blood clots.

Who may be eligible?

To join this study, you would need to be a woman between 18 and 65 years old. The study is divided into two main groups: one for women diagnosed with womb fibroids confirmed by an ultrasound scan, and another for women who don't have fibroids, also confirmed by an ultrasound, to serve as a comparison.

There are also some specific reasons why you wouldn't be able to take part. For example, if you've had a blood clot yourself, or if a close family member (parent, sibling, child) has had one, you wouldn't be eligible. You also can't be pregnant, have recently given birth (within 6 weeks), or had surgery recently (within 3 months). Certain health conditions like cancer, liver or kidney problems, or uncontrolled high blood pressure would also prevent participation.

Additionally, if you are taking certain medications, such as some types of birth control pills containing oestrogen, hormone replacement therapy with oestrogen, blood thinners, or medication for heavy periods (like Tranexamic Acid or Zoladex) within certain timeframes, you wouldn't be able to join. Your blood will also be checked for anaemia; if your iron levels are too low, you wouldn't be able to participate. This is to ensure the study results are clear and not affected by other health issues or treatments.

Quick self-check

Are you a woman between 18 and 65 years old?
Do you have confirmed womb fibroids, or a normal womb on ultrasound if you are in the comparison group?
Have you never had a blood clot yourself, and no close family members have either?
Are you currently not pregnant or recently given birth?
Are you not taking certain hormonal medications (like some birth control or HRT with oestrogen) or blood thinners?
Do you have good overall health without specific conditions like cancer or significant liver/kidney issues?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

Taking part in this study would involve providing blood samples for comparison. The study doesn't specify the number of visits or the total duration, but it focuses on analysing your blood to look for differences related to clotting. You won't be given any new medication as part of this research, as the main goal is to compare existing conditions and blood characteristics. Any follow-up would likely be related to collecting necessary samples.

Potential risks and benefits

Participating in this study might not offer direct personal health benefits, but your contribution could significantly help improve understanding and care for many women with fibroids in the future. The main risk would be the minor discomfort and very small chance of bruising or infection from blood tests, which are routine medical procedures. You are always free to withdraw from the study at any time without giving a reason, and this will not affect your usual medical care.

Locations (1)

King's College Hospital
London, United Kingdom

Common questions

What are womb fibroids?

Womb fibroids are common, non-cancerous growths that develop in or around the womb. They can range in size and may not cause any symptoms, but sometimes lead to heavy periods or discomfort.

What is a 'pro-thrombotic phenotype'?

This is a medical term for when your blood behaves in a way that makes it more likely to form clots. The study is looking to see if fibroids are linked to this tendency.

Why is it tricky to treat blood clots in women with fibroids?

Womb fibroids often cause heavy bleeding. Medication used to treat blood clots (blood thinners) can make this heavy bleeding much worse, making it a challenging situation for doctors and patients.

Will I be given new medication in this study?

No, this study is about comparing blood samples and won't involve giving you any new medications or treatments.

What will happen if fibroids are found to increase clot risk?

If a link is found, it could lead to doctors changing how they assess women with fibroids, potentially offering new ways to manage their risk of blood clots and prevent serious health problems.