RecruitingNCT03206372

Risk Factors of Venous Thromboembolism in Women During Hormonal Exposure

Risk of Venous Thromboembolism in First Degree Relatives of Women With or Without Venous Thromboembolism During Hormonal Exposure


Sponsor

University Hospital, Brest

Enrollment

2,640 participants

Start Date

Oct 24, 2017

Study Type

OBSERVATIONAL

Conditions

Summary

Young women have an increased risk of venous thromboembolism (VTE) during hormonale exposure (estrogen-containing pill or pregnancy). In order to detect women at higher risk of VTE during hormonal exposure, thrombophilia testing is often performed in order to adapt contraception methods and/or to increases thromboprophylaxy during pregnancy. However, such practice is probably not accurate nor discriminent. Indeed, there are evidence that the impact of the familial history of VTE might be stronger than that of detectable inherited thrombophilia. The "FIT-H" study is a cross-sectional study comparing the prevalence of previous venous thromboembolism in first-degree relatives of women (propositi) who had a first episode of venous thromboembolism in association with hormonal exposure with the prevalence of previous venous thromboembolism in first-degree relatives of women who did not have venous thromboembolism during a similar hormonal exposure. The primary objective is to determine the association between the presence or the absence of VTE in young women during hormonal exposure and the presence or the absence of a previous episode of VTE in their first-degree relatives. Secondary objective is to determine the impact of associated inherited thrombophilia on the risk of VTE in first-degree relatives.


Eligibility

Min Age: 16 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating why some women develop blood clots (deep vein thrombosis or pulmonary embolism — a clot in the leg veins or lungs) while using hormonal treatments such as the contraceptive pill or hormone replacement therapy, with the goal of identifying inherited or hormonal risk factors. **You may be eligible if...** - You are a first-degree relative (parent, sibling, or child) of a woman aged 18–50 who developed a confirmed blood clot while on hormonal treatment - You are a woman of childbearing age (18–50) currently on hormonal treatment and have never had a blood clot (as a comparison group) - You have provided written informed consent **You may NOT be eligible if...** - You are not a first-degree biological relative of an affected patient - You are unwilling to provide consent - You do not meet the age or hormonal exposure criteria Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERCase group

Questionnaire to be completed, blood sample and possibly echo-doppler

OTHERControl group

Questionnaire to be completed, blood sample and possibly echo-doppler


Locations(8)

CHRU Brest

Brest, France

HIA

Brest, France

Clermont Ferrand

Clermont-Ferrand, France

CH Morlaix

Morlaix, France

Paris HEGP

Paris, France

RENNES

Rennes, France

Saint Etienne

Saint-Etienne, France

Tours

Tours, France

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NCT03206372


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