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Risk Factors of Venous Thromboembolism in Women During Hormonal Exposure
Sponsor: University Hospital, Brest
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.
Official title: Risk of Venous Thromboembolism in First Degree Relatives of Women With or Without Venous Thromboembolism During Hormonal Exposure
Key Details
Gender
All
Age Range
16 Years - Any
Study Type
OBSERVATIONAL
Enrollment
2640
Start Date
2017-10-24
Completion Date
2026-10-24
Last Updated
2025-05-23
Healthy Volunteers
Yes
Conditions
Interventions
Case group
Questionnaire to be completed, blood sample and possibly echo-doppler
Control 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