Risk Factors of Venous Thromboembolism in Women During Hormonal Exposure

Condition(s) studied

Investigational drug(s) / intervention(s)

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

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

Study 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

Primary outcome measure(s)

• Presence of venous thromboembolic disease in first-degree relatives. — 1 day
  The primary outcome measure is defined by the presence of symptomatic venous thromboembolic disease in first degree relatives based on: * objective, validated and standardized criteria * or a validated and standardized questionnaire and leg ultrasound according to a validated algorithm

Trial sites (8)

More University Hospital, Brest trials in France

Other trials for the same condition