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RECRUITING
NCT03206372

Risk Factors of Venous Thromboembolism in Women During Hormonal Exposure

Sponsor: University Hospital, Brest

View on ClinicalTrials.gov

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

Interventions

OTHER

Case group

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

OTHER

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