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

Inclusion Criteria4

  • Eligibility criteria:
  • \- Propositi with objectively confirmed proximal deep vein thrombosis (i.e. ultrasonography) or pulmonary embolism (i.e. lung scanning) in women (18 to 50 years) while on hormonal exposure.
  • First-degree relatives (biological parents, brothers, sisters, children) of women of childbearing age 18-50 years (propositus) with a first MVTE in the hormonal setting and matched control women in the same hormonal setting who have never had MVTE, consenting to first-degree relatives being contacted to participate in the present study.
  • Written consent from propositi and family members.

Exclusion Criteria6

  • First-degree relatives whose propositus received preventive antithrombotic medication during pregnancy or contraception.
  • Family members of propositus who have had superficial or muscular venous thrombosis
  • No information can be obtained on first-degree relatives.
  • Family members under 16 years of age.
  • Vulnerable persons other than minors aged 16 to 18 (guardianship, curatorship).
  • Not affiliated to or not benefiting from a health insurance scheme.

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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