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Risk Factors of Venous Thromboembolism in Women During Hormonal Exposure

NCT03206372 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 2640

Last updated 2025-05-23

No results posted yet for this 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.

Conditions

  • Venous Thromboembolic Disease

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

Sponsors & Collaborators

  • University Hospital, Brest

    lead OTHER

Principal Investigators

  • Francis Couturaud, MD, PhD · EA3878 (GETBO), Brest University Hospital in France

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-10-24
Primary Completion
2026-10-24
Completion
2026-10-24

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03206372 on ClinicalTrials.gov