Actively Recruiting

Age: 16Years +
All Genders
Healthy Volunteers
NCT03206372

Risk Factors of Venous Thromboembolism in Women During Hormonal Exposure

Led by University Hospital, Brest · Updated on 2025-05-23

2640

Participants Needed

8

Research Sites

469 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Risk Factors of Venous Thromboembolism in Women During Hormonal Exposure

Who Can Participate

Age: 16Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • First-degree relatives of women aged 18 to 50 years with a first venous thromboembolism during hormonal exposure and matched control women without venous thromboembolism in similar hormonal exposure
  • Consent given by both the women (propositi) and their first-degree relatives to participate
Not Eligible

You will not qualify if you...

  • First-degree relatives whose propositus received preventive antithrombotic medication during pregnancy or contraception
  • Family members who have had superficial or muscular venous thrombosis
  • Lack of information on first-degree relatives
  • Family members under 16 years of age
  • Vulnerable persons other than minors aged 16 to 18 under guardianship or curatorship
  • Not affiliated to or not benefiting from a health insurance scheme

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 8 locations

1

CHRU Brest

Brest, France, 29200

Actively Recruiting

2

HIA

Brest, France

Actively Recruiting

3

Clermont Ferrand

Clermont-Ferrand, France

Not Yet Recruiting

4

CH Morlaix

Morlaix, France

Actively Recruiting

5

Paris HEGP

Paris, France

Not Yet Recruiting

6

RENNES

Rennes, France

Actively Recruiting

7

Saint Etienne

Saint-Etienne, France

Actively Recruiting

8

Tours

Tours, France

Actively Recruiting

Loading map...

Research Team

F

Francis Couturaud, MD, PHD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here