Actively Recruiting
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
Eligibility Criteria
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
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
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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
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
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