Actively Recruiting
Risk of Venous Thromboembolism in First-Degree Relatives of Women With or Without Venous Thromboembolism During Hormonal Exposure
Led by University Hospital, Brest · Updated on 2025-05-23
2640
Participants Needed
8
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Young women face an increased risk of venous thromboembolism (VTE) when exposed to hormones such as estrogen-containing pills or during pregnancy. This research compares the occurrence of VTE in first-degree relatives of women who had VTE during hormonal exposure with those whose relatives did not experience VTE under similar hormonal conditions. The study aims to better understand the influence of family history and inherited thrombophilia on VTE risk in this population. The study is a cross-sectional, case-control design involving two groups: first-degree relatives of women who had a VTE event related to hormonal exposure and relatives of women with similar hormonal exposure but no VTE. Participants in both groups complete questionnaires and provide blood samples; some may also undergo an echo-doppler exam. The research investigates the presence of VTE in these relatives and evaluates genetic factors like factor V Leiden and the prothrombin 20210A gene variant. Participants provide consent and undergo assessments including medical history questionnaires, blood tests, and possible imaging to detect previous VTE events. Researchers will evaluate the prevalence of symptomatic VTE in first-degree relatives and analyze associated hereditary factors. The primary outcome focuses on whether relatives have had venous thromboembolism, with data collected promptly on enrollment. The study duration and follow-up are based on initial assessments and data analysis periods.
CONDITIONS
Brief Title
Risk Factors of Venous Thromboembolism in Women During Hormonal Exposure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- First-degree relatives (parents, siblings, children) of women aged 18 to 50 who had a first venous thromboembolism (VTE) during hormonal exposure
- First-degree relatives of matched women with similar hormonal exposure but no VTE
- Written consent from both the women (propositi) and their first-degree relatives
- Women (propositi) with objectively confirmed proximal deep vein thrombosis or pulmonary embolism during hormonal exposure
You will not qualify if you...
- First-degree relatives whose related woman received preventive antithrombotic medication during pregnancy or contraception
- Family members who have had superficial or muscular venous thrombosis
- No information available on first-degree relatives
- Family members under 16 years old
- Vulnerable persons other than minors aged 16 to 18 (guardianship, curatorship)
- Not affiliated with or benefiting from a health insurance scheme
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 1 day
Participants complete a questionnaire, provide a blood sample, and may undergo an echo-doppler to assess venous thromboembolic disease status.
1 visit (in-person)
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
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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