Investigating risk factors for blood clots in women using hormonal treatments

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to identify risk factors for venous thromboembolism (VTE) in young women exposed to hormones, such as those using estrogen-containing contraceptives or during pregnancy. It compares the prevalence of VTE in first-degree relatives of women who experienced VTE during hormonal exposure with those who did not. The study seeks to understand the influence of family history on VTE risk, potentially leading to better screening and prevention strategies for at-risk women. By analyzing data from a large cohort, the study hopes to clarify the role of hereditary factors in VTE occurrences.

Why it matters

Who can join: the full rules

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.

Inclusion criteria

* 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 criteria

* 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.

Where it's running

• CHRU Brest
  Brest, France Recruiting
• Hia
  Brest, France Recruiting
• Clermont Ferrand
  Clermont-Ferrand, France Recruiting
• CH Morlaix
  Morlaix, France Recruiting
• Paris HEGP
  Paris, France Recruiting
• Rennes
  Rennes, France Recruiting

Study contacts

• Principal investigator: Francis Couturaud, MD, PhD — EA3878 (GETBO), Brest University Hospital in France
• Study coordinator: Francis Couturaud, MD, PHD
• Email: francis.couturaud@chu-brest.fr
• Phone: 33 2 98 34 73 47

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.