Risk Factors of Venous Thromboembolism in Women During Hormonal Exposure

Launched by UNIVERSITY HOSPITAL, BREST · Jun 30, 2017

Keywords

ClinConnect Summary

The "FIT-H" study is investigating the risk factors for a serious condition called venous thromboembolism (VTE) in young women who are using hormonal treatments, like birth control pills or during pregnancy. The study aims to understand if having family members who have experienced VTE affects the likelihood of young women having similar issues while on hormones. By comparing women who had VTE with those who did not, researchers hope to find out whether a family history of VTE plays a more significant role than previously thought.

To participate in this study, women aged 18 to 50 who have had a confirmed case of VTE during hormonal use can enroll, along with their first-degree relatives (like parents, siblings, or children). Participants will be asked to provide consent and may be approached to share information about their family’s health history concerning VTE. The study is taking place at six university hospitals in France and is currently recruiting participants. This research could lead to better understanding and management of VTE risks in women using hormonal treatments.

Gender

ALL

Eligibility criteria

• 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.