Prospective Multicentre Randomized Clinical Trial on Managing High-Risk Pregnancies for Venous Thrombosis Using the Lyon-VTE Score

What this Trial Is About

Pregnant women at high risk of venous thromboembolism (VTE) face challenges in managing their risk due to the lack of validated tools for physicians to assess and decide on appropriate preventative treatment. This study evaluates the use of the Lyon-VTE score, a risk assessment tool developed to personalize thromboprophylaxis by considering individual risk factors during pregnancy. The research aims to compare this innovative scoring strategy with current standard care recommendations to improve management and cost efficiency in high-risk pregnancies. The study randomly assigns 600 adult pregnant women with a personal history of VTE or known thrombophilia to one of two groups. One group will have their VTE risk managed using the Lyon-VTE score, which categorizes risk into three levels to guide anticoagulant treatment with low molecular weight heparin (LMWH) during pregnancy and postpartum. The other group will receive thromboprophylaxis according to existing guidelines from ACCP, UK, Canada, or France. All participants will be prescribed elasto-compression and recommended daily physical activity unless contraindicated. Participants will be followed through pregnancy and up to 12 months after delivery with scheduled visits at 3, 5, and 7 months during pregnancy and 3 and 12 months postpartum for the Lyon-VTE score group, and at 7 months and postpartum for the standard care group. Researchers will assess outcomes including the cost-utility ratio, occurrence of VTE, bleeding complications, and quality of life measured by the EQ-5D-3L survey. This comprehensive monitoring aims to determine the safety, efficacy, and economic impact of personalized VTE management in pregnancy.

Pregnancy and Risk of Venous Thromboembolism