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Pregnancy and Risk of Venous Thromboembolism

RecruitingNAAges 18 Years - 50 YearsAllHospices Civils de Lyon
NCT03659708 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The management of venous thromboembolism (VTE) risk in pregnancy still remains a challenge. An individual assessment of the VTE risk is crucial for optimal thromboprophylaxis, but there is no validated tool to help clinicians stratify the risk in pregnant women and introduce prophylactic anticoagulation at the appropriate time. Recommendations mostly based on case-control studies and expert opinions do not accurately reflect the physician's need. In view of the lack of international recommendations with a high level of evidence regarding prophylactic treatment of pregnant women at risk of thrombosis, the use of a risk stratification tool that takes all individual risk factors for VTE into consideration and which aids decisions over prophylaxis regimens may help. Investigators have previously described a VTE risk score (the Lyon-VTE-score), rating patients at increased risk of VTE and rec

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📋 Eligibility rules (as published)
Inclusion Criteria: * Adult pregnant women at high risk of VTE (with a personal history of VTE and/or thrombophilia) * At the time of inclusion, be at most in the 7th month of pregnancy * giving informed consent to participate to the study Exclusion Criteria: * contraindication to heparin therapy, * women with obstetrical complications only, with no history of VTE (pre-eclampsia, HELLP\[ Hemolysis, Elevated Liver enzymes, Low Platelet count\],intra-uterine growth retardation, miscarriage, etc), * patients with a history of superficial venous thrombosis, and those with the highest VTE risk for whom clear recommendations with a high level of evidence are available (patients on long-term anticoagulants, or those with antiphospholipid syndrome or antithrombin deficiency). * Patient participating in an ongoing study that could interfere with the study, * Patient under legal protection measure.
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What it tests

  • Lyon-VTE score
  • recommendations currently available
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Where

1 site
Hôpital Cardiologique L. Pradel
Bron, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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