Assessing venous thromboembolism risk in pregnant women
Prospective Multicentre Randomized Clinical Trial on the Management of Pregnancies With High Risk of Venous Thrombosis
This study is testing a new tool to see if it can help doctors figure out which pregnant women are at risk for blood clots so they can provide better care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | All |
| Sponsor | Hospices Civils de Lyon Academic / other |
| Locations | 1 site (Bron) |
| Trial ID | NCT03659708 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the risk of venous thromboembolism (VTE) in pregnant women using a newly developed risk stratification tool called the Lyon-VTE score. The tool is designed to help clinicians assess individual risk factors for VTE and make informed decisions regarding prophylactic anticoagulation. By tailoring management strategies based on this score, the study seeks to improve outcomes for pregnant women at high risk of VTE. The study will involve adult pregnant women with a personal history of VTE or thrombophilia who consent to participate.
Who should consider this trial
Good fit: Ideal candidates for this study are adult pregnant women with a personal history of VTE or thrombophilia who are at high risk for VTE.
Not a fit: Patients who may not benefit from this study include those with contraindications to heparin therapy or those with obstetrical complications without a history of VTE.
Why it matters
Potential benefit: If successful, this study could lead to more effective prevention of VTE in pregnant women, reducing complications and improving maternal and fetal health.
How similar studies have performed: Other studies have shown success with similar risk stratification approaches in different populations, but this specific tool is novel in the context of pregnancy.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult pregnant women at high risk of VTE (with a personal history of VTE and/or thrombophilia) * 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.
Where this trial is running
Bron
- Hôpital Cardiologique L. Pradel — Bron, France (Recruiting)
Study contacts
- Principal investigator: Yesim DARGAUD, Pr — Hospices Civils de Lyon
- Study coordinator: Yesim DARGAUD, Pr
- Email: ydargaud@univ-lyon1.fr
- Phone: 4 72118810
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.