Informations générales (source: ClinicalTrials.gov)
Prospective Multicentre Randomized Clinical Trial on the Management of Pregnancies With High Risk of Venous Thrombosis (PRESCOT)
Interventional
N/A
Hospices Civils de Lyon (Voir sur ClinicalTrials)
janvier 2021
octobre 2026
29 juin 2024
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 recommending
individually tailored management. A retrospective evaluation of the initial score showed
favorable outcomes in pregnancies with a high risk of thrombosis. A subsequent
multicenter prospective study reported promising results using this score and related
management strategy. The efficacy and safety after 10 years of prospective use of the
Lyon-VTE-score in daily practice to guide the prescription of antithrombotic prophylaxis
during pregnancy was recently evaluated and the results showed that the Lyon-VTE-score
allows a standardized approach with objective criteria and can help non-specialized
centers and young doctors manage these high-risk pregnancies.
The results of previous studies provide consistent conclusions on the safety and efficacy
of the approach of investigators and give background for a medico-economic study to
evaluate costs and consequences of this procedure. The most recent study (2005)
evaluating the cost of prophylaxis in pregnant women, evaluated this cost as $1292 for
each 6-week cycle of treatment. In addition, the use of such a score offers the prospect
of personalized medicine, which is probably more cost-efficient compared to "inclusive,
equal treatment for all".
In antepartum, the decision to administer thromboprophylaxis should be considered on an
individual basis with regard to lowering the absolute risk of thrombosis, the
inconvenience of daily subcutaneous heparin therapy and the potential risks of bleeding,
heparin-induced thrombocytopenia and osteoporosis. An individual assessment of the VTE
risk is crucial for optimal thromboprophylaxis, but there is no validated tool to help
clinicians to stratify VTE risk in pregnant women and to introduce prophylactic
anticoagulation at the right time.
Most of the recommendations are grade 2C. They are mostly based on case-control studies
and expert opinions and do not entirely highlight the physicians' need. The originality
of this approach is the use of a risk stratification tool that takes all individual risk
factors for VTE into consideration and that aids the decision-making process of antenatal
anti-thrombotic prophylaxis. This study will personalize care using a score to
individually assess the risk and propose appropriate prevention.
The main objective of this study is to conduct a medico-economic study to evaluate the
efficiency of an innovative strategy integrating the Lyon-VTE-score in the management of
pregnant patients with venous thromboembolism risk versus standard care.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Hôpital Cardiologique L. Pradel - 69677 - Bron - France | Yesim DARGAUD, Pr | Contact (sur clinicalTrials) | |||
Critères
Tous
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
- 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
- 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.