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.