Pregnancy and Risk of Venous Thromboembolism
PRESCOT
Prospective Multicentre Randomized Clinical Trial on the Management of Pregnancies With High Risk of Venous Thrombosis
2 other identifiers
interventional
600
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2021
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 13, 2018
CompletedFirst Posted
Study publicly available on registry
September 6, 2018
CompletedStudy Start
First participant enrolled
January 22, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 22, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 22, 2026
February 28, 2024
February 1, 2024
5.8 years
August 13, 2018
February 27, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
cost-utility ratio
Medico-economical data related to the score-based management strategy will be collected during all pregnancy and at months 3 and 12 in the postpartum period.
until 12 months after delivery
Secondary Outcomes (3)
occurrence of venous thromboembolism
until 12 months after delivery
occurrence of bleeding complications
until 12 months after delivery
Evaluation of quality of life of pregnant women at high risk of thrombosis by the EQ-5D-3L survey
until 12 months after delivery
Study Arms (2)
Lyon-VTE score
EXPERIMENTAL300 adult pregnant women with a personal history of VTE and/or known thrombophilia, will be randomly included in this group and their VTE risk during pregnancy will be managed according to the Lyon-VTE score : The Lyon score classifies patients into 3 risk categories and directs the preventive LMWH prescription: * A score strictly less than 3 indicates a moderate thrombotic risk: the patient does not receive LMWH in ante-partum; * A score between 3 and 5 indicates a high thrombotic risk: a preventive dose LMWH is introduced in the third trimester (from the beginning of the 7th month); * A score greater than or equal to 6 indicates a very high thrombotic risk: LMWH at a preventive dose is prescribed throughout the ante-partum. All patients receive an elasto-compression prescription and daily physical activity is recommended throughout pregnancy (except obstetric contraindication). All patients also receive systematic preventive LMWH treatment postpartum for 6 weeks.
recommendations currently available
EXPERIMENTAL300 adult pregnant women with a personal history of VTE and/or known thrombophilia, will be randomly included in this group and their VTE risk during pregnancy will be managed according to the last ACCP guidelines or UK guidelines or Canadian recommendations or French recommendations, according to the habits of the center.
Interventions
follow-up at 3 months, 5 months, 7 months during pregnancy and 3 months and 12 months after delivery.
follow-up at 7 months during pregnancy and 3 months and 12 months after delivery.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hôpital Cardiologique L. Pradel
Bron, 69677, France
Related Publications (1)
Middleton P, Shepherd E, Gomersall JC. Venous thromboembolism prophylaxis for women at risk during pregnancy and the early postnatal period. Cochrane Database Syst Rev. 2021 Mar 29;3(3):CD001689. doi: 10.1002/14651858.CD001689.pub4.
PMID: 33779986DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yesim DARGAUD, Pr
Hospices Civils de Lyon
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 13, 2018
First Posted
September 6, 2018
Study Start
January 22, 2021
Primary Completion (Estimated)
October 22, 2026
Study Completion (Estimated)
October 22, 2026
Last Updated
February 28, 2024
Record last verified: 2024-02