Pregnancy and Risk of Venous Thromboembolism (PRESCOT)

Prospective Multicentre Randomized Clinical Trial on the Management of Pregnancies With High Risk of Venous Thrombosis

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.

Study Overview

• Status: Recruiting
• Conditions: Pregnancy; Thromboembolism
• Intervention / Treatment: Procedure: Lyon-VTE score; Procedure: recommendations currently available

• Study Type: Interventional
• Enrollment (Estimated): 600
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yesim DARGAUD, Pr; Phone Number: +33 4 72118810; Email: ydargaud@univ-lyon1.fr
• Study Contact Backup: Name: Lucia RUGERI; Phone Number: +33 4 72118810; Email: lucia.rugeri@chu-lyon.fr

Study Locations

• France
  • Bron, France, 69677
    • Recruiting
    • Hôpital Cardiologique L. Pradel
    • Contact: Yesim DARGAUD, Pr; Phone Number: +33 4 72118810; Email: ydargaud@univ-lyon1.fr
    • Principal Investigator: Yesim DARGAUD, Pr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lyon-VTE score; 300 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.	Procedure: Lyon-VTE score; follow-up at 3 months, 5 months, 7 months during pregnancy and 3 months and 12 months after delivery.
Experimental: recommendations currently available; 300 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.	Procedure: recommendations currently available; follow-up at 7 months during pregnancy and 3 months and 12 months after delivery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
occurrence of venous thromboembolism	efficacy 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
occurrence of bleeding complications	safety 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
Evaluation of quality of life of pregnant women at high risk of thrombosis by the EQ-5D-3L survey	quality of life data will be collected during all pregnancy and at months 3 and 12 in the postpartum period using the EQ-5D-3L survey	until 12 months after delivery

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Yesim DARGAUD, Pr, Hospices Civils de Lyon

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2021
• Primary Completion (Estimated): October 22, 2031
• Study Completion (Estimated): October 22, 2031

Study Registration Dates

• First Submitted: August 13, 2018
• First Submitted That Met QC Criteria: September 5, 2018
• First Posted (Actual): September 6, 2018

Study Record Updates

• Last Update Posted (Actual): May 15, 2026
• Last Update Submitted That Met QC Criteria: May 13, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: quality of life; pregnancy; venous thromboembolism; low molecular weight heparin (LMWH); Lyon VTE-score; thromboprophylaxis; cost utility
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Embolism and Thrombosis; Thromboembolism; Venous Thromboembolism
• Other Study ID Numbers: 69HCL18_0032; 2018-A02777-48 (Other Identifier: ID-RCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No