ThromboembolismPRESCOTNCT03659708
Pregnancy and Risk of Venous Thromboembolism
A study testing Lyon-VTE score and recommendations currently available in people with Thromboembolism and Pregnancy, run by Hospices Civils de Lyon at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Thromboembolism, Pregnancy
- What is being tested?
- Lyon-VTE score and recommendations currently available
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteFrance
- Study dates
- 22 Jan 2021to 22 Oct 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital Cardiologique L. Pradel
Bron, 69677
Yesim DARGAUD, Pr, 4 72118810 ext. +33, ydargaud@univ-lyon1.fr
Yesim DARGAUD, Pr
About this study
Official title: 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".
Read more
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.
- Conditions
- Thromboembolism, Pregnancy
- Being tested
- Lyon-VTE score, recommendations currently available
- Keywords
- low molecular weight heparin (LMWH), Lyon VTE-score, pregnancy, thromboprophylaxis, venous thromboembolism, quality of life, cost utility
- Medical subject headings
- Thromboembolism, Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lyon-VTE scoreProcedure or surgery
follow-up at 3 months, 5 months, 7 months during pregnancy and 3 months and 12 months after delivery.
recommendations currently availableProcedure or surgery
follow-up at 7 months during pregnancy and 3 months and 12 months after delivery.
| Study group | Role | What they receive |
|---|---|---|
| Lyon-VTE score | Experimental | 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. Receives: Procedure: Lyon-VTE score |
| recommendations currently available | Experimental | 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. Receives: Procedure: recommendations currently available |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: until 12 months after delivery
Secondary outcomes (3)
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
Measured: 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
Measured: 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
Measured: until 12 months after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2018
- Study start22 Jan 2021
- Primary completion22 Oct 2031 (estimated)
- Study completion22 Oct 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ThromboembolismStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yesim DARGAUD, Pr, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03659708
- Sponsor's protocol ID
- 69HCL18_0032
- Other IDs
- 2018-A02777-48
- Acronym
- PRESCOT
- Status last verified
- May 2026
- First submitted
- 13 Aug 2018
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 33779986
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multicentre Randomized Clinical Trial on the Management of Pregnancies With High Risk of Venous Thrombosis
- ClinicalTrials.gov ID
- NCT03659708
- Acronym / sponsor ID
- PRESCOT / 69HCL18_0032
- Conditions
- Thromboembolism, Pregnancy
- Keywords
- low molecular weight heparin (LMWH), Lyon VTE-score, pregnancy, thromboprophylaxis, venous thromboembolism, quality of life, cost utility
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 22 Jan 2021 (actual)
- Primary completion
- 22 Oct 2031 (estimated)
- Study completion
- 22 Oct 2031 (estimated)
- First posted
- 6 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lyon-VTE score | Experimental | Procedure: Lyon-VTE score300 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 | Experimental | Procedure: recommendations currently available300 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lyon-VTE scorefollow-up at 3 months, 5 months, 7 months during pregnancy and 3 months and 12 months after delivery. | Procedure or surgery | Lyon-VTE score |
| recommendations currently availablefollow-up at 7 months during pregnancy and 3 months and 12 months after delivery. | Procedure or surgery | recommendations currently available |
Primary outcome
cost-utility ratio
Time frame: until 12 months after delivery
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.
3 secondary outcomes
occurrence of venous thromboembolism
Time frame: until 12 months after delivery
occurrence of bleeding complications
Time frame: until 12 months after delivery
Evaluation of quality of life of pregnant women at high risk of thrombosis by the EQ-5D-3L survey
Time frame: until 12 months after delivery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Derived from this study: PubMed 33779986Middleton 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yesim DARGAUD, Pr principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lyon-VTE score and recommendations currently available in people with Thromboembolism and Pregnancy, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yesim DARGAUD, Pr (4 72118810 ext. +33, ydargaud@univ-lyon1.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cost-utility ratio (time frame: until 12 months after delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03659708, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.