Deep Vein ThrombosisEDVIGENCT00740454
Single Complete Compression Ultrasonography to Rule Out Deep Vein Thrombosis During Pregnancy and Postpartum
An observational study of Deep Vein Thrombosis, run by University Hospital, Brest at 2 sites in 2 countries.
Trial summary
The objective of the EDVIGE study is to determine whether a negative single distal and proximal leg veins compression ultrasonography safely rules out the diagnosis of deep vein thrombosis in pregnant and post-partum women with clinical suspicion of DVT. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Deep Vein Thrombosis
- What is being tested?
- Lower limb veins compression ultrasonography
- How many people
- 200 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jan 2006to Apr 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Pregnant or post-partum women referred to primary care vascular medicine physicians or diagnostic imaging units of referral hospitals in Brittany (France) and Geneva (Switzerland)
Who may be able to join
- Women with an ongoing pregnancy or within three-months post-partum and a clinically suspected deep vein thrombosis
Who cannot join
- suspicion of pulmonary embolism
- age less than 18 years
- impossible follow-up
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Switzerland1 site
Division of Angiology and Hemostasis, Geneva University Hospital
Geneva, 1211
About this study
Official title: Diagnostic Exclusion Value of a Negative Single Distal and Proximal Lower Limb Veins Compression Ultrasonography in Pregnant and Post-partum Women With a Clinically Suspected Deep Vein Thrombosis
The objective of the EDVIGE study is to determine whether a negative single distal and proximal leg veins compression ultrasonography safely rules out the diagnosis of deep vein thrombosis in pregnant and post-partum women with clinical suspicion of DVT.
Read the detailed description
A single distal and proximal leg veins compression ultrasonography has been shown to safely rule out the diagnosis of DVT when negative. The safety of this strategy has never been verified in pregnant or postpartum women. It could however be limited in that clinical setting, because of modified hemodynamics, hampered observation conditions, lack of respiratory modulation, higher proportion of isolated iliac deep vein thromboses. The objective of the EDVIGE study is to assess the safety of this diagnostic strategy during pregnancy and post-partum.
- Conditions
- Deep Vein Thrombosis
- Being tested
- Lower limb veins compression ultrasonography
- Keywords
- pregnancy, postpartum, deep vein thrombosis, venous thromboembolism, diagnosis, compression ultrasonography
- Medical subject headings
- Venous Thrombosis, Venous Thromboembolism, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lower limb veins compression ultrasonographyOther
Distal and proximal lower limb veins compression ultrasonography
| Study group | Role | What they receive |
|---|---|---|
| A | Pregnant or post-partum women with a clinically suspected DVT and a negative distal and proximal leg veins compression ultrasonography Receives: Other: Lower limb veins compression ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objectively confirmed thromboembolic events
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2008 (estimated)
- Study startJan 2006
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Deep Vein ThrombosisStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Gregoire LE GAL, MD, PhD, Principal investigator, Brest University Hospital, Brest, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00740454
- Sponsor's protocol ID
- EDVIGE
- Acronym
- EDVIGE
- Status last verified
- Feb 2025
- First submitted
- 22 Aug 2008
- Last updated
- 5 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Le Gal G, Prins AM, Righini M, Bohec C, Lacut K, Germain P, Vergos JC, Kaczmarek R, Guias B, Collet M, Bressollette L, Oger E, Mottier D. Diagnostic value of a negative single complete compression ultrasound of the lower limbs to exclude the diagnosis of deep venous thrombosis in pregnant or postpartum women: a retrospective hospital-based study. Thromb Res. 2006;118(6):691-7. doi: 10.1016/j.thromres.2005.12.004. Epub 2006 Jan 18.
PubMed 16414102Righini M, Robert-Ebadi H, Cremonesi A, Elias A, Sanchez O, Le Moigne E, Schmidt J, Le Gall C, Cornuz J, Aujesky D, Roy PM, Chauleur C, Rouyer F, Poletti PA, Moreau C, Le Gal G; CT-PE-Pregnancy group. Risk of neonatal hypothyroidism in newborns from mothers exposed to CTPA during pregnancy: Ancillary data from a prospective outcome study. J Thromb Haemost. 2022 Nov;20(11):2550-2555. doi: 10.1111/jth.15843. Epub 2022 Aug 28.
PubMed 35950611Righini M, Robert-Ebadi H, Elias A, Sanchez O, Le Moigne E, Schmidt J, Le Gall C, Cornuz J, Aujesky D, Roy PM, Chauleur C, Rutschmann OT, Poletti PA, Le Gal G; CT-PE-Pregnancy Group. Diagnosis of Pulmonary Embolism During Pregnancy: A Multicenter Prospective Management Outcome Study. Ann Intern Med. 2018 Dec 4;169(11):766-773. doi: 10.7326/M18-1670. Epub 2018 Oct 23.
PubMed 30357273Righini M, Jobic C, Boehlen F, Broussaud J, Becker F, Jaffrelot M, Blondon M, Guias B, Le Gal G; EDVIGE study group. Predicting deep venous thrombosis in pregnancy: external validation of the LEFT clinical prediction rule. Haematologica. 2013 Apr;98(4):545-8. doi: 10.3324/haematol.2012.072009. Epub 2012 Oct 12.
PubMed 23065510Le Gal G, Kercret G, Ben Yahmed K, Bressollette L, Robert-Ebadi H, Riberdy L, Louis P, Delluc A, Labalette ML, Baba-Ahmed M, Bounameaux H, Mottier D, Righini M; EDVIGE Study Group. Diagnostic value of single complete compression ultrasonography in pregnant and postpartum women with suspected deep vein thrombosis: prospective study. BMJ. 2012 Apr 24;344:e2635. doi: 10.1136/bmj.e2635.
PubMed 22531869
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Exclusion Value of a Negative Single Distal and Proximal Lower Limb Veins Compression Ultrasonography in Pregnant and Post-partum Women With a Clinically Suspected Deep Vein Thrombosis
- ClinicalTrials.gov ID
- NCT00740454
- Acronym / sponsor ID
- EDVIGE / EDVIGE
- Conditions
- Deep Vein Thrombosis
- Keywords
- pregnancy, postpartum, deep vein thrombosis, venous thromboembolism, diagnosis, compression ultrasonography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- Jan 2006
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 25 Aug 2008 (estimated)
- 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 objective of the EDVIGE study is to determine whether a negative single distal and proximal leg veins compression ultrasonography safely rules out the diagnosis of deep vein thrombosis in pregnant and post-partum women with clinical suspicion of DVT.
Detailed description
A single distal and proximal leg veins compression ultrasonography has been shown to safely rule out the diagnosis of DVT when negative. The safety of this strategy has never been verified in pregnant or postpartum women. It could however be limited in that clinical setting, because of modified hemodynamics, hampered observation conditions, lack of respiratory modulation, higher proportion of isolated iliac deep vein thromboses. The objective of the EDVIGE study is to assess the safety of this diagnostic strategy during pregnancy and post-partum.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | – | Other: Lower limb veins compression ultrasonographyPregnant or post-partum women with a clinically suspected DVT and a negative distal and proximal leg veins compression ultrasonography |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant or post-partum women referred to primary care vascular medicine physicians or diagnostic imaging units of referral hospitals in Brittany (France) and Geneva (Switzerland)
Key inclusion criteria (1 listed)
- Women with an ongoing pregnancy or within three-months post-partum and a clinically suspected deep vein thrombosis
Key exclusion criteria (3 listed)
- suspicion of pulmonary embolism
- age less than 18 years
- impossible follow-up
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 |
|---|---|---|
| Lower limb veins compression ultrasonographyDistal and proximal lower limb veins compression ultrasonography | Other | A |
Primary outcome
Objectively confirmed thromboembolic events
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2025.
- Background: PubMed 16414102Le Gal G, Prins AM, Righini M, Bohec C, Lacut K, Germain P, Vergos JC, Kaczmarek R, Guias B, Collet M, Bressollette L, Oger E, Mottier D. Diagnostic value of a negative single complete compression ultrasound of the lower limbs to exclude the diagnosis of deep venous thrombosis in pregnant or postpartum women: a retrospective hospital-based study. Thromb Res. 2006;118(6):691-7. doi: 10.1016/j.thromres.2005.12.004. Epub 2006 Jan 18.
- Derived from this study: PubMed 35950611Righini M, Robert-Ebadi H, Cremonesi A, Elias A, Sanchez O, Le Moigne E, Schmidt J, Le Gall C, Cornuz J, Aujesky D, Roy PM, Chauleur C, Rouyer F, Poletti PA, Moreau C, Le Gal G; CT-PE-Pregnancy group. Risk of neonatal hypothyroidism in newborns from mothers exposed to CTPA during pregnancy: Ancillary data from a prospective outcome study. J Thromb Haemost. 2022 Nov;20(11):2550-2555. doi: 10.1111/jth.15843. Epub 2022 Aug 28.
- Derived from this study: PubMed 30357273Righini M, Robert-Ebadi H, Elias A, Sanchez O, Le Moigne E, Schmidt J, Le Gall C, Cornuz J, Aujesky D, Roy PM, Chauleur C, Rutschmann OT, Poletti PA, Le Gal G; CT-PE-Pregnancy Group. Diagnosis of Pulmonary Embolism During Pregnancy: A Multicenter Prospective Management Outcome Study. Ann Intern Med. 2018 Dec 4;169(11):766-773. doi: 10.7326/M18-1670. Epub 2018 Oct 23.
- Derived from this study: PubMed 23065510Righini M, Jobic C, Boehlen F, Broussaud J, Becker F, Jaffrelot M, Blondon M, Guias B, Le Gal G; EDVIGE study group. Predicting deep venous thrombosis in pregnancy: external validation of the LEFT clinical prediction rule. Haematologica. 2013 Apr;98(4):545-8. doi: 10.3324/haematol.2012.072009. Epub 2012 Oct 12.
- Derived from this study: PubMed 22531869Le Gal G, Kercret G, Ben Yahmed K, Bressollette L, Robert-Ebadi H, Riberdy L, Louis P, Delluc A, Labalette ML, Baba-Ahmed M, Bounameaux H, Mottier D, Righini M; EDVIGE Study Group. Diagnostic value of single complete compression ultrasonography in pregnant and postpartum women with suspected deep vein thrombosis: prospective study. BMJ. 2012 Apr 24;344:e2635. doi: 10.1136/bmj.e2635.
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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. This study is not recruiting at the moment.
Gregoire LE GAL, MD, PhD principal investigator
Brest University Hospital, Brest, France
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Deep Vein Thrombosis, run by University Hospital, Brest at 2 sites in 2 countries.
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 1 inclusion and 3 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: finished, as of the sponsor's last update on 5 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France, Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objectively confirmed thromboembolic events (time frame: 3 months). 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 NCT00740454, which also lists 5 linked publications.
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 5 Feb 2025.