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| Name | Class |
|---|---|
| Ministry of Health, France | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Pregnant or post-partum women with a clinically suspected DVT and a negative distal and proximal leg veins compression ultrasonography |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lower limb veins compression ultrasonography | Other | Distal and proximal lower limb veins compression ultrasonography |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objectively confirmed thromboembolic events | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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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)
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| Name | Affiliation | Role |
|---|---|---|
| Gregoire LE GAL, MD, PhD | Brest University Hospital, Brest, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| EA3878, Brest University Hospital | Brest | 29609 | France | |||
| Division of Angiology and Hemostasis, Geneva University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16414102 | Background | 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. | |
| 35950611 |
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| ID | Term |
|---|---|
| D020246 | Venous Thrombosis |
| D054556 | Venous Thromboembolism |
| D004194 | Disease |
| ID | Term |
|---|---|
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Geneva |
| 1211 |
| Switzerland |
| Derived |
| Righini 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. |
| 30357273 | Derived | Righini 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. |
| 23065510 | Derived | Righini 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. |
| 22531869 | Derived | Le 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. |
| D013923 |
| Thromboembolism |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |