Deep Vein Thrombosis
Conditions
Keywords
pregnancy, postpartum, deep vein thrombosis, venous thromboembolism, diagnosis, compression ultrasonography
Brief 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.
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.
Interventions
OTHERLower limb veins compression ultrasonography
Distal and proximal lower limb veins compression ultrasonography
Sponsors
Ministry of Health, France
University Hospital, Brest
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Women with an ongoing pregnancy or within three-months post-partum and a clinically suspected deep vein thrombosis
Exclusion criteria
* suspicion of pulmonary embolism * age less than 18 years * impossible follow-up
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objectively confirmed thromboembolic events | 3 months |
Countries
France, Switzerland
Outcome results
None listed