Single Complete Compression Ultrasonography to Rule Out Deep Vein Thrombosis During Pregnancy and Postpartum

University Hospital, Brest200 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

Deep Vein Thrombosis

Interventions

Lower limb veins compression ultrasonographyOTHER

Distal and proximal lower limb veins compression ultrasonography

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

EA3878, Brest University Hospital

Brest, France

Division of Angiology and Hemostasis, Geneva University Hospital

Geneva, Switzerland

Outcomes

Primary Outcomes

Objectively confirmed thromboembolic events

Time frame: 3 months

Data from ClinicalTrials.gov

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