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Completed

NCT Number: NCT00740454

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

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.

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Key information

Conditions

Deep Vein Thrombosis Cardiovascular Diseases Disease Embolism and Thrombosis Pathologic Processes Pathological Conditions, Signs and Symptoms Thromboembolism Thrombosis Vascular Diseases Venous Thromboembolism Venous Thrombosis

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

EA3878, Brest University Hospital, Brest, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lower limb veins compression ultrasonography

Other

Distal and proximal lower limb veins compression ultrasonography

Primary outcomes

  1. Objectively confirmed thromboembolic events

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Collaborators

  • Ministry of Health, France

Registry information

Official study 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

Acronym: EDVIGE

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Aug 25, 2008
Registry last updated
Feb 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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