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

This study has been completed.
Ministry of Health, France
Information provided by:
University Hospital, Brest Identifier:
First received: August 22, 2008
Last updated: December 27, 2010
Last verified: December 2010
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.

Condition Intervention
Deep Vein Thrombosis
Other: Lower limb veins compression ultrasonography

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:

Further study details as provided by University Hospital, Brest:

Primary Outcome Measures:
  • Objectively confirmed thromboembolic events [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: January 2006
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Pregnant or post-partum women with a clinically suspected DVT and a negative distal and proximal leg veins compression ultrasonography
Other: Lower limb veins compression ultrasonography
Distal and proximal lower limb veins compression ultrasonography

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.

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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)

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
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Please refer to this study by its identifier: NCT00740454

EA3878, Brest University Hospital
Brest, France, 29609
Division of Angiology and Hemostasis, Geneva University Hospital
Geneva, Switzerland, 1211
Sponsors and Collaborators
University Hospital, Brest
Ministry of Health, France
Principal Investigator: Gregoire LE GAL, MD, PhD Brest University Hospital, Brest, France
  More Information

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Dr Grégoire Le Gal, Brest University Hospital Identifier: NCT00740454     History of Changes
Other Study ID Numbers: EDVIGE
Study First Received: August 22, 2008
Last Updated: December 27, 2010
Health Authority: France: Direction Générale de la Santé

Keywords provided by University Hospital, Brest:
deep vein thrombosis
venous thromboembolism
compression ultrasonography

Additional relevant MeSH terms:
Venous Thrombosis
Cardiovascular Diseases
Embolism and Thrombosis
Vascular Diseases processed this record on November 25, 2015