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

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ClinicalTrials.gov Identifier: NCT00740454
Recruitment Status : Completed
First Posted : August 25, 2008
Last Update Posted : December 28, 2010
Ministry of Health, France
Information provided by:
University Hospital, Brest

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.

Condition or disease Intervention/treatment
Deep Vein Thrombosis Other: 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.

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Study Type : Observational
Estimated Enrollment : 200 participants
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
Study Start Date : January 2006
Actual Primary Completion Date : April 2009
Actual Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
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

Primary Outcome Measures :
  1. Objectively confirmed thromboembolic events [ Time Frame: 3 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00740454

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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
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Principal Investigator: Gregoire LE GAL, MD, PhD Brest University Hospital, Brest, France
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr Grégoire Le Gal, Brest University Hospital
ClinicalTrials.gov Identifier: NCT00740454    
Other Study ID Numbers: EDVIGE
First Posted: August 25, 2008    Key Record Dates
Last Update Posted: December 28, 2010
Last Verified: December 2010
Keywords provided by University Hospital, Brest:
deep vein thrombosis
venous thromboembolism
compression ultrasonography
Additional relevant MeSH terms:
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Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases