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

This study has been completed.
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by:
University Hospital, Brest
ClinicalTrials.gov Identifier:
NCT00740454
First received: August 22, 2008
Last updated: December 27, 2010
Last verified: December 2010
History of Changes
  Purpose

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:

U.S. FDA Resources

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
A
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.

  Eligibility

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)

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00740454

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

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Dr Grégoire Le Gal, Brest University Hospital
ClinicalTrials.gov 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:
pregnancy
postpartum
deep vein thrombosis
 venous thromboembolism
diagnosis
compression ultrasonography

Additional relevant MeSH terms:
Thrombosis
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 17, 2013