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

August 22, 2008
December 27, 2010
January 2006
April 2009   (final data collection date for primary outcome measure)
Objectively confirmed thromboembolic events [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00740454 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Single Complete Compression Ultrasonography to Rule Out Deep Vein Thrombosis During Pregnancy and Postpartum
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

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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)

Deep Vein Thrombosis
Other: Lower limb veins compression ultrasonography
Distal and proximal lower limb veins compression ultrasonography
A
Pregnant or post-partum women with a clinically suspected DVT and a negative distal and proximal leg veins compression ultrasonography
Intervention: Other: Lower limb veins compression ultrasonography

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
April 2009
April 2009   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France,   Switzerland
 
NCT00740454
EDVIGE
No
Dr Grégoire Le Gal, Brest University Hospital
University Hospital, Brest
Ministry of Health, France
Principal Investigator: Gregoire LE GAL, MD, PhD Brest University Hospital, Brest, France
University Hospital, Brest
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP