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

February 3, 2025 updated by: University Hospital, Brest

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Brest, France, 29609
        • EA3878, Brest University Hospital
  • Switzerland
      • Geneva, Switzerland, 1211
        • Division of Angiology and Hemostasis, Geneva University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

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)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Objectively confirmed thromboembolic events
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Brest

Collaborators

Ministry of Health, France

Investigators

  • Principal Investigator: Gregoire LE GAL, MD, PhD, Brest University Hospital, Brest, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

April 1, 2009

Study Completion (Actual)

April 1, 2009

Study Registration Dates

First Submitted

August 22, 2008

First Submitted That Met QC Criteria

August 22, 2008

First Posted (Estimated)

August 25, 2008

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 3, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EDVIGE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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