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

Completed

• Conditions: Deep Vein Thrombosis
• Interventions: Other: Lower limb veins compression ultrasonography

• Registration Number: NCT00740454
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2006-01
• Study First Submitted: 2008-08-22
• Study First Submitted QC: 2008-08-22
• Study First Posted: 2008-08-25
• Primary Completion: 2009-04
• Study Completion: 2009-04
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-03
• Last Update Posted: 2025-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
A	Lower limb veins compression ultrasonography	Pregnant or post-partum women with a clinically suspected DVT and a negative distal and proximal leg veins compression ultrasonography

Primary Outcome Measures

Name	Time	Method
Objectively confirmed thromboembolic events	3 months

Trial Locations

Locations (2)

Division of Angiology and Hemostasis, Geneva University Hospital; 🇨🇭 Geneva, Switzerland

EA3878, Brest University Hospital; 🇫🇷 Brest, France