NCT00740454

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2006

Typical duration for all trials

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

August 22, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 25, 2008

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

February 5, 2025

Status Verified

February 1, 2025

Enrollment Period

3.2 years

First QC Date

August 22, 2008

Last Update Submit

February 3, 2025

Conditions

Deep Vein Thrombosis

Keywords

pregnancypostpartumdeep vein thrombosisvenous thromboembolismdiagnosiscompression ultrasonography

Outcome Measures

Primary Outcomes (1)

  • Objectively confirmed thromboembolic events

    3 months

Study Arms (1)

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

Interventions

Lower limb veins compression ultrasonographyOTHER

Distal and proximal lower limb veins compression ultrasonography

A

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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)

You may qualify if:

  • Women with an ongoing pregnancy or within three-months post-partum and a clinically suspected deep vein thrombosis

You may not qualify if:

  • suspicion of pulmonary embolism
  • age less than 18 years
  • impossible follow-up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

EA3878, Brest University Hospital

Brest, 29609, France

Location

Division of Angiology and Hemostasis, Geneva University Hospital

Geneva, 1211, Switzerland

Location

Related Publications (5)

  • Le Gal G, Prins AM, Righini M, Bohec C, Lacut K, Germain P, Vergos JC, Kaczmarek R, Guias B, Collet M, Bressollette L, Oger E, Mottier D. Diagnostic value of a negative single complete compression ultrasound of the lower limbs to exclude the diagnosis of deep venous thrombosis in pregnant or postpartum women: a retrospective hospital-based study. Thromb Res. 2006;118(6):691-7. doi: 10.1016/j.thromres.2005.12.004. Epub 2006 Jan 18.

    PMID: 16414102BACKGROUND

  • Righini M, Robert-Ebadi H, Cremonesi A, Elias A, Sanchez O, Le Moigne E, Schmidt J, Le Gall C, Cornuz J, Aujesky D, Roy PM, Chauleur C, Rouyer F, Poletti PA, Moreau C, Le Gal G; CT-PE-Pregnancy group. Risk of neonatal hypothyroidism in newborns from mothers exposed to CTPA during pregnancy: Ancillary data from a prospective outcome study. J Thromb Haemost. 2022 Nov;20(11):2550-2555. doi: 10.1111/jth.15843. Epub 2022 Aug 28.

    PMID: 35950611DERIVED

  • Righini M, Robert-Ebadi H, Elias A, Sanchez O, Le Moigne E, Schmidt J, Le Gall C, Cornuz J, Aujesky D, Roy PM, Chauleur C, Rutschmann OT, Poletti PA, Le Gal G; CT-PE-Pregnancy Group. Diagnosis of Pulmonary Embolism During Pregnancy: A Multicenter Prospective Management Outcome Study. Ann Intern Med. 2018 Dec 4;169(11):766-773. doi: 10.7326/M18-1670. Epub 2018 Oct 23.

    PMID: 30357273DERIVED

  • Righini M, Jobic C, Boehlen F, Broussaud J, Becker F, Jaffrelot M, Blondon M, Guias B, Le Gal G; EDVIGE study group. Predicting deep venous thrombosis in pregnancy: external validation of the LEFT clinical prediction rule. Haematologica. 2013 Apr;98(4):545-8. doi: 10.3324/haematol.2012.072009. Epub 2012 Oct 12.

    PMID: 23065510DERIVED

  • Le Gal G, Kercret G, Ben Yahmed K, Bressollette L, Robert-Ebadi H, Riberdy L, Louis P, Delluc A, Labalette ML, Baba-Ahmed M, Bounameaux H, Mottier D, Righini M; EDVIGE Study Group. Diagnostic value of single complete compression ultrasonography in pregnant and postpartum women with suspected deep vein thrombosis: prospective study. BMJ. 2012 Apr 24;344:e2635. doi: 10.1136/bmj.e2635.

    PMID: 22531869DERIVED

MeSH Terms

Conditions

Venous ThrombosisVenous ThromboembolismDisease

Condition Hierarchy (Ancestors)

ThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesThromboembolismPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Gregoire LE GAL, MD, PhD

    Brest University Hospital, Brest, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 22, 2008

First Posted

August 25, 2008

Study Start

January 1, 2006

Primary Completion

April 1, 2009

Study Completion

April 1, 2009

Last Updated

February 5, 2025

Record last verified: 2025-02

Locations

CH(1)FR(1)