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

NCT ID: NCT00740454

Last Updated: 2025-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-01-31

Study Completion Date

2009-04-30

Brief Summary

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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

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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.

Conditions

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Deep Vein Thrombosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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A

Pregnant or post-partum women with a clinically suspected DVT and a negative distal and proximal leg veins compression ultrasonography

Lower limb veins compression ultrasonography

Intervention Type OTHER

Distal and proximal lower limb veins compression ultrasonography

Interventions

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Lower limb veins compression ultrasonography

Distal and proximal lower limb veins compression ultrasonography

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Health, France

OTHER_GOV

Sponsor Role collaborator

University Hospital, Brest

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gregoire LE GAL, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Brest University Hospital, Brest, France

Locations

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EA3878, Brest University Hospital

Brest, , France

Site Status

Division of Angiology and Hemostasis, Geneva University Hospital

Geneva, , Switzerland

Site Status

Countries

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France Switzerland

References

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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.

Reference Type BACKGROUND
PMID: 16414102 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35950611 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30357273 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23065510 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22531869 (View on PubMed)

Other Identifiers

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EDVIGE

Identifier Type: -

Identifier Source: org_study_id

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