Fetal Loss in Women With Unprovoked Thromboembolism (FLUTE)

Terminated

• Conditions: Fetal Death; Venous Thromboembolism
• Interventions: Other: Thrombophilia Testing

• Registration Number: NCT00149357
• Lead Sponsor: McMaster University

Brief Summary

The purpose of this study is to determine the risk of fetal loss in women with unprovoked venous thromboembolism (VTE) who do not have identifiable inherited thrombophilia compared with women who have the diagnosis of venous thromboembolism (VTE) excluded.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-07
• Study First Submitted: 2005-09-06
• Study First Submitted QC: 2005-09-06
• Study First Posted: 2005-09-08
• Primary Completion: 2008-02
• Study Completion: 2008-12
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-21
• Last Update Posted: 2017-03-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 239

Inclusion Criteria

• Female
• At least 18 years of age
• Symptomatic for unprovoked venous thromboembolism (deep vein thrombosis [DVT] or pulmonary embolism [PE])
• At least one pregnancy not terminated intentionally

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Exclusion Criteria

• Previous VTE in patients with current VTE excluded

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1, 2 ,3	Thrombophilia Testing	Group 1 Women with unprovoked VTE and No Known Thrombophilia Group 2 Women who are investigated for VTE and are negative (Control) Group 3 Women with unprovoked VTE who have Thrombophilia

Trial Locations

Locations (5)

McMaster University Medical Centre; 🇨🇦 Hamilton, Ontario, Canada

Hamilton General Hospital; 🇨🇦 Hamilton, Ontario, Canada

Monash Medical Centre; 🇦🇺 Clayton, Victoria, Australia

St. Joseph's Hospital; 🇨🇦 Hamilton, Ontario, Canada

Henderson Research Centre; 🇨🇦 Hamilton, Ontario, Canada