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Safely Ruling Out Deep Vein Thrombosis in Pregnancy With the LEFt Clinical Decision Rule and D-Dimer

NCT02507180 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 366

Last updated 2020-02-27

No results posted yet for this study

Summary

This is prospective cohort study in pregnant women who present with signs and symptoms of possible deep vein thrombosis (DVT). All patients will have the same method of assessment of their DVT symptoms (the LEFt clinical decision rule will be applied and D-dimer test will be done) to determine if a compression ultrasound is required. All patients will be followed for a period of 3 months.

Conditions

  • Pregnancy
  • Deep Vein Thrombosis

Interventions

OTHER

LEFt clinical decision rule

The LEFt rule Predictor Points Left leg symptoms +1 Extremity swelling (≥ 2 cm difference in calf circumference +1 First trimester symptom onset +1 Clinical probability Unlikely: 0 or 1 point Likely: \> 1 point

Sponsors & Collaborators

  • University Hospital, Geneva

    collaborator OTHER

  • Leiden University Medical Center

    collaborator OTHER

  • Ottawa Hospital Research Institute

    lead OTHER

Principal Investigators

  • Marc Rodger, MD · Ottawa Hospital Research Institute

  • Marc Righini, MD · Hopitaux Universitaires de Geneve

Eligibility

Min Age
16 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2021-09-30
Completion
2022-01-31

Countries

  • United States
  • Canada
  • Netherlands
  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02507180 on ClinicalTrials.gov