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

Status unconfirmed

Conditions studied: Pregnancy, Deep Vein Thrombosis

In brief

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.

Key facts

Study ID

NCT02507180

Run by

Ottawa Hospital Research Institute

People needed

366

Starts

2015-09-01

Expected to finish

2022-01-01

Last updated by the study team

2020-02-27

Who can join

Age: 16 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Unselected pregnant women (as self-reported by patient and/or previously documented positive beta hCG on urine or serum pregnancy tests) with
• Suspected acute symptomatic deep vein thrombosis, defined as:
• New leg swelling or edema with onset in the last month or,
• New leg pain (buttock, groin, thigh or calf) with onset in the last month.

You may not qualify if…

• Below the age of legal consent in jurisdiction of residence (18 years old for Quebec and 16 years old for rest of Canada)
• Baseline imaging (imaging done after a minimum of 3 months of treatment for prior proximal DVT) not available if suspected recurrence in the same leg as prior
• Unable or unwilling to provide informed consent
• Concomitant symptoms of suspected pulmonary embolism (chest pain or shortness of breath or syncope/pre-syncope or unexplained tachycardia)
• Therapeutic anticoagulant more than 48 hours.

Where it is running

• Jewish General Hospital — Montreal, Quebec, Canada (enrolling)
• Leiden University Medical Center — Leiden, Netherlands (enrolling)
• Hopitaux Universitaires de Geneve — Geneva, Switzerland (enrolling)
• Children's and Women's Health Centre of British Columbia — Vancouver, British Columbia, Canada (enrolling)
• Queen Elizabeth II Health Science Centre — Halifax, Nova Scotia, Canada (enrolling)
• Hamilton Health Sciences Centre — Hamilton, Ontario, Canada (enrolling)
• Foothills Medical Centre — Calgary, Alberta, Canada (enrolling)
• Ottawa Hospital Research Institute — Ottawa, Ontario, Canada (enrolling)
• Royal Alexandra Hospital — Edmonton, Alberta, Canada (enrolling)
• London Health Sciences Centre — London, Ontario, Canada
• Intermountain Healthcare, Inc. — Murray, Utah, United States
• Sunnybrook Medical Hospital — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.