Clinical Trials Logo

Clinical Trial Summary

This is prospective cohort study, in pregnant women who present with signs and symptoms of possible deep vein thrombosis. All patients will have the same method of assessment of their deep vein thrombosis (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.


Clinical Trial Description

VTE is a leading cause of maternal death in the developed world. Suspected DVT in pregnancy is a common clinical problem faced by clinicians daily. The only validated method to exclude DVT in pregnancy requires leg vein CUS imaging. This imaging modality is costly and has limited availability (only available in radiology departments and, usually, only during weekday daytime hours) often necessitating referral to the emergency room for initiation of heparin injections until leg vein CUS can be obtained. A simple and seemingly powerful clinical decision rule (LEFt) and a simple blood test (D-dimer) may be promising to exclude DVT in pregnancy without the need for diagnostic imaging. Validating the safety of a simple, non-invasive, widely available approach to suspected DVT in pregnancy would be an important advance in maternal health.

A prospective cohort diagnostic management study in pregnant women with suspected DVT, with three-month follow-up for symptomatic VTE will take place in multiple centres in Canada.

After obtaining informed consent, all patient will have the LEFt clinical decision rule applied by the attending physician and will have D-Dimer testing (D-Dimer results of test performed within 24 hours will be accepted and do not need to be repeated).

Patients with an "unlikely" LEFt score of 0 or 1 point and a negative D-dimer will not undergo diagnostic imaging.

Patients with either a "likely" LEFt score of 2 or 3 points or a positive D-dimer will undergo either a single complete leg vein compression ultrasound (CCUS) (Day 1) or a serial proximal leg vein (CUS) (Day 1 and Day 7).

All patients will be followed for 3 months for symptomatic VTE. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02507180
Study type Observational
Source Ottawa Hospital Research Institute
Contact Marc A Rodger, MD
Phone 613-737-8899
Email mrodger@ohri.ca
Status Recruiting
Phase N/A
Start date September 2015
Completion date December 2020

See also
  Status Clinical Trial Phase
Completed NCT01200979 - Assessment of Alterations in Immune Function During Pregnancy and Post Parturition
Recruiting NCT03218956 - Protein Requirement During Lactation N/A
Completed NCT02191605 - Computer-delivered Screening & Brief Intervention for Marijuana Use in Pregnancy N/A
Completed NCT02223637 - Meningococcal Quadrivalent CRM-197 Conjugate Vaccine Pregnancy Registry
Not yet recruiting NCT03632863 - PDA for Antidepressant Use in Pregnancy N/A
Not yet recruiting NCT03208179 - Improving PRegnancy Outcomes With Intermittent preVEntive Treatment in Africa Phase 3
Recruiting NCT02683005 - Study of Hepatitis C Treatment During Pregnancy Phase 1
Recruiting NCT02909712 - Cardio‑Safety of Dihydroartemisinin‑Piperaquine and Pharmacokinetics of Piperaquine Amongst Pregnant Women in Tanzania Phase 2
Active, not recruiting NCT02783170 - Safety and Immunogenicity of Simultaneous Tdap and IIV in Pregnant Women Phase 4
Active, not recruiting NCT02676882 - EnBrace HR for Depression Treatment and Prevention in Women Trying to Conceive and Early Pregnancy N/A
Active, not recruiting NCT02797327 - Molecular Signature Pregnancy
Not yet recruiting NCT02762773 - Effect of Non-Dissection of the Inferior Rectus Sheath on Intraoperative Blood Loss N/A
Recruiting NCT02564250 - Maternal Metabolism and Pregnancy Outcomes in Obese Pregnant Women N/A
Recruiting NCT02277782 - Intrathecal Hydromorphone for Labor Analgesia N/A
Recruiting NCT02528136 - The Clinical Carbetocin Myocardium Trial Phase 4
Recruiting NCT02619188 - Nutritional Markers in Normal and Hyperemesis Pregnancies N/A
Active, not recruiting NCT02408315 - Induction With Misoprostol: Oral Mucosa Versus Vaginal Epithelium (IMPROVE) Phase 3
Terminated NCT02537145 - PregnanT Moms Measure - Do-It-Yourself Health Monitoring and Simulation of Health in Pregnant Women
Completed NCT02520687 - Effects of Dietary Nitrate in Hypertensive Pregnant Women Phase 1
Terminated NCT02546193 - Outpatient Foley Catheter Compared to Usual Inpatient Care for Labor Induction N/A