This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Whole-leg Ultrasound in Pregnant Patients (CLOT-3)

This study is currently recruiting participants.
See Contacts and Locations
Verified April 2017 by Scott M. Stevens, Intermountain Health Care, Inc.
Information provided by (Responsible Party):
Scott M. Stevens, Intermountain Health Care, Inc. Identifier:
First received: March 17, 2011
Last updated: April 5, 2017
Last verified: April 2017
This study seeks to determine the rate of thromboembolic complications (blood clots), including death attributed to thromboembolic disease, when anticoagulation (blood thinner) therapy is withheld from pregnant patients suspected of deep vein thrombosis (DVT) after a whole-leg compression ultrasound shows no DVT. Patients are followed for three months after the ultrasound to determine if a blood clot is diagnosed during that time.

Condition Intervention
Deep Vein Thrombosis Other: Whole-leg compression ultrasound

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Use of Whole-leg Ultrasound for Diagnosis of Deep Vein Thrombosis in Pregnant Patients

Resource links provided by NLM:

Further study details as provided by Scott M. Stevens, Intermountain Health Care, Inc.:

Primary Outcome Measures:
  • Symptomatic VTE [ Time Frame: Three months ]
    The primary outcome measure will be DVT or PE, or death attributable to thromboembolic disease confirmed by objective testing in the 3 months following enrollment.

Secondary Outcome Measures:
  • Isolated iliac DVT [ Time Frame: At enrollment ]
    The exact rate of isolated iliac vein DVT identified on futher testing performed on the basis of suspicious doppler ultrasound findings.

Estimated Enrollment: 268
Study Start Date: February 2011
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Ultrasound for suspected DVT
Enrolled subjects suspected to have deep vein thrombosis undergo whole-leg compression ultrasound. Those with a normal result undergo clinical follow-up for thrombotic outcomes over the following three months.
Other: Whole-leg compression ultrasound
Duplex ultrasound assessment of the venous system of the leg(s) suspected of deep vein thrombosis. Assessment occurs from the most proximal assessable portion of the common femoral vein (usually at the inguinal ligament) to the level of the malleolus.

  Show Detailed Description


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Be suspected by the referring medical provider to have a first episode of acute DVT of the lower extremities.
  • Be presenting for the initial diagnostic ultrasound for the present symptom complex.
  • Pregnancy confirmed by an objective test.
  • Be > 18 years old.
  • Provide written informed consent.

Exclusion Criteria:

  • Compression ultrasonography cannot be performed due to physical or technical reasons.
  • The patient has a prior history of DVT in the ipsilateral leg.
  • Previous venous ultrasound has been performed during the same pregnancy.
  • The patient is suspected by the referring clinician to have symptomatic pulmonary embolism.
  • Long-term follow-up will not be possible due to geographic inaccessibility, homelessness or lack of a telephone.
  • Therapeutic doses of an anticoagulant have been received for more than 24 hours before enrollment.
  • Long term anticoagulation will be required for another diagnosis (e.g. atrial fibrillation).
  • Informed consent cannot be obtained.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01319474

Contact: Valerie Aston, MBA, RT (801) 507-4606
Contact: Scott Stevens, MD (801) 507- 3747

United States, Utah
Intermoutain Medical Center Recruiting
Murray, Utah, United States, 84157
Contact: Scott M Stevens, MD    801-507-3310   
Principal Investigator: Scott M Stevens, MD         
Sponsors and Collaborators
Intermountain Health Care, Inc.
Principal Investigator: Scott M Stevens, MD Intermountain Health Care, Inc.
  More Information

Responsible Party: Scott M. Stevens, Transitional Year Program Director, Intermountain Health Care, Inc. Identifier: NCT01319474     History of Changes
Other Study ID Numbers: 950359
Study First Received: March 17, 2011
Last Updated: April 5, 2017

Keywords provided by Scott M. Stevens, Intermountain Health Care, Inc.:
Deep vein thrombosis
Pulmonary embolism

Additional relevant MeSH terms:
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases processed this record on August 21, 2017