Whole-leg Ultrasound in Pregnant Patients
Status unconfirmed · Not applicable
Conditions studied: Deep Vein Thrombosis
In brief
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.
Key facts
- Study ID
- NCT01319474
- Run by
- Intermountain Health Care, Inc.
- People needed
- 268
- Starts
- 2011-02-01
- Expected to finish
- 2020-12-31
- Last updated by the study team
- 2019-08-07
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Intermoutain Medical Center — Murray, Utah, United States (enrolling)
Full record on ClinicalTrials.gov
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