BMJ (Clinical research ed.) · 2012
Diagnostic value of single complete compression ultrasonography in pregnant and postpartum women with suspected deep vein thrombosis: prospective study.
Клиническое исследованиеСтатьяПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Le Gal Grégoire, Kercret Geneviève, Ben Yahmed Khalil, Bressollette Luc, Robert-Ebadi Helia, Riberdy Louise, Louis Patrick, Delluc Aurélien, Labalette Marie-Luce, Baba-Ahmed Mohamed, Bounameaux Henri, Mottier Dominique, Righini Marc, EDVIGE Study Group
Аннотация
OBJECTIVE: To assess the safety of using single complete compression ultrasonography in pregnant and postpartum women to rule out deep vein thrombosis.
DESIGN: Prospective outcome study.
SETTING: Two tertiary care centres and 18 private practices specialising in vascular medicine in France and Switzerland.
PARTICIPANTS: 226 pregnant and postpartum women referred for suspected deep vein thrombosis.
METHODS: A single proximal and distal compression ultrasonography was performed. All women with a negative complete compression ultrasonography result did not receive anticoagulant therapy and were followed up for a three month period.
MAIN OUTCOME MEASURES: Symptoms of venous thromboembolism, second compression ultrasonography or chest imaging, a thromboembolic event, and anticoagulant treatment.
RESULTS: 16 women were excluded, mainly because of associated suspected pulmonary embolism. Deep vein thrombosis was diagnosed in 22 out of the 210 included women (10.5%). 10 patients received full dose anticoagulation despite a negative test result during follow-up. Of the 177 patients without deep vein thrombosis and who did not receive full dose anticoagulant therapy, two (1.1%, 95% confidence interval 0.3% to 4.0%) had an objectively confirmed deep vein thrombosis during follow-up.
CONCLUSIONS: The rate of venous thromboembolic events after single complete compression ultrasonography in pregnant and postpartum women seems to be within the range of that observed in studies in the non-pregnant population. These data suggest that a negative single complete compression ultrasonography result may safely exclude the diagnosis of deep vein thrombosis in this setting.
TRIAL REGISTRATION: clinicaltrials.gov NCT00740454.
DESIGN: Prospective outcome study.
SETTING: Two tertiary care centres and 18 private practices specialising in vascular medicine in France and Switzerland.
PARTICIPANTS: 226 pregnant and postpartum women referred for suspected deep vein thrombosis.
METHODS: A single proximal and distal compression ultrasonography was performed. All women with a negative complete compression ultrasonography result did not receive anticoagulant therapy and were followed up for a three month period.
MAIN OUTCOME MEASURES: Symptoms of venous thromboembolism, second compression ultrasonography or chest imaging, a thromboembolic event, and anticoagulant treatment.
RESULTS: 16 women were excluded, mainly because of associated suspected pulmonary embolism. Deep vein thrombosis was diagnosed in 22 out of the 210 included women (10.5%). 10 patients received full dose anticoagulation despite a negative test result during follow-up. Of the 177 patients without deep vein thrombosis and who did not receive full dose anticoagulant therapy, two (1.1%, 95% confidence interval 0.3% to 4.0%) had an objectively confirmed deep vein thrombosis during follow-up.
CONCLUSIONS: The rate of venous thromboembolic events after single complete compression ultrasonography in pregnant and postpartum women seems to be within the range of that observed in studies in the non-pregnant population. These data suggest that a negative single complete compression ultrasonography result may safely exclude the diagnosis of deep vein thrombosis in this setting.
TRIAL REGISTRATION: clinicaltrials.gov NCT00740454.