Pregnancy Related Clinical Trial
Official title:
Evaluation of the Performance of a Rapid Pregnancy Diagnostic Test.
The aim of the study is to evaluate the effectiveness of a rapid pregnancy diagnostic test to improve the medical care of patients in emergency room.
The most current gynecological consultations in emergency unit first lead to a pregnancy
diagnostic test. The gold standard used is the diagnostic test based on determination of the
β-human chorionic gonadotropin concentration. But this assay need time and expect women to
wait for hours. A 5-minutes pregnancy diagnostic test has been developed in France. A
62-patients study showed that results obtained with the rapid test were correlated with
results obtained with the test based on determination of the β-human chorionic gonadotropin
concentration.
The purpose of this study is to evaluate the efficiency of the 5-minutes pregnancy diagnostic
test realized in emergency room, in comparison with the blood determination of the β-human
chorionic gonadotropin concentration which is only tested in medical laboratory. A little
amount of total blood sample used for gold standard test will be used to assess sensibility,
specificity, positive or negative predictive values of the rapid pregnancy diagnostic test.
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