A NESTED CASE CONTROL STUDY EVALUATING THE ASSOCIATION BETWEEN THE FACTOR V LEIDEN GENOTYPE AND ADVERSE PREGANCY OUTCOME

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The factor V Leiden gene mutation is present in 1 in 20 of the general population. Recent studies suggest an association between the factor V Leiden gene mutation and adverse pregnancy outcomes. It is currently recommended that women with a history of recurrent pregnancy loss, including a second or third trimester intrauterine death should be screened for the factor V Leiden mutation. Controlled trials are currently underway assessing efficacy of treatment with anticoagulaton therapy for women who screen positive. However, population screening is currently not recommended because we do not know the significance of a factor V leiden gene mutation for women without a previous history of adverse pregnancy outcome. The question of why some women with a factor V Leiden mutation experience recurrent pregnancy loss whereas other women do not remains unanswered. The primary aim of this study is to determine whether the maternal and- or fetal genotype for factor V Leiden influences the risk of first and second trimester miscarriage within a cohort of 25,000 pregnant women. The aim of further research in this area is to identify a subset of women at increased risk of a second or third trimester fetal loss, based on a combination of genetic, acquired and environmental thrombophilic risk factors, who may benefit from prophylactic treatment with anticoagulation therapy.