Miscarriage, Recurrent Clinical Trial
Official title:
Prediction of Recurrent Pregnancy Loss by a New Thrombophilia Based Genetic Risk Score
Recurrent pregnancy loss (RPL) is a clinical problem affecting 1-5% of couples of
reproductive age. The contribution of thrombophilia to RPL is disputed. This controversy is
partly due to low sensitivity of the genetic variants currently used to evaluate hereditary
thrombophilia: the Leiden mutation (identified as rs6025) in the coagulation factor 5 (F5L)
gene and mutation G20210A (identified as rs1799963) in the prothrombin (PT) gene.
Our objective was to determine whether a wider algorithm that includes clinic and genetic
variants associated with thrombophilia could be more useful in the prediction for RPL than
FVL and PT alone.
Recurrent pregnancy loss can affect up to 5% of women in child-bearing age and is considered
one of the most common causes of female sterility. In recent years, the association between
thrombophilia and pregnancy failure has been observed in a number of studies, varying
according to the nature of the thrombophilia (for example the antiphospholipid syndrome as
opposed to the hereditary forms) or the type of pregnancy loss (either isolated or recurrent,
or early or late). It has therefore been accepted that thrombophilia is detected in a
significant number of idiopathic pregnancy losses, reaching 66% of the cases in some series.
Since the 1990's, a number of studies have associated recurrent pregnancy loss with FVL
mutations (most frequently) and G20210 PT. In a systematic review, it was confirmed that
women with thrombophilia have a higher risk of developing thromboembolism and complications
in pregnancy. Another recent meta-analysis of prospective cohort studies concluded that women
who were carriers of FVL had a higher risk of late pregnancy loss, at 52%, as opposed to
non-carriers (OR=1.52), though the differences in absolute risk were discreet (4.2% and 3.2%,
respectively). However, the analysis of these 2 single nucleotide polymorphisms (SNPs) showed
low discriminative capacity and diagnostic sensitivity.
This study hypothesize that the use of the Thrombo inCode® in the screening for hereditary
thrombophilia in patients with recurrent pregnancy loss can improve the diagnostic
sensitivity and predictive capacity of the routine genetic panel, based on FVL and G20210A
PT. Thus, the Thrombo inCode® model can accurately identify more patients with
clinical-genetic risk of thromboembolism and therefore establish the appropriate preventive
measures.
A transversal observational case-control study will be carried out, with retrospective data
analysis. The screening for hereditary thrombophilia will be performed through the Thrombo
inCode® panel in cases and controls. The results produced from a single genetic analysis will
allow comparison to the centres' routine protocol (FV Leiden and G20210A PT) with the
complete Thrombo inCode® panel, that also includes the previously-mentioned classical
variants.
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