An observational study in Miscarriage, Recurrent, sponsored by Ferrer inCode, S.L.. Completed at 8 sites in 2 countries. Open to female participants aged 18 Years to 37 Years. Per ClinicalTrials.gov, last updated 2017-11-08.
Sponsored by Ferrer inCode, S.L. (formerly part of Ferrer Internacional S.A.) · Observational
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.
102 studies on the registry are indexed under Abortion, Habitual; 21 are open to participants now.
This study's enrollment of 364 is above the median of 161 across 44 observational studies indexed under Abortion, Habitual.
Browse Abortion, Habitual studies →This is the only study on the registry with Ferrer inCode, S.L. as lead sponsor.
First submitted before Ferrer inCode, S.L. left Ferrer Internacional S.A..
Counted across the registry records on this site, refreshed daily.
The study will include women with recurrent pregnancy loss (> 2 consecutive or > 3 non-consecutive) before the 20th week of pregnancy (cases) and women with at least 1 pregnancy at term (controls).
CONTROLS
Inclusion Criteria:
Exclusion Criteria:
CASES
Inclusion Criteria:
Idiopathic origin:
Women \< 38 years old Non-severe seminal factor (sperm concentration > 2 mill/ml) Normal karyotypes in both spouses (or in the male and the donor in the case of ovocyte donation) Antiphospholipid syndrome negative Normal or corrected thyroid function \< 30
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
No intervention
No intervention
Recurrent Pregnancy Loss
Repeated clinical pregnancy loss and/or foetal death (≥ 2 consecutive or ≥ 3 non-consecutive) before the 20th weeks of pregnancy
Time frame: 20 weeks
Pregnancy at term
Pregnancy with life-birth
Time frame: 20 weeks
Plan to share: Undecided
Ran from Feb 2015 to primary completion in Nov 2016, 21 months.
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This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
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