Research objective To research the association of prothrombin (factor II) activity given the prothrombin G20210A mutation carriage with its clinical manifestations as thrombotic complications. Materials and methods A prospective clinical cohort study of 290 women of reproductive age was conducted. Two cohort groups were identified: the study group of 140 patients with prothrombin mutation G20210A genotype and the control group of 150 women with G20210G genotype. Results The prothrombin G20210A mutation carriage is associated with the risk of thrombotic complications compared to the wild G20210G type (RR =17.1; p <0.0001) and is characterized by thrombosis localized both in the venous (66.7%) and arterial (33.3%) vascular pools. The threshold value of prothrombin activity (174.8%) for G20210A genotype was calculated, making it possible to conclusively predict the risk of thrombotic events with the accuracy of 90.4%. Conclusion The phenotypic manifestation of the prothrombin G20210A mutation in the form of venous and arterial thromboses in women of reproductive age is associated with a super-threshold increase in prothrombin (factor II) activity, which makes it possible to stratify the patients into the group of high risk of thromboses.
Objective To study the association between high activity of Factor II (prothrombin) in blood plasma with G20210A mutation and the development of great obstetrical syndromes. Material and methods A prospective clinical cohort study was conducted on 290 pregnant women (average age 31.7 ± 4.7 years old). The main group was made up of 140 G20210A patients, while the control group comprised 150 women with the wild G20210G type. The aim was to evaluate the activity of Factor II in the venous blood plasma during the stages of pregnancy with regard to trophoblast invasion waves. As per results, association analysis of Factor II activity value and gestational complications was carried out. Results In the control group, the median (Me) of Factor II activity ranged from 108% (preconception period) to 144% (pregnancy) [95% CI 130–150]. In patients with the GA type, the value was significantly higher in related periods, ranging from 149 to 181% [95% CI 142–195], p < 0.0001. With Factor II activity ranging from 148.5 to 180.6%, pregnancies in the main group had no complications. Higher levels of Factor II activity were associated with the development of early and/or severe preeclampsia (PE) and fetal growth retardation (FGR). Conclusion The data obtained regarding Factor II activity in blood plasma, juxtaposed with the development of great obstetrical syndromes, allow to assume that manifestation of G20210A in early and/or severe PE and FGR is associated with this coagulation factor’s level of activity. Threshold value of the Factor II activity with G20210A mutation, allowing to predict the development of PE, comprised 171.0% at the preconception stage (AUC – 0.86; p < 0.0001) and within 7–8 weeks of gestation it was 181.3% (AUC – 0.84; p < 0.0001).
Hypothesis/aims of study. The current analysis was undertaken to elucidate the role of Factor Va resistance to proteolytic cleavage by activated protein C in FVL(1691)GA female carriers in the development of acute and recurrent thromboses. Study design, materials and methods. A prospective clinical cohort study of 1100 women of reproductive age was conducted, with the course and outcomes of 2,707 pregnancies analyzed. Two cohorts were specified: the main group consisted of 500 patients with FV(1691)GA genotype, and the control group consisted of 600 patients with FVL(1691)GG genotype. Results. FVL(1691)GA genotype was significantly associated with the development of venous thromboembolic complications (VTEC) compared to FVL(1691)GG genotype (OR 9.3; p < 0.0001). Episodes of recurrent thrombosis during and outside of pregnancy were registered only in FVL(1691)GA patients (OR 5.7, p = 0.2). In all cases, at the time of the thrombotic event and during the period before the episode of acute or recurrent thrombosis, an APC resistance normalized ratio (NR) value was ≤ 0.49, with no episodes of VTEC registered with an APC resistance NR value ≥ 0.5. Conclusion. Venous thromboses occur under the condition of expressed APC resistance with underlying FVL(1691)GA carriage. The APC resistance index can serve as an objective biochemical marker to determine the feasibility of thromboprophylaxis within the framework of personalized medicine.
The aim of the study was to determine the efficacy of heparin prophylaxis in preventing pregnancy complications in patients with the manifested laboratory phenotype – resistance to activated protein C (APC-resistance with NR ≤ 0.49) Factor V Leiden mutation (GA genotype). Materials and methods. A single-center, randomized, controlled trial of 141 pregnant women – carriers of the FVL(1691)GA mutation with APC-resistance ≤ 0.49 was determined at a gestation age of 7-8 weeks. Of these, 70 patients were included in the main group (mean age 30.2 ± 4.7 years); after the confirmation of the APC-resistance at 7-8 weeks of gestation, these women received a 14 day low-molecular-weight heparin (LMWH) course at elevated prophylactic doses. The comparison group (71 pregnant women of 30.3 ± 3.9 years old) received no LMWH. Results. The heparin prophylaxis (started from 7-8 weeks of gestation) at elevated doses in carriers of the FVL(1691)GA mutation with pronounced APC-resistance reduced the absolute risk (ARR) of pre-eclampsia by 29.5% (ARR: 29.5; p = 0.0003; NTT: 3.4; 95% Cl: 2.356.12), the risk of fetal growth retardation by 23.8% (ARR: 23.8; p = 0.0016; NTT: 4.2; 95% Cl: 2.8-8.7) and the risk of induced premature birth by 12.6% (ARR: 12.6; p = 0.0242; NTT: 5.8; 95% Cl: 3.7-14.1). Conclusion. The administration of LMWH at prophylactic doses for 14 days is indicated in patients with a manifested subclinical (laboratory) phenotype (APC-resistance with NR ≤ 0.49) of the FVL(1691)GA mutation starting from the gestation period of 7-8 weeks. If necessary (with a value of NR ≤ 0.49), it is advisable to repeat the courses of heparin prophylaxis at 18-19 and 27-28 weeks of pregnancy.
Objective: to study the association between high activity of Factor II (prothrombin) in blood plasma with G20210A mutation and the development of great obstetrical syndromes.Material and methods: A prospective clinical cohort study was conducted on 290 pregnant women (average age 31.7±4.7 years old). The main group was made up of 140 G20210A patients, while the control group comprised 150 women with the wild G20210G type. The aim was to evaluate the activity of Factor II in the venous blood plasma during the stages of pregnancy with regard to trophoblast invasion waves. As per results, association analysis of Factor II activity value and gestational complications was carried out.Results: In the control group, the median (Me) of Factor II activity ranged from 108% (preconception period) to 144% (pregnancy) [95% CI 130-150]. In patients with the GA type, the value was significantly higher in related periods, ranging from 149% to 181% [95% CI 142-195], p<0.0001. With Factor II activity ranging from 148.5% to 180.6%, pregnancies in the main group had no complications. Higher levels of Factor II activity were associated with the development of early and/or severe preeclampsia (PE) and fetal growth retardation (FGR).Conclusion: The data obtained regarding Factor II activity in blood plasma, juxtaposed with the development of great obstetrical syndromes, allow to assume that manifestation of G20210A in early and/or severe PE and FGR is associated with this coagulation factor's level of activity. Threshold value of the Factor II activity with G20210A mutation, allowing to predict the development of PE, comprised 171.0% at the preconception stage (AUC – 0.86; p<0.0001) and within 7-8 weeks of gestation it was 181.3% (AUC – 0.84; p<0.0001).
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