RU-2861520-C1 - METHOD FOR EARLY DIAGNOSIS OF HELLP SYNDROME IN PRENATAL PERIOD

RU2861520C1RU 2861520 C1RU2861520 C1RU 2861520C1RU-2861520-C1

Abstract

FIELD: medicine. SUBSTANCE: invention relates to anaesthesiology, intensive care, obstetrics, and can be used for early prenatal diagnosis of HELLP syndrome. Peripheral blood is collected from a pregnant woman after the 20th week of pregnancy at high risk of developing HELLP syndrome. The concentration of albumin, g/l, fibrinogen, g/l, and aspartate aminotransferase (AST), U/l, is determined in the blood sample. Each indicator is assigned a quantitative point on the Point scale according to the nomogram in Fig. 2. The obtained points are summed to obtain a total sum. The probability of HELLP syndrome is determined on the Overal point scale by projecting the total sum of points onto the curve of the dependence of the total sum of points and the probability of HELLP syndrome. If the probability is 50% or more, HELLP syndrome is diagnosed. If the probability is less than 50%, its absence is diagnosed. EFFECT: possibility of reliable and effective diagnosis of HELLP syndrome in the prenatal period at early stages by determining the concentration of albumin, fibrinogen, and AST in the blood of patients and evaluating the data using a nomogram. 1 cl, 3 dwg, 5 tbl, 2 ex

Inventors

Niziaeva Natalia Viktorovna
PLAKHOTINA ELENA NIKOLAEVNA
Baiazitov Rimir Radikovich
Belousova Tamara Nikolaevna
Chaplygina Oksana Vladimirovna
Leonskii Vladislav Dmitrievich

Dates

Publication Date: 20260505
Application Date: 20251016

Claims (1)

A method for early prenatal diagnosis of HELLP syndrome, which includes collecting peripheral blood from a pregnant woman after the 20th week of pregnancy at high risk of developing HELLP syndrome, characterized by the fact that the concentration of albumin, g/L, fibrinogen, g/L, and aspartate aminotransferase (AST), U/L, are determined in the blood sample, a quantitative score is assigned to each indicator on the Point scale, according to the nomogram in Fig. 2, the obtained scores are summed up to obtain a total sum, the probability of HELLP syndrome is determined on the Overal point scale by projecting the total score onto the curve of the dependence of the total score and the probability of HELLP syndrome; and if the probability is 50% or more, HELLP syndrome is diagnosed, and if the probability is less than 50%, its absence is diagnosed .

Description

The invention relates to the field of medicine, specifically to anesthesiology and resuscitation, obstetrics, and allows for the diagnosis of HELLP syndrome in the prenatal period based on laboratory parameters. A syndrome including hemolysis, elevated liver enzymes, and thrombocytopenia that develops in the third trimester of pregnancy or within 7 days postpartum is known by the acronym HELLP syndrome (Khruleva Yu.V., Kozlovskaya N.L., Efremovtseva M.A., et al. Severe preeclampsia with the development of severe HELLP syndrome in the postpartum period, 2021). In most cases, HELLP syndrome is considered a variant of severe preeclampsia (Makatsaria A.D., Bitsadze V.O., Khizroeva D.V. HELLP syndrome // Obstetrics, Gynecology and Reproduction. - 2014). Currently, there is no reliable way to diagnose HELLP syndrome. As a rule, the diagnosis is established based on a comprehensive clinical and laboratory picture, which does not allow for timely initiation of specific therapy and the prevention of complications. A method for diagnosing HELLP syndrome is known in the art by assessing the level of brain-derived neurotrophic factor (BDNF) in the serum of pregnant women with hypertensive disorders. A value equal to or greater than 11.1 ng/ml predicts a high risk of developing HELLP syndrome. A value below 11.1 ng/ml predicts a low risk of developing HELLP syndrome (RU2741730 C1, published January 28, 2021, A61B 5/00). This method assesses the risk of developing HELLP syndrome in the perinatal period based on only one indicator, which significantly reduces its specificity. Another disadvantage of this method is the requirement to perform this test on all patients with hypertension during pregnancy to identify the risk of HELLP syndrome. A method for predicting the risk of developing eclampsia, preeclampsia, or HELLP syndrome after childbirth is known. The method is based on determining the levels of sFlt-1 and P1GF or Endoglin and P1GF in the first sample obtained from the patient before the child's birth and a second sample obtained after childbirth (US 20160327564 A1, published November 10, 2016, G01N 33/68). This method does not diagnose HELLP syndrome, but only predicts the risk of its development. Since the sFlt-1 to P1GF or Endoglin to P1GF ratios are proven markers of preeclampsia, the dynamics of these parameters cannot differentiate between severe preeclampsia and HELLP syndrome. A method for predicting chronic kidney disease in children with acute kidney disease is known, using a nomogram developed using machine learning methods. This method determines the family history of kidney disease, daily protein loss, red blood cell count in urine, asthenic body type, and maternal anemia during pregnancy. Then, for each patient, the position of each variable on the corresponding axis of the nomogram is determined, and a perpendicular to the x-axis is drawn to determine the score. The total scores for all variables are summed, and then the total score is projected onto a probability line for developing CKD to determine the risk of progression from acute kidney disease to chronic disease. If the obtained value is >50%, then a conclusion is made about a high risk of developing CKD, the child is referred to a nephrologist for an in-depth examination and nephroprotective therapy is prescribed; if the obtained value is <50%, then a conclusion is made about a low risk of developing CKD (RU2841906 C1, published 06/18/2025 A61B 5/00). The closest analogue of the claimed (group) invention may be a method for predicting the risk of developing severe complications of preeclampsia using a laboratory blood test, according to which the concentration of brain-derived neurotrophic factor (BDNF) is determined in the blood serum of a pregnant woman with hypertensive disorders, and if its value is equal to or higher than 11.1 ng/ml, a high risk of developing a severe complication of preeclampsia, HELLP syndrome, is predicted, and if the value is below 11.1 ng/ml, a low risk of developing HELLP syndrome is predicted (RU2741730 C1, published 01/28/2021 A61B5/00). Disadvantages of this method include assessing the risk of developing HELLP syndrome in the perinatal period based on only one indicator, which significantly reduces its specificity. Disadvantages of this method also include the requirement to perform this test on all patients with hypertension during pregnancy to identify the risk of HELLP syndrome. The low specificity of this method is also due to the fact that brain-derived neurotrophic factor (BDNF) levels can increase not only in hypertension and preeclampsia, but also in normal pregnancies and with the development of gestational diabetes. The technical result of the proposed group of inventions consists in the development of a reliable and effective method for diagnosing HELLP syndrome in the prenatal period at early stages based on the evaluation of data using a nomogram. The achievement of the technical result is ensured b