Laboratory diagnostic technique for threatening miscarriage

FIELD: medicine.

SUBSTANCE: technique is implemented by biochemical blood analysis followed by determining a diagnostic index by formula: D=X1×K1+X2×K2+X3×K3+X4×K4+const, wherein the values X are described by the biological parameters: X1 is the ceruloplasmin concentration, g/l; X2 is the creatinine concentration, mcmole/l; X3 is the total protein concentration, g/l; X4 is the albumin concentration, g/l; K1, K2, K3; K4 are coefficients: K1=10.4, K2=-0.04, K3=-0.10, K4=0.26, const=-6.84. If D is more than 0, the uncomplicated gestation course is stated with certainty. If D is less than 0, the threatening miscarriage is predicted.

EFFECT: method enables the timely detection of a group of the threatening miscarriage risk, and enables the correct classification.

3 ex

 

The present invention relates to the field of medicine, namely to obstetrics. Can be used in the work of women's clinics, outpatient departments of perinatal centers, obstetric and gynecology.

Physiological pregnancy is accompanied by a complex dynamic system reactions aimed at maintaining homeostasis in the new changed environment and ensuring the normal development of the fetus. The degree of metabolic adaptation of women with early pregnancy is an important prognostic factor in the risk assessment of the threat of interruption.

The level of technology

An analogue of this invention are described in the literature methods for the laboratory diagnosis of threatened abortion. Currently, the most often for verification of threatened abortion use a definition of human chorionic gonadotropin (HCG) and autoantibodies to HCG, trophoblastic beta1-glycoprotein, placental lactogen, prostaglandins E2 and F2 (a) in serum by enzyme immunoassay[1, 2, 3, 4, 5].

Despite the high degree of informativeness these methods do not always allow to predict the development of the disease before the development of clinical symptoms. No precise mathematical calculation and OTS�NCA situation, only one index may also affect the accuracy of forecasting.

The prototype of the proposed method is described in the literature method prognosis of threatened abortion with early gestational ages [6]. Diagnosis by this method is calculated as follows using three indicators: estriol, placental lactogen, and interleukin-6 in serum, calculated diagnostic index, the value of which make the conclusion about the presence or absence of laboratory signs of this disease. The disadvantage is the need to identify indicators of the reach of most hospitals and antenatal clinics, high material costs in the study in commercial medical centers (enzyme-linked immunosorbent assay, a test system "DELFIA", Finland).

Summary of the invention

The purpose of the invention is to provide a method of laboratory diagnosis of threatened abortion, not requiring special diagnostic devices, high material costs, are available in any biochemical laboratory. The proposed method will allow for early identification of risk groups for the development of this complication. The method is based on the biochemical study of blood in pregnant women in the 1st trimester of pregnancy, followed by calculation of a diagnostic index.

The method is as follows.

And�following blood is carried out on an empty stomach in the morning time. Venous blood in the amount of 5.5 ml taken by puncturing the veins in the upper limb in a vacuum tube Venosafe Belgium) with a coagulation activator. The blood was centrifuged at 3000 rpm for 15 minutes, serum was separated from red cell mass.

Biochemical study of serum venous blood performed on an automatic analyzer "Sapphire 400 (Japan). Using standardized test systems manufactured by Cormay (Poland) in blood samples of patients to determine the quantity of total protein, albumin, creatinine, ceruloplasmin.

The used methods of cluster and stepwise discriminant analysis. The calculations were performed using the software package "quasar Plus. Were selected informative signs and formed a rule laboratory prognosis of threatened abortion, which is to determine the diagnostic index (D) according to the formula:

D=X1×K1+X2×K2+X3×K3+X4×K4+const,

where the X values correspond to biochemical parameters:

X1- the concentration of ceruloplasmin (g/l).

X2is the concentration of creatinine, µmol/l;

X3- the concentration of total protein, g/l;

X4- concentration of albumin, g/l;

K1, K2, K3, K4- coefficients:

K1=0,4, K2=-0,04, K3=-0,10, K4=0,26, const=-6,84.

When the D-value>0 make a conclusion about the absence of laboratory signs of threatened abortion. When the D-value<0 diagnose the presence of laboratory signs of this disease. The proposed method gives the probability of correct classification of 86.3% for normal (specificity), pathology (threatened miscarriage) - 77,8% (sensitivity method) at significance level of P<0.01. The algorithm efficiency of 84.7%.

Example 1. Pregnant With society E. Y., 22 years. Case history No. 8321. He entered ginekologicheskoe Department with diagnosis: 8-9 weeks of pregnancy, regressing pregnancy, obstetric and gynecological history. A biochemical examination of blood serum. The following results are obtained: ceruloplasmin is 0.34 g/l; creatinine - 51,30 µmol/l; total protein - 71,02 g/l; albumin - 47,19 g/l. Diagnostic index D=-0,19 indicates laboratory signs of threatened abortion.

In the period of 10-11 weeks of pregnancy, despite ongoing conserving therapy, had a spontaneous miscarriage.

Example 2. B-d B. C. (case No. 3640), 23, in a period of 9-10 weeks was admitted for planned treatment at the day hospital Department of pathology of pregnancy number 2. The biochemical examination of blood serum obtained SL�blowing indicators: concentration of ceruloplasmin - 0,51 g/l; creatinine - 67,90 µmol/l; total protein - 77,06 g/l; albumin - 51,09 g/l According to the formula determined the value of the diagnostic index (D). Received a value of D=1,32; consequently, there is no laboratory signs of threatened abortion. The pregnancy proceeded without deviation from the norm and ended at 39-40 weeks of term births.

Example 3. A-WA K. R., 24, perfoermance, medical history No. 7500, was admitted to the gynecology Department of the Institute on March 28, 2012 with a diagnosis of a developing pregnancy 8-9 weeks, toxemia first half of pregnancy. During the survey the following data were obtained: concentration of ceruloplasmin - 0.65 g/l; creatinine - 54,45 µmol/l; total protein - 68,94 g/l; albumin - scored 43.69 g/l According to the formula determined the value of the diagnostic index (D). Received a value of D=2,21; consequently, there is no laboratory signs of threatened abortion. The treatment of toxemia and with progressing pregnancy, the patient was discharged from the hospital.

According to the claimed method was examined 130 pregnant women in the first trimester. In 31 women whose pregnancies ended in miscarriage or regression of pregnancy, the mean value of the D on the results of blood tests amounted -1,41±0.33 and correctly classified 24 patients (77,4%). In 99 women with uncomplicated within the ber�form the mean value of D was 0,53±0,1. The forecast was confirmed in 85 people (85,9%).

Thus, the proposed method for the diagnosis enables early identification of pregnant women at risk. The technique does not require expensive material and technical base, special reagents, convenient in performance while using the minimum amount of material, provides the required information within the hour, reproducible at any level (from prenatal to the perinatal center).

Sources of information

1. Alekseeva M. L. the usefulness of the determination of human chorionic gonadotropin in monitoring pregnancy / M. L. Alekseeva, E. A. Novikov, N. D. Panchenko / / Roche - Moscow: Sat. Mat. seminar (Zvenigorod, March 1994). - Zvenigorod, 1994. - Pp. 13-19.

2. Kyrychenko P. A. Clinical and immunological significance of autoantibodies to HCG in miscarriage / P. A. Kyrychenko, G. T. Sukhikh, Vanko L. V., I. V. Ponomarev // Obstetrics and gynecology. - 1996. - No. 4. - Pp. 14-16.

3. Taranov A. G. Laboratory diagnosis in obstetrics and gynecology: a Handbook. - M.: Alexcom, 2004. - 79 S.

4. Smigel K. V. Trophoblastic β1-glycoprotein: biological role and clinical significance in obstetrics / K. V. Smigel, V. A. Chereshnev // Obstetrics and gynecology. - 2003. - No. 6. - S. 6-9.

5. Serova O. F. / Serova O. F., Krasnopolsky V. I., Marchenko, S. Y., Saroc�Nava N. In. // Patent RU 2341179. Publication date 2008.12.20.

6. Chistyakova G. N. / Chistyakova G. N., Cherdantseva G. A. / Patent RU №2285926. Date published: 2006.10.20.

The method of laboratory diagnosis of threatened abortion by biochemical studies of blood, characterized in that it explores the contents of total protein, albumin, creatinine, ceruloplasmin and determine the diagnostic index by the formula:
D=10,4×X1-0,04×X2-0,10×X3+0,26×X4-6,84,
where the X values correspond to biochemical parameters:
X1- the concentration of ceruloplasmin, g/l;
X2is the concentration of creatinine, µmol/l;
X3- the concentration of total protein, g/l;
X4- concentration of albumin, g/l;
and when D is more than 0 make a reliable conclusion about uncomplicated pregnancy, and when D is less than 0 predict the threat of miscarriage.



 

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