Method for predicting toxaemias of pregnancy

FIELD: medicine.

SUBSTANCE: predicting toxaemia of pregnancy is ensured by determining 24-hour urine placenta-like alkaline phosphatase and lactoferrin when the woman is 20-22 weeks pregnant, and then 2 weeks later, and the measured placenta-like alkaline phosphatase and lactoferrin of more than 16.0 ng/ml enable estimating potential toxaemia of pregnancy.

EFFECT: method enables predicting potential toxaemia of pregnancy, including the comprehensive assessment of protein risk factors taking into account the clinical presentation and significance of each factor in numeric equivalent.

1 tbl

 

The invention relates to medicine, namely to biochemistry to predict the development of preeclampsia in pregnant women.

Preeclampsia is a syndrome of multiple organ functional failure, which develops as a result of pregnancy or aggravated by the pregnancy. In the classification of preeclampsia include swelling pregnant, proteinuria, hypertension, preeclampsia and eclampsia. In recent years in pregnant women there is a significant increase of OPG-gestosis, the Frequency of preeclampsia according to the median estimates in the literature is 7-22% of all births. Preeclampsia remains a major cause of perinatal morbidity (64-68%) and mortality (18-30%). In the structure of causes of maternal mortality in the Russian Federation preeclampsia steadily ranks third and is of 11.8 to 14.8% (Repin, M. A., 2010. Gridchin A. L., 2012, Ailamazyan, 2013). The urgency of the problem and also due to the severe consequences of this disease. Preeclampsia leads to increased frequency of perinatal complications in mother, fetus and newborn, negatively affects the health of children in later years of life (Sidorova I. S., 2003; Savelyeva G. M., 2010; L. V. Vasilenko et al., 2012). In the pathogenesis of preeclampsia, premature birth pregnancy, the retardation (IUGR) plays a pivotal role dysfunction of the vascular endothelium (Sukhikh G. T. et al., 2008).

It is known that in women with Geus�eskers are observed impairment of many metabolic cycles:

aerobic oxidation in the Krebs cycle, lipid peroxidation, antioxidant protection, endogenous synthesis of prostaglandins, lipid metabolism, immune reactions, all contribute to the dysfunction of the vascular endothelium of the placenta, the change of rheological properties of blood, thrombophilic States. Therefore, the development of an integrated approach to the prediction and prevention of preeclampsia, severe forms of gestosis in pregnant women is an important problem in modern biochemistry and obstetrics.

In the practice of biochemistry known methods of predicting the development of preeclampsia, based on biomicroscopy vessels of the conjunctiva of the eye by slit lamp with computer processing of data by computer programs Adobe Photoshop CS in women in the first trimester of pregnancy. Conducted analysis of chroma pixels of a digital image of blood vessels of the conjunctiva of the eye in the disruption of the microcirculation in comparison with the chromaticity of the pixels in the image of the vessels of the bulbar conjunctiva of healthy subjects to assess the microcirculation was determined in points): score of 7-8 is the norm, aggregation of erythrocytes no; 9-10 points - increased erythrocyte aggregation; 11 points - aggregation of erythrocytes mild degree; 12 points - moderate erythrocyte aggregation; 14 or more points - pronounced aggregation, there is a severe disturbance of processes of microcirculatory�.

Blood test for homocysteine was performed in the first trimester of pregnancy by ELISA. Conditionally normal levels of homocysteine in the blood for women were considered from 4.6 to 12.4 µmol/L. the Levels of homocysteine in the blood in the first trimester of pregnancy proportional to the severity of preeclampsia. With the development of preeclampsia mild severity indicators of homocysteine was 13.4±0.3 μmol/l, with an average severity - 15,9±0.4 µmol/l, with severe degree of 31.4±0.7 µmol/l (p<0,001) (Odnokozova O. C., L. V. Vasilenko, trackin N. And., Kolbenev O. I. pregnancy, childbirth and infant health after the preventive treatment of preeclampsia in pregnant women at risk // Saratov scientific medical journal. - 2009. - T. 5. - No. 4. - Pp. 533-537). However, this predictive model is based on the combined determination of microcirculation and blood levels of homocysteine, has not proven effective for the prediction of preeclampsia as based on factors that are only remotely associated with the pathogenesis of gestosis and placental insufficiency (Roach m, Lu j, Pilepich MV., Asbell SO., Mohiuddin M., Terry R. et al.: Four prognostic groups predict long-term survival from prostate cancer following radiotherapy alone on Radiation Therapy Oncology Group clinical trials. Int. J. Radiat. Oncol. Biol. Phys. 2010, 1; 47:609-615; T. Steuber, M. Graefen, A. Haese et al. Validation of a nomogram for prediction of side-specific extracapsular extension at radical prostatectomy. J. Urol. 2006; 17:939 - 14).

There are also known methods of determination of other biochemical markers such as prostaglandins in combination with means for determining vascular tone. In pregnant women in trimester 1 determine the average MMPI profile, the orientation of vegetative regulation, the type of Central hemodynamics and the level of prostaglandins in serum and increasing the average MMPI profile, the sympathetic orientation of vegetative regulation, hypokinetic type of blood circulation and reduction of prostacyclin by increasing thromboxane predict the occurrence of preeclampsia (stolnikova I. I. Shpak, L. V., " a METHOD of PREDICTING OPG-GESTOSIS IN PREGNANT women WITH ESSENTIAL HYPERTENSION).

All the described methods have drawbacks:

- the above methods are based on a combination of sophisticated instrumental methods of examination (biomicroscopy retinal vessels, functional study of the Central nervous system and vascular tone), psychological tests (score on a scale of MMPI) and complex biochemical analyses determination of prostaglandins.

- lack of correlation of the level of prostaglandins with the MMPI profile;

- the technical complexity of implementation;

- the need for blood tests in the first 12 hours of collection because of the instability of prostaglandins.

- low accuracy of the research.�tion and the lack of clear limits for assessing the prognosis of developing preeclampsia.

Closest to the proposed method is a test to determine serum and urine other markers of preeclampsia Inhibin A and Activin a level in peripheral blood and urine correlates with the likelihood of developing preeclampsia. Especially pronounced is the increase in the concentration of the proposed markers in the urine (more than 100 times). The authors propose to consider the levels of inhibin A and Activin a in the blood equal or above 5.0 ng/ml, and the levels of inhibin A and Activin A in the urine above 1.0 PG/ml, as the boundary of the assessment of the probability of developing preeclampsia. (Muttukrishna S., Hyett J., Paine M., Moodley J., Groome N. and Rodeck C. Can vein and maternal urinary levels of activin A and inhibin A in pre-eclampsia patients Clinical Endocrinology - 2006 - v. 64 - p. 469-473).

However, the disadvantages of this method are:

- fuzzy differentiation in the evaluation of prognosis of preeclampsia;

- no communication with clinical signs of preeclampsia, in addition to hypertension;

- narrow range of concentrations of inhibin A and Activin A, proposed by the authors to assess the development of preeclampsia;

- complicated calculation for standardization and accounting of urine;

- the lack of data on the prediction of preeclampsia (preeclampsia) in the 1st or early 2nd trimester of pregnancy.

The invention is directed to predicting the development of preeclampsia on the basis of non-invasive dynamic immunochemical determination of placental alkaline phosphatase and lactoferrin in daily urine baie�variable item, correlated with subsequent development of preeclampsia. Said technical result is achieved in that to predict the development of preeclampsia, determine the concentration of placental alkaline phosphatase and lactoferrin, characterized in that determine the concentration of placental alkaline phosphatase and lactoferrin in daily urine of pregnant women at 20-22 weeks of pregnancy and again after 2 weeks and on the sums of the concentrations of placental alkaline phosphatase and lactoferrin concentrations above 16.0 ng/ml predict the development of preeclampsia.

The proposed method was successfully tested on the 96 women in the period from 2009 to 2012, observed in the antenatal clinic OKB №1 Astrakhan from 15 to 36 weeks of pregnancy, with an observation interval of 2 weeks.

The method is illustrated by the following clinical examples of its implementation.

Clinical example 1

Patient A., 23 years old (case History No. 14329). Turned 21.02.2009 G. Daily urine on the study of markers taken on 20 week of pregnancy 22.02.2009 G. concentrations of placental alkaline phosphatase was 0.9 ng/ml lactoferrin was 6.6 ng/ml, which amounted to a total of 7.5 ng/ml At 22 weeks of pregnancy (06.03.2009) urine for the study of markers taken again. Concentrations of placental alkaline phosphatase was 1.8 ng/ml, lactoferrin, and 11.1 ng/ml, for a total of two studies �left of 20.4 ng/ml. Prognosis - the likelihood of developing preeclampsia.

With 28 weeks of the current pregnancy was with transient proteinuria, recurrent swelling of the lower extremities. Given birth to the term, vaginally a living male fetus, weighing 3250 g with estimation on Apgar scale - 6-7 points.

Clinical example 2

Patient S., 24 years old (case History No. 23124). Turned 01.11.2010 Daily urine on the study of markers taken on 21 week of pregnancy (02.11.2010). Concentrations of placental alkaline phosphatase was 0.1 ng/ml lactoferrin 2.5 ng/ml, which was 2.6 ng/ml. 16.11.2010 urine in a study of markers taken again at 23 weeks of pregnancy. Concentrations of placental alkaline phosphatase was 4.7 ng/ml lactoferrin to 4.3 ng/ml, for a total of two studies was 11.6 ng/ml the Prognosis - the likelihood of developing preeclampsia is missing. During pregnancy carried out correction HELL, it was recommended that a diet low in salt. The pregnancy was uneventful. Given birth to the term, vaginally full-term baby girl weighing 3100 g with estimation on Apgar scale - 7-8 points.

Clinical example 3

Patient Sh, 26 years old (case History No. 10217), entered 02.04.2011 G. Daily urine on the study of markers taken at 22 weeks of pregnancy (03.04.2010). The values of concentration�ation placental alkaline phosphatase was 10.1 ng/ml, lactoferrin is 14.5 ng/ml, which in total amounted to 24.6 ng/ml. 16.04.2010 urine in a study of markers taken again on 24 week of pregnancy, the concentrations of placental alkaline phosphatase amounted to 13.0 ng/ml lactoferrin of 10.3 ng/ml, for a total of two studies was 47.8 ng/ml. Prognosis - the likelihood of developing preeclampsia. The pregnancy proceeded with transient proteinuria, recurrent swelling of the lower extremities. With 30 weeks of pregnancy was complicated by severe late preeclampsia to eclampsia. Given birth in the period 39-40 weeks of gestation by cesarean section live male fetus, weighing 2950 g with estimation on Apgar scale - 6-7 points.

The basis of the invention was based on the results of a survey of 96 pregnant women. The average age of patients was 23.5±0.4 years (21 to 24 years) (tab. 1).

The diagnosis of preeclampsia was established on the basis of clinical (complaints, the presence of hidden and overt edema, hypertension, the presence of concomitant extragenital pathology, the degree of violation of the utero-placental and fetal-placental blood flow, IUGR of the fetus, signs of fetal hypoxia), laboratory data (OAK, OAM, blood chemistry, coagulation, urinalysis in General, the Reichstag, Nechiporenko. The study of daily proteinuria), data instrumental examination (ultrasound, doplerometriya, CTG, studied�e fundus, monitoring blood pressure) were assessed severity of preeclampsia on the scale of G. M. Savelieva.

The conducted research has allowed to produce a comprehensive assessment of risk factors with regard to informative value of each factor. The results of the study are presented in table 1. Positive = 12; false positive = 8; false negative = 4. Sensitivity: True Positive/True Positive + false negative = 75,0%.

Specificity: True negative/true negative + false positive = 89.7 per cent.

Thus, this means: 75,0% of pregnant women with a total level PDF and lactoferrin above 16.0 ng/ml predict the development of preeclampsia appears to be true. Specificity is equal to 89.7% of it, therefore, in 89.7% of patients with a known negative Outlook, the test results are negative. The negative difference 14.7% between significantly positive and significantly negative Outlook is the uncertainty factor and in this case opens the possibility for the introduction of new prognostic markers to improve sensitivity.

The proposed method has the following advantages:

- improving the accuracy of predicting the development of preeclampsia on the basis of determination of total concentrations of placental alkaline phosphatase and lactoferrin with high verootstupnichestva 75,0% (r=0,7; P < 0,00001).

- has the availability and economic feasibility, as it is based on an assessment of only put into wide practice of laboratory methods and does not require expensive laboratory equipment.

- has the simplicity as it is based on non-invasive study

- is open prognostic system, since it allows to easily introduce additional laboratory markers to improve sensitivity and reduce the number of false positive results, i.e. to improve the specificity.

A METHOD of PREDICTING PREECLAMPSIA IN PREGNANT women

A method of predicting gestosis of pregnant women, namely, in the biochemical study of biological fluids, characterized in that determine the concentration of placental alkaline phosphatase and lactoferrin in daily urine of pregnant women at 20-22 weeks of pregnancy and again after 2 weeks and on the sums of the concentrations of placental alkaline phosphatase and lactoferrin concentrations above 16.0 ng/ml predict the development of preeclampsia.



 

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