The way to identify the risk of obstetric complications

 

(57) Abstract:

The invention relates to obstetrics and immunology, and is intended to identify the degree of risk of obstetric complications. Using enzyme immunoassay detect IgM and IgG antibodies to cardiolipin in phospholipid units, antibodies to denatured DNA (ssDNA) and native (dsDNA) DNA, antibodies to thyroglobulin (AT to TG) and thyroid peroxidase (TPO-AB) in conventional units, evaluate their performance in points, summarize them, depending on this index determines the degree of risk of complications. The method provides a reduction in the risk of obstetric complications by assigning adequate prevention through timely diagnosis risk of obstetric complications. 3 table.

The present invention relates to obstetrics and immunology, and is intended to identify the degree of risk of obstetric complications.

Autoimmune factors play a major role in the development of disturbances of microcirculation and hemostasis in pregnancy. Disturbance of microcirculation and hypercoagulation developing on the background of autoimmune abnormalities are a common cause of such complications during pregnancy how to stop pregnancy and miscarriages the social death of the fetus in the second and third trimesters of pregnancy, acute hypoxia at birth. Autoimmune abnormalities may increase such risk factors as the development of obstetric complications, hereditary thrombophilia and hyperhomocysteinemia. According to the literature, autoimmune and thrombophilic disorders are responsible for 80% of obstetric complications at different stages of pregnancy. Slowly developing during pregnancy microangiopathy lead to chronic intrauterine suffering of the fetus and to a sharp decline in the functional reserve of the newborn. Not distinct autoimmune disorders pregnant significantly increases the risk of developing diseases in newborns. Timely diagnosis of such disorders before pregnancy allows to identify groups of women at risk of developing placental disorders during pregnancy and the purpose of adequate prevention leads to a significant reduction in the risk of obstetric complications.

Given that planning pregnancy in the majority of cases occur in young age, most women do not pass a special examination before pregnancy and get to the doctor only after stopping the development of pregnancy, antenatal fetal death or severe intra - or is there begins only after 2 miscarriages or stops pregnancy in a row.

One of the most informative and promising in terms of high reliability ways to predict obstetric complications is different types of immunological research. So, there is a method of predicting recurrent miscarriage by research immunogenetic profile of peripheral blood leukocytes in couple, in which the prognostic conclusion do on the basis of indicators of HLA-I antigens, class II (EN 2184968, 10.07.2002).

However, this method does not account for autoimmune conditions as the causes of miscarriage and is mainly of women with alloimmunity forms of recurrent miscarriage.

There is a method of forecasting the threat of miscarriage in women with recurrent pregnancy loss by determining the concentration of factor inhibiting the migration of leukocytes in the peripheral blood before and after a single immunization leukocytes (EN 2014598, 15.06.1994).

However, this method also applies only to women undergoing treatment alloimmune forms of recurrent miscarriage. LASS="ptx2">There is a method for early diagnosis of pregnancy by estimating a modified reaction rosethorne (EN 2077729, 20.04.1997).

However, this method applies only to detect the risk of miscarriage after onset of pregnancy, is very time consuming and cannot be used as screening.

A known method for the diagnosis of threat of miscarriage of the fetus in the first trimester of pregnancy by determining the level of T-lymphocytes after incubation with soluble placental factors (RU 2077727, 20.04.1997).

However, this method also applies to diagnose the risk of miscarriage already in pregnancy and may not be used in preparation for pregnancy.

Known way to predict the outcome of pregnancy in women with threatening preterm births by determining the relative content of CD16+ and CD3+cells in the peripheral blood (EN 2132069, 20.06.1999).

However, this method relates to the diagnosis threat of premature birth in an already existing pregnancy.

A known method for the diagnosis of vascular disorders in pregnant women at an early stage of development of the pathological course of gestation, comprising determining the level protivosemom antigen lymphocytes, the number of platelets, the number and percentage of adhered platelets (EN 2061960, 10.06.1996).

However, this method also cannot be used at the planning stage of pregnancy and also difficult to use as screening due to its high cost.

The closest way to the same destination, the method comprising the prognosis unfavorable course and outcome of pregnancy detection using enzyme-linked immunosorbent variance analysis of immunoreactivity of antibodies to the exchange rate, S100 protein, ASVR/18 and MR, and serum level of human chorionic gonadotropin and dehydroepiandrosterone (EN 2190849, 10.10.2002). The method allows screening and accurately predict the development of the embryo/fetus, to evaluate the pregnancy in the dynamics and give a differentiated development forecast of possible complications, optimize pregravidarnoy training and to evaluate the effectiveness of therapy.

However, this method has several disadvantages.

1. The authors of this method offer for the forecast in the planning stages of pregnancy to determine the level of dehydroepiandrosterone and antibodies to the structural proteins of the nervous system, and in the case of the coming of beremend the ako recent studies have confirmed the importance of determining levels of deja and deja-S as a marker of the problems of the occurrence and outcome of pregnancy (see, for example, Clinical Gynecologic Endocrinology and Infertility, 6-th Edition, 2001).

2. Level 17-Oh-progesterone, which is also referenced by the authors, is used mainly for the diagnosis of classical and non-classical forms of hyperplasia of the adrenal cortex. This condition is a disease with an autosomal recessive mode of inheritance, and at the present time for its diagnosis are more reliable and accurate methods (molecular diagnostics).

3. The authors attribute the increase in blood women level of antibodies to the structural proteins of the nervous system with the risk of abnormalities in fetal development, for which at present there are also special screening methods.

Thus, in one group is mixed diagnosis of different etiology and pathogenesis of States, which complicates the interpretation and thereby significantly reduces the practical significance of the test.

4. Antibodies to structural proteins of the nervous system, proposed as the main markers have the following features. The level of these antibodies in the average population is very low with little variation, making it difficult to determine the physiological boundaries of the presence of these proteins in the blood of healthy donors. pregnancy based on comparison of the obtained performance is not the average for the population, and using reference sera, which have notoriously low levels of antibodies to structural proteins of the nervous system. This point greatly increases the probability of obtaining a high percentage of false-positive results.

5. In addition, beyond the scope of this method is the determination of the levels commonly found in populations of antibodies with well-characterized mechanism of action, including breach of normal placentation and microcirculation at the level of the placenta (antibodies to cardiolipin, antibodies to native and denatured DNA, antibodies to factors of the thyroid gland).

The task of the invention is to create a method that would allow not only to detect the risk of obstetric complications, but also to assess the degree of risk with a reasonable degree of accuracy.

The technical result of the proposed method is to reduce the risk of obstetric complications by assigning adequate prevention through timely diagnosis risk of obstetric complications.

The technical result is achieved due to the differentiated evaluation of the content and ratio of specific group of antibodies: IgM and IgG antibodies to cardiolipin, antibodies to den who is that serves to identify the degree of risk for obstetric complications in women of reproductive age at the planning stage, the first and/or subsequent pregnancies and in the early stages of pregnancy, based on the screening and subsequent assessment of the negative impact on the processes of gestation 6 types of autoimmune factors (individual and cumulative impact of all factors) using any of the methods of laboratory diagnostics, allowing to independently determine the amount of specific antibodies in the sample (at least semi-quantitative ELISA methods):

Antibodies IgM and IgG antibodies to cardiolipin (international phospholipid units mPL and gPL);

antibodies to denatured DNA (ssDNA) and native (dsDNA) DNA, quantitative method;

antibodies to thyroglobulin (AT to TG) and thyroid peroxidase (TPO-AB), a quantitative method.

These antibodies were chosen because of their greatest representative to identify the most common group of autoimmune disorders: antiphospholipid syndrome, systemic autoimmune disorders and chronic autoimmune thyroiditis.

In the prior art there are numerous data on increased risk of adverse IP the config spectrum of autoimmune antibodies are always present in healthy people, but their level is within physiological limits. In the body there is a whole system of suppression of autoimmunity and prevent its activation. In General, the number of violations of deterring mechanisms of autoimmunity are violated, which leads to the development of autoimmune diseases. Lower limit values of indicators specific to the disease, reflected in laboratory standards reagents.

Our research has shown that between neutral for the body's normal levels of autoantibodies and abnormal levels of these indicators typical for manifesting forms of autoimmune diseases, there are intermediate levels, allowing to assess the risk of obstetric complications.

Our research, including more than 2,000 women with different outcomes of pregnancies were allowed to identify these intervals. Studies were conducted using a set of reagents for ELISA “at-LDS”, developed by LLC “Laboratory diagnostic systems”, Moscow): for the detection of antibodies to cardiolipin was used quantitative method (international phospholipid units), for the remaining indicators semiquantitative method (conditional units). ofile”) you can select the following ranges of values, allowing to assess the risk of obstetric complications (table.1).

Interpretation of results is not difficult at all, if all the analyzed indicators fall into the same risk group.

In case of contact results in a heterogeneous group, as well as for estimating the overall risk of obstetric complications under the effect of influence factors, it is proposed to use the developed scoring according to the following scheme (table.2)

After scoring for each indicator, it is necessary to calculate the total amount of points received appropriate laboratory values given patient, and to classify the patient into one of four risk groups (table.3). The assignment of the patient to one of the risk groups determines the further tactics of reference. In the best case scenario in terms of the necessary correction of the screening is conducted at the planning stage of pregnancy (both the first and subsequent).

Forecast results above screening in early pregnancy.

When you hit a low risk woman is derived from special observation before planning the next pregnancy. Re-screening is desirable when ultrasound diagnosis of any California follow-up examinations after pregnancy and in the subsequent 1 every 4-6 weeks if the figures 5,6 (group screening of the thyroid gland) are in the low risk zone, again the necessary control only of figures 1-4. In case of transfer of the patient into a high risk group, the appointment of a special therapy under the supervision of autoantibodies.

When injected into the high and very high risk need special therapy and regular monitoring of indicators depending on therapy prior to pregnancy and throughout pregnancy. If the figures 5,6 (group screening of the thyroid gland) are in the low risk zone, re-control is necessary only indicators 1-4.

If screening before pregnancy have not been conducted, successful pregnancy outcome is more likely in the early beginning of the special therapy.

If between the planned preparation for pregnancy and the pregnancy is more than 6 months, the necessary control analysis on indicators 1-4 (if figures 5-6 consistently were in the low risk zone) or 1-6.

The method is illustrated by the following clinical examples.

Clinical case 1. A patient, 24 years old, asked for survey after two unsuccessful beremennost not burdened.

Blood and urine in the first half of pregnancy is normal. With 22 weeks of pregnancy there is an increase of the blood pressure to 140/90 mm RT.article Inpatient treatment in the hospital. Intrauterine fetal death at term of 25 weeks. Examination after birth at the clinic of occupational diseases and in the clinic of obstetrics and gynecology revealed no somatic and obstetric pathology.

Second pregnancy. Surveillance in antenatal clinics. Stop the development of pregnancy on term of 14 weeks. Blood and urine were normal.

The survey of the proposed method. The laboratory screening at the planning stage of pregnancy revealed the following:

The total score is(2+2+2+2+0+0=8), which corresponds to the high-risk group.

The patient in preparation for pregnancy, held a special therapy.

Planned control at the time of pregnancy: medium risk group on the background of therapy.

Planned control for 12, 20, 28 weeks - average risk group on the background of therapy.

Planned "anatomical" ULTRASONIC study on term of 20 weeks is the norm. Doppler blood flow in the uterine arteries and the arteries of the umbilical cord at the time 24, 28, nem a male fetus with a weight of 3600 g, estimation on Apgar scale 9-10 points.

Clinical case 2. Patient D., 25 years. The first pregnancy. Surveillance in antenatal clinics. Obstetric and medical history is not burdened. Blood and urine in the first half of pregnancy is normal. Stop the development of the fetal period of 7 weeks. Karyotyping material miscarriage - 46XY, aberrations not detected.

Second pregnancy. Surveillance in antenatal clinics. Stop development on term of 7 weeks. Postabortal endometritis. In the survey discovered the following antibody titers:

The total score was(2+2+0+0+0+0=4), which corresponds to the moderate risk group.

In preparation for pregnancy and up to 35 weeks of pregnancy - a special treat.

Planned "anatomical" ULTRASONIC study on the period of 19 weeks is the norm. Doppler blood flow in the uterine arteries and the arteries of the umbilical cord at the time 24 and 28 weeks is the norm. Cardiotocography at 32 weeks of pregnancy is the norm. Preeclampsia was not. 40 weeks birth live full-term male fetus weighing 3750 g, estimation on Apgar scale 9-10 points.

Clinical case 3. Patience F., 28 years old, came to prepare for pregnancy.

When obsl of the disease indicate increased family risk of thrombosis - early stroke from his father.

It was proposed dynamic monitoring during pregnancy, which the patient refused. The doctor of female consultation took utrogestan 2 capsules a day before the deadline of 9 weeks. Blood and urine in the first half of pregnancy is normal. There were no complaints. Planned "anatomical" ULTRASONIC study on term of 20 weeks is the norm.

From 28 weeks of pregnancy - traces of protein in the urine. 28 weeks according to abnormal Doppler waveforms - asymmetric increase in SRE and IL in the uterine arteries.

Control when you call:

Total points(3+3+1+1+0+0=8), that was confirmed by the data of ultrasound.

Conducted special therapy.

Delivery at 38 weeks routinely live full-term female fetus, weight 2900 g, estimation on Apgar scale 5-6 points. Muscle hypertonicity in the first 5 months of life, retarded weight gain up to 7 months after birth.

Clinical case 5. Patience Century, 32 years old, appealed to prepare for pregnancy.

From the anamnesis:

The first pregnancy at the age of 19, childbirth at term without complications. Second pregnancy in 30 years - surveillance in antenatal clinics. Swelling in the legs, starting from 14 weeks occurring examination after pregnancy pathology it is not revealed.

During examination: heredity: chronic autoimmune thyroiditis in the mother. Found titers of antibodies to cardiolipin group 2, antibodies to DNA group 3, the raising of antibodies to thyroglobulin and tirednes peroxidase to group 1. Thyroid hormones are normal, thyroid ultrasound - pathological changes were found.

Total points(1+1+3+3+1+1=10), which corresponds to the high-risk group.

In preparation for pregnancy - low-dose aspirin (50 mg/day), intravenous infusion of immunoglobulin 3 droppers per month for 2 menstrual cycles.

The pregnancy. Control tests: antibodies to the thyroid gland in gruppe, antibodies to DNA in group 1, antibodies to cardiolipin in group 0 for the period of 8 weeks. Total points(0+0+1+1+1+1=4), which corresponds to the average risk and indicates the need for special correction and continuation of dynamic monitoring parameters.

Control tests on term of 16 weeks. Total points(0+1+1+1+1+0=4), that confirms the need to further conduct special surveillance and special treatment.

Intravenous infusion of immunoglobulin prior 2">At 39 weeks of childbirth live full-term female fetus weighing 3200 g, estimation on Apgar scale 8-9.

Clinical case 6. Patient L., 27 years old, came after stopping the development of pregnancy on term of 8 weeks. Karyotyping material miscarriage - 46XY, aberrations not detected. Blood and urine in norm, standard hormonal examination of the thyroid gland - deviations, ultrasound of the thyroid gland is normal. When taking a history of complaints is not revealed. In the survey discovered the following antibody titers:

The total score was(3+3+3+3+3+3=18), that corresponds to a group of very high risk.

In preparation for pregnancy - consultation of the rheumatologist, endocrinologist, low-dose aspirin (50 mg/day), intravenous infusion of immunoglobulin 3 droppers per month during 3 menstrual cycles.

Control tests- (1+2+1+1+1+1=7), which corresponds to the moderate risk group.

The pregnancy. Control tests: antibodies to the thyroid gland in gruppe, antibodies to DNA in gruppe, antibodies to cardiolipin in group 0 for the period of 8 weeks. Total points(0+1+1+1+1+1=5), which corresponds to the average risk and indicates the necessity of Spetses on term of 16 weeks. Total points(0+1+1+2+0+0=4), that confirms the need to further conduct special surveillance and special treatment.

Intravenous infusion of immunoglobulin prior to 28 weeks.

Morphometric and diplomaticheskii indicators ULTRASOUND studies are normal. Preeclampsia was not.

At 39 weeks of childbirth live full-term male fetus with body weight 3350 g, estimation on Apgar scale 8-9.

Clinical case 7. Patient K., 20 years old, came after stopping the development of pregnancy on term of 5 weeks. Karyotyping material miscarriage was not conducted. Blood and urine in norm. When taking a history of complaints is not revealed. In the survey discovered the following antibody titers:

The total score was(0+0+0+0+0+0=0), which corresponds to low risk. Data for increased family risk of thrombosis was not. Follow-up examinations were not conducted.

Pregnancy monitoring. Morphometric and diplomaticheskii indicators ULTRASOUND studies are normal. Preeclampsia was not. Delivery on time, live full-term male fetus weighing 3850 g, estimation on Apgar scale 9-10 points.

Thus, the proposed method demonstrates high sepialine with the goal of preserving the pregnancy and prevent the development of complications.

The method of determining the risk of obstetric complications, including determination of serum antibodies enzyme-linked immunosorbent assay, wherein detect IgM and IgG antibodies to cardiolipin in international phospholipid units, antibodies to denatured DNA (ssDNA) and native (dsDNA) DNA, antibodies to thyroglobulin (AT to TG) and thyroid peroxidase (TPO-AB) in arbitrary units (UE) and if the performance of IgM and IgG antibodies to cardiolipin antibodies to denatured DNA (ssDNA) and native (dsDNA) DNA make up 16 of the respective units, to thyroglobulin and thyroid peroxidase to the UE 151, each of them evaluate a single point; if the indicators of IgM and IgG antibodies to cardiolipin, ranges from 16 to 23 phospholipid units, antibodies to denatured DNA (ssDNA) and native (dsDNA) DNA ranges from 16 to 20 UE, to thyroglobulin and thyroid peroxidase - from 151 to 200 ITEMS, each assessed at 2 points; if the indicators of IgM and IgG antibodies to cardiolipin, range from 23 and more phospholipid units, antibodies to denatured DNA (ssDNA) and to the native (dsDNA) DNA from 23 or more UE, to thyroglobulin and thyroid peroxidase - 200 or more ITEMS, each of them is appreciate by 3 points and with total balacing high.

 

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