RU2530774C1 - Method for prediction of risk level of unfavourable perinatal outcomes in intrauterine infection - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: mother's and foetus's heart rate variability is measured. A coefficient of variation the foetus's full array of RR intervals in the original state CV F I, a resistance index of the umbilical artery RI, a coefficient of variation of the mother's full array of RR intervals in the original state CV M, mother's RR_min in the period of recovery of a mental test RR_min M III are determined. ∑₁, ∑₂, ∑₃ are calculated by formulas: ∑₁=2 (original foetus's CV less than 5.4)+3 (RI less than 0.58)+3 (original mother's CV less than 7.8)+2 (original mother's RR_min less than 531); ∑₂=2 (CV F I less than 5.4)+3 (RI more than 0.58)+2 (CV M I less than 0.78)+4 (RR_min M I less than 531); ∑₃=3 (CV F I less than 5.4)+3 (CV M I less than 7.8)+3 (RI more than 0.58). The values ∑₁ falling within the range of 0 to 2 show a low risk; within the range of 3 to 5 points - a moderate risk; from 6 to 10 points - a high risk; the values ∑₂ from 0 to 2 show a low risk, from 3 to 5 points - a moderate risk, from 6 to 11 points - a high risk; the values ∑₃ from 0 to 3 testifies to a low risk, from 4 to 9 points - to a high risk of unfavourable perinatal outcomes. The risks derived from the three values: ∑₁, ∑₂, ∑₃ are used to evaluate a risk level of the unfavourable perinatal outcomes in intrauterine infection.

EFFECT: higher prediction accuracy.

3 ex, 6 tbl, 3 dwg

Description

The invention relates to medicine, obstetrics and perinatology and can be used to predict the degree of risk of adverse perinatal outcomes during intrauterine infection.

Despite the significant success of perinatology, intrauterine infections remain one of the most important problems of modern medicine [1; 2; 3], being the most frequent and dangerous causes of diseases of the fetus and newborn [4; 5; 6]. In the structure of perinatal mortality, the proportion of intrauterine infections is from 11 to 45% [7; 8]. Among intrauterine infections that cause embryo- and fetopathies, the most common are cytomegalovirus (CMV), herpes virus (HSV), toxoplasma, chlamydial infections, etc. [1; 9; 10].

The outcomes of perinatally significant infections are diverse - from the birth of a healthy baby to the formation of a crude pathology of the fetus and placenta. Prediction of pregnancy outcomes developing against the background of perinatally significant infections is an important and currently insufficiently solved problem, it requires new methodological approaches and clinical methods for studying the mother-placenta-fetus system. One of the clinical methods for assessing the functional systems of the mother and fetus, the relationship between them is the method of analysis of heart rate variability (HRV) [11; 12; 13]. The rhythm of the human heart is a complex oscillatory process, the dynamic structure of which carries information about the state of the most important neurohumoral regulatory systems of the body [11; 13].

In the literature there are only a few works devoted to the problem of studying the variability of the heart rate of the mother and fetus in obstetrics [14; fifteen; 16; 17; eighteen]. These studies prove the high prognostic value of the analysis of HRV in the mother and fetus for the diagnosis of obstetric and perinatal complications.

A known method for predicting the outcome of pregnancy in women at risk for intrauterine infection of the fetus [19]. The method consists in the fact that in the second trimester of pregnancy in women at risk for intrauterine infection, a complex of clinical and laboratory indicators of the mother and fetus is evaluated. Take into account the course of pregnancy, complicated by the development of moderate or severe gestosis (DK = + 6.3), not complicated by the development of gestosis (DK = -7.5); the presence of ultrasound markers of prenatal fetal pathology (DK = + 2.9); purity of vaginal smears of 3-4 degrees (DK = + 1.8); the number of segmented neutrophils in maternal blood 70% (DK = + 7.9), 65% (DK = -2.9); leukocytosis in fruit blood 4.510 9 / L (DK = + 6.8), 3.0109 / L (DK = -6.9); absolute lymphocytosis in the fetal blood 3.0109 / l (DC = + 4.1); the absolute content of CD3 + T cells is 1.9109 / l (DK = +5.4), 1.2109 / l (DK = -3.7) and the IgA level in the fetal blood is 0.3 g / l (DK = + 2.5), 0.4 g / l (DK = -5.5); the relative amounts of HLA-DR + monocytes and HLA-DR + lymphocytes in the fetal blood are 88 and 30%, respectively (DK = -6.2) and (DK = -4.0). With a total value of positive diagnostic coefficients (DK = + 13 and above), the development of an adverse perinatal outcome is predicted, and with a total value of negative diagnostic coefficients (DK = -17 and lower), a favorable pregnancy outcome is predicted. The method allows to optimize the management of pregnant women. The disadvantage of this method is the invasiveness of the technique (the use of fetal blood obtained by cordocentesis), which requires informed consent for the procedure and is associated with an increased risk of adverse reactions and complications, excludes the use in level I-II obstetric hospitals. The second significant drawback is the high cost of the study associated with genotyping (determination of HLA-DR + monocytes and HLA-DR + lymphocytes).

A known method for predicting perinatal morbidity [20]. The presence of anamnestic factors is determined: socio-biological risk factors, obstetric and gynecological anamnesis, extragenital diseases of the mother, as well as pregnancy factors: pregnancy complications, fetal status assessment, identified factors are assigned scores contained in the description using the table “Modified perinatal prediction scale incidence. " Then, the identified scores are summarized and, with a score of up to 15, a low risk of perinatal morbidity is predicted, with a score of 15 to 25 an average degree, with a score of more than 25 a high degree. The method is aimed at improving the accuracy and objectivity of predicting perinatal morbidity and mortality, allows you to classify a pregnant woman at risk and timely preventive and therapeutic measures, as well as choose the most appropriate methods and time of delivery. The disadvantage of this method is a large number of factors, which increases the time to calculate the total risk; the subjectivity of the assessment of individual characteristics obtained by conducting additional research methods; the method does not take into account the compensatory capabilities of the mother and fetus.

Closest to the proposed method selected for the prototype is a method for diagnosing the condition of the fetus and predicting the early neonatal period of the newborn [21]. The method consists in determining the index of stress (IN) of the fetus using variational pulsometry according to the Baevsky formula P.M. (KH = AMo / 2 · Mo · dX) at rest when the pregnant woman is lying on her back or on her side with a measurement duration of at least 15 minutes (resting ID); determining the fetal stress index after performing a functional maternal test with a measurement duration of 3-7 minutes (load ID). According to the measurement results, the coefficient of dynamics of the fetal stress index (KDIN) is calculated as the modulus of the difference between the values of (resting ID) and (loading ID), referred to the sum of these values and multiplied by 100, KDIN = 100 × [resting ID - load IN] / (IN rest + ID load). With values of CDIN from 3 to 10, the physiological state of the fetus and the physiological course of the early neonatal period of the newborn are determined. The fact that the CDIN exceeds these values indicates a violation of the functional state of the fetus and the risk of pathology of the newborn in the early neonatal period. The method allows to identify hidden manifestations of placental insufficiency and impaired fetal adaptation and to predict the course of the early neonatal period.

The disadvantage of this method is the use of a single indicator of the stress index (IN), the absence of a point system of the forecast scale, as a result of which it is impossible to distinguish between the severity of the expected deviations of the adaptation period.

A new technical result is an increase in the accuracy and information content of the method.

To achieve a new technical result in a method for predicting the risk of adverse perinatal outcomes during intrauterine infection by analyzing the variability of the heart rate of the mother and the fetus, the coefficient of variation of the full array of fetal cardiac intervals in the initial state CV P I, the index of resistance of the artery of the umbilical cord IR, the coefficient of variation of the full array are determined cardiointervals mother in the initial state CV M interval RR _min mothers during recovery from mental test RR _min M III and then calculate Σ _1, Σ _2, Σ ₃ formulas:

∑ ₁ = 2 (with CV of the fetus in the initial state less than 5.4) +3 (with IR less than 0.58) +3 (with CV of the mother in initial state less than 7.8) +2 (with RR _{min of the} mother in initial state less than 531);

∑ ₂ = 2 (with CV P I less than 5.4) +3 (with IR more than 0.58) +2 (with CV M I less than 0.78) +4 (with RR _min MI less than 531);

∑ ₃ = 3 (with CV P I less than 5.4) +3 (with CV MI less than 7.8) +3 (with IR more than 0.58) and

values ∑ ₁ from 0 to 2 indicate low risk; from 3 to 5 points - average; from 6 to 10 points - high risk;

values ∑ ₂ from 0 to 2 indicate low; from 3 to 5 points - average; from 6 to 11 points - high risk;

values ∑ ₃ from 0 to 3 indicate a low risk, from 4 to 9 points - a high risk of adverse perinatal outcomes;

based on the risks obtained, three indicators:: ₁ , ∑ ₂ , ∑ ₃ determine the degree of risk of adverse perinatal outcomes during intrauterine infection.

The method is as follows.

In a patient with a documented diagnosis of intrauterine infection, a simultaneous analysis of heart rate variability is performed. Registration of the record of heart rate variability (HRV) of the mother is carried out using a computer electrocardiograph for analysis of heart rate variability (vegetotester) "ANS rhythm" (certificate of conformity ROSS RU.IM 18.В00228 No. 6943114, RU. C.39.026.A No. 19009 from November 1, 2009). In order to diagnose the state of regulatory and adaptation processes in the body of a pregnant woman and the fetus, spectral, mathematical and temporal analysis of HRV is used. HRV analysis is based on calculations of statistical indicators recommended and approved by the European Society of Cardiology and the North American Society of Cardiac Stimulation and Electrophysiology [22] and a group of domestic authors [11; 13; 23].

HRV recording is carried out in the form of several successive stages: dynamic recording of heart rate, analysis, classification, clinical and spectral evaluation of the results.

Conditions for recording HRV: pregnant women perform HRV recording in the third trimester of pregnancy. The study is performed in the first half of the day (if available, at any time of the day), 2 hours after eating, in a quiet room, with a constant temperature of about + 20 ° C, in a state of calm wakefulness. Before the start of the study, a period of adaptation to environmental conditions (5-10 minutes) is necessary.

Each study includes 5 components of 256 R-R heart rate intervals and lasts 4.5-5 minutes:

- 1st — registration of the initial (background) state; for comparison with the background recording in the future use similar in duration recording;

- 2nd - the first functional test (mental test). Perform a mathematical calculation in the mind - a sequential calculation of 500 to 7. During the performance of this functional test, it is not recommended to pronounce the numbers aloud in connection with the influence of speech on the nature of the spectrogram;

- 3rd - recovery after the first functional test; recording is carried out 5 minutes after the end of the load with a preliminary control measurement of blood pressure;

- 4th — second functional test (hyperventilation); the depth and frequency of breathing is regulated depending on the state of the pregnant woman;

- 5th - recovery after the second functional test; registration of heart rate is carried out 5 minutes after the end of the load with a preliminary control measurement of blood pressure.

In order to eliminate artifacts associated with changes in the voltage in the network, movements during breathing, excessive excitement of a woman, as well as the elimination of functional extrasystoles, the “filter” function is used, which eliminates the deviations as much as possible.

Assessment of indicators of regulatory and adaptive processes of the mother and the fetus is carried out according to the results of the analysis of heart rate variability [24; 25; 26].

The following parameters are evaluated:

1. Statistical methods (temporary):

- SDNN (standard deviation of the full array of cardio intervals) - characterizes the total indicator of the variability of the values of the RR intervals for the entire considered period (short 5-minute records). In short 5-minute recordings, normal SDNN values are between 40-80 ms;

- RMSSD - the square root of the sum of the differences in a sequential series of cardio intervals, which reflects high-frequency fluctuations and the activity of the autonomous regulation loop. Normally, the values of this indicator are in the range of 20-50 ms;

- pNN ₅₀ (%) - the number of pairs of cardio intervals with a difference of more than 50 ms from the number of all analyzed cardio intervals in percent. The indicator indicates the degree of prevalence of the parasympathetic regulatory link over the sympathetic (relative value);

- CV (coefficient of variation of the full array of cardio intervals) - the normalized indicator of the total regulation effect is a normalized dispersion estimate (D), which reflects the amount of energy expended on the vibrations in different spectral ranges. A decrease in variance indicates a small scatter of values in a row with respect to the average value. In relation to the heart rhythm, a decrease in dispersion indicates its rigidity, which is associated with the regulation processes from the center (segmental structures).

2. Mathematical methods:

- mode (Mo) - the most common value of RR-intervals;

- mode amplitude (AMo) - the proportion of cardio intervals corresponding to the mode value;

- the range of variation in heart rate (DV) is the difference between the duration of the largest and smallest R-R interval.

To determine the degree of adaptation of the cardiovascular system, use the mathematical index of stress according to Baevsky P.M. [eleven]:

- IN - voltage index, IN = AMo (%) / 2Mo × DV (sec); expressed in arbitrary units; the degree of centralization of heart rate control indicates the degree of tension of regulatory systems. An increase in fluctuations in the R-R intervals (DV) and a slowdown in heart rhythm (an increase in Mo, a decrease in AMo) leads to a decrease in the IN value and indicates an increase in parasympathetic activity. Opposite shifts indicate an increase in sympathetic tone.

3. Spectral methods for the analysis of HRV:

- VLF (Very Low Frequency) - slow waves of the 2nd order (metabolic-moral waves) in the frequency range 0.003-0.04 Hz (25-333 s). The suprasegmental level of regulation is characterized, since the amplitude is closely related to psychoemotional stress, reflecting the state of the pituitary-hypothalamic and cortical levels [27]. There is evidence that VLF is a sensitive indicator of the control of metabolic processes, well reflects energy-deficient states [13]. Normally, at rest, the VLF power is 15-35% of the total spectrum power.

- LF (Low Frequency) - slow waves of the 1st order (vasomotor or sympathoadrenal waves) in the frequency range 0.05-0.15 Hz (6.5-25 s). An increase in the wave amplitude in this range may indicate a decrease in the activity of the vasomotor center or a slowdown in the processes of baroreflex regulation [13].

- HF (High Frequency) - slow waves (respiratory) in the frequency range 0.16-0.5 Hz (2.5-6.5 s). The main characteristic of this spectrum component is vagal (parasympathetic) activity. Normally, the HF power is 15-25% of the total spectrum power.

- LF / HF - sympatho-vagal index - a derivative value, indicating the predominance of a component in the regulation of heart rhythm.

The study of indicators of fetal heart rate variability was carried out according to the method of G.A. Ushakova, Yu.V. Retz [28; 29; thirty].

Recording and assessment of the fetal condition is carried out as follows: using the Fetalgard-2000 Dopplerometric cardiotocograph, a fetal heart beat rhythm is recorded mechanically in an amount of at least 256 beats (heart rate). The received data is entered into the protocol of the Pulsar biorhythmological computer program, then the data is transferred to the Converter program; in the Neurosoft program, fetal indicators are processed in real time. This program is adapted to assess the effectiveness of regulatory mechanisms of the fetal heart rhythm and determines the state of its protective and adaptive mechanisms by analogy with maternal spectral characteristics [31].

The spectrogram of the intrauterine fetus also distinguishes three main components of regulation: VLF - the metabolic-moral component that characterizes the metabolic regulation system, this circuit is presented in the range from 0.01 to 0.05 Hz; LF is a sympathoadrenal component that characterizes the oscillations of the own oscillator in the fetal pressure regulation system, this circuit is presented in the range of 0.05-0.14 Hz; HF is a parasympathetic component, often caused by respiratory movements of the mother and reflecting the reaction of the cardiovascular system of the fetus in response to a synchronous change in pressure within the amniotic fluid. This circuit can also reflect the functioning of the fetal vascular system, the regulation of which has its own characteristics in the antenatal period of development, is presented in the range of 0.14-0.5 Hz.

Based on the dynamics of the power spectral density of VLF spectra of HRV per load according to A.N. Fleishman (1999, 2009, 2011) is distinguished by the following types of energy-modified states: 1. Normally adaptive state; 2. Energy deficient (hypoadaptive) state; 3. Hyperactive state; 4. Hyperactive reaction; 5. Load (post-load) energy shortage; 6. The energy fold [13].

To determine the risk factors for adverse perinatal outcomes during intrauterine infection, a logistic regression analysis is performed. As independent factors, the regression analysis identifies: the presence of energy-deficient states of the mother, energy-deficient states of the fetus, and the aggregate indicator of energy-deficient states of the mother and fetus.

For calculations, qualitative signs are used, therefore quantitative indicators are encoded according to the median level. A prognostically significant sign is the fetal CV level in the initial state below 5.4 (3.2-7.1), the umbilical artery resistance index below 0.58 (0.49-0.75), the mother’s CV in the initial state below 7, 8 (4.2-10.4), the interval RR _{min of the} mother during the recovery period after the mental test below 531 (259-684) s.

After receiving a set of patient and fetal data, the probability of assigning it to a group with a high, medium and low risk of developing adverse perinatal outcomes is calculated. In this case, use the sum of the found coefficients of significant indicators (the coefficient of variation of the full array of fetal cardiac intervals in the initial state of CV is less than 5.4; the index of resistance of the artery of the umbilical cord arteries IR less than 0.58; the coefficient of variation of the full array of cardiac intervals of the mother in the initial state of CV is less than 7.8; interval RR _{min of the} mother during the recovery period after the mental test is less than 531).

To predict adverse perinatal outcomes, based on the state of the mother, a calculation is made according to the formula:

∑ ₁ = 2 (with CV P I less than 5.4) + 3 (with IR more than 0.58) + 3 (with CV M I less than 7.8) + 2 (with RR _min M I less than 531).

At values ∑ ₁ from 0 to 2, they predict low; from 3 to 5 points - average, and from 6 to 10 points - a high risk of adverse perinatal outcomes.

To predict adverse perinatal outcomes, based on the condition of the fetus, a calculation is made according to the formula:

∑ ₂ = 2 (with CV P I less than 5.4) + 3 (with IR more than 0.58) + 2 (with CV M I less than 0.78) + 4 (with RR _min MI less than 531).

At values ∑ ₂ from 0 to 2, they predict low; from 3 to 5 points - average, and from 6 to 11 points - a high risk of adverse perinatal outcomes.

To predict adverse perinatal outcomes, based on the combined state of the mother and fetus, the calculation is performed according to the formula:

∑ ₃ = 3 (with CV P I less than 5.4) + 3 (with CV M I less than 7.8) + 3 (with IR more than 0.58).

With values of ∑ ₃ from 0 to 3, low risk is predicted, and from 4 to 9 points - a high risk of adverse perinatal outcomes.

Intrauterine infection is extremely difficult to diagnose, treat and predict perinatal outcomes. This is due to several reasons: polyetiologicality, multifactorial effect of the infectious agent on the fetus, difficulty in antenatal diagnosis, lack of clear links between the severity of the mother’s infectious disease and the degree of fetal damage, ambiguous approach to therapeutic and preventive measures in pregnant women and newborns (immunomodulation, antibiotic prophylaxis, antibiotic therapy, etc. .) [32; 33]. Intrauterine infections often form processes that are almost indistinguishable by the results of objective examination and similar clinically. However, in the infected fetus, both local and generalized lesions can be noted [34]. Informative clinical symptoms of infection of the ovum are polyhydramnios, persistent tachycardia in the fetus, fetal malnutrition, less commonly, oligohydramnios. When studying perinatal outcomes in women with a high risk of intrauterine infection, a complicated course of labor was observed due to anomalies in labor (weak labor - 20.4%, quick delivery - 16.4%), chronic fetal hypoxia - 34.5 % [35; 36]. Cardiomonitorial monitoring of the state of the cardiac activity of the fetus was carried out in these pregnant women during childbirth. Changes in fetal cardiac activity ranged from mild cardiovascular reactivity disorder (54.5%) to moderate (21.4%). In all children, the leading diagnosis was hypoxic-ischemic damage to the central nervous system, while the implementation of intrauterine infection was observed in 63.6% of cases, the syndrome of massive aspiration by meconium amniotic fluid in 36.4%, morphofunctional immaturity in 16.4% of cases [36; 37].

A number of researchers [38], who studied the long-term consequences of the adverse effects of IUI on child development, noted neuro-vegetative and mental disorders, a lag in physical development. 85% of children may have a prolonged viral persistence: initially asymptomatic with the further emergence of delayed pathology (allergic and autoimmune diseases, hypertension-hydrocephalic syndrome) [39]. Moreover, depending on the infectious agent, various clinical manifestations develop: atherosclerosis, hearing loss (CMV) [40], diabetes and rectal cancer (rubella), conjunctivitis (chlamydial infection) [41], lung damage (mycoplasma infection) and etc. [38; 42].

Thus, the clinical manifestations of IUI are extremely diverse, therefore, in modern medicine, the development of the most informative methods for its diagnosis and the prediction of adverse outcomes are of particular importance [43; 44; 45; 46].

The proposed method is based on the analysis of experimental and clinical observations. A retrospective case-control study was performed. The study initially included 7680 pregnant women. All pregnant women underwent a general clinical, standard obstetric examination, ultrasound of the fetoplacental complex, bacterioscopic, bacteriological analysis of the contents of the vagina, ELISA of blood serum with the determination of infections of the TORCH complex, PCR diagnosis of mycoplasma, ureaplasma, chlamydial and other infections, fungi. At this stage, women with somatic pathology in the stage of subcompensation and decompensation, an extremely burdened obstetric and gynecological history, multiple pregnancy, bad habits (smoking, alcoholism, drug addiction), patients with a violation of the vaginal biocenosis, HIV-infected, positive for the virus were excluded from the study hepatitis B and C.

Upon further monitoring of pregnancy at 30 weeks, 1624 patients underwent fetoplacental complex ultrasound, Dopplerometry of vessels of the MPC and FPK, CTG, analysis of the variability of the heart rhythm of the mother and fetus, bacterioscopic, bacteriological analysis of the contents of the vagina, ELISA of blood serum with the determination of TORCH- infections complex, PCR diagnosis of mycoplasma, ureaplasma, chlamydial and other infections, fungi. At this stage, women with pre-eclampsia, isosensitization by ABO or Rh factor, severe anemia, violation of the vaginal biocenosis, presence of foci of chronic infection in the mother’s body (gestational pyelonephritis, bronchitis, pneumonia, skin infections, etc.) were excluded from the study at this stage, delivery in the period up to 37 weeks of pregnancy.

After the examination, all pregnant women (375 people) were divided into groups: the first group included women at risk of transplacental infection (clinical picture, detection of causative agents of transplacental infections by PCR or immunoglobulin titers of class M, G by ELISA) - 239 patients; the second group includes women who were not at risk of infection — 136 patients. Patients of the first group, depending on the clinical picture and examination results, were divided into three subgroups: 1A - 56 pregnant women with primary infection with transplacental infections during pregnancy; 1B - 98 pregnant women with exacerbation of chronic infections during pregnancy; 1B - 85 pregnant women with carriage of chronic infections without exacerbation of the process. Pregnant 1A and 1B groups were prescribed etiological treatment depending on the pathogen identified in accordance with the accepted protocols. Patients who refused treatment for any reason who underwent an incomplete course of therapy were the main group of the study.

After delivery, all patients underwent a study of the placenta. As a result, 187 women and their fruits were included in the main group, who were diagnosed with transplacental infections and, after histological examination of the placenta, showed morphological signs of hematogenous infection of the placenta.

The criteria for inclusion in the main group were: gestational age 37-41 weeks, the presence of transplacental infections, morphological signs of hematogenous lesions of the placenta. Exclusion criteria from the main group were: the presence of vaginal dysbiosis, chronic diseases of the internal organs in the stage of subcompensation and decompensation, an extremely burdened obstetric and gynecological history, complicated by severe preeclampsia during a real pregnancy, the presence of isosensitization by the ABO system and Rh factor, bad habits (smoking, addiction, alcoholism).

Thus, in the process of examination in the main group three subgroups were formed:

1A - with primary infection during pregnancy (n = 34);

1B - with exacerbation of chronic infections during pregnancy (n = 68);

1B - with carriage of chronic infections (n = 85).

The comparison group consisted of 136 pregnant women, in whom no transplacental infections were detected during pregnancy, and the vaginal normocenosis remained. Criteria for inclusion in the comparison group were: delivery term 37-41 weeks, absence of transplacental infections, vaginal normocenosis during pregnancy, absence of morphological signs of inflammation of the placenta. Exclusion criteria from the comparison group were: the presence of vaginal dysbiosis, chronic diseases of the internal organs in the stage of subcompensation and decompensation, an extremely burdened obstetric and gynecological history, severe obstetric complications during pregnancy, bad habits (smoking, drug addiction, alcoholism).

All patients underwent HRV analysis. In all types of clinical course of transplacental infection, placental insufficiency develops, adaptive disorders are represented by hypoadaptation (from 23.53 to 38.23%), the phenomenon of “functional rigidity” (from 11.77 to 38.24%), and “energy fold” (from 16.18 to 35.29%), an imbalance in the regulation of heart rate due to an autonomous or central regulation loop (from 47 to 60.29%), a decrease in the level of compensatory reactions in the recovery period (100%), and rigidity of heart rate variability (CV from 6.22 ± 2.1 to 7.1 ± 2.5%).

Based on the data obtained, prognostic models were developed for the development of adverse perinatal outcomes (severe asphyxia, IUI realization). To assess the relationship of risk factors for adverse perinatal outcomes during intrauterine infection, a logistic regression analysis was performed. The following factors were identified as independent factors in the regression analysis: the presence of energy-deficient states of the mother, energy-deficient states of the fetus, and the aggregate indicator of energy-deficient states of the mother and fetus.

As a result of the regression analysis, for each independent prognostic sign, the relative risk values with a 95% confidence interval (RR (95% CI)) were obtained. Each independent prognostic feature has been assigned a weight equal to its OR, and a point system has been developed to calculate the risk of adverse perinatal outcomes during intrauterine infection with energy-deficient conditions of the mother (Table 1), energy-deficient conditions of the fetus (Table 2), and a combined indicator of energy-deficient conditions of the mother and fetus (table 3).

For practical use of the scale, the boundary values of the total points were determined, dividing patients into groups of low, intermediate and high risk of adverse perinatal outcomes during intrauterine infection using ROC analysis (ROC - Receive Operative Curve). Tables 4, 5, 6 show the prognostic sensitivity and specificity of assessing new risk scales for the development of adverse perinatal outcomes in patients with intrauterine infection.

A sign with high specificity often gives a true result in the presence of a negative outcome (detects negative examples, i.e., adverse outcomes). A specific diagnostic test diagnoses authentic patients with a high risk of developing adverse perinatal outcomes during intrauterine infection with a specificity value of more than 50%. With a specificity index closer to 100%, the risk of an event is considered very high.

         Thus, obtained:

A) three risk groups for the development of adverse perinatal outcomes (NPI) in the presence of maternal energy-deficient conditions:

I - low risk group for the development of NPI: 0-2 points;

II - group of average risk of developing NPI: 3-5 points;

III - high-risk group for the development of NPI: 6-10 points.

B) three risk groups for the development of adverse perinatal outcomes in the presence of energy-deficient conditions of the fetus:

I - low risk group for the development of NPI: 0-2 points;

II - group of average risk of developing NPI: 3-5 points;

III - high-risk group for the development of NPI: 6-11 points.

C) two risk groups for the development of adverse perinatal outcomes in the presence of energy-deficient conditions in both the mother and the fetus:

I - low risk group for the development of NPI: 0-3 points;

II - high-risk group for the development of NPI: 4-9 points.

Further, in the course of the study, the efficiency of the models was tested on an independent sample of patients with intrauterine infection (n = 70).

The χ ² value ^{of the} obtained model for energy-deficient mother states was 51.956 with a confidence level of p <0.0001. The probability of a correct classification of the model was 78.33%.

The χ ² value ^{of the} obtained model for energy-deficient conditions of the fetus was 51.151 with a confidence level of p <0.0001. The probability of a correct classification of the model was 81.11%.

The χ ² value ^{of the} obtained model for energy-deficient states of the mother and fetus was 48.408 with a confidence level of p <0.0001. The probability of a correct classification of the model was 77.64%.

To visualize the prognostic efficiency of the new scales, characteristic curves are constructed with an estimate of the area under the ROC curve. For new prognostic scales, the area under the ROC curve was:

 A) with energy-deficient conditions of the mother - 0.763 (Figure 1);

             B) with energy-deficient conditions of the fetus - 0.768 (Figure 2);

             C) with a combination of energy-deficient states of the mother and fetus - 0.744 (Figure 3).

Based on the analysis of the data, it was concluded that the combined use of the HRV analysis parameters of the mother and the fetus and the dopplerometry of the umbilical artery can increase the correct classification coefficient to 77.64-81.11%, p <0.0001.

Example 1

Patient M., 21 years old, pre-pregnant, primiparous. Pregnancy out of wedlock. Somatic and obstetric-gynecological anamnesis are not burdened. From 12 weeks she was on the “D” pregnancy account. Pregnancy during anemia from 29 weeks (hemoglobin PO g / l), SARS at 31 weeks. At 32 weeks, CTG was diagnosed with antenatal distress of the fetus of moderate severity, by ultrasound - entanglement of the fetal neck with an umbilical cord. Weight gain for pregnancy 14 kg. Hospitalized in the maternity ward of the maternity hospital No. 1 MBUZ GKB No. 3 named after M.A. Podgorbunsky in order to prepare for childbirth due to fetal hypoxia.

The department conducted an examination: ultrasound - PMP 3200 g, pathology was not detected; CTG - 7-8 points according to Fisher.

Forecast?

According to the analysis of heart rate variability: the mother has an initial hypersensitive state with the correct ratio of spectrum components, during stress tests - the transition to an autonomous regulation circuit with a predominance of the parasympathetic component of regulation.

The fetus has the initial normo-adaptive state with the correct ratio of the spectrum components; when conducting stress tests in the mother, it has a pronounced hypo-adaptive reaction with post-load activation of the predominant sympathetic and parasympathetic components of the spectrum, which is regarded as the “energy fold” phenomenon.

A study according to the proposed method.

When using the developed mathematical model, the following data were obtained:

1. ∑ ₁ = 2 (CV = 3.2 - less than 5.4) + 3 (IR = 0.5 - less than 0.58) + 3 (CV = 7.6 - less than 7.8) + 0 (RR _min = 636 - more than 531) = 8 - high risk of adverse perinatal outcomes.

2. ∑ ₂ = 2 (CV = 3.2 - less than 5.4) + 3 (IR = 0.5 - less than 0.58) + 2 (CV = 7.6 - less than 0.78) + 0 (RR _min = 636 - over 531) = 7 - high risk of adverse perinatal outcomes.

3. ∑ ₃ = 3 (CV = 3.2 - less than 5.4) + 3 (CV = 7.6 - less than 7.8) + 3 (IR = 0.5 - less than 0.58) = 9 - high the risk of adverse perinatal outcomes based on the combined state of the mother and fetus.

Thus, on all three scales, the patient is assigned to a high risk group for adverse perinatal outcomes (IUI realization and severe asphyxiation).

Subsequent observation showed a lack of readiness of the birth canal for childbirth, as a result of which the cervix was prepared with kelp and 200 mg orally twice every 24 hours with mifepristone. Conducted induction in childbirth. In childbirth, primary discoordination of labor activity developed, which could not be managed by conservative methods. The patient is delivered by cesarean section. The duration of the first period is 6 hours, the anhydrous period is 8 hours.

A boy of 3660 g 55 cm long was removed for the operation with an Apgar score of 6/8 points. A placenta measuring 22 × 20 × 2 cm, weighing 685 g, and a placental-fetal index of 0.187. Histological conclusion: chronic subcompensated placental insufficiency. Focal deciduitis, interillusitis.

The postpartum period was complicated in the patient by exacerbation of genital herpes on the 2nd day of the postoperative period (localization of the eyelid, face).

In the child 45 minutes after birth, diagnosed with increasing respiratory failure, acrocyanosis, saturation with blood oxygen was 42%. In connection with the suspicion of intrauterine aspiration of amniotic fluid, intrauterine pneumonia, artificial ventilation of the lungs with the Servo-i apparatus has been started, and a comprehensive treatment has been prescribed. Extubated on the 3rd day. After 7 days, he was transferred to acute renal failure with a diagnosis of intrauterine infection (pneumonia, hepatitis, nonspecific enterocolitis).

Example 2. Patient P., 34 years old, re-pregnant, multiparous. Pregnancy in a registered marriage. Somatic history is not burdened. Obstetric and gynecological history is aggravated by the birth of the first child with IUI (intrauterine pneumonia, growth retardation), intranatal death of the second child. Pathologic diagnosis: intrauterine sepsis, antenatal bilateral total aspiration purulent pneumonia; intrapartum fetal hypoxia: plethora of internal organs, lack of glycogen in hepatocytes and cardiomyocytes; morphofunctional immaturity: foci of hematopoiesis in the liver. Pathology of the afterbirth: ascending infection of the III degree (parietal choriodeciditis, subchorial intravillusitis, vascular funiculitis). Secondary subcompensated chronic placental insufficiency, persistence of intermediate differentiated villi. A single tight cord entanglement around the neck of the fetus.

From 4-5 weeks she was registered at the dispensary for pregnancy. The course of pregnancy without complications. At 32 weeks, CTG was diagnosed with mild antenatal distress, and ultrasound - without pathology. Weight gain for pregnancy 10 kg. Hospitalized in the maternity ward of the maternity hospital No. 1 MBUZ GKB No. 3 named after M.A. Podgorbunsky in order to resolve the issue of the timing and method of delivery in connection with the burdened obstetric-gynecological history.

The department conducted an examination: ultrasound - PMP 3100 g, no pathology was detected; CTG - 7-8 points according to Fisher.

Forecast?

A study according to the proposed method.

According to the analysis of heart rate variability: at 35 weeks, the mother has an overactive state with the correct ratio of spectrum components, the correct reaction to stress tests, and a “satisfactory” level of compensatory reactions in the recovery period. The fetus has the initial normo-adaptive state with the correct ratio of the spectrum components; when conducting stress tests in the mother, there is a pronounced hyperactive reaction with restoration in the after-load period. The conclusion is made about the possibility of prolonging pregnancy under dynamic control.

A study was made of heart rate variability every 3 days. In the dynamics at 37 weeks, the mother registered an initial hypoadaptive state with the correct ratio of the components of the spectrum, during exercise tests - a hyperactive reaction, the transition to an autonomous regulation circuit with a predominance of the parasympathetic component of regulation.

The fetus has an initial hyperactive state with a predominance of the sympathetic component of the spectrum; when conducting stress tests in the mother, it has a hypoadaptive reaction with post-load activation of the predominant parasympathetic component of the spectrum.

When using the developed mathematical model, the following data were obtained:

1. ∑ ₁ = 0 (CV = 7.6 - more than 5.4) + 0 (IR = 0.68 - more than 0.58) + 3 (CV = 6.2 - less than 7.8) + 0 (RR _min = 696 - more than 531) = 3 - average risk of adverse perinatal outcomes.

2. ∑ ₂ = 0 (CV = 7.6 - more than 5.4) + 0 (IR = 0.68 - more than 0.58) + 2 (CV = 6.2 - less than 7.8) + 0 (RR _min = 696 - more than 531) = 2 - low risk of adverse perinatal outcomes.

3. ∑ ₃ = 0 (CV = 7.6 - more than 5.4) + 3 (CV = 6.2 - less than 7.8) + 0 (IR = 0.68 - more than 0.58) = 3 - low the risk of adverse perinatal outcomes based on the combined state of the mother and fetus.

Thus, the patient is assigned to the medium-risk group for the development of IUI and severe asphyxiation.

Further, taking into account the data obtained and the burdened obstetric-gynecological history, the patient was delivered by cesarean section on an emergency basis.

A girl weighing 3150 g, 51 cm long, with an Apgar score of 7/8 points, was removed for the operation. Placenta measuring 18 × 16 × 2 cm, weighing 480 g, placental-fetal index of 0.152. Histological conclusion: chronic subcompensated placental insufficiency. Focal deciduitis, interillusitis.

The postpartum period was uneventful. On the first day, the child had SDR, NEC of the 1st degree, subsequently was on a joint stay with his mother, was discharged home on the 7th day in satisfactory condition.

Example 3. Patient M., 24 years old, re-pregnant, multiparous. Pregnancy in a registered marriage. Somatic history is not burdened. Obstetric and gynecological history is not burdened.

From 6-7 weeks she was registered at the dispensary for pregnancy. The course of pregnancy without complications. The carrier of HSV, CMV without activation during pregnancy. At 34 weeks, CTG was diagnosed with mild antenatal distress, and ultrasound - without pathology. Weight gain for pregnancy 10 kg. Hospitalized in the maternity ward of the maternity hospital No. 1 MBUZ GKB No. 3 named after M.A. Podgorbunsky with a tendency to overshoot.

The department conducted a survey: ultrasound - PMP 3405 g, pathology was not detected; CTG - 7 points according to Fisher.

Forecast?

A study according to the proposed method.

According to the analysis of heart rate variability: at 39 weeks, the mother has an overactive state with the correct ratio of spectrum components, the correct reaction to stress tests, and a “satisfactory” level of compensatory reactions in the recovery period. The fetus has the initial normo-adaptive state with the correct ratio of the spectrum components; when conducting stress tests in the mother, there is a pronounced hyperactive reaction with restoration in the after-load period. The conclusion about the possibility of independent birth is given.

When using the developed mathematical model, the following data were obtained:

1. ∑ ₁ = 2 (CV = 5.3 - less than 5.4) + 0 (IR = 0.68 - more than 0.58) + 0 (CV = 8.2 - more than 7.8) + 0 (RR _min = 682 - more than 531) = 2 - low risk of adverse perinatal outcomes.

2. ∑ ₂ = 2 (CV = 5.3 - less than 5.4) + 0 (IR = 0.68 - more than 0.58) + 0 (CV = 8.2 - more than 7.8) + 0 (RR _min = 682 - more than 531) = 2 - low risk of adverse perinatal outcomes.

3. ∑ ₃ = 2 (CV = 5.3 - less than 5.4) + 0 (CV = 8.2 - more than 7.8) + 0 (IR = 0.68 - more than 0.58) = 2 - low the risk of adverse perinatal outcomes based on the combined state of the mother and fetus.

Thus, the patient is assigned to the low-risk group for the development of IUI and severe asphyxiation.

Independently developed labor at 41 weeks of gestation. The course of labor without complications. A girl was born weighing 3350 g, 52 cm long, with an Apgar score of 8/8 points. A placenta measuring 19 × 18 × 2.5 cm, weighing 520 g, placental-fetal index of 0.155. Histological conclusion: chronic subcompensated placental insufficiency.

The postpartum and neonatal periods were uneventful. The child was on a joint stay with his mother, was discharged home for 4 days in satisfactory condition.

Thus, the proposed method makes it possible to predict with a high degree of probability the severity of the expected perinatal complications during intrauterine infection and plan in the most optimal time the most appropriate combination of treatment and prophylactic measures to reduce complications in the mother and child.

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Applications

Table 1.

Independent prognostic factors for the development of adverse perinatal outcomes during intrauterine infection with maternal energy-deficient conditions

Table 2.

Independent prognostic factors for the development of adverse perinatal outcomes during intrauterine infection with energy-deficient conditions of the fetus

Table 3.

Independent prognostic factors for the development of adverse perinatal outcomes during intrauterine infection with energy-deficient conditions of the mother and fetus

Table 4.

Prognostic sensitivity and specificity for a new scale in relation to the development of adverse perinatal outcomes in patients with intrauterine infection and energy-deficient conditions

Table 5.

Prognostic sensitivity and specificity for a new scale in relation to the development of adverse perinatal outcomes for patients with intrauterine infection and energy-deficient conditions of the fetus

Table 6.

Prognostic sensitivity and specificity for a new scale in relation to the development of adverse perinatal outcomes for patients with intrauterine infection and energy-deficient conditions of the mother and fetus

Fig 1. The characteristic ROC-curve of the new model in the energy-deficient state of the mother

Fig 2. The characteristic ROC-curve of the new model with energy-deficient condition of the fetus

Figure 3. The characteristic ROC-curve of the new model in the energy-deficient state of the mother and fetus

Table 1 Prognostic sign OR 95% CI Score for scale The coefficient of variation of the full array of fetal cardiac intervals in the initial state CV≤5.4 2,4751 1.3953 to 4.3905 2 Umbilical artery resistance index ≤0.58 2,9300 1.6425 to 5.2270 3 The coefficient of variation of the full array of maternal cardiointervals in the initial state CV≤7.8 2,8338 1.5803 to 5.0818 3 Interval RR _{min of the} mother during the recovery period after the mental test ≤531 s 2,3418 1.3148 to 4.1709 2

table 2 Prognostic sign OR 95% CI Score for scale The coefficient of variation of the full array of fetal cardiac intervals in the initial state CV≤5.4 2,4666 1.3579 to 4.4806 2 Umbilical artery resistance index ≤0.58 3,2892 1.8036 to 5.9983 3 The coefficient of variation of the full array of maternal cardiointervals in the initial state CV≤7.8 2,3414 1.2440 to 4.4069 2 Interval RR _{min of the} mother during the recovery period after the mental test ≤531 s 3.8410 2.0487 to 7.2013 four

Table 3 Prognostic sign OR 95% CI Score for scale The coefficient of variation of the full array of maternal cardiointervals in the initial state CV≤7.8 3.2330 1.8299 to 5.7120 3 The coefficient of variation of the full array of fetal cardiac intervals in the initial state CV≤5.4 2.8835 1.6486 to 5.0435 3 Umbilical artery resistance index ≤0.58 3,0090 1.7080 to 5.3012 3

Table 4 Total points Sensitivity 95% CI Specificity 95% CI ≥0 100.00 95.0-100.0 0.00 0,0-5,0 > 0 97.22 90.3-99.7 22.22 13.3-33.6 > 2 90.28 81.0-96.0 50.00 38.0-62.0 > 3 81.94 71.1-90.0 70.83 58.9-81.0 > 4 77.78 66.4-86.7 75.00 63,4-84,5 > 5 52.78 40.7-64.7 87.50 77.6-94.1 > 6 50.00 38.0-62.0 91.67 82.7-96.9 > 7 33.33 22.7-45.4 94.44 86.4-98.5 > 8 12.5 5.9-22.4 100.00 95.0-100.0 > 10 0.00 0,0-5,0 100.00 95.0-100.0

Table 5 Total points Sensitivity 95% CI Specificity 95% CI ≥0 100.00 94.5-100.0 0.00 0,0-5,0 > 0 98.46 91.7-100.0 22.22 13.3-33.6 > 2 92.31 83.0-97.5 50.00 38.0-62.0 > 3 90.77 81.0-96.5 70.83 58.9-81.0 > 4 81.54 70.0-90.1 75.00 63,4-84,5 > 5 72.31 59.8-82.7 87.50 77.6-94.1 > 6 58.46 45.6-70.6 91.67 82.7-96.9 > 7 44.62 32.3-57.5 94.44 86.4-98.5 > 11 0.00 0,0-5,5 100.00 95.0-100.0

Table 6 Total points Sensitivity 95% CI Specificity 95% CI ≥0 100.00 95.3-100.0 0.00 0,0-4,7 > 0 94.81 87.2-98.6 41.56 30.4-53.4 > 3 66.23 54.6-76.6 93.51 85.5-97.9 > 6 19.48 11.3-30.1 100.00 95.3-100.0 > 9 0.00 0,0-4,7 100.00 95.3-100.0

Claims (1)

A method for predicting the risk of adverse perinatal outcomes during intrauterine infection by analyzing the heart rate variability of the mother and the fetus, characterized in that they determine the coefficient of variation of the full array of fetal cardiac intervals in the initial state CV P I, the index of resistance of the artery of the umbilical cord IR, the coefficient of variation of the full array of cardiac intervals mothers in the initial state CV M, the interval RR _min mother during the recovery period after the mental test RR _min M III and then calculate ывают ₁ , ∑ ₂ , ∑ ₃ are melted according to the formulas:
∑ ₁ = 2 (with CV of the fetus in the initial state less than 5.4) +3 (with IR less than 0.58) +3 (with CV of the mother in initial state less than 7.8) +2 (with RR _{min of the} mother in initial state less than 531);
∑ ₂ = 2 (with CV P I less than 5.4) +3 (with IR more than 0.58) +2 (with CV M I less than 0.78) +4 (with RR _min MI less than 531);
∑ ₃ = 3 (with CV P I less than 5.4) +3 (with CV M I less than 7.8) +3 (with IR more than 0.58) and
values ∑ ₁ from 0 to 2 indicate low risk; from 3 to 5 points - average; from 6 to 10 points - high risk;
values ∑ ₂ from 0 to 2 indicate low; from 3 to 5 points - average; from 6 to 11 points - high risk;
values ∑ ₃ from 0 to 3 indicate a low risk, from 4 to 9 points - a high risk of adverse perinatal outcomes;
based on the risks obtained, three indicators:: ₁ , ∑ ₂ , ∑ ₃ determine the degree of risk of adverse perinatal outcomes during intrauterine infection.

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