Gestational diabetes mellitus: clinical guidelines

List of Abbreviations

HAPO — Hyperglycemia and Adverse Pregnancy Outcomes

BP — blood pressure

GHT — gestational hypertension

GI — glycemic index

GDM — gestational diabetes mellitus

DF — diabetic fetopathy

BMI – body mass index

Insulin medicinal products — medicinal products of the ATC group A10A Insulins and analogues

HDL — high-density lipoproteins

ICD-10 — International Statistical Classification of Diseases and Related Health Problems, Tenth Revision

CGM - continuous glucose monitoring

OGTT - oral glucose tolerance test

DM - diabetes mellitus

TG - triglycerides

Ultrasound — ultrasound examination

CAH - chronic arterial hypertension

HbA1c - glycated hemoglobin

Terms and Definitions

Insulin analogues - a form of insulin (ATC code A10A Insulins and analogues) featuring specific modifications to the human insulin molecule. An analogue acts similarly to insulin, but with pharmacokinetic/pharmacodynamic differences that may provide clinical advantages.

Basal (long-acting) insulin - intermediate-acting insulin (NPH insulin; ATC code A10AC Intermediate-acting insulins and analogues for injection), long-acting, or ultra-long-acting insulin (ATC code A10AE Long-acting insulins and analogues for injection)

Insulin boluses - administration of short-acting (ultra-short-acting, rapid-acting) insulin (ATC code A10AB: Short-acting insulins and analogues for injection) required to maintain target glycemia postprandially and to correct hyperglycemia

Gestational (pregnancy-induced) arterial hypertension (GAH) - elevation of blood pressure first recorded after 20 weeks of gestation and not accompanied by significant proteinuria (<0.3 g/L)

Glycemia - blood glucose concentration

Glycated hemoglobin (HbA1c) - a marker that reflects the average blood glucose level over the preceding 2-3 months

Fasting plasma glucose (blood glucose in the morning before breakfast after a preliminary fast of >8 hours). It primarily characterizes basal glucose production.

Diabetic fetopathy - a general term for disorders in fetuses and newborns whose mothers suffered from diabetes mellitus, developing from the 84th day of intrauterine life (from the 12th week of gestation) until the onset of labor, characterized by polysystemic involvement, metabolic, and endocrine dysfunctions.

Insulin - a hormone physiologically secreted by the pancreatic beta cells, which regulates blood glucose levels by stimulating glucose uptake in tissues.

Insulin resistance - an impaired metabolic response to endogenous or exogenous insulin.

Short-acting (ultra-short-acting) insulin - a medicinal product form of insulin (ATC code A10AB Short-acting insulins and analogues for injection)

Macrosomia - macrosomia is defined as the birth of an infant weighing more than 4000 g at term pregnancy or >90th percentile on fetal growth charts for gestational age.

Continuous glucose monitoring - continuous measurement of glucose levels in the interstitial fluid using subcutaneously implanted sensors, followed by conversion to plasma glucose values

Oral antidiabetic drugs - ATC code A10B: Blood glucose lowering drugs, excluding insulins

Postprandial glycemia (from Latin *prandium* - "meal, food" and *post* - "after") - blood glucose 1-2 hours after the start of a meal

Preprandial glycemia - blood glucose 3 hours after a main meal and before the next meal

Preeclampsia - a complication of pregnancy, childbirth, and the postpartum period characterized by an increase after the 20th week of gestation in systolic blood pressure (SBP) >140 mm Hg and/or diastolic blood pressure (DBP) >90 mm Hg, regardless of the baseline blood pressure history, combined with proteinuria or at least one other parameter indicating the onset of multi-organ dysfunction.

Self-monitoring of blood glucose - independent determination of blood glucose by patients at home using a glucometer or a continuous glucose monitoring device

Chronic arterial hypertension - a condition characterized by an elevation in systolic blood pressure (SBP) >140 mm Hg and/or diastolic blood pressure (DBP) >90 mm Hg, defined as the average of at least 2 measurements taken on the same arm with a 15-minute interval.

1. Brief information on the disease or condition

1.1 Definition of the disease or condition

Gestational diabetes mellitus (GDM) is a condition characterized by hyperglycemia first detected during pregnancy, but not meeting the criteria for "manifest" diabetes mellitus (DM).

1.2 Etiology and pathogenesis of the disease or condition (group of diseases or conditions)

During pregnancy, insulin resistance increases day by day, which is the main cause of the development of GDM. The primary role in this process is played by fetoplacental hormones (placental lactogen and progesterone) and maternal hormones (cortisol, estrogens, prolactin), the concentration of which in the blood also increases as the pregnancy progresses. This process is compensated by increased production and decreased clearance of maternal endogenous insulin. Insulin resistance is exacerbated by an increase in the caloric intake of the mother's diet, decreased physical activity, and weight gain. With a genetic predisposition to type 2 DM and obesity, insulin secretion becomes insufficient to overcome insulin resistance, leading to hyperglycemia. Considering the strong pathogenetic similarity between GDM and type 2 DM, there is every reason to consider GDM as a typical multifactorial disease in the development of which numerous genetic and epigenetic factors take part.

The results of the multicenter HAPO (Hyperglycemia and Adverse Pregnancy Outcomes) study demonstrated a correlation between maternal glycemic levels and adverse pregnancy outcomes for both the mother and the fetus [1]. Maternal hyperglycemia leads to the development of diabetic fetopathy. Pregnant women with GDM are more likely than women without carbohydrate metabolism disorders to develop preeclampsia and eclampsia, which frequently necessitates emergency delivery via Cesarean section. Other studies have shown a higher lifetime risk of obesity and the development of type 2 DM in offspring in adulthood, regardless of risks associated with obesity and genetic predisposition [2, 3].

The HAPO study, conducted in 2000–2006, showed that the WHO criteria used at the time, adopted in 1999 for the diagnosis of GDM, required revision [4, 5]. Thus, among the observed women, adverse pregnancy outcomes increased in direct proportion, starting from a significantly lower glycemic level than the threshold considered as the GDM criterion at that time. In 2008 in Pasadena (USA), the International Association of Diabetes and Pregnancy Study Groups (IADPSG) proposed new diagnostic criteria for GDM for discussion, based on the results of the HAPO study [6]. During 2010–2011, a number of developed countries (USA, Japan, Germany, Israel, etc.) independently adopted these new criteria. In 2012, based on the consensus opinion of experts from the Russian Association of Endocrinologists and the Russian Association of Obstetricians and Gynecologists, the Russian national consensus "Gestational diabetes mellitus: diagnosis, treatment, postpartum follow-up" was adopted [7]. In 2013, the WHO also revised and adopted new GDM diagnostic criteria based on the HAPO study results [8].

1.3 Epidemiology of the Disease or Condition

According to the International Diabetes Federation Atlas, in 2019 the prevalence of hyperglycemia in pregnancy was approximately 15.8%, of which 83.6% of cases were associated with GDM [9].

1.4 Features of Coding the Disease or Condition

O24.0 – Pre-existing type 1 diabetes mellitus

O24.1 – Pre-existing type 2 diabetes mellitus

O24.3 – Pre-existing diabetes mellitus, unspecified

O24.4 – Diabetes mellitus arising in pregnancy

O24.9 – Diabetes mellitus in pregnancy, unspecified

1.5 Classification of the disease or condition

Classification of GDM depending on the time of onset [10, 11]:

- Early GDM - developed before 24 weeks of gestation

- Late GDM - developed after 24 weeks of gestation

1.6 Clinical presentation of the disease or condition

In most cases, GDM does not present with clinical features typical of the onset of DM, or symptoms of hyperglycemia may be regarded as manifestations of pregnancy, such as frequent urination, weakness, fatigue, and memory impairment.

2. Diagnostics, medical indications and contraindications for diagnostic methods

Criteria for establishing the diagnosis/condition:

- A fasting venous plasma glucose of ≥5.1 mmol/L establishes the diagnosis of GDM.

- A fasting venous plasma glucose of ≥7.0 mmol/L or ≥11.1 mmol/L at 2 hours post-load diagnoses manifest diabetes mellitus.

The diagnosis of DM is established when the HbA1c level is greater than or equal to 6.5%. According to World Health Organization recommendations, an HbA1c level of 6.0–6.4% (42–47 mmol/mol) alone does not allow establishing any diagnoses, but does not exclude the possibility of diagnosing DM based on blood glucose levels.

If symptoms of acute metabolic decompensation are absent, the diagnosis must be established based on two values falling within the diabetic range.

In rapidly developing DM, the HbA1c level may not be significantly elevated despite the presence of classic DM symptoms.

Threshold values of venous plasma glucose and glycated hemoglobin for diagnosing overt (newly diagnosed) DM during pregnancy.

Comments: the diagnosis of GDM can be made based on a single glycemia determination. This GDM diagnostic criterion applies to the entire gestation period. The diagnosis of GDM is established when fasting venous plasma glucose ≥5.1 mmol/L is detected at any gestational age, including after an OGTT which showed no carbohydrate metabolism disorders. The increase in insulin resistance may be associated with excessive weight gain, the need for strict bed rest, and limited physical activity.

Comments: A systematic review of cohort studies showed that women with hyperglycemia detected during pregnancy have a high risk of adverse obstetric and perinatal outcomes. Treatment of GDM reduces the rate of adverse pregnancy outcomes: birth weight greater than 4000 g or greater than the 90th percentile for gestational age, shoulder dystocia, and preeclampsia / hypertensive pregnancy complications [16, 17].

2.1 Complaints and Anamnesis

• When taking the medical history, it is necessary to actively identify complaints that may be associated with hyperglycemia, clarify data on family history of type 2 DM, presence of GDM in previous pregnancies (time of detection and therapy received), children's birth weights, fetal malformations, polyhydramnios in previous pregnancies, presence of PCOS, arterial hypertension, dyslipidemia. Pregnancy is an independent risk factor for hyperglycemia due to physiological changes occurring in a woman's body; therefore, it is necessary to actively screen for this carbohydrate metabolism disorder in all pregnant women, regardless of the presence/absence of complaints or risk factors [18, 19].

GRC CLEL 4Grade of Recommendation C (Level of Evidence – 4)

2.2 Physical Examination

There are no specific signs of GDM that can be identified on physical examination. General propaedeutic principles of patient examination must be followed, including pre-pregnancy BMI calculation and weight dynamics during pregnancy. Patients undergo:

- height measurement;

- body weight measurement;

- blood pressure measurement;

- assessment of fetal dimensions (fetal palpation, abdominal circumference measurement, uterine fundal height) (see the clinical guidelines "Normal Pregnancy").

2.3 Laboratory Diagnostics

Comments: Glucose is measured exclusively in venous plasma. Determination of glucose in blood serum or whole capillary blood is not permitted. Venous plasma glucose is measured strictly in a laboratory using biochemical analyzers or glucose analyzers after preliminary fasting for at least 8 hours and no more than 14 hours.

The use of personal glucometers for blood glucose testing is prohibited.

• In case of a pregnant woman's first visit after the 24th week, fasting blood (venous plasma) glucose testing is also recommended prior to further investigations for GDM screening [6, 8, 10].

GDR CLE 5Grade of recommendation C (level of evidence – 5)

Comments: Risk factors for overt diabetes mellitus during pregnancy are presented in Appendix G-1.

• In the presence of two or more risk factors for type 1 DM, it is recommended to determine the blood levels of antibodies to pancreatic islet cell antigens (GADA, ICA, IAA, IA-2A, Zn-T8A) to rule out overt diabetes mellitus. In case of a pregnant woman's first visit after the 24th week, diagnostics for overt diabetes mellitus can also be performed at later stages of gestation [25-29].

LeveL of Recommendation BGrade of Evidence 3LeveL of Recommendation B (Grade of Evidence - 3)

Comments: the diagnosis of overt diabetes mellitus must be confirmed by a repeat test of blood (venous plasma) glucose levels on an empty stomach or at any time of day regardless of food intake on subsequent days, or by blood glycated hemoglobin (HbA1c) testing, except in cases of unequivocal hyperglycemia with acute metabolic decompensation or obvious symptoms. HbA1c (glycated hemoglobin) must be confirmed either by fasting venous plasma glucose levels, or by venous plasma glucose levels determined at any time of day regardless of food intake, or during an OGTT.

In the presence of a clinical picture of carbohydrate metabolism disorders, blood (venous plasma) glucose testing at any time of day regardless of food intake is required to rule out overt DM.

In the presence of hyperglycemia symptoms, a single determination in the diabetic range (glycemia or HbA1c) is sufficient to establish a diagnosis of DM.

Blood HbA1c testing must be performed using a method certified in accordance with the National Glycohemoglobin Standardization Program (NGSP) and standardized according to the reference values adopted in the DCCT (Diabetes Control and Complications Study). An HbA1c level up to 6.0% (42 mmol/mol) is considered normal.

Comments: The recommended optimal period for performing an OGTT is 24-28 weeks, but it can be performed up to 32 weeks of gestation (high risk of GDM, fetal dimensions according to ultrasound tables >75th percentile, ultrasound signs of diabetic fetopathy, disproportionate fetal dimensions), but no later. If signs of fetal macrosomia are detected on fetal ultrasound (fetal dimensions according to ultrasound tables >90th percentile) at 32 weeks and later, blood glucose testing (fasting venous plasma glucose determination) is required.

The OGTT is a safe diagnostic loading test. During pregnancy, blood (venous plasma) glucose levels are measured during the OGTT: fasting, 1 hour, and 2 hours after the load.

Contraindications to performing an OGTT:

- GDM / overt diabetes mellitus diagnosed before 24 weeks of gestation

- Malabsorption syndrome (gastric resection syndrome, bariatric surgery, dumping syndrome)

- Vomiting, nausea

- Acute inflammatory or infectious disease

- Exacerbation of gastrointestinal diseases

- Strict hospital bed rest due to obstetric complications (threatened abortion, cervical cerclage, infusions of beta-2 agonists (R03AA: Alpha- and beta-adrenoreceptor agonists), prevention of neonatal respiratory distress syndrome).

In this cohort, the OGTT can be performed, if necessary, after resumption of physical activity and discontinuation of hyperglycemic drugs. After discontinuation of glucocorticoids, the OGTT can be performed after 3 days.

In pregnant women with a history of bariatric surgery, GDM is diagnosed based on fasting blood (venous plasma) glucose levels. This category of pregnant women should be considered at maximum risk for developing GDM; therefore, from the very beginning of pregnancy, these patients should be advised to follow dietary recommendations for GDM, and starting from the 24th week of pregnancy, to perform self-monitoring of glycemia using a glucometer [34].

The interpretation of OGTT results is carried out by an obstetrician-gynecologist, general practitioner/family physician, or endocrinologist.

Rules for performing the oral glucose tolerance test (OGTT)

The test is performed against the background of a normal diet (at least 150 g of carbohydrates per day) for at least 3 days preceding the test. The test is performed in the morning on an empty stomach after an 8-hour overnight fast. The last meal must contain 30–50 g of carbohydrates. Drinking water is not restricted. During the test, the patient must remain seated. Smoking is prohibited until the test is completed. Medications that affect blood glucose levels (multivitamins (ATC classification A11BA) and iron preparations (ATC classification B03A) containing carbohydrates, glucocorticoids (ATC classification S01BA), β-blockers (ATC classification C07), β-agonists (R03AA: Alpha- and beta-adrenoreceptor agonists), etc.) should, whenever possible, be taken after the test is completed.

Stages of OGTT execution:

· Stage 1: Collection of the first fasting venous plasma blood sample.

· Stage 2: Within 5 minutes, drink a dextrose solution consisting of 75 grams of dry (anhydrous) dextrose dissolved in 250–300 ml of warm (37–40^oC) non-carbonated drinking (or distilled) water. When using dextrose with the active substance dextrose monohydrate, 82.5 g of the substance is required for the test. The start of drinking the dextrose solution is considered the start of the test.

· Stage 3: Subsequent blood samples for determining blood (venous plasma) glucose levels are taken 1 and 2 hours after the glucose load.

The determination of blood glucose (venous plasma) levels is performed exclusively in a laboratory using biochemical analyzers or glucose analyzers. Blood is collected into a chilled vacuum tube containing sodium fluoride preservatives (6 mg per 1 ml of whole blood) as an enolase inhibitor to prevent spontaneous glycolysis, and EDTA or sodium citrate as anticoagulants. The tube is placed on ice. Then, immediately (no later than the next 30 minutes), the blood is centrifuged to separate plasma and cellular elements. The plasma is transferred to a secondary tube. The determination of the glucose level is performed in this biological fluid (venous plasma).

Threshold values of venous plasma glucose for diagnosing GDM based on OGTT results:

If it is the pregnant woman's first visit after 24 weeks, a fasting venous plasma glucose test must be performed before the OGTT. If the fasting venous plasma glucose level is <5.1 mmol/L, an OGTT must be performed.

At 32 weeks of gestation and later, the OGTT is not performed; only a fasting venous plasma glucose test is required.

2.4 Instrumental Diagnostics

There are no instrumental diagnostics for GDM; see also the clinical guidelines "Normal Pregnancy".

2.5 Other Procedures

• In the presence of complaints, risk factors for type 2 diabetes mellitus, and test results corresponding to the category of overt (newly diagnosed) diabetes mellitus, it is recommended to refer the pregnant woman to an endocrinologist, who decides on the diagnostics of diabetes mellitus (see also the relevant clinical guidelines) [35, 36].

GCR CLEL 5Grade of Recommendation C (Level of Evidence - 5)

Comments: If an OGTT is performed for the purpose of diagnosing type 2 diabetes mellitus, the test results are interpreted according to the norms for the general population [8, 30]. Further monitoring and treatment of the pregnant woman are carried out as for pregestational diabetes mellitus, with mandatory reclassification of the diagnosis after delivery. According to a number of studies, 40% of women diagnosed with overt diabetes mellitus during pregnancy showed impaired glucose tolerance or normoglycemia after delivery, which should be interpreted as prediabetes and type 2 diabetes mellitus remission, respectively.

3. Treatment, including drug and non-drug therapies, diet therapy, and pain management

3.1 Conservative Treatment

Comments: dietotherapy excluding carbohydrates with a high glycemic index (GI), easily digestible carbohydrates, trans fats, with a daily carbohydrate intake of 175 g or at least 40% of the calculated daily caloric intake, under the control of glycemia and ketone bodies in the urine, for all pregnant women with GDM to adequately meet the needs of the mother and fetus and prevent obstetric and perinatal complications [40, 41]. Carbohydrate-containing foods are distributed throughout the day into 3 main meals and 2-3 snacks. Each meal must contain slowly digestible carbohydrates, protein, mono- and polyunsaturated fats, and dietary fiber. The daily amount of dietary fiber should be at least 28 grams in total from fiber, permitted vegetables, fruits, leafy salads, cereals, and bran. In pregnant women with obesity, it is recommended to limit saturated fats to 10% of daily fat intake. Calorie restriction is recommended for pregnant women with pre-pregnancy obesity based on BMI and with pathological weight gain during pregnancy, but no less than 1800 kcal per day to prevent ketonuria.

Distribution of carbohydrate content throughout the day: breakfast 15-30 g, second breakfast 15-30 g, lunch 30-60 g, afternoon snack 15-45 g, dinner 30-60 g, second dinner 10-15 g - on average 150-175 g of carbohydrates per day. The interval between meals is 2.5 - 3 hours, and between the last meal and the first meal the next day - no more than 10 hours. The consumption of easily digestible carbohydrates and carbohydrates with a high glycemic index is completely excluded. To prevent ketonuria or ketonemia, it is recommended to introduce an additional carbohydrate snack (~12-15 g) before bedtime or at night [42] (Appendix - B)

If hyperglycemia persists after breakfast, it may be recommended to have a protein-fat breakfast with the exclusion or minimal content of complex (or difficult-to-digest) carbohydrates.

As a sugar substitute, those approved during pregnancy may be used - sucralose, stevia.

Types of physical activity, volume, load, contraindications, and activity restrictions are specified in Appendix G-5. Dosaged aerobic physical activity for at least 20-50 minutes twice a week improves glycemic parameters and reduces insulin doses. The intensity of classes should be at least moderate [43, 44].

3.2. Glucose level monitoring

Comments: Self-monitoring is performed by the patient and includes determining glycemia using portable devices (glucometers) calibrated to plasma. If the patient is on dietotherapy alone, self-monitoring of glycemia is performed daily in the morning on an empty stomach and 1 hour after the start of main meals [46]. If insulin therapy is prescribed in addition to dietotherapy, self-monitoring of glycemia is performed daily from 4 to 8 times a day according to the prescribing physician's instructions: in the morning on an empty stomach, before main meals (to calculate the dose of prandial insulin (A10AB: Short-acting insulins and analogues for injection) for a meal and correction of hyperglycemia), 1 hour after the start of main meals, in the evening before bedtime, at 03:00, and in case of poor well-being [47, 50-52].

Additional glycemic control 2 hours after a meal is advisable in the following cases: gastropathy, meals with a high fat and protein content, use of short-acting insulin (ATX classification A10AB short-acting insulins and their analogues for injection); presence of signs of macrosomia with normal fasting blood glucose and 1 hour after a meal, morbid obesity. The target blood glucose level 2 hours after a meal is less than 6.7 mmol/L.

Personal blood glucose meters must comply with GOST R ISO 15197-2015 (ISO 2013) regarding analytical and clinical accuracy [53]. At a plasma glucose level <5.6 mmol/L, 95% of measurements must deviate from the reference analyzer by no more than ±0.8 mmol/L; at a plasma glucose level >5.6 mmol/L, 95% of measurements must deviate from the reference analyzer by no more than ±15%.

Target indicators for self-monitoring of glycemia

• For timely detection of ketonuria and dietary correction, monitoring of ketone bodies in the urine is recommended to prevent the development of ketoacidosis [10].

LoR CGoE 3Level of Recommendation C (Level of Evidence - 3)

Comments: Determination of ketone bodies in the urine using visual test strips (detection of ketone bodies in the urine by rapid test) or laboratory methods (detection of ketone bodies in the urine) should be performed in case of insufficient caloric intake according to pregnancy management guidelines. False-positive results for ketonuria on test strips may be associated with the intake of multivitamins containing riboflavin, ascorbic acid**, fluid restriction, and urinary tract infections. With adequate caloric intake and a fasting period < 10 hours, it is advisable to detect ketone bodies in the urine in a laboratory.

• All pregnant women with GDM are recommended to keep a self-monitoring diary, recording capillary blood glucose levels, dietary details, and the time and type of physical activity for an adequate and timely assessment of GDM treatment efficacy [54].

GCR CLEL 4Grade of Recommendation C (Level of Evidence - 4)

3.3 Insulin therapy

Comments: when prescribing insulin therapy, it is necessary to train the pregnant woman in the technique of insulin drug injections. Further studies are required to determine the optimal injection technique in pregnant women. The currently most acceptable recommendations are presented in Appendix G-2.

It is possible to use insulin medicinal products approved for use during pregnancy.

When prescribing insulin therapy, the pregnant woman must be referred to an endocrinologist/general practitioner/family physician. The insulin regimen and the type of insulin product are selected individually. The dose varies among individuals due to varying degrees of obesity, ethnic characteristics, degree of hyperglycemia, and other demographic criteria.

• Since insulin resistance varies in degree among all pregnant women, insulin requirements also differ; therefore, it is recommended to select insulin product doses individually. It is common practice to initiate insulin therapy with small doses followed by titration until target glycemic goals are achieved [57, 58].

LoR CGoE 5Level of Recommendation C (Grade of Evidence - 5)

Comments: When the acceptable whole capillary blood glucose level is exceeded 1 hour after the start of a meal — initiate bolus insulin therapy (A10AB: Short-acting insulins and their analogues for injection). Starting dose of ultra-short-acting/short-acting insulin product: 6 IU before the meal associated with elevated capillary blood glucose, administered 15-20/20-30 minutes before a meal accompanied by postprandial hyperglycemia. Dose titration is performed every 3-4 days with an increase of 1-2 IU until the target postprandial glycemia value is reached. Taking into account insulin resistance in the second half of pregnancy, administration of ultra-short-acting insulin 20-30 minutes before a meal, or short-acting insulin 40-60 minutes before a meal, is possible [59].

In case of elevated fasting glycemia — initiate basal insulin therapy (ATC classification A10AC intermediate-acting insulins and their analogues for injection). The starting dose of the basal insulin product (ATC classification A10AC intermediate-acting insulins and their analogues for injection) is 0.1 IU/kg body weight (0.16–0.2 IU/kg for overweight/obesity before pregnancy), administered once at bedtime at 22.00–24.00. Dose titration is performed every 3 days with an increase of 2 IU until the target fasting glycemia value is reached [59].

When overt diabetes mellitus is detected — initiate basal-bolus insulin therapy. The starting daily dose of insulin product is 0.4 IU/kg of body weight (0.5 IU/kg for overweight/obesity), distributed 50% into basal and bolus insulins (ATC classification A10A insulins and their analogues). Such patients are managed similarly to women with pregestational diabetes mellitus. Initiate basal-bolus insulin therapy with a starting basal insulin dose of at least 0.1 IU/kg body weight. Titrate insulin doses every 2-3 days until target glycemic goals are reached [59].

Basal insulin product (ATC classification A10AC intermediate-acting insulins and their analogues for injection) is administered once at bedtime at 22.00-24.00.

Bolus insulin product (A10AB: Short-acting insulins and their analogues for injection) is divided into 3 injections given 15-20 minutes before main meals in proportions: 40% before breakfast and 30% before each lunch and dinner. Dose titration is performed under glycemic control every 3 days using the algorithms presented above [55].

If GDM is diagnosed and insulin therapy is prescribed, inpatient hospitalization is not required in the absence of obstetric complications.

Comments: with additional glycemic control 2 hours after the start of a meal, the target level is less than 6.7 mmol/L.

Comments: if biguanides (metformin**) were prescribed before pregnancy, the drug must be discontinued upon detection of pregnancy. Taking metformin** in early pregnancy is not an indication for termination of pregnancy.

3.4 Follow-up

Comments: Fetal ultrasound in GDM should include:

- Standard fetometry, percentile evaluation of fetometric parameters and fetal weight.

- Doppler assessment of fetoplacental blood flow (pulsatility index in the umbilical artery, middle cerebral artery, uterine arteries, calculation of the cerebroplacental ratio (CPR)) with percentile evaluation, and fetal venous hemodynamics assessment if necessary.

- Detection of phenotypic and visceral signs of diabetic fetopathy.

- Evaluation of parafetal structures: placental thickness, amniotic fluid volume.

Diagnosis of diabetic fetopathy is based on [71, 72]:

1. Detection of asymmetric macrosomia

Comments: two types of macrosomia are distinguished:

- symmetric macrosomia type: constitutional, genetically determined, is not determined by maternal glycemia levels and is characterized by a proportional increase in all fetometric parameters.

- symmetric macrosomia type is observed in diabetic fetopathy. There is an increase in abdominal circumference above the 90th percentile for the given gestational age with normal head size and femur length values.

2. Detection of ultrasound phenotypic signs of diabetic fetopathy:

- thickness of the subcutaneous adipose tissue of the chest and abdomen > 0.5 cm.

- double contour of the fetal head

- increase in the buccal index greater than 0.9

- thickness of the subcutaneous adipose tissue of the neck > 0.32 cm

Comments: these signs are not stratified or standardized by gestational age and therefore may be nonspecific. Individual signs (double contour of the head) may occur in syndromic pathology, fetal hydrops, metabolic disorders, and also in the physiological course of pregnancy at the end of the 3rd trimester. In this regard, it is important to perform a comprehensive clinical and laboratory assessment of the obstetric situation and differential diagnosis of various fetal diseases.

3. Detection of visceral signs of diabetic fetopathy

- hepatomegaly

- cardiomegaly (increase in the cardiothoracic index greater than 50%)

Comments: Russian studies have demonstrated that hepatomegaly, the double contour of the head, and thickening of the fetal subcutaneous adipose tissue have high sensitivity and specificity for diabetic fetopathy, yet the positive predictive value of these indicators remains low [73].

It is advisable for obstetrician-gynecologists to provide information on the development of fetal macrosomia/diabetic fetopathy to a general practitioner/endocrinologist/general practitioner when managing pregnant women with GDM for the timely prescription of insulin therapy [55].

• In the case of threatened or incipient preterm labor and premature rupture of membranes at 24 0/7 – 33 6/7 weeks of gestation, as well as in the presence of clinical feasibility (poor glycemic control, lack of a previously administered course of antenatal prophylaxis), it is recommended to perform prophylaxis of neonatal respiratory distress syndrome using glucocorticoids (see clinical guidelines "Preterm birth") [75]. During glucocorticoid therapy, a short-term increase in glycemia is possible, which requires more careful self-monitoring and, in some cases, adjustment of insulin doses [76].

LeR CLoE 5Level of Recommendation C (Level of Evidence — 5)

3.5 Delivery

Comments:

Maternal complications:

- hypertensive complications;

- preeclampsia;

- pregnancy-induced proteinuria.

Fetal complications:

- macrosomia;

- diabetic fetopathy;

- fetal growth restriction;

- progressive polyhydramnios;

- fetal distress.

Comments: Delivery by cesarean section in pregnant women with GDM is performed according to generally accepted indications in obstetrics, as well as in the presence of diabetic fetopathy with an estimated fetal weight > 4500 g at 38–39 weeks of gestation in the absence of uncomplicated spontaneous vaginal delivery of a large fetus in history due to the risk of shoulder dystocia to prevent maternal and fetal birth trauma [83]. Preterm delivery in pregnant women with GDM is performed only according to generally accepted indications in obstetrics [38].

• If the pregnant woman administered long-acting insulin before the onset of labor (A10AE: Long-acting insulins and analogues for injection), clinical or laboratory-confirmed hypoglycemia may develop during labor. In such cases, additional intake of easily digestible carbohydrates (juice, sugar) or intravenous administration of dextrose** solution is recommended [89].

GCR CLEL 5Grade of Recommendation C (Level of Evidence - 5)

• Glycemia monitoring during labor (in the laboratory or using a portable glucometer) must be performed only in pregnant women who received insulin therapy, once every 2–2.5 hours for the timely diagnosis of hypo- and hyperglycemia during labor [10, 89].

LoR CGoE 5Level of Recommendation C (Grade of Evidence - 5)

Comments: The postpartum discharge summary must indicate the timing of the postpartum OGTT. All women who have had GDM should be recommended lifestyle modification.

lifestyle modification at the pregnancy planning stage.

4. Medical Rehabilitation and Sanatorium-Resort Treatment

Specific medical rehabilitation is not required for patients with GDM.

5. Prevention and Dispensary Observation

Comments: it is necessary to continue follow-up by an endocrinologist for patients who have had GDM to prevent the development of type 2 diabetes mellitus. All women with risk factors for type 2 diabetes mellitus must undergo standard examination (see relevant clinical guidelines) to detect pregestational diabetes mellitus at the pregnancy planning stage, and also be recommended lifestyle modification at the pregnancy planning stage.

6. Organization of Medical Care

Indications for hospitalization in a medical organization

Scheduled and emergency hospitalization of pregnant women with GDM to an obstetric hospital is carried out according to generally accepted indications in obstetrics.

In the presence of maternal and/or fetal obstetric complications in pregnant women with GDM, scheduled hospitalization is performed no later than 38 weeks to a level 3 obstetric hospital to determine the optimal timing and method of delivery.

In the absence of maternal and/or fetal obstetric complications in pregnant women with GDM, scheduled hospitalization is performed no later than 40 weeks to a level 2–3 obstetric hospital to prevent maternal and perinatal complications during delivery (in the absence of spontaneous onset of labor at an earlier stage).

Maternal complications:

- hypertensive complications

- preeclampsia

- pregnancy-induced proteinuria

Fetal complications:

- macrosomia

- diabetic fetopathy

- fetal growth restriction

- progressive polyhydramnios fetal distress

Indications for patient discharge from a medical organization

Discharge of patients with GDM from the obstetric hospital is carried out according to obstetric indications.

7. Additional Information

• Pregnant women with GDM are recommended to monitor blood pressure throughout pregnancy for the timely diagnosis and treatment of hypertensive complications of pregnancy [92].

LeveL of Recommendation BGrade of Evidence 3LeveL of Recommendation B (Grade of Evidence - 3)

Comments: Blood pressure monitoring is carried out at outpatient appointments and using a self-monitoring blood pressure diary (independent blood pressure measurement by the patient 2–4 times a day) with subsequent presentation to the doctor during the visit.

• Antihypertensive therapy is recommended for BP ≥140/90 mm Hg at any gestational age in a clinic or office setting (or ≥135/85 mm Hg at home) with a target office DBP of 85 mm Hg (and SBP of 110–140 mm Hg) to reduce the likelihood of developing severe maternal hypertension [93-95].

Level of Evidence CGrade of Recommendation 5Level of recommendation C (level of evidence - 5).

Comment: in pregnant women with baseline low BP, antihypertensive therapy may be prescribed if BP >130/85 mm Hg.

• In chronic hypertension, episodes of elevated BP during outpatient visits, an increase in BP according to home blood pressure monitoring logs, the appearance of proteinuria, edema, and/or a history of early-onset preeclampsia, 24-hour ambulatory blood pressure monitoring is recommended for the timely diagnosis of preeclampsia and gestational hypertension, and the prescription of antihypertensive therapy [96-98].

LeveL of Recommendation BGrade of Evidence 3LeveL of Recommendation B (Grade of Evidence - 3)

• Pregnant women with GDM are recommended to undergo weekly weight control for timely lifestyle modification [99]. To correct excessive weight gain, patients should be advised to reduce daily caloric intake (decrease food portion sizes, exclude high-calorie foods from the diet, etc.) and increase physical activity. Dietary recommendations for abnormal weight gain should be followed continuously by pregnant women [10, 100, 101].

LeR CLoE 4Level of Recommendation C (Level of Evidence — 4)

Criteria for Evaluating the Quality of Medical Care

In outpatient settings

In inpatient settings

References

Appendix A1. Working Group Composition

1. Elena N. Andreeva, MD, PhD, Professor, Higher Category Physician, Deputy Director - Director of the Institute of Reproductive Medicine, National Medical Research Center for Endocrinology of the Ministry of Health of Russia.

2. Natalia Yu. Arbatskaya, PhD, Endocrinologist, Nutritionist, Founder of the PM Clinic, Moscow.

3. Olga N. Arzhanova - MD, PhD, Professor, Honored Physician of the RF, Leading Researcher at the Department of Obstetrics and Perinatology, FSBSI "Ott Research Institute of Obstetrics, Gynecology and Reproductology", St. Petersburg; Member of the Russian Society of Obstetricians and Gynecologists (RSOG).

4. Nadezhda V. Bashmakova, MD, PhD, Professor, Chief Researcher at the Federal State Budgetary Institution "Ural Research Institute of Maternal and Child Care" of the Russian Ministry of Health; Chief freelance obstetrician-gynecologist for the Ural Federal District; Member of the Russian Society of Obstetricians and Gynecologists (RSOG), Interdisciplinary Association of Reproductive Medicine Specialists (MARS).

5. Natalia V. Borovik, PhD, Endocrinologist, St. Petersburg State Budgetary Healthcare Institution "Maternity Hospital No. 6 named after Professor V.N. Snegirev", Multidisciplinary Clinic "Sestroretskaya", St. Petersburg.

6. Fatima F. Burumkulova, MD, PhD, Leading Researcher at the Therapeutic Group, Moscow Regional Research Institute of Obstetrics and Gynecology (MONIIAG), Higher Qualification Category Physician, Professor at the Department of Obstetrics and Gynecology, Faculty of Advanced Medical Training, Moscow Regional Research Institute of Clinical Medicine (MONIKI) named after M.F. Vladimirsky; Honored Worker of Science of Moscow Region; Member of the International Association of Reproductive Medicine Specialists (MARS), member of the Russian Association of Endocrinologists (RAE), member of the board presidium of the "Gestational Diabetes Association".

7. Gagik R. Galstyan - MD, PhD, Professor, Higher Category Physician; Acting Deputy Director of the Diabetes Institute, National Medical Research Center for Endocrinology of the Ministry of Health of Russia, Associate Professor at the Department of Diabetology and Dietetics, National Medical Research Center for Endocrinology of the Ministry of Health of Russia; Laureate of the Government Prize of the Russian Federation for the creation and introduction into healthcare practice of modern technologies for the diagnosis, treatment, and prevention of diabetes mellitus for 2012; President of the All-Russian Public Organization of Disabled People "Russian Diabetes Association"; Member of the Russian Association of Endocrinologists (RAE), American Diabetes Association (ADA), European Association for the Study of Diabetes (EASD), European Diabetic Neuropathy Study Group (NeuroDiab).

8. Grigoryan Olga Rafaelievna — Doctor of Medical Sciences, Chief Researcher, Department of Endocrine Gynecology, National Medical Research Center for Endocrinology of the Russian Ministry of Health; Professor, Institute of Postgraduate Professional Education, National Medical Research Center for Endocrinology of the Russian Ministry of Health. Member of the Russian Association of Endocrinologists (RAE).

9. Grineva Elena Nikolaevna — Doctor of Medical Sciences, Professor, Director of the Institute of Endocrinology, Almazov National Medical Research Centre of the Russian Ministry of Health; Chief freelance endocrinologist for the Northwestern Federal District, St. Petersburg.

10. Deryabina Elena Gennadyevna — Doctor of Medical Sciences, Leading Researcher, Department of Antenatal Fetal Protection, Endocrinologist, Ural Research Institute of Maternity and Infancy Care of the Russian Ministry of Health; Member of the Interdisciplinary Association of Specialists in Reproductive Medicine (MARS) and the Russian Association of Endocrinologists (RAE).

11. Dedov Ivan Ivanovich — Academician of the Russian Academy of Sciences, Doctor of Medical Sciences, Professor; President of the National Medical Research Center for Endocrinology of the Russian Ministry of Health; President of the Russian Association of Endocrinologists (RAE); Chief freelance endocrinologist of the Ministry of Health of the Russian Federation.

12. Demidova Irina Yuryevna — Doctor of Medical Sciences, Head of the Department of Endocrinology and Diabetology, Faculty of Further Professional Education, Pirogov Russian National Research Medical University of the Ministry of Health of the Russian Federation; Member of the Russian Association of Endocrinologists (RAE).

13. Dreval Alexander Vasilyevich — Doctor of Medical Sciences, Professor, Leading Researcher, Moscow Regional Research Clinical Institute named after M.F. Vladimirsky.

14. Esayan Roza Mikhailovna — Candidate of Medical Sciences, Head of the Therapeutic Department, National Medical Research Center for Obstetrics, Gynecology and Perinatology named after Academician V.I. Kulakov of the Russian Ministry of Health; Associate Professor, Department of Obstetrics and Gynecology, Institute of Professional Education, National Medical Research Center for Obstetrics, Gynecology and Perinatology named after Academician V.I. Kulakov of the Russian Ministry of Health.

15. Zazerskaya Irina Evgenyevna — Doctor of Medical Sciences, Professor, Head of the Department of Obstetrics and Gynecology with Clinic, Institute of Medical Education, Almazov National Medical Research Centre of the Russian Ministry of Health; Leading Researcher, Department of Obstetrics and Perinatology, Ott Research Institute of Obstetrics, Gynecology and Reproductology; Board Member of the Russian Society of Obstetricians and Gynecologists (ROAG); Member of the Interregional Public Organization "Association of Gynecological Endocrinologists, RAM"; Chairperson of the Central Antenatal Group Expert Panel for the Northwestern Federal District, St. Petersburg.

16. Ibragimova Lyudmila Ibragimovna — Candidate of Medical Sciences, Head of the Department of Diabetes Forecasting and Innovation, National Medical Research Center for Endocrinology of the Russian Ministry of Health; Member of the Russian Association of Endocrinologists (RAE).

17. Kapustin Roman Viktorovich — Doctor of Medical Sciences, Head of the Department of Obstetrics and Perinatology, Ott Research Institute of Obstetrics, Gynecology and Reproductology; Associate Professor, Department of Obstetrics, Gynecology and Reproductology, Medical Institute of St. Petersburg State University; Member of the Russian Society of Obstetricians and Gynecologists (ROAG).

18. Lukanovskaya Olga Borisovna — Head of the Pregnancy Pathology Department, City Clinical Hospital No. 29 named after N.E. Bauman of the Moscow Healthcare Department; highest-category obstetrician-gynecologist. Holder of the "Moscow Doctor" title. Assistant Professor, Department of Obstetrics and Gynecology with a Course in Perinatology, Peoples' Friendship University of Russia. Secretary of the Gestational Diabetes Mellitus Association; Member of the Moscow Society of Obstetricians and Gynecologists.

19. Malgina Galina Borisovna — Doctor of Medical Sciences, Professor, Scientific Secretary, Ural Research Institute of Maternity and Infancy Care of the Russian Ministry of Health; Member of the Russian Society of Obstetricians and Gynecologists (ROAG) and the Interdisciplinary Association of Specialists in Reproductive Medicine (MARS).

20. Melnichenko Galina Afanasyevna — Doctor of Medical Sciences, Professor, Deputy Director for Research, National Medical Research Center for Endocrinology of the Russian Ministry of Health; Academician of the Russian Academy of Sciences; Chairperson of the Moscow Association of Endocrinologists; Vice-President of the Russian Association of Endocrinologists (RAE); Member of the European Society of Neuroendocrinology, European Thyroid Association, and the Endocrine Society; Cavalier of the Order of Honour of the Russian Federation for contribution to science; Laureate of the National "Prizvanie" (Vocation) Award in the category "For the creation of a new direction in medicine."

21. Petrukhin Vasily Alekseevich — Doctor of Medical Sciences, Professor, Department of Obstetrics and Gynecology, Faculty of Advanced Medical Training, Moscow Regional Research Clinical Institute named after M.F. Vladimirsky; Honored Doctor of the Russian Federation; Board Member of the Russian Society of Obstetricians and Gynecologists; Chairman of the Moscow Regional Public Organization of Obstetricians and Gynecologists; Honored Worker of Science and Technology of the Moscow Region; Laureate of the Moscow Region Governor's Award in the category "For achievements in healthcare" for 2009.

22. Putilova Natalya Viktorovna — Doctor of Medical Sciences, Associate Professor, Head of the Scientific Department of Antenatal Fetal Protection, Ural Research Institute of Maternity and Infancy Care of the Russian Ministry of Health. Member of the Russian Society of Obstetricians and Gynecologists (ROAG) and the Interdisciplinary Association of Specialists in Reproductive Medicine (MARS).

23. Ragozin Anton Konstantinovich — Candidate of Medical Sciences, Associate Professor, Department of Endocrinology and Diabetology, Faculty of Further Professional Education, Pirogov Russian National Research Medical University of the Ministry of Health of the Russian Federation; Head of the Endocrinology Department, Central Clinical Hospital with Polyclinic of the Presidential Administration of the Russian Federation, Moscow.

24. Radzinsky Victor Evseevich — Corresponding Member of the Russian Academy of Sciences, Professor, Doctor of Medical Sciences, Honored Worker of Science of the Russian Federation, Head of the Department of Obstetrics and Gynecology with a Course in Perinatology, Medical Institute of the Patrice Lumumba Peoples' Friendship University of Russia; Vice-President of the Russian Society of Obstetricians and Gynecologists; President of the Interdisciplinary Association of Specialists in Reproductive Medicine (MARS).

25. Serov Vladimir Nikolaevich — Doctor of Medical Sciences, Professor, Chief Researcher, Department of Scientific and Educational Programs, Research Organization Department, National Medical Research Center for Obstetrics, Gynecology and Perinatology named after Academician V.I. Kulakov of the Russian Ministry of Health; Academician of the Russian Academy of Sciences; President of ROAG.

26. Startseva Nadezhda Mikhailovna — Doctor of Medical Sciences, Professor, Department of Obstetrics and Gynecology with a Course in Perinatology, Medical Institute of the Patrice Lumumba Peoples' Friendship University of Russia, Moscow; Member of the Moscow Society of Obstetricians and Gynecologists; Member of the Presidium of the Board of the Gestational Diabetes Mellitus Association.

27. Tiselko Alena Viktorovna — Doctor of Medical Sciences, Leading Researcher, Endocrinologist, Department of Gynecology and Endocrinology, Ott Research Institute of Obstetrics, Gynecology and Reproductology; Member of the St. Petersburg Association of Endocrinologists, Member of the European Society of Gynecological Endocrinologists, Member of the Society of Obstetricians and Gynecologists of St. Petersburg and the Northwestern Region.

28. Fadeev Valentin Viktorovich — Doctor of Medical Sciences, Corresponding Member of the Russian Academy of Sciences, Professor, Head of the Department and Director of the Clinic of Endocrinology, I.M. Sechenov First Moscow State Medical University; Member of the Russian Association of Endocrinologists (RAE).

29. Khodzhaeva Zulfiya Sagdullaevna — Doctor of Medical Sciences, Professor; Deputy Director for Research, Institute of Obstetrics, National Medical Research Center for Obstetrics, Gynecology and Perinatology named after Academician V.I. Kulakov of the Russian Ministry of Health; Professor, Department of Obstetrics and Gynecology, Institute of Professional Education, National Medical Research Center for Obstetrics, Gynecology and Perinatology named after Academician V.I. Kulakov of the Russian Ministry of Health; Member of the Presidium of the Board of the Russian Society of Obstetricians and Gynecologists (ROAG); Member of the International Society for the Study of Hypertension in Pregnancy (ISSHP); Member of the Preterm Birth International Collaborative (Prebic); Member of the FIGO Working Group on Hyperglycemia in Pregnancy.

30. Shestakova Marina Vladimirovna — Academician of the Russian Academy of Sciences, Doctor of Medical Sciences, Professor; Deputy Director — Director of the Institute of Diabetes, National Medical Research Center for Endocrinology of the Russian Ministry of Health; Head of the Department of Diabetology and Dietetics, National Medical Research Center for Endocrinology; Honored Worker of Science of the Russian Federation; Chief Scientific Secretary and Member of the Presidium of the Board of the Russian Association of Endocrinologists (RAE); Laureate of the Government of the Russian Federation Prize in Science and Technology for the creation and clinical implementation of modern technologies for the diagnosis, treatment, and prevention of diabetes mellitus in the healthcare practice of the Russian Federation; Member of the European Association for the Study of Diabetes (EASD); Member of the American Diabetes Association (ADA); Co-chair of the Section for Cardiovascular Complications of Diabetes Mellitus at the Russian Cardiological Society; Member of the Higher Attestation Commission (VAK) Expert Council on Therapeutic Sciences.

31. Shmakov Roman Georgievich — Doctor of Medical Sciences, Professor of the Russian Academy of Sciences; Director, Moscow Regional Research Institute of Obstetrics and Gynecology named after Academician V.I. Krasnopolsky; Chief freelance specialist in obstetrics of the Ministry of Health of the Russian Federation; Head of the Department of Obstetrics and Gynecology, Moscow Regional Research Clinical Institute named after M.F. Vladimirsky; Professor, Department of Obstetrics and Gynecology named after Academician G.M. Savelieva, Pediatric Faculty, Pirogov Russian National Research Medical University; Board Member of the Russian Society of Obstetricians and Gynecologists; Member of the International Network on Cancer, Infertility and Pregnancy (INCIP) under the auspices of the European Society of Gynaecological Oncology (ESGO); Expert of the Federal Service for Surveillance in Healthcare.

32. Yarygina Tamara Aleksandrovna – PhD in Medical Sciences, Head of the Ultrasound Diagnostics Department at the Moscow Regional Research Institute of Obstetrics and Gynecology named after Academician V.I. Krasnopolsky; Researcher at the Perinatal Cardiology Center of the Bakulev National Medical Research Center for Cardiovascular Surgery of the Russian Ministry of Health; Associate Professor at the Department of Ultrasound Diagnostics, Faculty of Continuing Medical Education, Medical Institute, Peoples' Friendship University of Russia named after Patrice Lumumba.

Conflict of interest:

None of the working group members had a conflict of interest during the development of these clinical guidelines, namely a personal interest in obtaining, personally or through a company representative, material gain or other advantage that would or could affect the proper performance of their professional duties.

Appendix A2. Methodology for Developing Clinical Guidelines

Target audience of these clinical guidelines:

1. Endocrinologists

2. Obstetrician-gynecologists

3. General practitioners

4. Internists

Table 1. Scale for grading levels of evidence (LE) for diagnostic methods (diagnostic interventions)

Table 2. Scale for assessing the levels of evidence certainty (LEC) for prevention, treatment, and rehabilitation methods (preventive, therapeutic, rehabilitative interventions)

Table 3. Scale for assessing the recommendation strength grades (RSG) for prevention, diagnostic, treatment, and rehabilitation methods (preventive, diagnostic, therapeutic, rehabilitative interventions)

Procedure for updating clinical guidelines.

The mechanism for updating clinical guidelines provides for their systematic revision at least once every three years, as well as upon the emergence of new evidence-based medicine data regarding the diagnosis, treatment, prevention, and rehabilitation of specific diseases, or in the presence of justified additions/comments to previously approved clinical guidelines, but no more frequently than once every 6 months.

Appendix A3. Reference Materials

1) Injection and infusion techniques in the treatment of diabetes mellitus. Methodological guide

http://democenter.nitrosbase.com/clinrecalg5/Files/recomend/MP102.PDF

2) Characteristics of insulin drugs used in the treatment of patients with gestational diabetes mellitus

[102]

¹ Mix thoroughly before administration

Appendix B. Physician Action Algorithms

Appendix C. Patient Information

Table 1. Glycemic index (GI) of carbohydrate-containing foods + their absorption rate

Table 2. Dietary fats

Self-monitoring diary of a pregnant woman with gestational diabetes mellitus

Appendix G. Assessment Scales, Questionnaires, and Other Evaluation Tools

Appendix G1. Risk factors for overt diabetes mellitus during pregnancy.

Risk factors for overt (first diagnosed during pregnancy) type 2 diabetes mellitus [32]:

• Obesity (BMI ≥ 30 kg/m²)

• First-degree relatives with diabetes mellitus

• Membership in a high-risk population for type 2 diabetes mellitus

• Cardiovascular diseases

• Arterial hypertension (> 140/90 mm Hg or antihypertensive therapy)

• HDL cholesterol <35 mg/dL (0.9 mmol/L) and/or triglycerides >250 mg/dL (2.82 mmol/L)

• Low physical activity

• Insulin resistance (e.g., acanthosis nigricans, PCOS)

• Women with prediabetes (HbA1c > 5.7%, impaired glucose tolerance, impaired fasting glycemia), history of GDM

Additional risk factors for screening for type 2 diabetes mellitus during pregnancy [103]

• Maternal birth weight >4.1 kg or <2.7 kg

• Significant weight gain between pregnancies or in early pregnancy

• History of macrosomia

• Glucosuria at the first prenatal visit

• Previous unexplained perinatal losses, birth of children with congenital malformations

• Previous preterm birth, preeclampsia

• Glucocorticoid treatment in the current pregnancy

• Pregnancy-induced hypertension in the current pregnancy

Risk factors for overt (newly diagnosed during pregnancy) type 1 diabetes mellitus [104]:

• Young age

• Low BMI

• Presence of ketones in urine or blood

• Other autoimmune disease (e.g., Graves' disease, thyroiditis)

• Early insulin therapy (89% basal-bolus)

Appendix G2. Venous plasma glucose threshold values for the diagnosis of GDM

Appendix G3. Technique for injecting insulin drugs during pregnancy

Currently, the following recommendations appear acceptable:

• The abdomen is generally a safe site for insulin product administration during pregnancy. Given the thinning of fat in the anterior abdominal wall due to uterine enlargement, pregnant women with diabetes (of any type) should use 4 mm needles.

• In the first trimester of pregnancy, insulin can be injected across the entire surface of the abdomen, but proper skin fold formation is required.

• In the second trimester of pregnancy, insulin can be injected across the entire surface of the abdomen, but proper skin fold formation is required. The lateral abdominal areas can be used for insulin product injections without skin fold formation.

• In the third trimester, injections may be performed only into the lateral areas of the abdomen provided that a proper skin fold is formed. If patients have any doubts, they can inject into the thigh, arm, or buttocks instead of the abdomen.

Appendix G4. Percentile charts for newborns (adjusted for sex)

[105]

Russian title: The International Fetal and Newborn Growth Consortium for the 21st Century.

Original title: The International Fetal and Newborn Growth consortium for the 21st Century.

Source: https://intergrowth21.tghn.org/

Type: rating scale

Purpose: personalized assessment of newborn weight adjusted for sex and percentile values

Content: a large international, multinational, multi-ethnic prospective study of fetal and newborn growth and development within the INTERGROWTH-21st project, which includes: the Fetal Growth Longitudinal Study (FGLS), the Newborn Cross-Sectional Study (NCSS), and the Postnatal Follow-up Study of Preterm Infants (PFSP), enabling the unification of concepts regarding true fetal and newborn developmental parameters and standardization of approaches to their assessment

Appendix G5. Percentile charts for fetometric parameters

[106]

Russian title: The International Fetal and Newborn Growth Consortium for the 21st Century.

Original title: The International Fetal and Newborn Growth consortium for the 21st Century.

Source: https://intergrowth21.tghn.org/

Type: rating scale

Purpose: personalized assessment of estimated fetal weight and abdominal circumference adjusted for percentile values.

Appendix G6. Physical activity

Recommended types of physical activity:

• Aerobic — walking*, Nordic walking, swimming in a pool, cross-country skiing, stationary bicycle.

• Yoga or pilates in a modified form (excluding exercises that impair venous return to the heart)

• Strength training aimed at strengthening core and limb muscles.

* a walk before bedtime to achieve target morning glycemia; after a meal that shows the maximum increase in glycemia to achieve target postprandial glycemic levels

Recommended activity volume: 150–270 minutes per week. Preferably, this activity should be distributed evenly across the days of the week (i.e., at least 25–35 minutes daily).

Recommended intensity: 65–75% of HRmax. HRmax is calculated as follows: HRmax = 220 − age. Intensity can also be assessed using the "talk test": as long as the pregnant woman is able to converse during exercise, she is likely not overexerting herself.

Physical activity must be stopped if symptoms of malaise occur in a pregnant woman with GDM to prevent the development of pregnancy complications.

Physical activity should be discontinued if the following symptoms occur:

• Appearance of spotting from the genital tract

• Painful uterine contractions

• Leaking of amniotic fluid

• Dizziness

• Headache

• Feeling of severe fatigue

• Shortness of breath before starting activity

Injury-prone activities are contraindicated (downhill skiing, snowboarding, roller skating, water skiing, surfing, off-road bicycling, gymnastics, and horseback riding), contact and team sports (e.g., hockey, boxing, martial arts, football, and basketball, tennis), jumping, and scuba diving.

Absolute contraindications to physical activity during pregnancy:

• Hemodynamically significant heart disease (heart failure functional class 2 and above)

• Pulmonary hypertension

• Cervical incompetence or cervical cerclage

• Multiple pregnancy with the risk of preterm birth

• Episodes of spotting in the second or third trimester

• Placenta previa after 26 weeks of gestation

• Leaking of amniotic fluid

• Preeclampsia or gestational hypertension

• Severe anemia (Hb < 80 g/L).

Conditions in which the question of prescribing physical activity, its type, and volume is decided individually:

• Moderate anemia

• Clinically significant cardiac arrhythmias

• Chronic obstructive pulmonary disease

• Severe morbid obesity (pregravid BMI > 50).

• Extremely low weight (BMI less than 12)

• Extremely sedentary lifestyle

• Fetal growth restriction in the current pregnancy

• Poorly controlled chronic arterial hypertension

• Orthopedic limitations

• Poorly controlled epilepsy

• Decompensated thyrotoxicosis

• Smoking more than 20 cigarettes per day.