List of Abbreviations
BP | blood pressure |
|---|---|
Anti-TPO | antibodies to thyroid peroxidase |
SFH | fundal height |
HIV | human immunodeficiency virus |
HSV | herpes simplex virus |
ART | assisted reproductive technologies |
GDM | gestational diabetes mellitus |
DNA | deoxyribonucleic acid |
BMI | body mass index |
ELISA | enzyme-linked immunosorbent assay |
CLIA | chemiluminescent immunoassay |
ICI | isthmic-cervical incompetence |
FGR | fetal growth restriction |
CTG | cardiotocography |
CRL | crown-rump length |
NIPT | non-invasive prenatal testing (detection of cell-free fetal DNA in maternal blood) |
LMWH | low molecular weight heparins |
AC | abdominal circumference |
OGTT | oral glucose tolerance test |
PPRD | placental abruption |
CR | preterm birth |
PE | preeclampsia |
TSH | thyroid-stimulating hormone |
VTE | venous thromboembolic events |
ultrasound | ultrasound examination |
CA | chromosomal abnormalities |
CH | chorionic gonadotropin |
CMV | cytomegalovirus |
HR | heart rate |
HCV | hepatitis C virus |
PAPP-A | pregnancy-associated plasma protein A |
Terms and Definitions
Normal pregnancy is a singleton pregnancy with a fetus free of genetic abnormalities or developmental malformations, lasting 370-416 weeks, and proceeding without obstetric and perinatal complications.
Clinical pregnancy – pregnancy diagnosed by visualization of one or more gestational sacs/fetuses during ultrasound examination (ultrasound), or by the presence of reliable clinical signs of pregnancy. The term applies to both intrauterine and ectopic pregnancy.
1. Brief information on the disease or condition
1.1 Definition of the disease or condition
Normal pregnancy is a singleton pregnancy with a fetus free of genetic abnormalities or developmental malformations, lasting 370-416 weeks, and proceeding without obstetric and perinatal complications.
1.2 Etiology and pathogenesis of the disease or condition (group of diseases or conditions)
Not applicable.
1.3 Epidemiology of the Disease or Condition
According to federal statistical observation form No. 32, in 2021 in Russia, 1,385,706 pregnant women came under observation, 1,290,849 women completed their pregnancy (out of those under observation at the beginning of the year and those newly registered in the reporting year) , of whom 1,236,566 women did so after 22 weeks. The number of singleton births in hospitals and at home was 1,338,957.
1.4 Features of Coding the Disease or Condition
Z32 – Pregnancy examination and test
Z33 – Pregnant state
Z34 – Supervision of normal pregnancy
Z35 – Supervision of high-risk pregnancy
Z36 – Antenatal screening for fetal anomaly
1.5 Classification of the disease or condition
Classification is absent.
1.6 Clinical presentation of the disease or condition
The clinical picture corresponds to the complaints presented by women with a normal pregnancy, as well as the data from physical examination, laboratory, and instrumental diagnostic studies.
2. Diagnostics, medical indications and contraindications for diagnostic methods
Diagnostic criteria
Normal pregnancy is diagnosed upon visualization of a single embryo/fetus with a heartbeat and no developmental malformations in the uterine cavity by ultrasound examination.
2.1 Complaints and Anamnesis
It is recommended to take the medical history of a patient planning a pregnancy (at the pre-pregnancy stage) and a pregnant patient at the 1st visit for the timely assessment of risk factors and pathological conditions in order to provide timely prevention and treatment [1].
GPP CLoE 5Level of Evidence/Grade of Recommendation C (level of evidence - 5).
Comment: The medical history taking should include the following patient data:
age,
presence of occupational hazards,
presence of bad habits (smoking, alcohol, drug use),
family history (indication of first-degree relatives having diseases such as diabetes mellitus, venous thromboembolic events (VTE), hypertension, mental disorders, obstetric and perinatal complications),
characteristics of menstruation (age at menarche, duration and regularity of the menstrual cycle, duration of menstrual bleeding, pain),
obstetric history (number of previous pregnancies and births and their outcome, presence of complications in pregnancy, childbirth and/or abortions, height, weight, and health status of born children, method of achieving pregnancy—spontaneous pregnancy or pregnancy resulting from assisted reproductive technologies (ART)),
past and current gynecological diseases, surgical interventions on the pelvic organs,
past and current somatic diseases (in particular, childhood infections, cardiovascular diseases, kidney diseases, endocrine diseases, allergic diseases, VTE, etc.),
for individual risk stratification and selection of prevention methods in the planned and current pregnancy, childbirth, and postpartum period, the VTE risk assessment scale may be used according to the clinical guidelines "Venous complications during pregnancy and the postpartum period. Obstetric thromboembolism" 2022 [2],
history of trauma, surgeries, and blood component transfusions,
allergic reactions,
medicines taken,
age and health status of the husband/partner, his blood group and Rhesus factor, presence of occupational hazards and bad habits.
It is recommended to assess complaints in a patient planning a pregnancy (at the pre-pregnancy stage) and in a pregnant patient at the 1st and every subsequent visit for the timely detection of pathological conditions and their treatment [1].
GPP CLoE 5Level of Evidence/Grade of Recommendation C (level of evidence - 5).
Comment: Complaints characteristic of a normal pregnancy:
Nausea and vomiting are observed in every 3rd pregnant woman. In 90% of cases, nausea and vomiting in pregnancy are a physiological sign, and in 10%, a pregnancy complication. In a normal pregnancy, vomiting occurs no more than 2–3 times a day, usually on an empty stomach, and does not impair the patient's general condition. In most cases, nausea and vomiting resolve spontaneously by 16–20 weeks of pregnancy and do not worsen its outcome [3, 4].
Mastalgia is a normal symptom during pregnancy, observed in the majority of women in the 1st trimester of pregnancy, and is associated with edema and engorgement of the mammary glands due to hormonal changes.
Lower abdominal pain during pregnancy can be a normal phenomenon, such as when stretching the uterine ligamentous apparatus during its growth (aching pains or sudden stabbing pain in the lower abdomen) or during Braxton Hicks contraction false labor after the 20th week of pregnancy (pulling pains in the lower abdomen, accompanied by uterine tone, lasting up to a minute, non-regular in nature).
Heartburn (gastroesophageal reflux disease) during pregnancy is observed in 20–80% of cases. Most frequently, it develops in the 3rd trimester of pregnancy [5–7]. Heartburn occurs due to relaxation of the lower esophageal sphincter, decreased intraesophageal pressure, and simultaneous increase in intra-abdominal and intragastric pressure, which leads to repeated reflux of gastric and/or duodenal contents into the esophagus.
Constipation is the most common intestinal pathology in pregnancy, occurring in 30–40% of cases [8]. Constipation is associated with impaired passage through the colon and is characterized by a stool frequency of less than 3 times a week. Signs of constipation: see the clinical guidelines "Constipation" 2021 [9].
Approximately 8–10% of women develop hemorrhoids during each pregnancy [10]. Causes of hemorrhoids during pregnancy may include: pressure from the uterus on the bowel wall, portal vein congestion, increased intra-abdominal pressure, congenital or acquired connective tissue weakness, and alterations in rectal innervation.
Varicose veins develop in 30% of pregnant women [11]. The cause of varicose veins during pregnancy is increased venous pressure in the lower extremities and the relaxing effect of progesterone, relaxin, and other biologically active substances on the vascular wall of veins - see the 2021 clinical guidelines "Varicose veins of the lower extremities" [12].
Vaginal discharge without itching, pain, unpleasant odor, or dysuric symptoms is a normal finding during pregnancy and is observed in the majority of women.
Back pain during pregnancy occurs with a frequency of 36 to 61%. Among women with back pain, 47–60% experience it for the first time at 5–7 months of gestation [13–15]. The most common cause of back pain during pregnancy is increased load on the back due to an enlarging abdomen and shifting center of gravity, coupled with decreased muscle tone under the influence of relaxin.
The prevalence of pelvic girdle pain during pregnancy is 0.03–3%, and it typically occurs in late pregnancy [16].
Carpal tunnel syndrome during pregnancy occurs in 21–62% of cases [17, 18] as a result of median nerve compression in the carpal tunnel, and is characterized by a tingling sensation, burning pain, hand numbness, as well as decreased sensitivity and motor function of the hand.
2.2 Physical Examination
A general physical examination is recommended for patients planning pregnancy (at the preconception stage) and for pregnant patients at the 1st visit to diagnose developmental disorders [1].
GPP CLoE 5Level of Evidence/Grade of Recommendation C (level of evidence - 5).
Comment: The general physical examination includes assessment of body habitus, subcutaneous fat distribution pattern, condition of the skin and visible mucous membranes, as well as the degree and pattern of hair growth.
Measurement of body weight and height is recommended for patients planning pregnancy (at the preconception stage) and for pregnant patients at the 1st and every subsequent visit to determine the body mass index (BMI) (body weight in kg / height in m2) and monitor weight gain dynamics during pregnancy [19], [20], [21].
LeveL of Recommendation BGrade of Evidence 2LeveL of Recommendation B (Grade of Evidence - 2).
Comment: Obstetric and perinatal outcomes are influenced by the baseline pre-pregnancy BMI, but particularly by gestational weight gain [20], [21], [22], [23]. The recommended weight gain in the 1st trimester is no more than 0.5–2 kg [24]. Weight gain occurs partly due to fluid accumulation (edema) characteristic of the gestation period (Table 1).
Table 1
Recommended weekly and total weight gain according to BMI [24]
Category | BMI (kg/m2) | Recommended weight gain | |
total for pregnancy (kg) | weekly (kg/week) (in the 2nd and 3rd trimesters) | ||
Underweight | < 18,5 | 12,5 – 18 | 0,45 (0,45 – 0,58) |
Normal weight | 18,5 – 24,9 | 11,5 – 16 | 0,45 (0,35 – 0,45) |
Overweight | 25,0 – 29,9 | 7 – 11,5 | 0,27 (0,23 – 0,30) |
Obesity | ≥30,0 | 5 – 9 | 0,23 (0,18 – 0,27) |
Measurement of blood pressure (BP) on peripheral arteries and pulse assessment are recommended for patients planning pregnancy (at the preconception stage) and for pregnant patients at the 1st and every subsequent visit for the early diagnosis of hypertensive disorders [24–26].
GPP CLoE 5Level of Evidence/Grade of Recommendation C (level of evidence - 5).
Comment: Guidelines for measuring BP on peripheral arteries in patients at risk for preeclampsia (PE) - see the 2021 clinical guidelines "Preeclampsia. Eclampsia. Edema, proteinuria, and hypertensive disorders in pregnancy, childbirth, and the postpartum period" [27].
Palpation of the mammary glands is recommended for patients planning pregnancy (at the preconception stage) and for pregnant patients at the 1st visit to diagnose nodular breast masses [28], [29].
GCR CLOE 4Grade of Recommendation C (Level of Evidence - 4).
Comment: For rules on breast palpation, see the 2020 clinical guidelines "Benign breast dysplasia" [30]. If nodular breast masses are detected, referral to an oncologist is recommended. Routine breast palpation during pregnancy is not indicated [19].
A gynecological examination is recommended for patients planning pregnancy (at the preconception stage) and for pregnant patients at the 1st visit to: identify or rule out gynecological diseases in patients planning pregnancy (at the preconception stage); perform differential diagnosis with ectopic pregnancy, determine uterine size and its correspondence to gestational age, as well as the condition and tenderness of the appendages and vaginal fornices in pregnant patients [1].
GPP CLoE 5Level of Evidence/Grade of Recommendation C (level of evidence - 5).
Comment: The gynecological examination includes visual inspection of the external genitalia, examination of the vagina and cervix using specula, and bimanual vaginal examination to determine the size, consistency, mobility, and tenderness of the uterus and uterine appendages. Repeat gynecological examinations of pregnant patients are performed according to indications: in the presence of symptoms related to the reproductive system, signs of miscarriage, cervical incompetence, and preterm labor, taking into account relevant clinical guidelines [31], [32], [33]. In the absence of indications, repeat gynecological examinations of pregnant patients are not recommended [34].
Determination of the gestational age and expected date of delivery based on the last menstrual period and ultrasound data is recommended for pregnant patients at the 1st visit [35–37].
LeveL of Recommendation AGrade of Evidence 2LeveL of Recommendation A (Grade of Evidence - 2).
Comments: When calculating the due date based on the last menstrual period, 280 days (40 weeks) should be added to the first day of the last menstrual period (for a 28-day menstrual cycle). For a different cycle length, adjustments to the due date calculation must be made: extending the duration for a longer cycle and shortening it for a shorter cycle.
If pregnancy occurs as a result of ART, the due date calculation must be based on the embryo transfer date (transfer date plus 266 days (38 weeks) minus the number of days equal to the embryo culture stage).
When calculating gestational age and the due date using ultrasound data in the 1st trimester of pregnancy, the crown-rump length (CRL) of the fetus should be used; at later stages of pregnancy (when CRL > 84 mm), the fetal head circumference should be used [38].
In the absence of a 1st-trimester ultrasound and lack of information about the date of the last menstrual period, gestational age and the due date may be established based on other ultrasound scans.
In case of a discrepancy between the gestational age estimated by the last menstrual period and by the ultrasound performed at 110–136 weeks, gestational age and the due date should be established based on the ultrasound data, as this method is the most accurate [35–37], [39], [40], [41].
Measurement of abdominal circumference (AC), uterine dimensions (fundal height - FH), and completion of a gravidogram are recommended for pregnant patients at each visit after 20 weeks of gestation [1], [42], [43].
GPP BLE 2Grade of Recommendations B (Level of Evidence 2).
Comments: The correspondence of FH to gestational age is presented in Table 2. An example of a gravidogram is provided in Appendix G. If the FH according to the gravidogram falls below the 10th percentile or above the 90th percentile of the FH distribution, a fetal ultrasound is recommended to assess fetal development and determine the amniotic fluid volume.
Table 2
Correspondence of FH to gestational age [1]
Gestational age | FH |
20–21 weeks | 18–24 cm |
22–23 weeks | 21–25 cm |
24–25 weeks | 23–27 cm |
26–27 weeks | 25–28 cm |
28–29 weeks | 26–31 cm |
30–31 weeks | 29–32 cm |
32–33 weeks | 31–33 cm |
34–35 weeks | 32–33 cm |
36–37 weeks | 32–37 cm |
38–39 weeks | 35–38 cm |
40–42 weeks | 34–35 cm |
Determination of fetal position and presentation is recommended for pregnant patients at each visit after 34–36 weeks of gestation to determine the management of labor [19], [43], [44], [45], [46].
LeveL of Recommendation BGrade of Evidence 2LeveL of Recommendation B (Grade of Evidence - 2).
Interviewing the pregnant patient regarding the character of fetal movements is recommended at each visit after 16–20 weeks of gestation (following the onset of perceived fetal movements) to confirm fetal viability [47].
GGR ALEL 1Grading of Recommendations Assessment, Development and Evaluation (GRADE) level A (Level of evidence - 1).
Comments: There is no evidence regarding the effectiveness of preventing adverse perinatal outcomes based on fetal movement counting [47]. The patient should be advised that if she notices a subjective decrease in fetal activity and/or the frequency of movements, she should immediately contact a specialized hospital or antenatal clinic for additional evaluation.
2.3 Laboratory Diagnostics
It is recommended to refer a pregnant patient during her first-trimester visit for a blood serum human chorionic gonadotropin (hCG) (free β-subunit) assay, or a urine hCG test (if blood testing is not feasible) when ultrasound is not feasible, for the purpose of diagnosing pregnancy [1].
GGR CLEL 5Grading of Recommendations Assessment, Development and Evaluation (GRADE) level C (Level of evidence - 5).
Comment: This recommendation is relevant regardless of the patient's report of contraception, sterilization, or absence of sexual activity.
It is recommended to refer a patient planning pregnancy (at the preconception stage) once, and a pregnant patient twice: at the first visit (at the first visit in the 1st or 2nd trimester of pregnancy) and in the 3rd trimester of pregnancy, for blood testing for antibodies of classes M and G (IgM, IgG) to human immunodeficiency virus HIV-1/2 and p24 antigen (Human immunodeficiency virus HIV 1/2 + Agp24) for the purpose of timely detection of infection and prevention of fetal infection [48], [50], [51], [52], [49].
GGR ALEL 1Grading of Recommendations Assessment, Development and Evaluation (GRADE) level A (Level of evidence - 1).
Comments: According to paragraph 4.3 of the sanitary and epidemiological rules SP 3.1.5.2826-10 "Prevention of HIV Infection", the standard laboratory diagnostic method for HIV infection is the simultaneous determination of antibodies to HIV-1,2 and HIV p24/25 antigen using ELISA and CLIA diagnostic tests [53]. Re-examination in the 3rd trimester is best performed before 36 weeks of gestation [24]. If an infection is detected, the pregnant woman should be referred to the AIDS Center for confirmation/exclusion of the diagnosis. It is also recommended to refer the patient's partner for this test for the purpose of timely detection of infection and prevention of infection in the patient.
It is recommended to refer a patient planning pregnancy (at the preconception stage) once, and a pregnant patient twice: at the first visit (at the first visit in the 1st or 2nd trimester of pregnancy) and in the 3rd trimester of pregnancy, for the determination of hepatitis B surface antigen (HBsAg) in the blood (Hepatitis В virus) or hepatitis B virus surface antigen (HBsAg) in the blood (Hepatitis В virus) for the purpose of timely detection of infection and prevention of newborn infection [24], [54].
GGR CLEL 4Grading of Recommendations Assessment, Development and Evaluation (GRADE) level C (Level of evidence - 4).
Comments: If an infection is detected, the pregnant woman should be referred for a consultation with an infectious disease specialist to confirm/exclude the diagnosis. It is also recommended to refer the patient's partner for this test for the purpose of timely detection of infection and prevention of infection in the patient. Hepatitis B vaccination is carried out according to the rules specified in Chapter 5.3.
It is recommended to refer a patient planning pregnancy (at the preconception stage) once, and a pregnant patient twice: at the first visit (at the first visit in the 1st or 2nd trimester of pregnancy) and in the 3rd trimester of pregnancy, for the determination of total class M and G antibodies (anti-HCV IgG and anti-HCV IgM) to hepatitis C virus (Hepatitis С virus) in the blood for the purpose of timely detection of infection and therapy administration [55].
GGR CLEL 4Grading of Recommendations Assessment, Development and Evaluation (GRADE) level C (Level of evidence - 4).
Comment: If an infection is detected, the pregnant woman should be referred for a consultation with an infectious disease specialist to confirm/exclude the diagnosis. It is also recommended to refer the patient's partner for this test for the purpose of timely detection of infection and prevention of infection in the patient.
It is recommended to refer a patient planning pregnancy (at the preconception stage) once, and a pregnant patient twice: at the first visit (at the first visit in the 1st or 2nd trimester of pregnancy) and in the 3rd trimester of pregnancy, for the determination of antibodies to Treponema pallidum in the blood for the purpose of timely detection of infection and prevention of fetal infection [56, 57].
LeveL of Recommendation BGrade of Evidence 2LeveL of Recommendation B (Grade of Evidence - 2).
Comments: Screening and timely treatment of syphilis contribute to better pregnancy outcomes. If an infection is detected, the pregnant woman should be referred for a consultation with a dermatovenereologist to confirm/exclude the diagnosis. It is also recommended to refer the patient's partner for this test for the purpose of timely detection of infection and prevention of infection in the patient.
It is recommended to refer a patient planning pregnancy (at the preconception stage) once, or a pregnant patient once at the first visit (at the first visit in the 1st or 2nd trimester of pregnancy) for the determination of class G (IgG) and class M (IgM) antibodies to Rubella virus in the blood for the purpose of identifying seronegative patients [58].
GPP CLoE 5Level of Evidence/Grade of Recommendation C (level of evidence - 5).
Comments: In case of a seronegative status during pregnancy, the patient must be provided with information on minimizing the risk of rubella infection. At the preconception stage, vaccination is carried out according to the rules specified in Chapter 5.3.
It is recommended to refer a patient planning pregnancy (at the preconception stage) once, and a pregnant patient twice: at the first visit (at the first visit in the 1st or 2nd trimester of pregnancy) and in the 3rd trimester of pregnancy, for microscopic examination of vaginal smears, including microscopic examination of female genital discharge for Neisseria gonorrhoeae, microscopic examination of female genital discharge for Trichomonas vaginalis, and microscopic examination of vaginal discharge for yeast fungi for the purpose of timely detection and treatment of infectious and inflammatory diseases of the genital tract to prevent ascending infection [1], [19], [59], [60], [61], [62], [63].
LeveL of Recommendation AGrade of Evidence 2LeveL of Recommendation A (Grade of Evidence - 2).
Comment: It is not advisable to routinely refer a pregnant patient for molecular biological testing of female mucous membrane discharge for sexually transmitted infection pathogens (Neisseria gonorrhoeae, Trichomonas vaginalis, Chlamydia trachomatis, Mycoplasma genitalium), PCR quantification and detection of DNA of Gardnerella vaginalis, Atopobium vaginae, Lactobacillus spp. and total bacterial load in vaginal discharge, or molecular biological testing of female genital discharge for opportunistic genital mycoplasmas (Ureaplasma parvum, Ureaplasma urealyticum, Mycoplasma hominis). These tests should be recommended upon complaints of vaginal discomfort, changes in the nature of genital discharge, itching, burning, foul-smelling discharge, or if microscopic examination of vaginal smears reveals an inflammatory pattern.
It is recommended to refer a patient planning pregnancy (at the preconception stage) and a pregnant patient once at the first visit (if testing was not performed at the preconception stage) for the determination of main ABO blood groups and Rh D antigen (Rhesus factor) for the timely assessment of blood compatibility in case of a need for transfusion during labor or in the event of obstetric complications, as well as to determine the risk of Rh incompatibility [64], [65, 66].
GGR BLEL 1Grading of Recommendations Assessment, Development and Evaluation (GRADE) level B (Level of evidence - 1).
It is recommended to refer an Rh-negative pregnant patient for the determination of antibodies to Rhesus system antigens at the first visit (at the first visit in the first half of pregnancy), then in the absence of antibodies at 180–200 weeks of gestation, and subsequently in the absence of antibodies at 280 weeks of gestation to determine the risk of Rh incompatibility [65, 66], [67].
Strength of Recommendation = BEvidence Level = 1Strength of recommendation B (level of evidence - 1).
Comments: If antibodies to Rhesus system antigens are detected, the pregnant woman should be referred for consultation to a Level III medical organization for further follow-up. In Rhesus-negative women, the partner's Rhesus factor should be determined. If the partner's blood is Rhesus-negative, testing for antibodies to Rhesus system antigens is not performed. If the partner's Rhesus status is unknown or Rhesus-positive, the pregnant woman can be offered non-invasive prenatal testing (detection of cell-free fetal DNA in maternal blood) to determine the fetal Rhesus D antigen (Rhesus factor). If the fetus is determined to be Rhesus-negative, testing for antibodies to Rhesus system antigens in the maternal blood is not performed. For a commentary on this thesis, see details in the 2020 clinical guidelines "Rhesus Isoimmunization. Fetal Hemolytic Disease" [68].
It is recommended to refer a patient planning pregnancy (at the pregravid stage) once, and a pregnant patient three times: at the 1st visit (at the 1st visit in the 1st trimester of pregnancy), in the 2nd, and in the 3rd trimester of pregnancy, for a complete blood count (CBC) in order to timely detect and treat anemia and other pathological conditions [69–72].
Strength of Recommendation B (SRB)Level of Evidence 2 (LoE 2)Strength of Recommendation Grade B (Level of Evidence — 2).
Comment: Early screening and detection of anemia contributes to timely treatment and a reduction in the risk of negative perinatal outcomes. The normal hemoglobin level in the 1st and 3rd trimesters is ≥110 g/L, and in the 2nd trimester – ≥105 g/L. To confirm latent iron deficiency, blood ferritin testing may be recommended as the most accurate indicator for determining iron levels [73].
It is recommended to refer a pregnant patient at the 1st visit for a general medical biochemical blood test in order to detect and timely treat carbohydrate metabolism disorders, gastrointestinal and urinary system pathologies for the prevention of obstetric and perinatal complications [74], [75–77], [78].
LoE CGoE 3Level of Evidence C (Grade of Recommendation - 3).
Comment: The general medical biochemical blood test includes: total protein blood test, blood urea test, blood creatinine test, total bilirubin blood test, conjugated (direct) bilirubin blood test, alanine aminotransferase (ALT) activity determination in the blood, aspartate aminotransferase (AST) activity determination in the blood, blood glucose test. The diagnosis of gestational diabetes mellitus (GDM) can be made based on a single glucose test. The diagnostic criterion for GDM is a fasting venous plasma glucose value of ≥5.1 mmol/L, but not more than 7.0 mmol/L. At the pregravid stage, a blood glucose test is recommended (this test is included in the procedure for routine medical check-ups and health screening of the adult population and is performed annually).
It is recommended to refer a pregnant patient for additional blood glucose testing if a fasting venous blood glucose level of ≥7.0 mmol/L is detected, in order to rule out/confirm overt diabetes mellitus [79], [80]
GCP CLEL 5Level of Evidence C (Level of Likelihood of Evidence - 5).
Comment: The diagnosis of overt diabetes mellitus can be established upon repeat blood glucose testing or glycated hemoglobin (HbA1c) blood testing. The diagnostic criterion for overt diabetes mellitus is a fasting glucose level above 7.0 mmol/L or an HbA1c level >6.5%. For detailed rules of blood sampling for glucose testing, diagnostic criteria for overt diabetes mellitus, and GDM, see the 2023 draft clinical guidelines "Gestational Diabetes Mellitus" [81].
It is recommended to refer the pregnant patient for a glucose tolerance test (oral glucose tolerance test - OGTT) with 75 g of dextrose at 240-280 weeks of gestation, provided that no carbohydrate metabolism disorder has been detected or screening for GDM has not been performed in early pregnancy [76, 77, 82], [83].
GCR BLEL 2Grade of Recommendation B (Level of Evidence – 2).
Comment: For the rules of performing the OGTT, see the 2023 draft clinical guidelines "Gestational Diabetes Mellitus" [81].
It is recommended to refer a patient planning pregnancy (at the pregravid stage) and a pregnant patient once at the 1st visit for a blood thyroid-stimulating hormone (TSH) test and determination of anti-thyroperoxidase antibodies (anti-TPO) in the blood for early detection and treatment of thyroid dysfunction [84, 85], [86], [87].
LeveL of Recommendation AGrade of Evidence 2LeveL of Recommendation A (Grade of Evidence - 2).
Comments: If a pregnant woman's TSH level is >2.5 IU/mL and anti-TPO are positive, or if the TSH level is >4.0 IU/mL regardless of anti-TPO status, the pregnant woman should be referred for a consultation with an endocrinologist to prescribe hypothyroidism therapy [88], [89]. For the algorithm of examination and treatment of patients with hypothyroidism, see the 2021 clinical guidelines "Hypothyroidism" [90].
It is recommended to refer a patient planning pregnancy (at the pregravid stage) once, and a pregnant patient three times: at the 1st visit (at the 1st visit in the 1st trimester of pregnancy), in the 2nd and 3rd trimesters of pregnancy, for a general (clinical) urine test to detect and timely treat urinary system diseases in order to prevent obstetric and perinatal complications [91–93].
LoR CGoE 4Level of Recommendation C (Grade of Evidence - 4).
Comment: If a urinary tract infection is suspected, the patient management is carried out in accordance with the clinical guidelines "Urinary tract infection in pregnancy" 2022 [94].
It is recommended to determine protein in the urine of a pregnant patient after 22 weeks of gestation at each visit for the timely detection of proteinuria to choose the management strategy for pregnancy [19], [91], [95].
LoR CGoE 4Level of Recommendation C (Grade of Evidence - 4).
Comment: Protein in urine can be measured in a laboratory setting or using special reagent strips.
It is recommended to refer a patient planning pregnancy (at the pregravid stage) and a pregnant patient at the 1st visit for a cytological examination of a cervical smear (a smear from the surface of the cervix and the cervical canal) for cervical cancer screening [96].
LeveL of Recommendation AGrade of Evidence 2LeveL of Recommendation A (Grade of Evidence - 2).
Comment: A cytological examination of a smear from the surface of the cervix and from the cervical canal should be recommended depending on the date of the previous examination, its results, the presence of human papillomavirus infection, and the patient's age, in accordance with the clinical guidelines "Cervical intraepithelial neoplasia, erosion and ectropion of the cervix" 2020 [97].
It is recommended to refer a pregnant patient at the 1st visit for a microbiological (culture) urine test for bacterial pathogens using automated inoculation to detect asymptomatic bacteriuria [98].
GCR ALeE 1Grade of Recommendation A (Level of Evidence - 1).
Comment: Asymptomatic bacteriuria is the presence of bacterial colonies ≥105 in 1 ml of a midstream urine sample in the absence of clinical symptoms. Early detection of bacteriuria and therapy reduce the risk of pyelonephritis, preterm birth (PTB), and fetal growth restriction (FGR). If bacteriuria is detected, patient management is carried out in accordance with the clinical guidelines "Urinary tract infection in pregnancy" 2022 [94].
It is recommended to refer a pregnant patient at 350–370 weeks of gestation for a bacteriological examination of vaginal and rectal discharge for group B streptococcus (S. agalactiae) or determination of group B streptococcus (S. agalactiae) DNA in a vaginal and rectal swab by PCR for the timely detection and treatment of infection caused by S. agalactiae to reduce the risk of intrauterine infection [99, 100], [101].
Strength of Recommendation = BEvidence Level = 1Strength of recommendation B (level of evidence - 1).
Comments: If the test result is positive, patients are prescribed antibiotic prophylaxis during labor – see the clinical guidelines "Singleton childbirth, spontaneous delivery in occipital presentation (normal labor)" 2021 [102].
It is recommended to refer a pregnant patient at 110–136 weeks of gestation for 1st-trimester screening, which includes a combination of serum hCG (free beta-subunit) testing and pregnancy-associated plasma protein A (PAPP-A) blood testing, along with ultrasound screening to assess antenatal fetal development in order to detect chromosomal abnormalities (CA), malformations, and risks of FGR, PTB, and preeclampsia (screening I) (medical service code A04.30.001.003), followed by software calculation of the specified risks [103].
GCR ALeE 1Grade of Recommendation A (Level of Evidence - 1).
Comments: For an additional assessment of the risk of fetal CA, the patient may additionally be offered non-invasive prenatal testing (cell-free fetal DNA testing from maternal blood) (NIPT) after 10 weeks of pregnancy [104], [105].
It is not recommended to routinely refer pregnant patients for 2nd-trimester biochemical screening, which includes serum human chorionic gonadotropin (free β-subunit) testing, serum alpha-fetoprotein testing, serum unconjugated estriol testing (triple screening), and blood inhibin A testing (quadruple screening) [103, 106, 107].
LoR CGoE 1Level of recommendation C (grade of evidence - 1).
Comment: Second-trimester biochemical screening may be prescribed if 1st-trimester screening results are absent [1].
It is not recommended to routinely refer pregnant patients for blood group antibody testing (anti-A, anti-B) [108, 109].
GCR CLOE 4Grade of Recommendation C (Level of Evidence - 4).
Comment: There is no evidence base for predicting fetal hemolytic disease associated with the ABO system.
It is not recommended to routinely refer patients planning pregnancy (at the preconception stage) and pregnant patients for blood tests for immunoglobulin G (IgG) and immunoglobulin M (IgM) antibodies to Toxoplasma gondii [110, 111].
GCR BLEL 3Recommendation Grade B (Level of Evidence — 3).
Comments: This test has low specificity, a high rate of false-positive results, and consequently leads to unjustified toxoplasmosis therapy. There is no evidence base regarding the efficacy of antenatal toxoplasmosis therapy in reducing adverse perinatal outcomes. Pregnant women should be informed about toxoplasmosis prevention methods: hand hygiene before meals, washing fresh fruits and vegetables, thermal processing of meat, using gloves when handling soil and washing hands after soil contact, and avoiding contact with cats.
It is not recommended to routinely refer patients planning pregnancy (at the preconception stage) and pregnant patients for blood tests for immunoglobulin M and G (IgM, IgG) antibodies to Cytomegalovirus [24], [112, 113].
GCP CLEL 5Level of Evidence C (Level of Likelihood of Evidence - 5).
Comment: This test has low specificity, a high rate of false-positive results, and consequently leads to unjustified therapy for CMV infection. Etiotropic therapy and prevention of intrauterine transmission of CMV infection are not available.
It is not recommended to routinely refer patients planning pregnancy (at the preconception stage) and pregnant patients for blood tests for antibodies to Herpes simplex virus, regardless of the presence or absence of a history of recurrent HSV infection symptoms [24].
GCP CLEL 5Level of Evidence C (Level of Likelihood of Evidence - 5).
Comment: This test has low specificity, a high rate of false-positive results, and consequently leads to unjustified therapy for HSV infection.
If a high risk of chromosomal abnormalities (CA) and/or fetal malformations associated with CA is confirmed by NIPT and/or 1st or 2nd-trimester screening data with recalculation of the individual risk of giving birth to a child with CA based on repeated fetal ultrasound data, it is recommended to refer the pregnant patient for invasive prenatal diagnosis (chorionic villus sampling, placental biopsy, amniocentesis, cordocentesis) with cytogenetic testing (cytogenetic analysis (karyotype)) or molecular genetic testing of the obtained material [24, 114–116], [117], [118].
GCR ALeE 1Grade of Recommendation A (Level of Evidence - 1).
Comments: Chorionic villus sampling is performed at 10–14 weeks of gestation. Amniocentesis is performed at a gestational age of >15 weeks [114]. The individual high risk of fetal CA according to screening is ≥1/100. Contraindications to invasive prenatal diagnosis include: infectious and inflammatory diseases of any localization, threatened miscarriage, or preterm birth. In cases of Rh(D) sensitization, the potential benefit versus risk of invasive diagnostics must be carefully weighed [24].
2.4 Instrumental Diagnostics
It is recommended to refer patients planning pregnancy (at the preconception stage) for an ultrasound of the uterus and appendages (transvaginal, or transabdominal/transrectal if transvaginal is not feasible) during the early follicular phase of the menstrual cycle [1].
GCP CLEL 5Level of Evidence C (Level of Likelihood of Evidence - 5).
Comments: Uterine and adnexal ultrasound is recommended to determine the size of the uterus and ovaries, diagnose uterine and adnexal neoplasms, developmental anomalies, pathological endometrial processes (polyps, hyperplasia, chronic endometritis), endometrial thickness, assess a previous uterine scar (if present), and determine the antral follicle count. Antral follicles are defined as follicles with a mean diameter of 2–10 mm in the largest two-dimensional plane.
It is recommended to refer a pregnant patient during their first visit in the 1st trimester of pregnancy at a menstrual delay of ≥7 days for an ultrasound of the uterus and appendages (up to 96 weeks of gestation) or fetal ultrasound (after 100 weeks of gestation) to diagnose pregnancy, determine its location, assess whether the gestational sac/embryo/fetus corresponds to the gestational age, and confirm the presence of embryonic/fetal heartbeat [119].
GCP CLEL 5Level of Evidence C (Level of Likelihood of Evidence - 5).
Comments: Transvaginal ultrasound is the method of choice. If transvaginal ultrasound is unavailable, transabdominal ultrasound may be used; however, this method is less accurate than transvaginal ultrasound for diagnosing early pregnancy complications.
It is recommended to refer pregnant patients at 110–136 weeks of gestation for a fetal ultrasound at a medical institution providing expert-level prenatal diagnosis to determine gestational age [35–37], perform 1st-trimester screening [103], and diagnose multiple pregnancy [120].
GCR ALeE 1Grade of Recommendation A (Level of Evidence - 1).
Comment: During ultrasound at 110–136 weeks, it is recommended to measure the pulsatility index (PI) in the uterine arteries to predict early preeclampsia.
It is recommended to refer pregnant patients at their first visit and in the 3rd trimester for an electrocardiogram to rule out myocardial hypertrophy, ischemia, rhythm disturbances, and conduction abnormalities [1], [121].
GCP CLEL 5Level of Evidence C (Level of Likelihood of Evidence - 5).
Comment: Electrocardiography is recommended at the preconception stage (this test is included in the routine preventive medical examination and health check-up protocol for the adult population and is performed starting from age 18 at the first visit, then annually from age 35+).
Fetal auscultation (determination of fetal heart rate [FHR]) using a fetal Doppler (compact maternal-fetal cardiovascular activity Doppler analyzer) or an obstetric stethoscope is recommended for pregnant patients at every visit starting from 220 weeks of gestation to confirm fetal viability [43], [122].
GPP CLoE 5Level of Evidence/Grade of Recommendation C (level of evidence - 5).
Comment: In the absence of FHR or in case of fetal heart rate abnormalities (tachycardia, bradycardia, arrhythmia), it is recommended to refer the pregnant patient for a fetal ultrasound, ultrasound Doppler study of uteroplacental and fetoplacental blood flow, or fetal cardiotocography (CTG).
It is recommended to refer pregnant patients at 180–206 weeks of gestation for a screening ultrasound to assess antenatal fetal development in order to detect CA, malformations, risks of fetal growth restriction (FGR), preterm birth, preeclampsia (Screening II) (medical service code A04.30.001.005), congenital malformations, assess extraembryonic structures (localization, thickness, placental structure, amniotic fluid volume), and perform cervical ultrasound (ultrasound cervicometry) at a medical institution specializing in prenatal diagnosis [106], [123], [124], [125], [126], [127], [128], [129].
GCR ALeE 1Grade of Recommendation A (Level of Evidence - 1).
Comment: Additional 2nd-trimester ultrasounds should be scheduled if FHR is absent or abnormal (tachycardia, bradycardia, arrhythmia) during fetal auscultation, or if fetal growth restriction is suspected based on the gravidogram. For the timing and frequency of ultrasound cervicometry in patients at high risk for late miscarriage and preterm birth, see the 2021 clinical guidelines "Incompetent Cervix" [32].
It is recommended to refer pregnant patients with a high risk of CA and/or fetal malformations associated with CA based on 1st or 2nd-trimester screening data for a repeat fetal ultrasound [130], [131].
GCP CLEL 5Level of Evidence C (Level of Likelihood of Evidence - 5).
Comment: Repeat fetal ultrasound is performed at a level III obstetric medical institution or a medical genetic center (consultation) holding licenses for "obstetrics and gynecology (excluding assisted reproductive technologies and artificial termination of pregnancy)," "ultrasound diagnostics," and "clinical laboratory diagnostics" for the purpose of programmatic recalculation of the risk of giving birth to a child with CA.
It is recommended at 340–356 weeks of gestation to refer the patient for a fetal ultrasound to diagnose late-manifesting fetal malformations, large-for-gestational-age, or small-for-gestational-age fetuses [132, 133], [134], [135], [136], [137].
GCR ALeE 1Grade of Recommendation A (Level of Evidence - 1).
Comments: Additional ultrasound examinations in the 3rd trimester of pregnancy (after 340–366 weeks) may be prescribed if fetal malpresentation or placenta previa is suspected [19, 46], if fetal heart rate is absent or abnormal (tachycardia, bradycardia, arrhythmia) during fetal heart auscultation, or if uterine size does not correspond to gestational age.
Recommended twice: at 180-206 weeks and at 300-336 weeks of gestation, to refer a pregnant patient at high risk for obstetric and perinatal complications (PE, PTB, FGR) for ultrasonic dopplerography of uteroplacental and fetoplacental blood flow in order to reduce perinatal mortality, address the issue of labor induction, and delivery via cesarean section [138–140], [141].
GOM BLOE 1Grade of Recommendation B (Level of Evidence - 1).
Comment: In pregnant patients from the low-risk group for obstetric and perinatal complications (preeclampsia, preterm birth, fetal growth restriction), ultrasonic dopplerography of uteroplacental and fetoplacental blood flow does not lead to an improvement in maternal or perinatal outcomes.
It is recommended to perform fetal CTG for a pregnant patient starting from 320 weeks of gestation with a frequency of once every 2 weeks [142].
GCR ALeE 1Grade of Recommendation A (Level of Evidence - 1).
It is recommended to measure pelvic dimensions (pelvimetry) in a pregnant patient in the 3rd trimester of pregnancy [1].
GCP CLEL 5Level of Evidence C (Level of Likelihood of Evidence - 5).
Comment: Pelvic dimensions are measured using an obstetric pelvimeter to determine obstetric management during delivery.
2.5 Other Procedures
It is recommended to refer a patient planning pregnancy (at the preconceptional stage) and a pregnant patient for a consultation with a general practitioner and a dentist twice: at the 1st visit (during the 1st visit in the 1st or 2nd trimester of pregnancy) and in the 3rd trimester of pregnancy, for the timely diagnosis and treatment of somatic diseases and sanitation of infection foci [1], [143].
GCP CLEL 5Level of Evidence C (Level of Likelihood of Evidence - 5).
It is recommended to refer a pregnant patient at the 1st visit for a consultation with an ophthalmologist for the diagnosis and treatment of eye diseases and the identification of contraindications to vaginal delivery [144].
GCP CLEL 5Level of Evidence C (Level of Likelihood of Evidence - 5).
It is recommended to refer a patient planning pregnancy (at the preconceptional stage) and a pregnant patient for a genetic counseling consultation if risk factors for giving birth to a child with a chromosomal or genetic anomaly are identified in her and/or her husband/partner [104].
GCP CLEL 5Level of Evidence C (Level of Likelihood of Evidence - 5).
Comments: Risk factors for giving birth to a child with a chromosomal or genetic anomaly include: presence of chromosomal or genetic anomalies in at least one of the spouses/partners; presence of children with chromosomal or genetic anomalies, congenital malformations, or mental retardation in at least one of the spouses/partners; consanguineous marriage.
It is recommended to refer a pregnant patient with pathological electrocardiogram changes for a consultation with a cardiologist [1].
GCP CLEL 5Level of Evidence C (Level of Likelihood of Evidence - 5).
It is recommended to refer a pregnant patient for a consultation with a medical psychologist twice: at the 1st visit (during the 1st visit in the 1st or 2nd trimester of pregnancy) and in the 3rd trimester of pregnancy, in order to reduce the risk of obstetric and perinatal complications and to foster positive attitudes toward carrying and giving birth to a child [145], [146], [147], [148], [149], [150], [151], [152], [153].
GCR ALeE 1Grade of Recommendation A (Level of Evidence - 1).
3. Treatment, including drug and non-drug therapies, diet therapy, and pain management
3.1 Non-pharmacological methods for managing symptoms occurring during normal pregnancy
* The recommendations in this section apply only to patients with a normal pregnancy.
It is recommended to suggest following a diet in case of complaints of nausea and vomiting [4, 154–156].
GCR ALeE 1Grade of Recommendation A (Level of Evidence - 1).
Comments: The diet includes: frequent, small meals; exclusion of fatty, fried foods, chocolate, spicy foods, carbonated beverages, coffee, and strong tea.
It is recommended to suggest avoiding body positions that contribute to heartburn, following a diet, and wearing loose clothing that does not put pressure on the stomach area in case of complaints of heartburn [1].
GCP CLEL 5Level of Evidence C (Level of Likelihood of Evidence - 5).
It is recommended to suggest increasing physical activity and adding dietary fiber (plant-based foods) to the diet in case of complaints of constipation and hemorrhoids [157].
GPP ALOE 2Grade of Recommendation A (Level of Evidence – 2).
Elastic compression of the lower extremities is recommended in case of complaints of varicose veins of the lower extremities [158].
LeveL of Recommendation BGrade of Evidence 2LeveL of Recommendation B (Grade of Evidence - 2).
Comments: Wearing compression stockings helps compress superficial veins, reduce congestion, and increase blood flow velocity in the deep veins of the lower extremities. In addition to compression hosiery, the pregnant patient may be prescribed a set of exercises (medical gymnastics) and contrast showers combined with a proper work-rest schedule. If there is pronounced dilatation of the lower extremities' veins, a consultation with a cardiovascular surgeon is recommended.
It is recommended to suggest maintaining a physical activity regimen in case of complaints of back pain [159, 160].
GPP ALOE 1Grade of Recommendation A (Level of Evidence – 1).
Comment: Adherence to the physical activity regimen includes swimming and exercise.
It is recommended to suggest wearing a special orthopedic belt and using elbow crutches when moving in case of complaints of pubic pain [161].
Level CLevel 5Level of recommendation evidence C (reliability level of evidence – 5).
3.2 Pharmacological methods for managing symptoms occurring during normal pregnancy
* The recommendations in this section apply only to patients with a normal pregnancy.
It is recommended to prescribe antacid preparations (ATC antacids) for complaints of heartburn and lack of effect from lifestyle and dietary modifications [162, 163].
LeveL of Recommendation BGrade of Evidence 2LeveL of Recommendation B (Grade of Evidence - 2).
It is recommended to prescribe medications approved for use during pregnancy in accordance with the 2020 clinical guidelines on "Hemorrhoids" for complaints of hemorrhoids when conservative measures for constipation prevention are ineffective [164, 165], [166].
Level of Evidence BLevel of Confidence 2Level of recommendation B (level of evidence – 2).
3.3 Prescription of vitamins and trace elements
It is recommended to prescribe oral folic acid** at a dose of 400–800 mcg daily to a patient planning pregnancy (at the preconceptional stage) 2–3 months before conception and throughout the first 12 weeks of pregnancy to reduce the risk of fetal neural tube defects [19], [167, 168], [169], [170], [171].
GCR ALeE 1Grade of Recommendation A (Level of Evidence - 1).
Comment: Prescribing folic acid to pregnant minors under 18 years of age is recommended in the form of a dietary supplement if childhood is listed as a contraindication in the drug's package leaflet. The dose of folic acid depends on the risk of neural tube defects. High risk is present in cases of a personal or family history of neural tube defects, or maternal malabsorption syndrome. Folic acid can be prescribed as a single agent or as part of multivitamins and multivitamin-mineral combinations.
It is recommended to prescribe oral iodine preparations (potassium iodide**) at a dose of 200 mcg daily to a patient planning pregnancy (at the preconceptional stage) 2–3 months before conception and throughout pregnancy to eliminate iodine deficiency for the prevention of fetal neurogenesis disorders [87], [172].
GCP CLEL 5Level of Evidence C (Level of Likelihood of Evidence - 5).
Comments: Iodine preparations can be prescribed as a single agent or as part of multivitamins and multivitamin-mineral combinations.
It is recommended to prescribe oral cholecalciferol** at a dose of 500–1000 IU daily throughout pregnancy to a pregnant patient from the high-risk group for hypovitaminosis to prevent vitamin D deficiency and reduce the risk of obstetric complications [173, 174], [175], [176], [177], [178].
GOM BLOE 1Grade of Recommendation B (Level of Evidence - 1).
Comments: The high-risk group for vitamin D hypovitaminosis includes women with dark skin [179], vitiligo [180], limited sun exposure [181], gastrointestinal diseases [182], poor nutrition [183], obesity [184], anemia [185], and diabetes [186]. According to the drug's instructions, a dose of 500 IU is recommended in the 1st and 2nd trimesters of pregnancy; from 28 weeks of gestation, prescribing 1000 IU of cholecalciferol** is possible to prevent vitamin D deficiency and insufficiency. Cholecalciferol** can be prescribed as a single agent or as part of multivitamins and multivitamin-mineral combinations. If laboratory-confirmed vitamin D deficiency is present, an endocrinologist consultation and adjustment of the cholecalciferol** dose are required in accordance with the draft clinical guidelines of the Russian Association of Endocrinologists "Vitamin D Deficiency" 2023 [187]. In the low-risk group for vitamin D hypovitaminosis, its administration does not reduce the risk of such obstetric complications as preeclampsia, fetal growth restriction, and gestational diabetes mellitus [188, 189].
It is not recommended to routinely prescribe multivitamins and multivitamin-mineral combinations to pregnant patients from the low-risk hypovitaminosis group [190].
Gar CLoE 1Grade of Recommendation C (Level of Evidence - 1).
Comment: The positive effect of certain vitamins and micronutrients (folic acid**, cholecalciferol**, iron supplements) on perinatal outcomes has been proven [191], [192], [193]. Oral intake of multivitamins or multivitamins combined with minerals throughout pregnancy (taking into account the vitamin and micronutrient dosages recommended above) is recommended for pregnant patients at high risk of hypovitaminosis [194]. Women at high risk of hypovitaminosis include those with conditions that impair vitamin metabolism [195], [196], specific dietary habits (vegetarian/vegan diet, calorie-restricted diet) [197], obesity [198], and excessive physical exertion [199].
It is not recommended to routinely prescribe Omega-3 polyunsaturated fatty acids (ATC: Omega-3 triglycerides, including other esters and acids) to a pregnant patient [178], [200], [201], [202], [203], [204], [205], [206].
Strength of Recommendation = BEvidence Level = 1Strength of recommendation B (level of evidence - 1).
Comment: The administration of Omega-3 triglycerides, including other esters and acids, does not reduce the risk of GDM, preterm birth, neurocognitive developmental disorders in children, postpartum depression, preeclampsia, or fetal growth restriction. A pregnant patient at risk of preterm birth and fetal growth restriction, such as a smoking pregnant patient, may be advised to take Omega-3 triglycerides, including other esters and acids, as this reduces the risk of spontaneous preterm birth and low birth weight infants [207].
It is not recommended to routinely prescribe iron supplements to a pregnant patient with normal hemoglobin levels [208], [209], [210].
CoSR ALoE 2Grade of Recommendation A (Level of Evidence - 2).
Comments: There is no evidence of a benefit from routine iron supplementation for maternal or child health [211]. Meanwhile, patients at risk of latent iron deficiency and iron deficiency anemia (in whom the cause of the iron-deficient state cannot be eliminated, or those following a vegetarian or vegan diet) are recommended to receive prophylactic doses of iron medicinal products, while patients with iron deficiency anemia should receive therapeutic doses of iron products in accordance with the 2021 clinical guidelines on "Iron Deficiency Anemia" [212].
It is not recommended to routinely prescribe retinol** (vitamin A) to a pregnant patient [213], [214].
GCR ALeE 1Grade of Recommendation A (Level of Evidence - 1).
Comments: There is no evidence of a benefit from routine vitamin A supplementation. Vitamin A intake does not reduce the risk of maternal, perinatal, and neonatal mortality, stillbirth, or the birth of low birth weight infants [213]. High doses of vitamin A (>10,000 IU) can have a teratogenic effect [214], [215], [216], [217], [218], [219].
It is not recommended to routinely prescribe vitamin E to a pregnant patient [220], [221].
GCR ALeE 1Grade of Recommendation A (Level of Evidence - 1).
Comments: Vitamin E supplementation does not reduce the risk of obstetric and perinatal complications such as preeclampsia, preterm birth, fetal growth restriction, antenatal fetal death, and neonatal death.
It is not recommended to routinely prescribe ascorbic acid** (vitamin C) to a pregnant patient [220], [222], [223].
LeR ALoE 1Level of Evidence Recommendation A (Level of Evidence - 1).
Comments: Routine administration of ascorbic acid** does not reduce the risk of obstetric and perinatal complications such as preeclampsia, preterm birth, fetal growth restriction, antenatal fetal death, and neonatal death.
4. Medical Rehabilitation and Sanatorium-Resort Treatment
Not applicable
5. Prevention and Dispensary Observation
5.1 Recommendations for the elimination of risk factors for the prevention of pregnancy complications
It is recommended to inform patients planning pregnancy (at the preconception stage) and pregnant patients about the need to normalize body weight prior to conception and ensure appropriate weight gain during pregnancy based on pre-pregnancy BMI in order to prevent obstetric and perinatal complications [24, 224–227].
GPP ALE 2Grade of Recommendations A (Level of Evidence 2).
Comments: Both excessive and inadequate weight gain during pregnancy are associated with obstetric and perinatal complications. Pregnant patients with obesity (BMI ≥ 30 kg/m2) constitute a high-risk group for perinatal complications: miscarriage, GDM, hypertensive disorders, preterm birth, operative delivery, antenatal and intranatal fetal death, and thromboembolic events [24, 228]. Pregnant women with BMI ≤ 18.5 kg/m2 constitute a high-risk group for fetal growth restriction [227].
It is recommended to inform a pregnant patient about the need to avoid work associated with prolonged standing or excessive physical exertion, night shifts, and fatiguing labor in order to prevent obstetric and perinatal complications [229–231].
LeveL of Recommendation BGrade of Evidence 2LeveL of Recommendation B (Grade of Evidence - 2).
Comment: These types of work are associated with an increased risk of preterm birth, hypertension, preeclampsia, and fetal growth restriction.
It is recommended to inform patients planning pregnancy (at the preconception stage) and pregnant patients about the need to avoid work involving exposure to X-ray radiation in order to prevent obstetric and perinatal complications [232, 233].
GCR CLOE 4Grade of Recommendation C (Level of Evidence - 4).
It is recommended to inform a pregnant patient about the benefits of regular moderate physical activity (20–30 minutes per day) to prevent obstetric and perinatal complications [234].
GCP CLEL 5Level of Evidence C (Level of Likelihood of Evidence - 5).
Comment: Physical exercises not associated with excessive strain or potential trauma to the woman do not increase the risk of preterm birth and impaired child development [235, 236].
It is recommended to inform a pregnant patient about the need to avoid physical exercises that can lead to abdominal trauma, falls, or stress (e.g., contact sports such as wrestling, racket and ball sports, scuba diving) in order to prevent obstetric and perinatal complications [237].
GCP CLEL 5Level of Evidence C (Level of Likelihood of Evidence - 5).
It is recommended to inform a pregnant patient planning a long-haul flight about the need for preventive measures against thromboembolic events, such as walking in the aircraft cabin, drinking plenty of fluids, avoiding alcohol and caffeine [238, 239], and wearing compression stockings during the flight [240, 241].
GCP CLEL 5Level of Evidence C (Level of Likelihood of Evidence - 5).
Comments: Air travel increases the risk of thromboembolic events, which ranges from 1/400 to 1/10,000 cases, regardless of pregnancy. Since asymptomatic thromboembolic events frequently occur, this risk may be even higher (approximately 10-fold) [238].
It is recommended to inform a pregnant patient about the correct use of a car seatbelt, as proper seatbelt use reduces the risk of fetal loss in the event of an accident by 2 to 3 times [242, 243].
LoR CGoE 4Level of Recommendation C (Grade of Evidence - 4).
Comment: Proper seatbelt use in a pregnant woman involves using a three-point belt, where the lap strap is positioned below the bump across the hips, the diagonal strap goes across the shoulder, and the third section runs above the bump between the breasts [244].
It is recommended to inform patients planning pregnancy (at the preconception stage) and pregnant patients about healthy lifestyle rules aimed at reducing exposure to harmful environmental factors (pollutants) in order to prevent obstetric and perinatal complications [245–249].
LeveL of Recommendation BGrade of Evidence 2LeveL of Recommendation B (Grade of Evidence - 2).
Comment: An increased risk of miscarriage, preterm birth, gestational arterial hypertension, and other pregnancy complications has been identified due to exposure to pollutants present in ambient air, water, and food (e.g., heavy metals such as arsenic and lead, and other organic compounds such as bisphenol A).
It is recommended to inform patients planning pregnancy (at the preconception stage) and pregnant patients about the need to quit smoking in order to prevent obstetric and perinatal complications [250–252].
LeveL of Recommendation BGrade of Evidence 2LeveL of Recommendation B (Grade of Evidence - 2).
Comments: Smoking during pregnancy is associated with complications such as fetal growth restriction, preterm birth, placenta previa, placental abruption, maternal hypothyroidism [250, 251], premature rupture of membranes [252], low birth weight, perinatal mortality [250], and ectopic pregnancy [250]. Approximately 5–8% of preterm births, 13–19% of term births with low birth weight, 23–34% of sudden infant death syndrome cases, and 5–7% of deaths in childhood due to causes related to prenatal pathology may be associated with maternal smoking during pregnancy [253]. Children born to smoking mothers have an increased risk of asthma, infantile colic, and obesity [254–256].
It is recommended to inform patients planning pregnancy (at the preconception stage) and pregnant patients about the need to abstain from alcohol in order to prevent obstetric and perinatal complications [257, 258].
GPP CLoE 5Level of Evidence/Grade of Recommendation C (level of evidence - 5).
Comment: Despite the lack of high-level evidence regarding the negative impact of small doses of alcohol on obstetric and perinatal complications, a sufficient body of observations has accumulated concerning the negative impact of alcohol on the course of pregnancy regardless of the dose consumed [257, 259–261], such as fetal alcohol syndrome and psychomotor developmental delay [258].
It is recommended to inform patients planning pregnancy (at the preconception stage) and pregnant patients about the need for proper nutrition, specifically avoiding vegetarianism [262] and reducing caffeine intake in order to prevent obstetric and perinatal complications [263–266].
LeveL of Recommendation BGrade of Evidence 2LeveL of Recommendation B (Grade of Evidence - 2).
Comments: Vegetarianism during pregnancy increases the risk of fetal growth restriction [262]. High caffeine intake (more than 300 mg/day) increases the risk of miscarriage and low birth weight infants [263–266].
It is recommended to inform patients planning pregnancy (at the preconceptional stage) and pregnant patients about the need for proper nutrition, in particular avoiding the consumption of fish rich in methylmercury [267, 268], reducing the consumption of foods rich in vitamin A (e.g., beef, chicken, and duck liver and products made from it) [269], and consuming foods with adequate caloric value, protein, vitamin, and mineral content in order to prevent obstetric and perinatal complications [270].
LoR CGoE 4Level of Recommendation C (Grade of Evidence - 4).
Comments: High consumption of fish rich in methylmercury (e.g., tuna, shark, swordfish, mackerel) can cause fetal developmental abnormalities [267, 268]. A healthy diet during pregnancy is characterized by adequate caloric value and sufficient content of protein, vitamins, and minerals obtained by consuming a variety of foods, including green and orange vegetables, meat, fish, legumes, nuts, fruits, and whole-grain products [270].
It is recommended to inform patients planning pregnancy (at the preconceptional stage) and pregnant patients about the need to avoid the consumption of unpasteurized milk, ripened soft cheeses, pâté, and poorly cooked meat and eggs, as these products are sources of listeriosis and salmonellosis [271, 272].
GCP CLEL 5Level of Evidence C (Level of Likelihood of Evidence - 5).
Comments: The most common foodborne infections are listeriosis and salmonellosis. The incidence of listeriosis in pregnant women is higher (12/100,000) than in the general population (0.7/100,000) [271].
It is recommended to assess risk factors for pregnancy complications in order to identify risk groups and ensure timely prevention of obstetric and perinatal complications [1].
GPP CLoE 5Level of Evidence/Grade of Recommendation C (level of evidence - 5).
Comment: Assessment of risk factors for obstetric and perinatal complications should be carried out in accordance with current clinical guidelines for the relevant diseases (conditions) (possibly using automated information systems).
5.2 Specific antenatal prevention of Rhesus isoimmunization
A pregnant Rh-negative patient with a negative anti-Rh antibody titer at 28 weeks is recommended to be administered human anti-Rh₀(D) immunoglobulin** at 28–30 weeks of gestation at a dose according to the product instructions, intramuscularly [65, 273].
LeR ALoE 1Level of Evidence Recommendation A (Level of Evidence - 1).
Comments: If the husband/partner has Rh-negative blood or the fetus has Rh-negative blood determined by non-invasive testing, the administration of human anti-Rh₀(D) immunoglobulin** at 28–30 weeks is not performed. If prophylaxis was not performed at 28 weeks, it is indicated after 28 weeks of gestation provided that anti-Rh antibodies are absent.
A pregnant Rh-negative patient with a negative anti-Rh antibody titer after amniocentesis, cordocentesis, chorionic villus sampling, or placental biopsy is recommended to receive an additional dose of human anti-Rh₀(D) immunoglobulin** according to the product instructions, administered intramuscularly [24, 274], [275], [276].
GPP CLOE 4Grade of Recommendation C (Level of Evidence – 4).
5.3 Vaccination at the pre-pregnancy stage and during pregnancy
A patient planning pregnancy is recommended to evaluate her vaccination status, infection risk, and the consequences of past infections in order to determine the need for and type of vaccination [277], [278], [279], [280].
Level CLevel 5Level of recommendation evidence C (reliability level of evidence – 5).
Comment: For non-pregnant patients at the preconceptional stage, the following vaccination rules apply:
Revaccination against diphtheria and tetanus is carried out every 10 years. In preparation for a planned pregnancy, vaccination against diphtheria and tetanus should be performed at least 1 month before conception.
Hepatitis B vaccination is carried out in a three-dose schedule at 0–1–6 months. In preparation for a planned pregnancy, hepatitis B vaccination should be started no later than 7 months before conception.
Rubella vaccination is administered to women who have not been previously vaccinated, have received only one dose, or have not had the disease. In preparation for a planned pregnancy, rubella vaccination should be performed no later than 2 months before the planned pregnancy.
Measles vaccination is administered to women ≤35 years of age (women of certain occupations aged ≤55 years) who have not been previously vaccinated, have received only one dose, or have not had the disease.
The use of a combined measles, mumps, and rubella vaccine** in women requires avoiding pregnancy for 1 month after vaccine administration.
Varicella vaccination is administered to women who have not been previously vaccinated and have not had the disease. In preparation for a planned pregnancy, varicella vaccination should be performed no later than 3 months before the planned pregnancy.
COVID-19 vaccination is administered to patients planning pregnancy (at the preconceptional stage) and pregnant patients using COVID-19 vaccines** with an up-to-date antigenic composition in accordance with the product instructions [281]. The frequency of vaccination is determined by regulatory documents of the Russian Ministry of Health.
During the influenza season, vaccination with influenza vaccines is recommended for patients planning pregnancy (at the preconceptional stage, 1 month before planned pregnancy) and for pregnant patients in the 2nd–3rd trimesters of pregnancy (in high-risk groups, starting from the 1st trimester) [282], [283].
GCP CLEL 5Level of Evidence C (Level of Likelihood of Evidence - 5).
Comment: During pregnancy, influenza vaccines are used (trivalent or quadrivalent inactivated vaccines, preservative-free).
Pregnant patients are not recommended to receive viral vaccines containing attenuated strains (against measles, rubella, mumps, varicella, etc.) [284], [285], [279].
GCP CLEL 5Level of Evidence C (Level of Likelihood of Evidence - 5).
Comment: Pregnant patients are contraindicated for vaccination with viral infection vaccines containing attenuated strains (against measles, rubella, mumps, varicella, etc.) [284] (Table 3). Vaccinating a pregnant patient who has not been previously vaccinated or infected against yellow fever is permissible only in the event of impending relocation to an endemic area or due to epidemiological indications [277]. Pregnant patients may receive inactivated vaccines, recombinant vaccines, or toxoids (bacterial infection vaccines) in case of a high risk of infection.
Vaccinating a pregnant patient against poliomyelitis, hepatitis A and B, meningococcal, and pneumococcal infections should be performed in the event of impending relocation to an endemic area, as post-exposure prophylaxis, and in case of a high risk of infection, provided vaccination was not performed during preconceptional preparation [286], [287]. When vaccinating against viral hepatitis B, preservative-free vaccines are used.
Therapeutic and prophylactic immunization with a rabies vaccine** may be administered to a pregnant woman if there is a risk of rabies infection as a result of contact and a bite from rabid animals, animals suspected of having rabies, wild or unknown animals.
A pregnant patient should be vaccinated against tetanus if there is a high risk of infection and if vaccination was not performed at the preconceptional stage.
A pregnant patient should be vaccinated against diphtheria and pertussis if there is a high risk of infection and if vaccination was not performed at the preconceptional stage. Adsorbed diphtheria (with reduced antigen content), pertussis (with reduced antigen content, acellular), and tetanus vaccine** is used, which additionally promotes the production of serum anti-pertussis antibodies in the woman with subsequent transplacental transfer and prevention of pertussis in infants. Vaccination of pregnant women against pertussis can be carried out in the 2nd or 3rd trimesters, but no later than 15 days before the expected delivery date for the prevention of pertussis infection [288].
Artificial termination of pregnancy is not recommended in the event of inadvertent administration of viral vaccines containing attenuated strains (vaccines against measles, rubella, mumps, varicella, influenza, etc.) because the risk of complications from pregnancy termination significantly exceeds the likelihood of adverse events following vaccination [277], [289].
GCP CLEL 5Level of Evidence C (Level of Likelihood of Evidence - 5).
Table 3
Vaccination during pregnancy [290]
Disease for which vaccination is performed | Vaccination during pregnancy | Comment |
Influenza | During influenza season in the 2nd–3rd trimester; in high-risk groups — starting from the 1st trimester | Trivalent/quadrivalent inactivated vaccines |
COVID-19 | Gestational age — according to the vaccine instructions | COVID-19 vaccines** according to the vaccine instructions |
Rubella* | No | Pregnancy should be planned no earlier than 2 months after vaccination |
Varicella* | No | Pregnancy should be planned no earlier than 3 months after vaccination |
Tuberculosis* | No | |
Measles* | No | |
Mumps* | No | |
Yellow fever* | No | Only according to epidemiological indications |
Q fever* | No | |
Tularemia* | No | |
Plague* | No | |
Anthrax* | No | |
Brucellosis* | ||
Ebola virus disease | No | Safety not established |
Typhoid fever | No | Safety not established |
Cholera | No | Safety not established |
Leptospirosis | No | Safety not established |
HPV infection | No | Safety not established |
Hepatitis A | Yes | Only in case of high risk of infection |
Hepatitis B | Yes | Only in case of high risk of infection. Preservative-free vaccines. |
Meningococcal infection | Yes | Only in case of high risk of infection |
Pneumococcal infection | Yes | Only in case of high risk of infection |
Poliomyelitis | Yes | Only in case of high risk of infection |
Rabies | Yes | Therapeutic and prophylactic immunization |
Tick-borne encephalitis | Yes | Only in case of high risk of infection |
Diphtheria, tetanus, pertussis | Yes | In case of high risk of infection |
* – live vaccine, contraindicated during pregnancy
6. Organization of Medical Care
In an uncomplicated pregnancy, hospitalization is required only for delivery and for therapeutic and prophylactic desensitization measures performed up to 36 weeks of gestation in a day hospital setting.
Main indications for hospitalization in an obstetric and gynecological inpatient facility:
Onset of labor.
Rupture or leakage of amniotic fluid.
Bloody vaginal discharge indicating the threat of miscarriage.
Signs of threatened preterm labor.
Signs of placental abruption.
Signs of cervical incompetence.
Vomiting of pregnancy > 10 times per day and weight loss > 3 kg over 1–1.5 weeks in the absence of a response to ongoing therapy.
A single elevation of diastolic BP ≥110 mm Hg or a twofold elevation of diastolic BP ≥90 mm Hg at least 4 hours apart.
Systolic BP elevation ≥160 mm Hg.
Proteinuria (1+).
Symptoms of multiple organ failure (headache, visual disturbances, epigastric pain, vomiting, liver damage symptoms, oliguria/anuria, altered consciousness, history of seizures, hyperreflexia).
Signs of chorioamnionitis.
Fetal growth restriction grade 2–3.
Impairment of the functional state of the fetus according to dopplerometry and CTG.
Intrauterine fetal demise.
Acute abdomen.
Acute infectious and inflammatory diseases.
Indications for patient discharge from a medical organization: In accordance with the identified pathology (see relevant clinical guidelines).
Frequency of visits to an obstetrician-gynecologist during a normal pregnancy: The optimal frequency of visits to an obstetrician-gynecologist for a pregnant woman with an uncomplicated pregnancy is 5 to 7 times. The optimal time for the first visit to a doctor is the 1st trimester of pregnancy (up to 10 weeks) [19].
In small, remote, and hard-to-reach settlements lacking specialized medical organizations (their structural subdivisions), primary pre-medical health care for women during pregnancy is provided by a midwife or feldsher at feldsher-midwife stations (including mobile ones) or feldsher health posts; primary general medical care is provided by general practitioners (family physicians) in general practice (family medicine) offices; primary specialized health care is provided by obstetricians-gynecologists in central district hospitals (district hospitals) that include women's consultations or obstetric and gynecological departments (offices).
When medical care during pregnancy is provided by general practitioners (family physicians) or medical staff of feldsher-midwife stations and feldsher health posts, in the event of complications, consultation with an obstetrician-gynecologist and a disease-specific specialist is ensured, including through the use of telemedicine technologies.
Some laboratory and instrumental examinations can be performed at women's consultations or obstetric and gynecological departments (offices) of central district hospitals (district hospitals) ensuring transport accessibility for women, or in mobile medical units.
Also, pregnant women living in areas remote from obstetric inpatient facilities who have no indications for hospitalization in the pregnancy pathology department are referred for antenatal hospitalization to obstetric care departments for pregnant women for observation.
In the event of an emergency and/or urgent condition of the woman and/or fetus, a pregnant woman living in areas remote from obstetric inpatient facilities is hospitalized in the urgent delivery room / labor ward / maternity hospital of central district hospitals (district hospitals).
7. Additional Information
Not applicable
Criteria for Evaluating the Quality of Medical Care
№ | Quality criteria | Yes/No |
|---|---|---|
1. | Determination of the gestational age and expected date of delivery based on the date of the last menstruation and/or ultrasound data was performed at the 1st visit of the pregnant patient | Yes/No |
2. | Blood pressure measurement on peripheral arteries and pulse assessment were performed at each visit of the pregnant patient | Yes/No |
3. | Measurement of uterine dimensions (fundal height) at each visit of the pregnant patient and maintenance of a gravidogram after 20 weeks of gestation were performed | Yes/No |
4. | Fetal auscultation (determination of fetal heart rate) using a fetal Doppler (compact maternal-fetal cardiovascular activity Doppler analyzer) or an obstetric stethoscope after 22 weeks of gestation was performed at each visit of the pregnant patient | Yes/No |
5. | The pregnant patient was referred for testing for class M and G antibodies (IgM, IgG) to human immunodeficiency virus HIV 1/2 and p24 antigen (Human immunodeficiency virus HIV 1/2 + Agp24) in the blood at the 1st visit (at the 1st visit in the 1st or 2nd trimester of pregnancy) and in the 3rd trimester of pregnancy | Yes/No |
6. | The pregnant patient was referred for determination of antibodies to hepatitis B surface antigen (HBsAg) in the blood (Hepatitis B virus) or determination of hepatitis B virus surface antigen (HBsAg) in the blood (Hepatitis B virus) at the 1st visit (at the 1st visit in the 1st or 2nd trimester of pregnancy) and in the 3rd trimester of pregnancy | Yes/No |
7. | The pregnant patient was referred for testing for antibodies to Treponema pallidum in the blood at the 1st visit (at the 1st visit in the 1st or 2nd trimester of pregnancy) and in the 3rd trimester of pregnancy | Yes/No |
8. | The pregnant patient was referred for microscopic examination of vaginal smears at the 1st visit (at the 1st visit in the 1st or 2nd trimester of pregnancy) and in the 3rd trimester of pregnancy | Yes/No |
9. | The pregnant patient was referred for determination of ABO blood groups and Rh factor (D antigen) once at the 1st visit | Yes/No |
10. | The pregnant patient was referred for a complete blood count (CBC) at the 1st visit, in the 2nd, and in the 3rd trimester of pregnancy | Yes/No |
11. | The pregnant patient was referred for fasting blood glucose testing and additional blood glucose testing if a fasting venous blood glucose level ≥7.0 mmol/L is detected | Yes/No |
12. | The pregnant patient was referred for an oral glucose tolerance test with 75 g of dextrose at 240-280 weeks of gestation if carbohydrate metabolism disorders have not been identified or testing was not performed in early pregnancy | Yes/No |
13. | The pregnant patient was referred for blood thyroid-stimulating hormone (TSH) testing and anti-thyroperoxidase antibody testing once at the 1st visit | Yes/No |
14. | The pregnant patient was referred for a urinalysis at the 1st visit, in the 2nd, and in the 3rd trimester of pregnancy | Yes/No |
15. | The pregnant patient was referred for microbiological (cultural) urine testing for bacterial pathogens using automated seeding once at the 1st visit | Yes/No |
16. | The pregnant patient was referred for bacteriological testing of vaginal and rectal secretions for group B Streptococcus (S. agalactiae) or detection of group B Streptococcus DNA (S. agalactiae) in a vaginal swab and rectal swab by PCR at 350-370 weeks of gestation | Yes/No |
17. | The pregnant patient was referred at 110-136 weeks of gestation for 1st-trimester screening, which includes a combination of serum human chorionic gonadotropin (free beta-subunit) testing and pregnancy-associated plasma protein A (PAPP-A) testing, and ultrasound screening to assess fetal antenatal development in order to identify chromosomal abnormalities, malformations, risks of fetal growth restriction, preterm birth, and preeclampsia (Screening I) (medical service code - A04.30.001.003) | Yes/No |
18. | The pregnant patient was referred at 180-206 weeks of gestation for ultrasound screening to assess fetal antenatal development in order to identify chromosomal abnormalities, malformations, risks of fetal growth restriction, preterm birth, and preeclampsia (Screening II) (medical service code - A04.30.001.005), congenital developmental anomalies, assessment of extraembryonic structures (localization, thickness, structure of the placenta, amount of amniotic fluid), and ultrasound of the cervix (ultrasound cervicometry) | Yes/No |
19. | The pregnant patient was referred at 340-356 weeks of gestation for a fetal ultrasound examination | Yes/No |
20. | Oral administration of folic acid** was prescribed to the pregnant patient throughout the first 12 weeks of pregnancy at a dose of 400–800 mcg per day | Yes/No |
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Immunization of adults. Methodological recommendations. / O.M. Drapkina, N.I. Briko, M.P. Kostinov, I.V. Feldblium [et al.]. — M., National Medical Research Center for Therapy and Preventive Medicine of the Russian Ministry of Health: 2020. — 248 p.
Appendix A1. Working Group Composition
Dolgushina Nataliya Vitalievna – MD, Professor, Deputy Director for Research, National Medical Research Center for Obstetrics, Gynecology and Perinatology named after Academician V.I. Kulakov of the Russian Ministry of Health, Chief Freelance Specialist in Women's Reproductive Health of the Russian Ministry of Health (Moscow). No conflict of interest.
Shmakov Roman Georgievich – D.Sc. (Medicine), Professor, Director of the Institute of Obstetrics, National Medical Research Center for Obstetrics, Gynecology and Perinatology named after Academician V.I. Kulakov of the Russian Ministry of Health, Chief Freelance Specialist of the Russian Ministry of Health in Obstetrics (Moscow). There is no conflict of interest.
Baranov Igor Ivanovich – MD, Professor, Head of the Department of Scientific and Educational Programs, National Medical Research Center for Obstetrics, Gynecology and Perinatology named after Academician V.I. Kulakov of the Russian Ministry of Health (Moscow). No conflict of interest.
Bayev Oleg Radomirovich – MD, Professor, Head of the 1st Maternity Ward, Head of the Department of Obstetrics and Gynecology, National Medical Research Center for Obstetrics, Gynecology and Perinatology named after Academician V.I. Kulakov of the Russian Ministry of Health (Moscow). No conflict of interest.
Pavlovich Stanislav Vladislavovich – PhD, Associate Professor, Scientific Secretary, National Medical Research Center for Obstetrics, Gynecology and Perinatology named after Academician V.I. Kulakov of the Russian Ministry of Health (Moscow). No conflict of interest.
Pryalukhin Ivan Alexandrovich – PhD, Researcher, Department of Analysis and Development of Regional Healthcare, National Medical Research Center for Anesthesiology and Intensive Care for Pregnant Women, National Medical Research Center for Obstetrics, Gynecology and Perinatology named after Academician V.I. Kulakov of the Russian Ministry of Health (Moscow). No conflict of interest.
Romanov Andrey Yuryevich – PhD, Head of the Department of Planning and Support of Scientific Projects, Department of Scientific Activity Organization, National Medical Research Center for Obstetrics, Gynecology and Perinatology named after Academician V.I. Kulakov of the Russian Ministry of Health (Moscow). No conflict of interest.
Serov Vladimir Nikolayevich - Academician of the RAS, MD, Professor, Chief Researcher, National Medical Research Center for Obstetrics, Gynecology and Perinatology named after Academician V.I. Kulakov of the Russian Ministry of Health, President of the Russian Society of Obstetricians and Gynecologists (ROAG) (Moscow). No conflict of interest.
Natalia V. Artymuk – MD, PhD, Professor, Head of the Department of Obstetrics and Gynecology named after Professor G.A. Ushakova, Kemerovo State Medical University of the Russian Ministry of Health, Chief Freelance Specialist in Obstetrics, Gynecology, and Women's Reproductive Health of the Russian Ministry of Health in the Siberian Federal District (Kemerovo). No conflict of interest.
Bashmakova Nadezhda Vasilyevna - MD, Professor, Chief Researcher, Ural Research Institute of Maternity and Infancy Care of the Russian Ministry of Health, Chief Freelance Specialist in Obstetrics, Gynecology, and Women's Reproductive Health of the Russian Ministry of Health in the Ural Federal District. No conflict of interest.
Belokrinitskaya Tatyana Evgenyevna – Doctor of Medical Sciences, Professor, Head of the Department of Obstetrics and Gynecology at the Faculty of Advanced Training and Professional Retraining of Specialists, Chita State Medical Academy of the Russian Ministry of Health, Honored Doctor of the Russian Federation, Chief Freelance Specialist of the Russian Ministry of Health for Obstetrics, Gynecology and Women's Reproductive Health in the Far Eastern Federal District (Chita). No conflict of interest.
Malyshkina Anna Ivanovna - MD, Professor, Director, Ivanovo Research Institute of Motherhood and Childhood named after V.N. Gorodkov of the Russian Ministry of Health, Head of the Department of Obstetrics and Gynecology, Medical Genetics, Faculty of General Medicine, Ivanovo State Medical Academy of the Russian Ministry of Health, Chief Freelance Specialist in Obstetrics, Gynecology, and Women's Reproductive Health of the Russian Ministry of Health in the Central Federal District (Ivanovo). No conflict of interest.
Mikhailov Anton Valerievich – MD, Professor, Chief Physician, Maternity Hospital No. 17 of St. Petersburg, Professor of the Department of Obstetrics and Gynecology, North-Western State Medical University named after I.I. Mechnikov of the Russian Ministry of Health, and the Department of Obstetrics, Gynecology and Perinatology, First Saint Petersburg State Medical University named after Academician I.P. Pavlov of the Russian Ministry of Health, Chief Freelance Specialist in Obstetrics and Gynecology of the Russian Ministry of Health in the North-Western Federal District (St. Petersburg). No conflict of interest.
Namazova-Baranova Leyla Seymurovna - Academician of the RAS, MD, Professor, Head of the Department of Faculty Pediatrics, Pediatric Faculty, Pirogov Russian National Research Medical University of the Russian Ministry of Health, Head of the Research Institute of Pediatrics and Children's Health, National Medical Research Center No. 2 of the Russian Research Center of Surgery named after Academician B.V. Petrovsky of the Ministry of Science and Higher Education of Russia, Chief Freelance Pediatric Specialist in Preventive Medicine of the Russian Ministry of Health (Moscow). No conflict of interest.
Victoria Popandopulo – D.Sc. in Medicine, Professor, Head of the Department of Obstetrics and Gynecology, Maykop State Technological University, Professor at the Department of Obstetrics and Gynecology, Faculty of Medicine, Astrakhan State Medical University of the Russian Ministry of Health, Chief Medical Officer, Kuban Medical Center LLC, Chief freelance specialist in obstetrics, gynecology, and women's reproductive health for the Southern Federal District, Ministry of Health of Russia (Krasnodar). No conflict of interest.
Viktor E. Radzinsky - Corresponding Member of the RAS, D.Sc. (Medicine), Professor, Head of the Department of Obstetrics and Gynecology with a Course in Perinatology, Peoples' Friendship University of Russia (Moscow). No conflict of interest.
Sakharova Viktoriya Vladislavovna – PhD, Deputy Director of the Department of Medical Care for Children, Maternity Services and Public Health, Ministry of Health of the Russian Federation (Moscow). No conflict of interest.
Selimzyanova Lilia Robertovna - Cand. of Med. Sci., Head of the Department of Standardization and Study of Evidence-Based Medicine, Leading Researcher at the Research Institute of Pediatrics and Children's Health, NMRC No. 2, Ministry of Science and Higher Education of Russia, Academician B.V. Petrovsky Russian Research Center of Surgery, Associate Professor at the Department of Faculty Pediatrics, Pediatric Faculty, Pirogov Russian National Research Medical University, Russian Ministry of Health (Moscow). No conflict of interest.
Fatkullin Ildar Faridovich — Dr. of Med. Sci., Professor, Head of the Prof. V.S. Gruzdev Department of Obstetrics and Gynecology, Kazan State Medical University, Russian Ministry of Health, Chief Freelance Specialist in Obstetrics and Gynecology of the Russian Ministry of Health in the Volga Federal District (Kazan). No conflict of interest.
Fedoseenko Marina Vladislavovna - Cand. of Med. Sci., Head of the Department for the Development of Scientific Approaches to Immunization of Patients with Health Deviations and Chronic Diseases, Leading Researcher at the Research Institute of Pediatrics and Children's Health, NMRC No. 2, Ministry of Science and Higher Education of Russia, Academician B.V. Petrovsky Russian Research Center of Surgery, Associate Professor at the Department of Faculty Pediatrics, Pediatric Faculty, Pirogov Russian National Research Medical University, Russian Ministry of Health (Moscow). No conflict of interest.
Sheshko Elena Leonidovna – Cand. of Med. Sci., Director of the Department of Pediatric Medical Care, Obstetrical Services and Public Health, Ministry of Health of the Russian Federation (Moscow). No conflict of interest.
Appendix A2. Methodology for Developing Clinical Guidelines
Target audience for these clinical guidelines:
1. obstetrician-gynecologists
2. obstetrics and gynecology residents
Table 1. Level of Evidence (LoE) grading scale for diagnostic methods (diagnostic interventions)
LoE | Definition |
|---|---|
1 | Systematic reviews of studies with reference standard control or systematic reviews of randomized controlled trials with meta-analysis |
2 | Individual studies with reference standard control or individual randomized controlled trials and systematic reviews of studies of any design, except randomized controlled trials, with meta-analysis |
3 | Studies without consecutive reference standard control or studies with a reference standard not independent of the test method, or non-randomized comparative studies, including cohort studies |
4 | Non-comparative studies, case report |
5 | Only justification of mechanism of action or expert opinion is available |
Table 2. Level of Evidence (LoE) grading scale for prevention, treatment, and rehabilitation methods (preventive, therapeutic, and rehabilitative interventions)
LoE | Definitions |
|---|---|
1 | Systematic review of RCTs with meta-analysis |
2 | Individual RCTs and systematic reviews of studies of any design except RCTs, with meta-analysis |
3 | Non-randomized comparative studies, including cohort studies |
4 | Non-comparative studies, case reports or case series, case-control studies |
5 | Only justification of the mechanism of action of the intervention (preclinical studies) or expert opinion is available |
Table 3. Grade of Recommendation (GoR) scale for prevention, diagnostic, treatment, and rehabilitation methods (preventive, diagnostic, therapeutic, and rehabilitative interventions)
GoR | Definition |
|---|---|
A | Strong recommendation (all considered efficacy criteria (outcomes) are important, all studies are of high or acceptable methodological quality, and their conclusions on the outcomes of interest are consistent) |
B | Conditional recommendation (not all considered efficacy criteria (outcomes) are important, not all studies are of high or acceptable methodological quality, and/or their conclusions on the outcomes of interest are inconsistent) |
C | Weak recommendation (lack of adequate quality evidence (all considered efficacy criteria (outcomes) are unimportant, all studies are of low methodological quality, and their conclusions on the outcomes of interest are inconsistent) |
Appendix A3. Reference Materials
Not applicable.
Appendix B. Physician Action Algorithms

MANAGEMENT ALGORITHM FOR PRECONCEPTION CARE (FAMILY PLANNING PATIENTS)
Name of examination | Frequency |
|---|---|
Physical examination | |
Anamnesis collection | Once |
VTE risk assessment | Once |
Assessment of complaints | Once |
General physical examination | Once |
Measurement of height, body weight, BMI | Once |
Measurement of blood pressure and pulse | Once |
Palpation of the mammary glands | Once |
Gynecological examination | Once |
Laboratory diagnostic examinations | |
Referral for blood test for HIV-1/2 antibodies (classes M, G) and p24 antigen | Once (+examination of the patient's partner) |
Referral for determination of hepatitis B surface antigen (HBsAg) or hepatitis B core/surface antigen in blood | Once (+examination of the patient's partner) |
Referral for determination of total antibodies (classes M and G) to hepatitis C virus in blood | Once (+examination of the patient's partner) |
Referral for blood test for antibodies to Treponema pallidum | Once (+examination of the patient's partner) |
Referral for determination of antibodies (classes M and G) to rubella virus in blood | Once |
Referral for microscopic examination of vaginal smears, including microscopic examination of female genital discharge for gonococci (Neisseria gonorrhoeae), microscopic examination of female genital discharge for trichomonads (Trichomonas vaginalis), and microscopic examination of vaginal discharge for yeast fungi | Once |
Referral for determination of ABO blood group and Rhesus D antigen (Rh factor) | Once (+determination of the patient's partner's Rh factor in Rh-negative patients) |
Referral for general (clinical) blood count | Once |
Referral for blood glucose level determination | Once |
Referral for TSH level testing and thyroid peroxidase antibody (TPOAb) assay in blood | Once |
Referral for general (clinical) urinalysis | Once |
Referral for cytological examination of a cervical smear (smear from the surface of the cervix and cervical canal) | Once. Performed depending on the date of the previous examination, its results, the presence of human papillomavirus infection, and the patient's age in accordance with the 2020 clinical guidelines "Cervical Intraepithelial Neoplasia, Cervical Erosion and Ectropion" |
Instrumental diagnostic examinations | |
Referral for ultrasound of the uterus and appendages | Once |
Referral for electrocardiogram recording | Once |
Consultations with allied specialists | |
Referral for general practitioner consultation | Once |
Referral for dentist consultation | Once |
Referral for geneticist consultation | Once if risk factors for giving birth to a child with a chromosomal or gene disorder are identified in the patient and/or her husband/partner |
Prescription of medications | |
Prescription of folic acid** | 400–800 mcg daily orally 2–3 months before pregnancy |
Prescription of potassium iodide** | 200 mcg daily orally 2–3 months before pregnancy |
MANAGEMENT ALGORITHM FOR PATIENTS WITH NORMAL PREGNANCY
Name of examination | 1st trimester | 2nd trimester | 3rd trimester |
|---|---|---|---|
Physical examination | |||
Anamnesis collection | At the 1st visit | ||
VTE risk assessment | At the 1st visit, then as indicated | ||
Assessment of complaints | At each visit | ||
General physical examination | At the 1st visit | ||
Measurement of height, body weight, BMI | At each visit | ||
Measurement of blood pressure and pulse | At each visit | ||
Palpation of the mammary glands | At the 1st visit | ||
Gynecological examination | At the 1st visit, then as indicated | ||
Determination of gestational age and expected date of delivery | At the 1st visit | ||
Measurement of abdominal circumference, fundal height, and filling out the gravidogram | - | At each visit after 20 weeks | At each visit |
Inquiry regarding fetal movements | - | At each visit after 16–20 weeks (after the onset of fetal movement perception) | At each visit |
Determination of fetal position and presentation | - | - | At each visit after 34–36 weeks |
Laboratory diagnostic examinations | |||
Referral for serum or urine hCG level testing | At the first visit in the 1st trimester if no ultrasound was performed to diagnose pregnancy | - | - |
Referral for blood test for HIV-1/2 antibodies (classes M, G) and p24 antigen | Once at the 1st visit (+ examination of the patient's partner) | Once in the 3rd trimester | |
Referral for determination of hepatitis B surface antigen (HBsAg) or hepatitis B core/surface antigen in blood | Once at the 1st visit (+ examination of the patient's partner) | Once in the 3rd trimester | |
Referral for determination of total antibodies (classes M and G) to hepatitis C virus in blood | Once at the 1st visit (+ examination of the patient's partner) | Once in the 3rd trimester | |
Referral for blood test for antibodies to Treponema pallidum | Once at the 1st visit (+ examination of the patient's partner) | Once in the 3rd trimester | |
Referral for determination of antibodies (classes M and G) to rubella virus in blood | Once at the 1st visit | - | |
Referral for microscopic examination of vaginal smears, including microscopic examination of female genital discharge for gonococci (Neisseria gonorrhoeae), microscopic examination of female genital discharge for trichomonads (Trichomonas vaginalis), and microscopic examination of vaginal discharge for yeast fungi | Once at the 1st visit | Once in the 3rd trimester | |
Referral for determination of ABO blood group and Rhesus D antigen (Rh factor) | Once at the 1st visit (+ determination of the partner's Rh factor in Rh-negative patients) | ||
Referral for anti-Rh antibody testing in Rh-negative women (if the partner is Rh-negative, testing for antibodies to Rh antigens is not performed) | At the 1st visit | At 180-200 weeks | At 280 weeks |
Referral for general (clinical) blood count | Once at the 1st visit | Once in the 2nd trimester | Once in the 3rd trimester |
Referral for a general general-medical blood chemistry test | Once at the 1st visit | ||
Referral for blood glucose level determination | When fasting venous blood glucose is ≥7.0 mmol/L | ||
Referral for OGTT | - | At 240-280 weeks, if no carbohydrate metabolism disorder was detected or early pregnancy screening was not performed | - |
Referral for TSH level testing and thyroid peroxidase antibody (TPOAb) assay in blood | Once at the 1st visit | ||
Referral for general (clinical) urinalysis | Once at the 1st visit | Once in the 2nd trimester | Once in the 3rd trimester |
Protein determination in urine using special indicator strips or in a laboratory setting | - | At each visit after 22 weeks | At each visit |
Referral for cytological examination of a cervical smear (smear from the surface of the cervix and cervical canal) | At the 1st visit. Performed depending on the date of the previous study, its results, the presence of human papillomavirus infection, and the patient's age according to the 2020 clinical guidelines "Cervical Intraepithelial Neoplasia, Erosion, and Ectropion of the Cervix". | ||
Referral for microbiological (culture) urine test for bacterial pathogens using automated plating | Once at the 1st visit | ||
Referral for bacteriological examination of vaginal and rectal discharge for group B streptococcus (S. agalactiae) or detection of group B streptococcus (S. agalactiae) DNA in a vaginal swab and rectal swab by PCR | - | - | Once at 350-370 weeks |
1st trimester screening (testing serum hCG and pregnancy-associated plasma protein A [PAPP-A] levels) | At 110-136 weeks | - | - |
Instrumental diagnostic examinations | |||
Referral for ultrasound of the uterus and appendages (up to 96 weeks of pregnancy) or fetal ultrasound (after 100 weeks of pregnancy) | At the 1st visit in the 1st trimester of pregnancy and with a menstrual delay of ≥7 days | - | - |
Referral for fetal ultrasound | At 11-136 weeks (as part of 1st trimester screening) + measurement of pulsatility index (PI) | At 18-206 weeks (2nd trimester ultrasound screening) + cervical ultrasound (ultrasound cervicometry) | At 340-356 weeks |
Referral for repeat fetal ultrasound | In case of a high risk of chromosomal abnormalities and/or fetal malformations associated with chromosomal abnormalities according to screening ultrasound data | In case of a high risk of chromosomal abnormalities and/or fetal malformations associated with chromosomal abnormalities according to screening ultrasound data | If abnormal fetal lie or presentation is suspected, in the absence of fetal heart rate or fetal heart rate abnormalities, or if uterine size does not correspond to gestational age |
Referral for color Doppler ultrasound of uteroplacental and fetoplacental blood flow | - | At 180-206 weeks in the high-risk group for obstetric and perinatal complications | At 300-336 weeks in the high-risk group for obstetric and perinatal complications |
Referral for electrocardiogram recording | Once at the 1st visit | Once in the 3rd trimester | |
Fetal auscultation using a fetal Doppler or obstetric stethoscope | - | At each visit starting from 220 weeks | At each visit |
Referral for fetal cardiotocography (CTG) | - | - | Starting from 320 weeks, once every 2 weeks |
Performing pelvimetry | - | - | Once |
Consultations with allied specialists | |||
Referral for general practitioner consultation | Once at the 1st visit | Once in the 3rd trimester | |
Referral for dentist consultation | Once at the 1st visit | Once in the 3rd trimester | |
Referral for ophthalmologist consultation | Once at the 1st visit | ||
Referral for geneticist consultation | Once if risk factors for giving birth to a child with a chromosomal or gene disorder are identified in the patient and/or her husband/partner | ||
Referral for cardiologist consultation | In case of pathological electrocardiogram changes | ||
Referral for medical psychologist consultation | Once at the 1st visit | Once in the 3rd trimester | |
Prescription of medications | |||
Prescription of folic acid** | 400-800 mcg daily orally | - | - |
Prescription of potassium iodide** | 200 mcg daily orally | 200 mcg daily orally | 200 mcg daily orally |
Prescription of cholecalciferol** in the high-risk group for vitamin D hypovitaminosis | 500-1000 IU daily orally | 500-1000 IU daily orally | 500-1000 IU daily orally |
Administration of human anti-Rh Rho[D] immunoglobulin to an Rh-negative patient with a negative anti-Rh antibody titer | - | - | At a dose according to the product instructions, intramuscularly at 28-30 weeks |
Appendix C. Patient Information
Pregnancy is a physiological process occurring in a woman's body and ending with the birth of a child.
The first and most important step at the beginning of pregnancy is a consultation with an obstetrician-gynecologist, during which the fact of pregnancy is confirmed and its gestational age is determined, a general and gynecological examination is performed, a plan for further examinations and check-ups is drawn up, and recommendations on lifestyle, nutrition, necessary vitamins, and medications (if required) are given.
The optimal approach is pregnancy planning, when at the preconception stage (before pregnancy) it is possible to conduct a full examination and treatment of identified diseases if necessary, routine vaccination, start following a healthy lifestyle, and take folic acid to maximize the likelihood of having a healthy child.
On average, the frequency of visits to the obstetrician-gynecologist during an uncomplicated pregnancy ranges from 5 to 7 times. The optimal time for the first visit to the doctor is the 1st trimester of pregnancy (up to 10 weeks).
You must strictly follow all medical recommendations, undergo scheduled examinations on time, and follow recommendations for a healthy lifestyle during pregnancy, namely:
avoid work involving prolonged standing or excessive physical exertion, night shift work, and work causing fatigue,
avoid physical exercises that can lead to abdominal trauma, falls, or stress: contact sports, various martial arts, racket and ball sports, scuba diving,
be sufficiently physically active, walk, and do prenatal exercise for 20-30 minutes a day (in the absence of complaints and contraindications),
when traveling by plane, especially on long-haul flights, wear compression stockings for the duration of the flight, walk around the cabin, stay well hydrated, and avoid alcohol and caffeine,
when traveling by car, use a special three-point seat belt,
inform your doctor about planned travel to tropical countries for timely vaccination,
eat a proper and regular diet: consume food of adequate caloric value with an optimal content of protein, vitamins, and minerals, with mandatory inclusion of vegetables, meat, fish, legumes, nuts, fruits, and whole-grain products in the diet,
avoid using plastic bottles and tableware, especially during thermal processing of food and liquids in them, due to the toxicant bisphenol A contained in them,
limit consumption of fish rich in methylmercury (e.g., tuna, shark, swordfish, mackerel),
reduce consumption of foods rich in vitamin A (beef, chicken, duck liver and products made from it),
limit caffeine intake to less than 300 mg/day (1.5 cups of espresso at 200 ml each, or 2 cups of cappuccino/latte/americano at 250 ml each, or 3 cups of instant coffee at 250 ml each),
avoid unpasteurized milk, ripened soft cheeses, pâtés, and poorly thermally processed foods,
if you smoke, try to quit or reduce the number of cigarettes smoked per day,
avoid alcohol consumption during pregnancy, especially in the first 3 months.
An important factor for a pregnant woman is her emotional state. Throughout your pregnancy, you need to avoid stressful situations and emotional distress.
Sexual intercourse during pregnancy is not prohibited if you are feeling well. In case of pain, discomfort, spotting during intercourse, as well as vaginal itching, burning, and leukorrhea, you must stop sexual intercourse and consult a doctor.
You should also consult a doctor if you experience the following complaints:
vomiting > 5 times a day,
weight loss > 3 kg in 1–1.5 weeks,
blood pressure elevation > 120/80 mm Hg,
vision problems such as blurred vision or flashing lights before the eyes,
severe headache,
lower abdominal pain of any character (aching, cramping, stabbing, etc.),
epigastric pain (in the stomach area),
swelling of the face, hands, or feet,
appearance of bloody or abundant watery vaginal discharge,
fever above 37.5 °C,
absence or alteration of fetal movements for more than 12 hours (after 20 weeks of pregnancy).
If you are Rh-negative, it is advisable for your husband to take a blood test to determine his Rh factor. If your husband's blood is Rh-negative, your further tests for anti-Rh antibodies and administration of anti-Rh immunoglobulin will not be required.
Starting from the second half of pregnancy, you are recommended to attend parenting classes where your questions regarding pregnancy will be answered.
Appendix G. Assessment Scales, Questionnaires, and Other Evaluation Tools
Gravidogram sample
