List of Abbreviations
Complete Blood Count | complete blood count (CBC) |
|---|---|
CRL | crown-rump length |
ultrasound | ultrasound examination |
β-hCG | β-subunit of human chorionic gonadotropin |
Cx | cervix |
ECG | electrocardiogram |
Terms and Definitions
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.
Induced abortion (medical abortion) – artificial termination of pregnancy up to and including 216 weeks.
1. Brief information on the disease or condition
1.1 Definition of the disease or condition
Induced abortion (medical abortion) – artificial termination of pregnancy up to and including 216 weeks.
1.2 Etiology and pathogenesis of the disease or condition (group of diseases or conditions)
Induced abortion (medical abortion) is performed for: (1) medical indications on the part of the mother (when prolongation of pregnancy is associated with a high risk of maternal death) or on the part of the fetus (in case of uncorrectable fetal diseases incompatible with life and/or with an unfavorable prognosis for life and health) (regardless of gestational age), (2) social indications (up to and including 216 weeks of gestation), (3) the insistent desire of the woman, provided that mandatory professional psychological counseling is conducted in the medical and social assistance office of the women's consultation clinic or in the center for medical and social support of pregnant women in a difficult life situation (up to and including 116 weeks of gestation). The list of medical indications for artificial termination of pregnancy is determined by the Ministry of Health of the Russian Federation [1]. Social indications for induced abortion are determined by the Government of the Russian Federation [2].
1.3 Epidemiology of the Disease or Condition
According to the Federal State Statistics Service, in 2022 the number of pregnancy terminations amounted to 503,809 cases. According to Rosstat data (form No. 13 of federal state statistical observation), in 2022 in the Russian Federation the proportion of legal medical abortions up to 12 weeks of the total number of pregnancy terminations up to 22 weeks was 45.5%, of which 46.8% were by medical method, and the proportion of medical abortions for medical indications at 12–216 weeks of gestation was 2.3%, of which 64.3% were by medical method.
1.4 Features of Coding the Disease or Condition
O04 (O04.0-O04.1, O04.3-O04.6, O04.8-O04.9) Medical abortion
O06 (O06.0 – O06.1, O06.3 – O06.6, O06.8-O06.9) Unspecified abortion
O07 (O07.0-O07.1, O07.3-O07.6, O07.8-O07.9) Failed attempted abortion
O35 (O35.0 – O35.9) Maternal care for known or suspected fetal anomaly and damage
1.5 Classification of the disease or condition
Classification of medical abortion by gestational age [2], [3]:
up to 116 weeks of gestation;
from 120 to 216 weeks of gestation.
Classification of medical abortion by method:
medical abortion;
surgical abortion.
1.6 Clinical presentation of the disease or condition
Not applicable.
2. Diagnostics, medical indications and contraindications for diagnostic methods
The information provided in this section applies to all patients seeking a medical abortion, unless otherwise indicated.
Diagnostic criteria
Not applicable.
2.1 Complaints and Anamnesis
It is recommended to assess the patient's complaints and medical history to rule out contraindications to medical abortion [4], [5], [6], [7].
GCP CLEL 5Level of Evidence C (Level of Likelihood of Evidence - 5).
Comment: Contraindications for medical abortion are determined depending on the pregnant woman's condition, gestational age and location, indications for termination, tolerance to the medications used, and the presence of acute infectious and inflammatory diseases. In the presence of contraindications, the issue is decided individually by a medical consilium, taking into account the gestational age and the capabilities (conditions) of the medical organization where the pregnancy is terminated.
2.2 Physical Examination
It is recommended to perform a therapeutic visual examination, general thermometry, heart rate measurement, respiratory rate measurement, and blood pressure measurement on peripheral arteries twice: when the patient applies for a medical abortion to assess the general condition and rule out contraindications to medical abortion, and after the medical abortion (in 10–15 days) to assess the general condition and rule out complications of medical abortion [3], [4], [6], [8], [9].
GCP CLEL 5Level of Evidence C (Level of Likelihood of Evidence - 5).
It is recommended to determine gestational age by the date of the last menstruation and data from ultrasound of the uterus and appendages or fetal ultrasound in order to choose the method of medical abortion [4], [6], [7], [8], [10], [11], [12].
GPP BLE 2Grade of Recommendations B (Level of Evidence 2).
Comment: To determine gestational age in the 1st trimester of pregnancy, the fetal crown-rump length (CRL) should be used. To determine gestational age at a later stage (at CRL > 84 mm), the fetal head circumference should be used.
It is recommended to perform a bimanual pelvic examination and inspection of the cervix using specula twice: when the patient applies for a medical abortion for differential diagnosis with ectopic pregnancy, determining the size of the uterus and its correspondence to gestational age, the state and tenderness of the appendages, vaginal fornices, presence and nature of vaginal discharge, and after medical abortion (in 10–15 days) to rule out its complications [4], [6], [8].
GCR CLOE 5Grade of Recommendation C (Level of Evidence – 5).
2.3 Laboratory Diagnostics
It is recommended to determine the main ABO blood groups and Rh antigen D (Rh factor) before medical abortion in the absence of this test during the current pregnancy in order to carry out Rh isoimmunization prophylaxis if necessary and ensure readiness for blood transfusion [4], [6], [7], [8], [13], [14], [15], [16].
GPP CLoE 5Level of Evidence/Grade of Recommendation C (level of evidence - 5).
It is recommended to determine anti-(RhD) antibodies in Rh-negative patients pregnant by a partner with Rh-positive or unknown Rh blood group, before medical abortion in the absence of this test during the current pregnancy in order to perform Rh isoimmunization prophylaxis [15], [16], [17], [18].
GPP CLoE 5Level of Evidence/Grade of Recommendation C (level of evidence - 5).
It is recommended to perform a complete blood count (CBC) and platelet count in the blood before surgical abortion at any gestational age and before medical abortion at ≥120 weeks of gestation to rule out infectious and inflammatory diseases, anemia, and thrombocytopenia [4], [6], [8], [13].
GCP CLEL 5Level of Evidence C (Level of Likelihood of Evidence - 5).
It is recommended to perform a coagulogram (exploratory study of the hemostatic system) before medical (surgical or medical) abortion at ≥120 weeks of gestation to rule out hemostatic disorders [8], [13], [19].
GCP CLEL 5Level of Evidence C (Level of Likelihood of Evidence - 5).
Comment: The coagulogram study includes: activated partial thromboplastin time, fibrinogen, international normalized ratio, and thrombin time.
It is recommended to perform microscopic examination of vaginal smears before medical abortion to rule out an infectious and inflammatory process [4], [8], [13].
GCP CLEL 5Level of Evidence C (Level of Likelihood of Evidence - 5).
In medical abortion for medical indications on the part of the fetus, it is recommended to perform fetal karyotyping (cytogenetic or molecular karyotyping) to verify chromosomal/genetic diseases in the fetus [20], [21], [22].
GCP CLEL 5Level of Evidence C (Level of Likelihood of Evidence - 5).
Comment: Based on the results of fetal karyotyping, the patient should be referred for a geneticist consultation.
After surgical abortion at any gestational age and medical abortion at ≥120 weeks of gestation, it is recommended to perform a pathoanatomical examination of early and late miscarriage material to confirm the fact of pregnancy, presence of fetal anomalies in case of pregnancy termination for fetal indications, and to rule out trophoblastic disease [23], [24].
GCR CLOE 5Grade of Recommendation C (Level of Evidence – 5).
After medical abortion, it is recommended to test the level of human chorionic gonadotropin (free β-subunit) (β-hCG) in blood serum according to indications (in the clinical picture of incomplete abortion or suspicion of combination with ectopic pregnancy) to confirm the fact of complete pregnancy termination [4], [6], [8], [25].
GCP CLEL 5Level of Evidence C (Level of Likelihood of Evidence - 5).
Comment: It is advisable to test the β-hCG level no earlier than 14 days after medical abortion. The diagnosis of ongoing pregnancy is established based on the serum β-hCG value or the results of a semi-quantitative urine test for hCG (urine test for human chorionic gonadotropin) [26], [27]. Determination of serum β-hCG or via a semi-quantitative urine test in assessing the effectiveness of medical abortion is considered a more reliable method compared to ultrasound of the uterus and appendages and avoids unjustified instrumental interventions [28].
2.4 Instrumental Diagnostics
It is recommended to perform an ultrasound of the uterus and appendages (up to 96 weeks of gestation) or a fetal ultrasound (after 100 weeks of gestation) before a medical abortion to diagnose pregnancy, determine its location, assess whether the gestational sac/embryo/fetus corresponds to the gestational age, check for the presence of embryonic/fetal heartbeat and demonstrate the image and heartbeat (if present) to the patient, assess the presence and condition (if any) of a uterine scar, and determine the location of the chorion/placenta (placenta previa, attachment at the site of the scar if present) [4], [6], [8], [13].
GCP CLEL 5Level of Evidence C (Level of Likelihood of Evidence - 5).
It is recommended to perform an electrocardiogram (ECG) before a surgical abortion at any gestational age and before a medical abortion at a gestational age of ≥120 weeks to rule out cardiovascular diseases [13], [29].
GCP CLEL 5Level of Evidence C (Level of Likelihood of Evidence - 5).
It is recommended to perform a transvaginal ultrasound of the uterus and appendages (or transabdominal/transrectal if transvaginal is not feasible) after a medical abortion based on indications (in case of clinical presentation of incomplete abortion or suspected ectopic pregnancy) to confirm complete termination of pregnancy [4], [6], [8], [25].
GCP CLEL 5Level of Evidence C (Level of Likelihood of Evidence - 5).
Comment: Evaluation of complaints is usually performed during a follow-up visit 10-15 days after a medical abortion. The diagnosis of continuing pregnancy is established based on the presence of a gestational sac and/or embryonic/fetal heartbeat. Endometrial evaluation (M-echo greater than 15 mm, presence of echogenic and echolucent inclusions) in the absence of clinical signs of incomplete abortion (bleeding requiring surgical intervention, and/or signs of infection) is of limited value and is not an indication for surgical management [30], [31], [32], [33].
2.5 Other Procedures
It is recommended to consult a general practitioner (therapist) before a surgical abortion at any gestational age and before a medical abortion at a gestational age of ≥120 weeks to evaluate the electrocardiogram, rule out somatic diseases, and assess contraindications to abortion [13], [29].
GCP CLEL 5Level of Evidence C (Level of Likelihood of Evidence - 5).
3. Treatment, including drug and non-drug therapies, diet therapy, and pain management
The information provided in this section applies to all patients seeking a medical abortion, unless otherwise indicated.
3.1. Non-pharmacological treatments
For medical abortion at a gestational age of ≥120 weeks, it is recommended to use a hygroscopic cervical dilator (DILAPAN-S) or a set of sterile laminaria tents for non-pharmacological cervical preparation within 12 hours after mifepristone administration or prior to surgical pregnancy termination [9, 13, 34–42].
Level of Evidence BLevel of Confidence 2Level of recommendation B (level of evidence – 2).
3.2. Pharmacotherapy
For medical abortion in the 1st trimester of pregnancy with an amenorrhea duration of ≤42 days, it is recommended to administer mifepristone orally once, followed (36–48 hours later) by a single oral dose of misoprostol** in accordance with the medication's instructions for use, with the aim of emptying the uterine cavity [4], [8], [28], [38], [43], [44].
GCP CLEL 5Level of Evidence C (Level of Likelihood of Evidence - 5).
Comment: It has been proven that 200 mg of mifepristone is just as effective as 600 mg, therefore prescribing 200 mg of mifepristone is advisable [38], [43], [44], [45]. If there is no response (no vaginal bleeding) 4 hours after the first dose (400 mcg) of misoprostol**, an additional dose of #misoprostol** 400 mcg may be administered orally, vaginally, sublingually, or buccally [4], [6], [7], [8].
For medical abortion in the 1st trimester with an amenorrhea duration of >42 days, it is recommended to administer #mifepristone once orally at a dose of 200 mg, followed (24–48 hours later) by #misoprostol** 800 mcg vaginally, sublingually, or buccally to empty the uterine cavity [4], [6], [7], [8], [28], [38], [46].
GCP CLEL 5Level of Evidence C (Level of Likelihood of Evidence - 5).
Comment: If there is no response (no vaginal bleeding) 4 hours after the first dose of #misoprostol**, an additional dose of #misoprostol** 400 mcg may be administered vaginally, sublingually, or buccally [4], [6], [7]. The vaginal route of misoprostol** administration is more effective than the oral route and has fewer side effects than the sublingual or buccal routes [47]. If the patient submits a written application demanding to stop the medical abortion after taking the first tablet of mifepristone, progesterone preparations** may be prescribed in a hospital or day hospital setting [48], [49], [50], [51], [52]. The recommended regimens are in accordance with the medication instructions for use for the indication of prevention and treatment of threatened and incipient miscarriage associated with progesterone deficiency: progesterone 10–25 mg/day intramuscularly, or progesterone** 200–400 mg/day vaginally, or 200–600 mg/day orally. The duration of administration is determined by embryo/fetus viability based on ultrasound data and the course of the pregnancy.
For medical abortion at 120–216 weeks of gestation, it is recommended to administer #mifepristone once orally at a dose of 200 mg, followed (24–48 hours later) by #misoprostol** 800 mcg vaginally, sublingually, or buccally, and then 400 mcg every 3 hours after the first dose until pregnancy termination [13], [25], [28], [38], [53], [54], [55], [56], [57].
GCP CLEL 5Level of Evidence C (Level of Likelihood of Evidence - 5).
Comment: A repeated course of #mifepristone once orally at a dose of 200 mg, followed (12 hours later) by #misoprostol** 400 mcg vaginally, sublingually, or buccally may be prescribed if abortion does not occur within 24 hours after administration of the specified regimen [13]. Caution and clinical judgment should be exercised when determining the maximum number of misoprostol doses in women with a uterine scar and uterine myoma.
In the 2nd trimester of pregnancy, on the day of abortion (but no earlier than 4 hours later), it is recommended to prescribe bromocriptine** or cabergoline in accordance with the manufacturer's instructions for the purpose of suppressing/preventing lactation [58].
GCP CLEL 5Level of Evidence C (Level of Likelihood of Evidence - 5).
In surgical medical abortion, regardless of the risk of infectious and inflammatory complications, and in medical abortion in patients at high risk for infectious and inflammatory complications, it is recommended to administer broad-spectrum antibiotic prophylaxis to prevent infectious and inflammatory processes [3], [4], [9], [7], [59], [60], [61], [62], [63].
GCR ALeE 1Grade of Recommendation A (Level of Evidence - 1).
Comment: For antibiotic prophylaxis, in accordance with national and international clinical guidelines 1 hour before or immediately after the intervention, the following are prescribed either doxycycline** according to instructions (100 mg 1 hour before abortion and 200 mg 30 minutes after) [4], [7], [59], [64], or #azithromycin 500–1000 mg once orally [4], [64], [65], or #metronidazole** (500 mg orally before abortion, 500 mg orally 4 and 8 hours after) [4], [7], [59], [65], [66]. Beta-lactam antibacterials and penicillins may also be used in accordance with the instructions [7]. If signs of an infectious and inflammatory process are detected, antimicrobial therapy should be prescribed taking into account pathogen susceptibility, without delaying the medical abortion for the duration of treatment [61], [63].
For patients who are Rhesus (D) negative, pregnant by a Rhesus (D) positive partner or a partner with unknown Rhesus status, in the absence of Rhesus (D) isoimmunization, it is recommended to administer human anti-Rhesus Rho[D] immunoglobulin** within 72 hours after medical abortion [16, 18], [67].
GCP CLEL 5Level of Evidence C (Level of Likelihood of Evidence - 5).
In case of medical abortion failure (incomplete abortion), it is recommended to use #misoprostol** 400 mcg sublingually or 600 mg orally to empty the uterine cavity, provided there are no indications (bleeding requiring blood component replacement) for immediate instrumental revision of the uterine cavity (for hemostasis and/or in the presence of signs of infection) [28], [68].
GCP CLEL 5Level of Evidence C (Level of Likelihood of Evidence - 5).
Comment: The efficacy of treating incomplete abortion with #misoprostol** is 89–99%. Misoprostol** and vacuum aspiration of the uterine cavity are comparable in safety and efficacy for the treatment of incomplete abortion [69].
3.3 Surgical treatments
If medical abortion cannot be performed up to 116 weeks of gestation or if there are contraindications to the medications used in the medical abortion regimen, it is recommended to perform vacuum aspiration of the uterine cavity to empty it [6], [7].
GCP CLEL 5Level of Evidence C (Level of Likelihood of Evidence - 5).
Comment: Curettage is considered an obsolete method of surgical abortion, is associated with a high number of complications, and is not among the recommended surgical methods of artificial pregnancy termination up to 12 weeks [6], [9], [38], [46], [70], [71].
If medical abortion cannot be performed at gestational age ≥120 weeks or if there are contraindications to the medications used in the medical abortion regimen, it is recommended to perform cervical dilation and evacuation of the uterine cavity (fetal reduction surgery) [7], [13], [57], [72], [73], [74].
GCP CLEL 5Level of Evidence C (Level of Likelihood of Evidence - 5).
Comment: This intervention should preferably be performed under ultrasound guidance.
For medical abortion at a gestational age of ≥12 weeks, hysterotomy is recommended if there are contraindications to vaginal termination of pregnancy [57], [75].
GCP CLEL 5Level of Evidence C (Level of Likelihood of Evidence - 5).
Comment: Contraindications to vaginal termination of pregnancy include conditions such as complete placenta previa, placenta accreta, urogenital malformations making vaginal termination impossible, and hemorrhage.
If medical abortion fails (incomplete abortion), vacuum aspiration of the uterine cavity is recommended to empty it [4], [8].
GCP CLEL 5Level of Evidence C (Level of Likelihood of Evidence - 5).
Comment: Ultrasound of the uterus and appendages can be used as an adjunct to clinical examination for diagnosing incomplete abortion, but it is not an indication for surgical uterine evacuation. Assessment of the endometrium (endometrial echo >15 mm, presence of echogenic and hypoechoic inclusions) in the absence of clinical signs of incomplete abortion (bleeding requiring surgical intervention and/or signs of infection) is of limited value [30], [31], [32], [33].
Anesthesia for surgical intervention is recommended using methods chosen by the anesthesiologist-resuscitologist [76–80].
Level CLevel 5Level of recommendation evidence C (reliability level of evidence – 5).
Comments: Intravenous anesthesia is predominantly used for vacuum aspiration. For general anesthesia, propofol** (not more than 2.5 mg/kg), sodium thiopental**, fentanyl**, and ketamine** are recommended. During general anesthesia, oxygenation should be ensured using a face mask, laryngeal mask, or via endotracheal intubation. Risk stratification and aspiration prophylaxis measures should be based on gestational age: up to 16 weeks, the risk of complications does not differ from that in the non-pregnant state. When performing spinal anesthesia, small-diameter 25-27G spinal needles are used. The recommended dosages of local anesthetics are 5-10 mg for bupivacaine** (isobaric or hyperbaric solution), 5-7.5 mg for levobupivacaine**, and 20-40 mg for lidocaine**. Lidocaine** gel is used for local anesthesia [7]. For hysterotomy, the anesthetic management described in the clinical guidelines "Single-term delivery, delivery via cesarean section" is applied.
During medical abortion, upon the development of regular uterine contractions, medical methods of pain relief are recommended for analgesia [6], [46], [81, 82].
Level CLevel 5Level of recommendation evidence C (reliability level of evidence – 5).
Comments: Various medical methods can be used for pain relief. At a gestational age of ≥12 weeks of pregnancy, epidural analgesia has a number of advantages among all pain relief methods. Modern local anesthetics (ropivacaine**, bupivacaine**, lidocaine**, levobupivacaine**) are used for neuraxial analgesia in obstetrics. In addition to epidural, spinal, and combined spinal-epidural analgesia, paravertebral lumbar sympathetic blockade can be used. Systemic pain relief methods include the use of opioids. Inhalation methods of pain relief can be used, although they are less effective. Nonsteroidal anti-inflammatory drugs may also be prescribed [7].
4. Medical Rehabilitation and Sanatorium-Resort Treatment
Not applicable.
5. Prevention and Dispensary Observation
The information provided in this section applies to all patients seeking a medical abortion, unless otherwise indicated.
Family planning methods (contraception) are recommended to prevent unintended pregnancy [28], [83].
GSI CLEL 5 Grade of Recommendation C (Level of Evidence – 5).
Comment: If the patient has a persistent desire to terminate the pregnancy, contraception issues are discussed and prescribed prior to medical abortion [84], [85]. After pregnancy termination, both hormonal contraception (systemic hormonal contraceptives, which can be administered orally, via injections, subcutaneous implants, vaginal rings, patches) and intrauterine contraception can be used. Hormonal contraception in medical abortion is prescribed after taking the 1st tablet, and in surgical abortion, immediately after pregnancy termination. Intrauterine contraception in artificial termination of pregnancy by any method is prescribed after its successful completion [9], [28], [84], [86].
Psychological counseling (by a medical psychologist or social worker) is recommended for pre-abortion counseling [3].
GCP CLEL 5Level of Evidence C (Level of Likelihood of Evidence - 5).
Comment: During counseling, work is carried out to prevent abortion. If the pregnancy is continued, psychological support for the pregnant patient should be provided throughout the pregnancy and in the postpartum period.
6. Organization of Medical Care
Indications for inpatient hospitalization:
· Medical abortion up to 11 weeks of gestation in the presence of clinically significant signs of uterine scar thinning, large uterine myomas, genital malformations, or severe somatic diseases.
· Medical abortion at 12–21 weeks of gestation.
Criteria for discharge from the hospital:
· Absence of complications after medical abortion.
It is recommended to hospitalize patients planning to terminate a pregnancy and patients with threatened abortion wishing to preserve the pregnancy in different departments of gynecological hospitals or different wards if there is a single department.
7. Additional Information
Not applicable.
Criteria for Evaluating the Quality of Medical Care
№ | Criteria for diagnostic and treatment quality | Yes/No |
|---|---|---|
1. | Gestational age was determined based on the date of the last menstrual period and ultrasound data of the uterus and appendages or fetal ultrasound upon the patient's presentation for medical abortion. | Yes/No |
2. | Bimanual vaginal examination and inspection of the cervix using specula were performed upon the patient's presentation for medical abortion. | Yes/No |
3. | Ultrasound of the uterus and appendages (up to 9 weeks of gestation) or fetal ultrasound (after 10 weeks of gestation) was performed upon the patient's presentation for medical abortion. | Yes/No |
4. | Psychological counseling (by a medical psychologist, social worker) was performed upon the patient's presentation for medical abortion. | Yes/No |
5. | Blood typing for the ABO system and D antigen (Rh factor) determination were performed upon the patient's presentation for medical abortion (if this test was not performed during the current pregnancy). | Yes/No |
6. | Anti-(RhD) antibodies were tested in Rh-negative patients pregnant with an Rh-positive or unknown Rh status partner upon presentation for medical abortion (if this test was not performed during the current pregnancy). | Yes/No |
7. | Microscopic examination of vaginal smears was performed upon the patient's presentation for medical abortion. | Yes/No |
8. | In medical abortion, mifepristone (#mifepristone) and misoprostol** (#misoprostol**) were prescribed according to the regimen depending on the gestational age, in the absence of contraindications to medical abortion. | Yes/No |
9. | Anesthesia was performed during surgical intervention. | Yes/No |
10. | Antibiotic prophylaxis was performed during surgical medical abortion and medical abortion in patients at high risk of infectious and inflammatory complications. | Yes/No |
11. | Administration of human anti-Rh Rho[D] immunoglobulin** was performed within 72 hours after medical abortion in Rh(D)-negative patients pregnant with an Rh(D)-positive or unknown Rh status partner, in the absence of Rh(D) isoimmunization. | Yes/No |
12. | Bimanual vaginal examination and inspection of the cervix using specula were performed upon the patient's presentation following medical abortion. | Yes/No |
13. | Human chorionic gonadotropin (free β-subunit) serum level assay and/or ultrasound of the uterus and appendages were performed upon the patient's presentation with the clinical picture of incomplete abortion or suspected ectopic pregnancy. | Yes/No |
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Appendix A1. Working Group Composition
Serov Vladimir Nikolayevich – Academician of the RAS, D.Sc. (Medicine), Professor, Honored Scientist of the Russian Federation, President of the Russian Society of Obstetricians and Gynecologists, Chief Researcher, National Medical Research Center for Obstetrics, Gynecology and Perinatology named after Academician V.I. Kulakov of the Russian Ministry of Health (Moscow). There is no conflict of interest.
Dolgushina Nataliya Vitalievna – D.Sc. (Medicine), 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 of the Russian Ministry of Health in Women's Reproductive Health (Moscow). There is 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.
Amiraslanov Elrad Yusifovich – Ph.D. (Medicine), Head of the Obstetric Department, National Medical Research Center for Obstetrics, Gynecology and Perinatology named after Academician V.I. Kulakov of the Russian Ministry of Health (Moscow). There is no conflict of interest.
Baev Oleg Radomirovich – D.Sc. (Medicine), Professor, Honored Physician of the Russian Federation, 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). There is no conflict of interest.
Baranov Igor Ivanovich – D.Sc. (Medicine), Professor, Head of the Department of Scientific and Educational Programs, Department of Research Organization, National Medical Research Center for Obstetrics, Gynecology and Perinatology named after Academician V.I. Kulakov of the Russian Ministry of Health. There is no conflict of interest.
Kan Natalia Enkynovna – D.Sc. (Medicine), 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 (Moscow). There is no conflict of interest.
Priputnevich Tatyana Valerievna – D.Sc. (Medicine), Corresponding Member of the RAS, Director of the Institute of Microbiology, Antimicrobial Therapy and Epidemiology, 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 Medical Microbiology (Moscow). There is no conflict of interest.
Pyregov Aleksey Viktorovich – D.Sc. (Medicine), Professor, Deputy Chief Physician for Anesthesiology and Intensive Care, Moscow Regional Perinatal Center, Chairman of the Committee on Anesthesiology and Intensive Care in Obstetrics and Gynecology, Association of Anesthesiologists-Intensivists (Moscow). There is no conflict of interest.
Viktor L. Tyutyunnik - MD, PhD, Professor, Leading Researcher at the Department of Innovative Scientific Projects of the 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). There is no conflict of interest.
Artymuk Natalia Vladimirovna – D.Sc. in Medicine, 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 of the Russian Ministry of Health, Chief freelance specialist in gynecology of the Russian Ministry of Health, Chief freelance specialist in women's reproductive health in the Siberian Federal District (Kemerovo). No conflict of interest.
Bashmakova Nadezhda Vasilevna – D.Sc. (Medicine), Professor, Chief Researcher, Ural Research Institute of Maternity and Infancy Welfare of the Russian Ministry of Health, Chief Freelance Specialist of the Russian Ministry of Health in Obstetrics, Chief Freelance Specialist of the Russian Ministry of Health in Gynecology, Chief Freelance Specialist in Women's Reproductive Health in the Ural Federal District. There is no conflict of interest.
Bezhenar Vitaly Fedorovich – D.Sc. (Medicine), Professor, Head of the Departments of Obstetrics, Gynecology and Neonatology/Reproductology, Head of the Clinic of Obstetrics and Gynecology, First Pavlov State Medical University of St. Petersburg of the Russian Ministry of Health, Chief Freelance Specialist in Obstetrics and Gynecology of the Healthcare Committee of the Government of Saint Petersburg (Saint Petersburg). There is no conflict of interest.
Belokrinitskaya Tatyana Evgenievna – D.Sc. (Medicine), Professor, Head of the Department of Obstetrics and Gynecology of the Faculty of Advanced Training and Professional Retraining, Chita State Medical Academy of the Russian Ministry of Health, Honored Physician of the Russian Federation, Chief Freelance Specialist of the Russian Ministry of Health in Obstetrics, Chief Freelance Specialist of the Russian Ministry of Health in Gynecology, Chief Freelance Specialist in Women's Reproductive Health in the Far Eastern Federal District (Chita). There is no conflict of interest.
Kalugina Alla Stanislavovna – D.Sc. (Medicine), Professor, Professor at the Department of Obstetrics, Gynecology and Neonatology, First Pavlov State Medical University of St. Petersburg of the Russian Ministry of Health (Saint Petersburg), Chief Freelance Specialist in Women's Reproductive Health in the Northwestern Federal District. There is no conflict of interest.
Krutova Viktoria Aleksandrovna – D.Sc. (Medicine), Professor, Chief Physician of the Clinic, Vice-Rector for Clinical Work, Kuban State University of the Russian Ministry of Health, Chief Freelance Specialist of the Russian Ministry of Health in Obstetrics, Chief Freelance Specialist of the Russian Ministry of Health in Gynecology, Chief Freelance Specialist in Women's Reproductive Health in the Southern Federal District (Krasnodar). There is no conflict of interest.
Kulikov Alexander Veniaminovich – D.Sc. (Medicine), Professor at the Department of Anesthesiology, Intensive Care and Transfusiology of the Faculty of Advanced Training and Professional Retraining, Ural State Medical University of the Russian Ministry of Health (Yekaterinburg). Member of the Board of the Federation of Anesthesiologists and Intensivists and the Association of Obstetric Anesthesiologists-Intensivists. There is no conflict of interest.
Malyshkina Anna Ivanovna – D.Sc. (Medicine), Professor, Director of the Ivanovo Research Institute of Maternity and Childhood named after V.N. Gorodkov, Head of the Department of Obstetrics and Gynecology, Medical Genetics of the Faculty of Medicine, Ivanovo State Medical Academy of the Russian Ministry of Health, Chief Freelance Specialist of the Russian Ministry of Health in Obstetrics, Chief Freelance Specialist of the Russian Ministry of Health in Gynecology, Chief Freelance Specialist in Women's Reproductive Health in the Central Federal District (Ivanovo). There is no conflict of interest.
Mikhailov Anton Valerievich – D.Sc. (Medicine), Professor, Chief Physician of Maternity Hospital No. 17, Professor at 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 Pavlov State Medical University of St. Petersburg of the Russian Ministry of Health, Chief Freelance Specialist of the Russian Ministry of Health in Obstetrics, Chief Freelance Specialist of the Russian Ministry of Health in Gynecology in the Northwestern Federal District (Saint Petersburg). There is no conflict of interest.
Moiseeva Irina Valerievna – D.Sc. (Medicine), Head of the Department of Assisted Reproductive Technologies, Samara Regional Medical Center "Dynasty", Chief Freelance Specialist in Reproductive Health of the Ministry of Health of the Samara Region, Chief Freelance Specialist in Women's Reproductive Health in the Privolzhsky Federal District (Samara). There is no conflict of interest.
Olenev Anton Sergeevich – D.Sc. (Medicine), Chief Freelance Specialist in Obstetrics of the Moscow Healthcare Department, Deputy Chief Physician for Obstetric and Gynecological Care, City Clinical Hospital No. 31 named after Academician G.M. Savelieva of the Moscow Healthcare Department, Associate Professor at the Department of Obstetrics and Gynecology with a Course in Perinatology, Medical Institute of RUDN University. There is no conflict of interest.
Olina Anna Aleksandrovna – D.Sc. (Medicine), Professor, Advisor on Project Activities, Research Institute of Obstetrics, Gynecology and Reproductology named after D.O. Ott (Saint Petersburg). There is no conflict of interest.
Vasily A. Petrukhin – MD, Professor, Honored Doctor of the RF, Director of the Moscow Regional Research Institute of Obstetrics and Gynecology (MONIIAG) (Moscow). No conflict of interest.
Radzinsky Viktor Evseevich - D.Sc. (Medicine), Professor, Corresponding Member of the RAS, Head of the Department of Obstetrics and Gynecology with a Course in Perinatology, Peoples' Friendship University of Russia (Moscow). There is no conflict of interest.
Fatkullin Ildar Faridovich — MD, Professor, Head of the Prof. V.S. Gruздеv Department of Obstetrics and Gynecology, Kazan State Medical University; Chief Freelance Specialist in Obstetrics of the Russian Ministry of Health; Chief Freelance Specialist in Gynecology of the Russian Ministry of Health in the Privolzhsky Federal District (Kazan). No conflict of interest.
Shifman Efim Munevich — MD, Professor at the Department of Anesthesiology and Reanimatology, Faculty for Advanced Medical Training, Moscow Regional Research Clinical Institute named after M.F. Vladimirsky (MONIKI); President of the Association of Obstetric Anesthesiologists-Reanimatologists; Honored Physician of the Republic of Karelia; Expert in Anesthesiology and Reanimatology of the Federal Service for Surveillance in Healthcare; Member of the Presidium of the Federation of Anesthesiologists and Reanimatologists (Moscow). No conflict of interest.
Appendix A2. Methodology for Developing Clinical Guidelines
Target audience for these clinical guidelines:
obstetrician-gynecologists
anesthesiologists-reanimatologists
residents in obstetrics and gynecology and anesthesiology-reanimatology
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 | There is only a rationale for the mechanism of action or expert opinion |
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
B1. Algorithm for medical abortion in the 1st trimester ≤ 42 days of amenorrhea (up to 56 weeks of gestation)
B2. Algorithm for medical abortion in the 1st trimester with amenorrhea >42 days of amenorrhea (60-116 weeks of gestation)
B3. Algorithm for medical abortion at 120-216 weeks of gestation
Appendix C. Patient Information
Information for the patient undergoing medical abortion
Abortion is an unsafe procedure associated with the risk of various complications!
Medical abortion can be performed using a medical (pharmacological) or surgical method. During surgical intervention, the following complications are possible directly during the procedure: anesthesia-related complications, trauma and perforation of the uterus with potential injury to internal organs and blood vessels, and hemorrhage, which may require extending the scope of surgery up to laparotomy and hysterectomy, etc. Postoperative complications include: blood accumulation and retained products of conception in the uterine cavity, acute and/or subacute inflammatory process of the uterus and/or appendages up to peritonitis, which will require re-operation, not excluding hysterectomy, etc. Complications are also observed during medical abortion, such as retained products of conception, ongoing pregnancy, and hemorrhage, the development of which requires completing the abortion surgically.
Long-term consequences and complications of abortion include: infertility, chronic inflammatory processes of the uterus and/or uterine appendages, adenomyosis, ovarian dysfunction, ectopic pregnancy, miscarriage, various complications during subsequent pregnancies and childbirth: premature birth, labor abnormalities, bleeding during childbirth and/or the postpartum period. A link between abortion and the development of cardiovascular diseases, breast cancer, and mental disorders has been proven.
Before making a final decision to undergo an abortion, you must consult a psychologist/psychotherapist or another specialist to whom you are referred by your attending physician for pre-abortion counseling. You will also undergo an ultrasound examination (US), during which you will hear the fetal heartbeat. You should not undergo an abortion unless you are absolutely sure that you want to terminate the pregnancy, or if you do not have medical indications for it.
If the abortion is performed before 12 weeks without medical or social indications (at your insistence), it can be performed no earlier than after observing the "week of silence": 48 hours from the date of application to a medical organization for an artificial abortion at a gestational age of 4-66 weeks or at a gestational age of 10-114 weeks, but no later than the end of the 12th week of pregnancy, and no earlier than 7 days from the date of application to a medical organization for an artificial abortion at a gestational age of 7 – 96 weeks of pregnancy.
When performing a medical abortion up to 12 weeks, you will be prescribed medications that must be taken strictly as directed by your attending physician. These drugs cause fetal death followed by expulsion from the uterine cavity. After taking the medications, you will remain under observation for 1.5–4 hours.
Before performing a surgical abortion (vacuum aspiration of the gestational sac) up to 12 weeks, you will receive anesthesia. The duration of your inpatient observation will be determined by the attending physician based on your condition and will be at least 3–4 hours.
If you change your decision to have an abortion after taking the first pills in a medical abortion, you must immediately consult a doctor who will perform an ultrasound, and if a fetal heartbeat is present, prescribe treatment aimed at preserving the pregnancy. At the same time, you should be aware that the pills may have a negative impact on the health of the future child, so before making a decision on artificial pregnancy termination, you must be firmly convinced that this decision is correct and final.
Even before the medical abortion is performed, you will be given recommendations on contraception, which is prescribed immediately after the abortion (hormonal contraception or intrauterine device insertion). You must use contraception to prevent abortions until you plan to have children.
Appendix G. Assessment Scales, Questionnaires, and Other Evaluation Tools
Not applicable.