List of Abbreviations
PID | pelvic inflammatory disease |
|---|---|
ICI | isthmic-cervical incompetence |
STI | sexually transmitted infections |
RPL | recurrent pregnancy loss |
PROM | premature rupture of membranes |
CR | preterm birth |
RDS | respiratory distress syndrome |
ultrasound | ultrasound examination |
CC | cervical canal |
Cx | cervix |
Terms and Definitions
Cervical insufficiency (CI) is defined as a cervical length (Cx) of ≤25 mm and/or dilation of the cervical canal (CC) of ≥10 mm (along its entire length) prior to 37 weeks of gestation, in the absence of clinical signs of threatened miscarriage/preterm labor (PTL).
Miscarriage is the spontaneous termination of pregnancy (expulsion or extraction of the embryo/fetus) prior to 22 weeks of gestation.
Recurrent miscarriage (RPL) is defined as the occurrence of two or more consecutive spontaneous pregnancy losses prior to 22 weeks of gestation.
1. Brief information on the disease or condition
1.1 Definition of the disease or condition
CI is defined as shortening of the Cx ≤25 mm and/or dilation of the CC ≥10 mm (along its entire length) prior to 37 weeks of gestation without clinical signs of threatened miscarriage/PTL [1], [2].
A pathognomonic sign of CI is rapid, painless shortening and dilation of the cervix in the 2nd or early 3rd trimester of pregnancy, which can lead to miscarriage or PTL. The stages of CI progression include structural changes in the cervix, often accompanied by prolapse of the amniotic sac into the cervical canal or vagina and premature rupture of membranes (PROM).
1.2 Etiology and pathogenesis of the disease or condition (group of diseases or conditions)
CI occurs due to functional or structural changes in the cervix influenced by various etiological factors. A key factor in the development of functional CI is a defect in the synthesis of collagen, which accounts for up to 85% of cervical tissue weight. Studies of cervical collagen in non-pregnant women with previously diagnosed CI have revealed a reduced concentration of hydroxyproline compared to women with normal cervical structure. The exact causes of this disturbance have not yet been established [2].
An infectious and inflammatory process in the uterine cavity can act as a pathogenetic factor for CI [3], [4]. At least 80% of CI cases are associated with intraamniotic infection, as the barrier function of cervical mucus is compromised when the cervix shortens and the cervical canal widens [3].
Risk factors for CI include [1], [3], [5], [6], [7], [8], [9], [10], [11], [12], [13], [14], [15]:
burdened obstetric and gynecological history: late miscarriage, recurrent pregnancy loss (RPL), PTL, PROM before 32 weeks, cervical shortening ≤25 mm before 27 weeks.
Course features of the current pregnancy: multiple gestation, polyhydramnios.
Somatic diseases: overweight and obesity, iron deficiency anemia, systemic connective tissue disorders.
Infectious-inflammatory diseases and vaginal dysbiosis: bacterial vaginosis, vulvovaginitis, pelvic inflammatory disease (PID).
Hormonal disorders (polycystic ovary syndrome, congenital adrenal hyperplasia, progesterone deficiency).
Genital infantilism.
Uterine malformations (bicornuate, septate, or saddle uterus).
Congenital cervical shortening.
Acquired cervical deformations due to cervical lacerations during childbirth, instrumental dilation of the CC during gynecological surgeries, or surgical interventions on the cervix (diathermocoagulation, conization, including electrosurgical procedures).
Heredity (≈30% of pregnant women with CI have first-degree female relatives with a history of CI).
Connective tissue dysplasia, including Ehlers-Danlos and Marfan syndromes.
Polymorphism of genes responsible for connective tissue metabolism and the production of inflammatory mediators.
1.3 Epidemiology of the Disease or Condition
The prevalence of CI during pregnancy is 0.8–1% [16]; in patients with a history of second-trimester miscarriage, it is 20% [1], and with early PTL, 30% [17].
1.4 Features of Coding the Disease or Condition
O34.3 Incompetence of cervix, care given to mother.
1.5 Classification of the disease or condition
Classification of CI by etiopathogenesis:
Anatomic CI.
Functional CI.
Congenital CI.
1.6 Clinical presentation of the disease or condition
CI is characterized by painless or mildly painful shortening of the cervix and dilation of the cervical canal, accompanied by prolapse of the amniotic sac into the CC. The clinical presentation of CI varies from a complete absence of symptoms to the appearance of mucous or bloody-mucous vaginal discharge, and crampy lower abdominal pain that may lead to subsequent miscarriage or PTL.
2. Diagnostics, medical indications and contraindications for diagnostic methods
Diagnostic criteria
Asymptomatic shortening of the Cx ≤25 mm and/or dilation of the CC ≥10 mm (along its entire length) according to ultrasound cervicometry prior to 37 weeks of gestation, in the absence of clinical signs of threatened miscarriage/PTL.
2.1 Complaints and Anamnesis
It is recommended to evaluate complaints and take a medical history to identify risk factors for CI [19].
GCP CLEL 5Level of Evidence C (Level of Likelihood of Evidence - 5).
Comment: Patients with CI may complain of a sensation of pressure, fullness, stabbing pains in the vagina, lower abdominal and lower back discomfort, or mucous or blood-tinged mucous discharge from the vagina. In the majority of patients, CI is asymptomatic.
2.2 Physical Examination
It is recommended to perform a speculum examination of the cervix upon presentation and once every 4 weeks after cervical cerclage placement to assess the state of the cervix and check for amniotic fluid leakage [19], [38].
GCP CLEL 5Level of Evidence C (Level of Likelihood of Evidence - 5).
Comment: The volume and character of discharge (bloody, blood-tinged mucous, purulent), amniotic sac prolapse, cervical anatomy, and the condition of the external os and cervical canal are evaluated. Bimanual vaginal examination is not performed for the diagnosis of CI due to its low diagnostic value and the increased risk of pregnancy termination.
2.3 Laboratory Diagnostics
If surgical treatment is required, it is recommended to determine the main ABO blood groups and Rh factor (D antigen) if this test has not been performed during the current pregnancy, in order to select the correct screening algorithm for the prevention of fetal hemolytic disease and ensure readiness for blood transfusion [22], [23].
GPP CLoE 5Level of Evidence/Grade of Recommendation C (level of evidence - 5).
Comment: For evaluation and treatment of fetal hemolytic disease, refer to the clinical guidelines "Rhesus Isoimmunization. Fetal Hemolytic Disease" [24].
If surgical treatment is required, it is recommended to test for Rhesus antibodies in Rhesus-negative patients who are pregnant by a partner with Rhesus-positive or unknown blood type, if this test has not been performed during the current pregnancy, in order to select the correct management algorithm for the prevention of fetal hemolytic disease [22], [23].
GPP CLoE 5Level of Evidence/Grade of Recommendation C (level of evidence - 5).
It is recommended to perform a complete blood count (CBC) and test serum C-reactive protein (CRP) levels to diagnose infectious and inflammatory diseases and determine the feasibility of surgical correction [19], [25], [26].
LeR ALoE 1Level of Evidence Recommendation A (Level of Evidence - 1).
It is recommended to perform microscopic examination of vaginal smears and measure the hydrogen ion concentration (pH) of the vaginal mucosa discharge to diagnose infectious-inflammatory and dysbiotic conditions [19].
GCP CLEL 5Level of Evidence C (Level of Likelihood of Evidence - 5).
Comment: Alteration of the vaginal flora increases the risk of miscarriage. If vaginal dysbiosis is detected, the patient should be referred for DNA testing of Gardnerella vaginalis, Atopobium vaginae, Lactobacillus spp. and total bacterial load in vaginal discharge using polymerase chain reaction (PCR), as well as molecular-biological testing of female genital secretions for opportunistic genital mycoplasmas (Ureaplasma parvum, Ureaplasma urealyticum, Mycoplasma hominis).
It is recommended to perform microscopic examination of vaginal smears and determine the pH of the vaginal mucosa discharge once a month after cervical cerclage placement or the insertion of an obstetric pessary, in order to diagnose infectious-inflammatory and dysbiotic conditions [19].
GCP CLEL 5Level of Evidence C (Level of Likelihood of Evidence - 5).
It is recommended to perform molecular-biological testing of female genital mucosal discharge for sexually transmitted infections (STIs) (Neisseria gonorrhoeae, Trichomonas vaginalis, Chlamydia trachomatis, Mycoplasma genitalium) to detect infection and provide timely treatment [27], [28], [29], [30].
LeveL of Recommendation BGrade of Evidence 2LeveL of Recommendation B (Grade of Evidence - 2).
It is recommended to perform an amniotic fluid leakage test during a speculum examination of the cervix if PROM is suspected [38], [31].
GCR BLEL 3Recommendation Grade B (Level of Evidence — 3).
Comment: Laboratory tests include cytological tests (ferning test, false-negative rate >20%), nitrazine test (false-positive rate = 5–30%), and the detection of phosphorylated insulin-like growth factor-binding protein 1 (phIGFBP-1) or placental alpha-microglobulin-1 (PAMG-1) in cervical mucus [20, 32–36].
2.4 Instrumental Diagnostics
It is recommended to refer pregnant patients at high risk for late miscarriage and PTL for cervical ultrasound (ultrasound cervicometry) every 1–2 weeks from 15–16 to 24 weeks of gestation for the timely diagnosis of cervical shortening [37, 38], [39].
GCR ALeE 1Grade of Recommendation A (Level of Evidence - 1).
Comments: High-risk patients for late miscarriage and preterm birth (PTB) include those with a history of late miscarriage/PTB. Transvaginal ultrasound is the method of choice for measuring the cervix [1]. In some cases, if technical capability for transvaginal ultrasound cervicometry is lacking, transabdominal and transperineal ultrasound may be used. At 20 weeks of gestation, a cervical length of ≤25 mm is associated with a 6-fold increase in the risk of PTB. Up to 34 weeks in singleton pregnancies, a cervical length of ≤25 mm has a sensitivity of 76% and specificity of 68% for diagnosing PTB [40], [41]. (Appendix A3).
Not recommended is cervical ultrasound (ultrasound cervicometry) in patients with cervical cerclage, preterm premature rupture of membranes (PPROM), placenta previa, or an in-situ pessary [42].
GCP CLEL 5Level of Evidence C (Level of Likelihood of Evidence - 5).
2.5 Other Procedures
Not applicable.
3. Treatment, including drug and non-drug therapies, diet therapy, and pain management
3.1. Non-pharmacological treatments
For patients with a singleton pregnancy and a history of late miscarriage or PTB, in order to reduce the risk of miscarriage or PTB and improve perinatal outcomes, it is recommended to insert an obstetric support pessary [15], [43], [44], [45].
LeR ALoE 1Level of Evidence Recommendation A (Level of Evidence - 1).
Comments: The main methods of treatment for cervical insufficiency (CI) are: a combination of an obstetric support pessary or cerclage with vaginal progesterone** preparations in the absence of contraindications to progesterone** therapy [46], [47]. The obstetric support pessary is inserted between 12 and 37 weeks of gestation and is the preferred method after 24 weeks of gestation. Contraindications to the insertion of an obstetric support pessary include: onset of PTB and placental abruption with normally positioned placenta. There is no need for periodic removal and sanitizing treatment (replacement) of the obstetric support pessary.
For patients with a multiple pregnancy, in order to reduce the risk of miscarriage or PTB and improve perinatal outcomes, it is recommended to insert an obstetric support pessary [48], [49–51], [52], [53].
LeR ALoE 1Level of Evidence Recommendation A (Level of Evidence - 1).
Comment: The obstetric support pessary is inserted between 12 and 34 weeks of gestation and is the preferred method in multiple pregnancies.
3.2. Pharmacotherapy
For patients with a singleton or multiple pregnancy, in order to reduce the risk of miscarriage or PTB and improve perinatal outcomes, it is recommended to prescribe vaginal progesterone** preparations at 200 mg/day until 34 weeks of gestation, provided there are no contraindications to progesterone** therapy [29], [46], [54], [55], [56], [57], [58], [59], [1, 60], [15], [61], [62], [63], [64], [65].
GCR ALeE 1Grade of Recommendation A (Level of Evidence - 1).
Comments: For the prevention of PTB, vaginal administration of progesterone** is more effective and has fewer side effects than intramuscular administration [66]. Prevention of PTB with vaginal progesterone** preparations in patients with a cervical length of ≤25 mm reduces the rate of pregnancy termination before 33 weeks by 45%, and significantly reduces the incidence of fetal respiratory distress syndrome (RDS) and neonatal morbidity [67]. Pregnant women receiving dydrogesterone** for indications who develop CI may continue its use up to 20 weeks of gestation, followed by a transition to vaginal progesterone** after 20 weeks [68], [69].
When performing cervical cerclage, systemic broad-spectrum antibiotic prophylaxis is recommended to prevent infectious and inflammatory complications [19], [70], [71].
GCP CLEL 5Level of Evidence C (Level of Likelihood of Evidence - 5).
Comments: For perioperative antibiotic prophylaxis, systemic broad-spectrum antibacterial drugs according to the ATX classification are used (J01CR - combinations of penicillins, including combinations with beta-lactamase inhibitors, penicillins: ampicillin + [sulbactam]**, amoxicillin + [clavulanic acid]**; and J01D - other beta-lactam antibacterials: cefazolin**, cefuroxime**) [72].
In cases of fetal bladder prolapse and emergency cervical cerclage, it is recommended to prescribe broad-spectrum antibacterial therapy for 5–7 days to prevent infectious and inflammatory complications [4], [14], [73], [74], [75].
GCP CLEL 5Level of Evidence C (Level of Likelihood of Evidence - 5).
Comments: For antibiotic therapy, systemic broad-spectrum antibacterial drugs according to the ATX classification are used (J01CR - combinations of penicillins, including combinations with beta-lactamase inhibitors, penicillins: ampicillin**, ampicillin + [sulbactam]**, amoxicillin + [clavulanic acid]**; and J01D - other beta-lactam antibacterials) [72]. Adjustment of antibacterial therapy should be performed 48–72 hours after the start of treatment in the absence of improvement in clinical and laboratory parameters indicating a positive disease trajectory and/or pathogen resistance to the administered therapy [76].
3.3. Surgical treatment
During the preconception stage (preferred) or at 10 to 14 weeks of gestation, it is recommended to refer patients with CI caused by cervical tissue deficiency (conization, trachelectomy), when cervical cerclage cannot be performed during pregnancy, for laparoscopic (preferred) or laparotomic cervicaloplasty [77], [78], [79], [80], [81], [82].
GCR BLEL 3Recommendation Grade B (Level of Evidence — 3).
Comments: Transabdominal cerclage is technically more complex than transvaginal cerclage and is associated with a higher number of complications (wound infection, hemorrhage) [78], [83], [84]. Therefore, transabdominal cerclage is indicated only in special cases: when there are at least 2 failed attempts at transvaginal cerclage; cervical anatomy that does not allow for a vaginal stitch (e.g., after loop electrosurgical excision of the cervix (LLETZ) or cone biopsy); and post-trachelectomy [1], [77], [85], [86]. Cerclage is performed by an obstetrician-gynecologist with high surgical training and laparoscopic technique proficiency [83]. A non-absorbable tape or a flexible thin probe threaded onto a tapered Mayo #4 needle is used for cerclage (providing greater elasticity). The tension of the suture material should be adjusted to allow passage of Hegar #5 cervical dilators. Removal of a transabdominally placed cervical stitch is impossible in most cases due to ingrowth of surrounding tissues; therefore, delivery via Cesarean section is recommended, including in the 2nd trimester of pregnancy, even in the event of an unfavorable perinatal outcome. The stitch may remain in place for subsequent pregnancies.
For patients with a singleton pregnancy and a history of late miscarriage or PTB with intact fetal membranes, in order to reduce the risk of miscarriage or PTB and improve perinatal outcomes, cervical cerclage is recommended as an alternative method to the obstetric support pessary [17], [87, 88], [89].
GCR ALeE 1Grade of Recommendation A (Level of Evidence - 1).
Comments: Cervical cerclage is performed at 120–266 weeks of gestation [90]. Cerclage may also be performed as an emergency procedure when the patient exhibits cervical shortening of ≤15 mm, often accompanied by prolapse of the fetal membranes [91]. The risks and benefits of the procedure must be carefully weighed considering the gestational age (risks increase with advancing gestation), degree of cervical dilation, qualifications of the obstetrician-gynecologist, and hospital capabilities. After 240 weeks of gestation, cerclage is performed only in Level 3 hospitals. Cerclage is preferred in pregnant women with CI and a history of ≥2 late miscarriages or PTBs. For cerclage technique, see Appendix A3.
In multiple pregnancies, routine cervical cerclage is not recommended for the prevention of miscarriage and PTB [49–51], [92, 93].
GCR ALeE 1Grade of Recommendation A (Level of Evidence - 1).
Comments: In twin pregnancies with cervical shortening of ≤15 mm or cervical canal dilation of ≥10 mm according to ultrasound cervicometry, cervical cerclage is recommended [94]. Additionally, the need for cerclage in multiple pregnancies may be considered consultatively for CI in patients with a history of late miscarriages and PTB, and in pregnancies complicated by twin-to-twin transfusion syndrome.
Not recommended is cervical cerclage in the presence of signs of infection, vaginal bleeding, or symptoms of threatened miscarriage or PTB [17], [95].
LoR CGoE 4Level of Recommendation C (Grade of Evidence - 4).
When performing cervical cerclage at a gestational age of ≥24 weeks, given the high risk of PTB, antenatal prevention of fetal RDS is recommended [96, 97], [98].
GCR ALeE 1Grade of Recommendation A (Level of Evidence - 1).
Comment: The maximum effect of fetal RDS prevention is observed on days 2–7 from the start of prevention; however, if a full course cannot be administered, prevention of fetal RDS should still be initiated (the "incomplete dose" effect has been proven) [99]. Prevention of fetal RDS should not be carried out if there are no serious concerns regarding impending preterm birth and justified certainty that it will begin within 7 days [100]. There is evidence that in the presence of chorioamnionitis, RDS prevention is safe and improves perinatal outcomes [101, 102]. For the prevention of fetal RDS, #betamethasone** intramuscularly at a dose of 12 mg twice at a 24-hour interval or #dexamethasone** intramuscularly at a dose of 6 mg 4 times at a 12-hour interval or at a dose of 8 mg 3 times at an 8-hour interval (total dose 24 mg) is recommended [96], [103].
After cervical cerclage, for the purpose of analgesia, anti-inflammatory, and tocolytic effect after 22 weeks of gestation, the administration of #indometacin is recommended [104].
Gar CLoE 1Grade of Recommendation C (Level of Evidence - 1).
Comment: #Indometacin is used starting with 50-100 mg rectally or orally, then 25 mg every 6 hours (for no more than 48 hours) [105]. Contraindications for administration include blood clotting disorders, increased bleeding tendency, liver dysfunction, gastric/duodenal ulcer, bronchial asthma, hypersensitivity to aspirin, fetal growth restriction, and fetal renal malformations [106]. The frequency of side effects is significantly lower when used for no more than 48 hours at a gestational age of less than 32 weeks. The presence of oligohydramnios and/or detection of constriction of the ductus arteriosus is an indication to discontinue therapy.
In patients with Rhesus (D) negative blood type, pregnant by a partner with Rhesus (D) positive or unknown Rhesus blood type, when the Rhesus type of the fetus has not been determined by a non-invasive method, and in the absence of Rhesus (D) isoimmunization after cervical cerclage, it is recommended to administer anti-Rhesus Rho[D] human immunoglobulin** [107].
GCP CLEL 5Level of Evidence C (Level of Likelihood of Evidence - 5).
Comment: For evaluation and treatment of fetal hemolytic disease, refer to the clinical guidelines "Rhesus Isoimmunization. Fetal Hemolytic Disease" [24].
To ensure adequate anesthesia during cervical cerclage, the use of both neuroaxial anesthesia techniques (epidural, spinal, combined spinal-epidural) and general anesthesia is recommended [108–112].
Level CLevel 5Level of recommendation evidence C (reliability level of evidence – 5).
Comments: There is compelling evidence that none of the specified types of anesthesia increases the concentration of endogenous oxytocin or affects surgical outcomes [113], [114]. If the patient is in the Trendelenburg position, hyperbaric local anesthetic solutions should not be administered during spinal anesthesia. Anesthesia is performed while maintaining spontaneous breathing; for transabdominal laparoscopic access, anesthesia with artificial lung ventilation is used [115]. After 20 weeks of gestation (earlier in multiple pregnancies), aortocaval compression syndrome may occur, which should be taken into account when choosing the patient's body position during surgery [116]. 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 outside of pregnancy. When performing spinal anesthesia, small-diameter spinal needles 25-27G are used. The recommended dosage of local anesthetics is 5-10 mg for bupivacaine** (isobaric or hyperbaric solution), 5-7.5 mg for levobupivacaine**, and 20-40 mg for lidocaine**. The routine use of epidural and spinal-epidural anesthesia is not recommended; indications are determined individually [114]. When performing general anesthesia, oxygenation is recommended via a facemask, laryngeal mask, or endotracheal intubation. Propofol** (no more than 2.5 mg/kg), sodium thiopental**, fentanyl**, and ketamine** are used as anesthetics [114].
4. Medical Rehabilitation and Sanatorium-Resort Treatment
Not applicable.
5. Prevention and Dispensary Observation
It is recommended to refer pregnant patients at 18-206 weeks for fetal ultrasound and cervical ultrasound (ultrasound cervicometry), and pregnant women at high risk of late miscarriage and preterm birth for cervical ultrasound (ultrasound cervicometry) from 15-16 to 24 weeks of gestation at a frequency of once every 1-2 weeks for the timely diagnosis of cervical shortening [37, 38], [39].
GCR ALeE 1Grade of Recommendation A (Level of Evidence - 1).
6. Organization of Medical Care
The high risk of very early preterm birth dictates the need for treatment of these patients in level 3 obstetric and gynecological medical organizations, or in their absence, in level 2 obstetric and gynecological medical organizations equipped with an intensive care unit (wards) for newborns.
Indications for hospital admission in pregnant women with cervical incompetence are:
Need for surgical correction of cervical incompetence.
Threatened preterm birth.
Premature rupture of membranes (PROM).
Indications for discharging the patient from the hospital are:
Postpartum (see clinical guidelines "Postpartum Care and Examination").
After relief of symptoms of threatened miscarriage, threatened preterm birth, or cervical incompetence with a progressive pregnancy (see clinical guidelines "Miscarriage", "Preterm Birth").
7. Additional Information
Not applicable.
Criteria for Evaluating the Quality of Medical Care
№ | Criteria for the quality of diagnosis and treatment of cervical incompetence | Yes/No |
|---|---|---|
1. | Cervix examination with speculum performed | Yes/No |
2. | Referral for a general (clinical) blood test and blood serum C-reactive protein level test performed | Yes/No |
3. | Referral for microscopic examination of vaginal smears performed | Yes/No |
4. | Referral for molecular biological testing of female genital mucosal discharge for sexually transmitted infection pathogens (Neisseria gonorrhoeae, Trichomonas vaginalis, Chlamydia trachomatis, Mycoplasma genitalium) performed | Yes/No |
5. | Referral for ultrasound examination of the cervix (ultrasound cervicometry) from 15-16 to 24 weeks of gestation at a frequency of once every 1-2 weeks performed | Yes/No |
6. | Insertion of an obstetric pessary or cervical cerclage performed in a patient with a singleton pregnancy with a history of preterm birth or late miscarriage | Yes/No |
7. | Insertion of an obstetric pessary performed in a patient with a multiple pregnancy | Yes/No |
8. | Vaginal progesterone** preparations prescribed at 200 mg/day up to 34 weeks of gestation provided there are no contraindications to progesterone** | Yes/No |
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Appendix A1. Working Group Composition
Nana K. Tetruashvili – MD, PhD, Head of the 2nd Department of Obstetric Pathology of Pregnancy, Deputy 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 (Moscow). There is no conflict of interest.
Natalia V. Dolgushina – MD, PhD, 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). There is no conflict of interest.
Natalia E. Kan – MD, PhD, Professor, Deputy Director for Research – 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 (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.
Baranov Igor Ivanovich – D.Sc. in Medicine, 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. No conflict of interest.
Pyregov Aleksey Viktorovich – D.Sc. in 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 of the Association of Anesthesiologists and Intensivists (Moscow). No conflict of interest.
Radzinsky Viktor Evseevich – Corresponding Member of the Russian Academy of Sciences, D.Sc. in 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.
Savelyeva Galina Mikhailovna – Academician of the Russian Academy of Sciences, D.Sc. in Medicine, Professor, Honored Scientist of the Russian Federation, Hero of Labour of the Russian Federation (Moscow). No conflict of interest.
Serov Vladimir Nikolaevich – Academician of the Russian Academy of Sciences, D.Sc. in Medicine, Professor, Chief Researcher at the 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.
Khodzhaeva Zulfiya Sagdullaevna – D.Sc. in Medicine, Professor, Deputy 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 (Moscow). No conflict of interest.
Shabanova Natalia Evgenievna – Ph.D. in Medicine, Associate Professor, Head of the Department of Clinical Pharmacology of Antimicrobial and Immunobiological Drugs, 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 (Moscow). No conflict of interest.
Shmakov Roman Georgievich – D.Sc. in Medicine, Professor, Professor of the Russian Academy of Sciences, Director of the Moscow Regional Research Institute of Obstetrics and Gynecology named after Academician V.I. Krasnopolsky, Chief freelance specialist in obstetrics of the Russian Ministry of Health (Moscow). No conflict of interest.
Shifman Efim Munevich – D.Sc. in Medicine, Professor of the Department of Anesthesiology and Intensive Care, Faculty of Advanced Medical Training, Moscow Regional Research Clinical Institute named after M.F. Vladimirsky, President of the Association of Obstetric Anesthesiologists and Intensivists (Moscow). No conflict of interest.
Sheshko Elena Leonidovna – Ph.D. in Medicine, Director of the Department of Medical Care for Children, Maternity Services and Public Health (Moscow). No conflict of interest.
Chief Freelance Specialists
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 Vasilievna – D.Sc. in Medicine, Professor, Chief Researcher, Ural Research Institute for Maternal and Infant Welfare 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 Ural Federal District. No conflict of interest.
Bezhenar Vitaly Fedorovich – D.Sc. in Medicine, Professor, Head of the Department of Obstetrics, Gynecology and Reproductology, Academician I.P. Pavlov First Saint Petersburg State Medical University of the Russian Ministry of Health, Chief freelance specialist in obstetrics and gynecology of the Russian Ministry of Health in the Northwestern Federal District (Saint Petersburg). No conflict of interest.
Belokrinitskaya Tatiana Evgenievna – D.Sc. in Medicine, Professor, Head of the Department of Obstetrics and Gynecology, Faculty of Additional Professional Education, Chita State Medical Academy of the Russian Ministry of Health, Honored Doctor of the Russian Federation, Chief freelance specialist in obstetrics of目 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 Far Eastern Federal District (Chita). No conflict of interest.
Kalugina Alla Stanislavovna – D.Sc. in Medicine, Professor, Professor of the Department of Obstetrics, Gynecology and Neonatology, Academician I.P. Pavlov First Saint Petersburg State Medical University of the Russian Ministry of Health (Saint Petersburg), Chief freelance specialist in women's reproductive health in the Northwestern Federal District. No conflict of interest.
Kogan Igor Yuryevich – D.Sc. in Medicine, Professor, Corresponding Member of the Russian Academy of Sciences, Director of the D.O. Ott Research Institute of Obstetrics, Gynecology and Reproductology (Saint Petersburg), Chief freelance specialist in reproductive health of the Healthcare Committee of Saint Petersburg. No conflict of interest.
Krasnopolskaya Ksenia Vladislavovna – Corresponding Member of the Russian Academy of Sciences, D.Sc. in Medicine, Professor, Head of the Department of Reproductology at MONIIAG, Chief freelance specialist in women's reproductive health of the Ministry of Health of the Moscow Region (Moscow). No conflict of interest.
Malyshkina Anna Ivanovna – D.Sc. in Medicine, Professor, Director of the V.N. Gorodkov Ivanovo Research Institute of Motherhood and Childhood, Head of the Department of Obstetrics, Gynecology and Medical Genetics of the Faculty of General Medicine, Ivanovo State Medical Academy 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 Central Federal District (Ivanovo). No conflict of interest.
Mikhailov Anton Valerievich – D.Sc. in Medicine, Professor, Chief Physician of Maternity Hospital No. 17 of Saint Petersburg, Professor of the Department of Obstetrics and Gynecology, I.I. Mechnikov North-Western State Medical University of the Russian Ministry of Health, and the Department of Obstetrics, Gynecology and Perinatology, Academician I.P. Pavlov First Saint Petersburg State Medical University of the Russian Ministry of Health, Chief freelance specialist in obstetrics and gynecology of the Russian Ministry of Health in the Northwestern Federal District (Saint Petersburg). No conflict of interest.
Moiseeva Irina Valerievna – D.Sc. in 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 Volga Federal District (Samara). No conflict of interest.
Anton S. Olenev – PhD, Chief freelance specialist in obstetrics and gynecology of the Moscow Healthcare Department, Head of the Perinatal Center branch of City Clinical Hospital No. 24, Associate Professor of the Department of Obstetrics and Gynecology with a Course in Perinatology, Medical Institute of RUDN University. No conflict of interest.
Popandopulo Victoria Alexandrovna – D.Sc. in Medicine, Professor, Head of the Department of Obstetrics and Gynecology, Maykop State Technological University, Professor of the Department of Obstetrics and Gynecology of the Faculty of General Medicine, Astrakhan State Medical University of the Russian Ministry of Health, Chief Physician of Kuban Medical Center LLC, 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 Southern Federal District (Krasnodar). No conflict of interest.
Fatkullin Ildar Faridovich – D.Sc. in Medicine, Professor, Head of the Prof. V.S. Gruzdev 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 Volga Federal District (Kazan). No conflict of interest.
Appendix A2. Methodology for Developing Clinical Guidelines
Target audience for these clinical guidelines:
obstetrician-gynecologists
obstetrician-gynecologist 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
Sample surgery protocol "McDonald Cervical Cerclage"
"__" ____________ 20__ at __ h __ min
Under ___________________________ anesthesia, after preparation of the ________________ external genitalia and vagina, the cervix was exposed with specula and fixed with fenestrated forceps. At the level of the vaginal fornices in the submucosal layer of the cervix, _________________ suture was placed on the cervix according to the McDonald method. Knot at 12 o'clock in the anterior vaginal fornix. Toilet of the vaginal mucosa. Disinfection of the vagina with an antiseptic solution. Blood loss _______________ ml.
Surgical details: _________________________________________________________
Physician ___________________________
Operating nurse ____________________
Sample surgery protocol "A.I. Lyubimova Cervical Cerclage as Modified by N.M. Mamedalieva"
"__" ____________ 201_ at __ h __ min
Under ____________________ anesthesia, after preparation of the ______________________ external genitalia and vagina, the cervix was exposed with specula, grasped with fenestrated forceps on the anterior and posterior lips, and mobilized. Two U-shaped sutures with ________________________ threads were placed at the junction of the anterior vaginal fornix mucosa and the cervix according to the A.I. Lyubimova method modified by N.M. Mamedalieva. The ends of the threads were placed on clamps, tensioned in a dosed manner, and tied. Toilet of the vaginal mucosa. Treatment of the vagina with an antiseptic solution. Blood loss ________________ mL.
Surgical details: _________________________________________________________
Physician _____________________________
Operating nurse _______________________
Technique of cervical suturing (cerclage)
The following types of cerclage are distinguished: prophylactic (elective, based on history), therapeutic (emergent, based on ultrasound cervicometry results), and emergency (rescue, in cases of fetal membrane prolapse).
Conditions for performing cerclage:
Leukocytes <15,000/mL.
C-reactive protein level <5 ng/dL.
No PPROM.
No labor activity.
No pelvic inflammatory disease.
Normal body temperature.
No fetal RDS.
Informed consent of the woman has been obtained and documented in writing.
Cerclage can be performed via vaginal or abdominal approach. Vaginal approach is preferred due to fewer complications.
The technique of vaginal cerclage involves three main methods:
- suture placement without tissue dissection (McDonald method);
- double U-shaped intramucosal suture in the area of the internal os (Lyubimova method modified by Mamedalieva);
- submucosal suture (so-called high cervical suture) with bladder dissection (Shirodkar method), extremely rarely used due to high invasiveness, currently of historical significance [117].
Non-absorbable suture material in the form of threads or tape is used. The tension of the suture material should be adjusted so that Hegar dilator No. 5 can pass through the cervical canal.
There is no convincing evidence of the superiority of any particular method or suture material over others.
McDonald method. The suture is placed as close as technically possible at the junction of the cervix and vagina, without tissue dissection (Fig. 1).
Fig. 1. McDonald method [118]
A.I. Lyubimova method modified by N.M. Mamedalieva. The suture is placed at the boundary where the mucosa of the anterior vaginal fornix transitions into the exocervix. Moving 0.5 cm to the right of the midline, the cervix is pierced with a needle carrying a synthetic thread through its entire thickness, exiting in the posterior part of the vaginal fornix. The second stitch pierces the mucosa and part of the cervical thickness, entering 0.5 cm to the left of the midline. The second synthetic thread is placed symmetrically: into the right lateral part of the cervix through its entire thickness, then into the anterior part of the vaginal fornix 0.5 cm to the left of the midline (Fig. 2).
Fig. 2. Diagram. A.I. Lyubimova method modified by N.M. Mamedalieva [118]
There is no data indicating the superiority of one technique over another, therefore, the choice of method is made at the surgeon's discretion [119], [120].
Complications of cerclage: chorioamnionitis, PPROM, suture displacement, preterm birth, cervical dystocia, cervical laceration, formation of cervicovaginal fistula. The risk and nature of complications depend on whether the cerclage was placed prophylactically or emergently (upon detection of prolapsed fetal membranes).
Cerclage is associated with an increased need for medical interventions (hospitalizations, administration of tocolytics). A higher rate of cesarean section has been confirmed [121], as well as a twofold increased risk (compared to the general population) of postpartum fever and sepsis in patients of this group [122], [121], [123].
Removal of the fixing material (suture or tape) is recommended at 36–37 weeks of gestation [1]. The procedure can be performed without anesthesia. At the onset of labor, the suture or tape should be removed as early as possible. If this is not feasible (e.g., due to suture cutting through), the suture is removed after delivery. In case of preterm labor with no response to tocolysis and/or suspected inflammatory complications, immediate removal of the cerclage is indicated [117]. In case of PPROM with normal C-reactive protein values (<5 ng/dL) and no clinical signs of chorioamnionitis [124], [125], delayed suture removal is possible for the duration of fetal RDS prevention course (48 hours) up to 34 weeks of gestation.
Ultrasound cervicometry technology
US cervicometry should be performed with the woman in a lying position [66], [126].
The bladder must be empty—a full bladder "lengthens" the cervix.
The probe is placed in the anterior vaginal fornix.
Probe pressure on the cervix should be minimized. To orient properly, at the beginning of cervicometry, press slightly on the cervix with the probe, and then, moving the probe back, minimize the compression.
Before starting measurements, it is advisable to identify spontaneous contractions of the cervix by observing for approximately 30 seconds [66], [126].
The length of the closed part of the cervical canal should be measured along a straight line drawn from the internal os to the external os, and this axis may not coincide with the axis of the woman's body [2].
Ultrasound image magnification is necessary, and the image of the cervix should occupy at least 50–75% of the ultrasound machine screen area [2].
The duration of the examination should be 3–5 minutes [2], [66]–[126].
Several measurements (at least three) should be performed over a 5-minute period; the shortest value is chosen as the final result.
If the cervical length is >25 mm, in more than half of the patients it will be curved. In this case, the standard measurement method—along a straight line—will lead to an underestimation of cervical length. However, this circumstance is not clinically significant, since in these patients, regardless of measurement accuracy, the risk of cervical insufficiency is low.
In the high-risk group in patients with a cervical canal length <16 mm, the cervix will always be straight [126].
Diagnostic tests such as measuring funneling of the internal os with preserved cervical length, fundal pressure, and coughing have no diagnostic value.
Measurement of cervical length by transabdominal scanning can be used as an initial assessment, but it should be kept in mind that this method tends to increase cervical length, especially when it is shortened.
As an alternative to transvaginal US cervicometry, transperineal scanning is possible: the probe is placed on the perineum and moved until complete visualization of the external and internal orifices of the cervical canal is achieved. The probe is placed further from the cervix than in transvaginal scanning, which impairs cervical visualization. In 95% of observations, the difference between measurements in transvaginal and transperineal scanning is +/- 5 mm, which is extremely critical for the reliability of the diagnostic criterion of "less than 25 mm" [2].
Appendix B. Physician Action Algorithms
Appendix C. Patient Information
Cervical insufficiency (CI) is the inability of the cervix to perform its retaining function during pregnancy, which can result in miscarriage or premature birth.
There are many causes for this condition, including: connective tissue weakness, inflammation, genetic predisposition, increased load on the cervix (e.g., if you are carrying twins), congenital features of the uterus and cervix. There are situations where the cervix was damaged as a result of childbirth, abortions, miscarriages, or surgeries for cervical dysplasia.
Whatever the cause, as a result, the cervix shortens and as pregnancy progresses, it may dilate. This is dangerous as it can lead to late miscarriage or premature birth.
Usually, the condition of the cervix is assessed during ultrasound screenings.
However, there are situations when a doctor may prescribe additional examinations if you have already had problems carrying a previous pregnancy. In this case, it will be necessary to come for an additional ultrasound examination to measure the cervical length with a vaginal probe.
If cervical shortening progresses, you will be offered the insertion of a specific "ring"—a pessary into the vagina. An obstetric pessary is the method of choice for treating CI after 24 weeks of gestation and in multiple pregnancies, in which case it is the safest.
An alternative to the pessary is cervical cerclage, which is performed in a hospital setting. This surgery is performed under anesthesia and takes about 15 minutes. As a result, the cervix is "held" by special stitches that support its function until 36–37 weeks of gestation. Upon reaching this term, you will be invited to have the cervical stitches removed. This procedure is performed on an outpatient basis, without anesthesia, and usually takes a few minutes.
Whatever method you and your doctor choose, remember that a pregnancy complicated by cervical insufficiency is a high-risk pregnancy, so it is essential to rest more, avoid lifting heavy objects, and refrain from thermal procedures. If bloody or watery vaginal discharge, contractions, or pain in the lower abdomen or vagina occur, you must immediately call an ambulance for hospitalization. If labor has begun, the suture or obstetric pessary is removed from the vagina.
Overall, with timely diagnosis and treatment, in the vast majority of cases it is possible to carry the pregnancy to term and deliver a healthy baby.
Appendix G. Assessment Scales, Questionnaires, and Other Evaluation Tools
Not applicable.