List of Abbreviations
OF – obstetric forceps
VE – vacuum extractor
VEP – vacuum extraction of the fetus
ABG – acid-base balance of blood
Terms and Definitions
Obstetric forceps (application of obstetric forceps, forceps obstetrica) is a vaginal surgical delivery procedure involving the extraction of a live fetus by the head using obstetric forceps at the end of the second stage of labor.
Vacuum extraction of the fetus (lat. vacuum - void; extrahere - to draw out) is a vaginal surgical delivery procedure involving the extraction of a live fetus by the head using a vacuum extractor at the end of the second stage of labor.
1. Brief information on the disease or condition
1.1 Definition of the disease or condition
Operative vaginal delivery refers to vaginal deliveries performed using a vacuum extractor or obstetric forceps with or without the parturient's pushing efforts [1][2].
1.2 Etiology and pathogenesis of the disease or condition (group of diseases or conditions)
Not applicable.
1.3 Epidemiology of the Disease or Condition
Currently, the rate of operative vaginal delivery worldwide ranges from 2.1% to 19.2% [3]. The frequency of obstetric forceps accounts for approximately 1.1% of all vaginal births [4]. At the same time, there is a wide range in the use of obstetric forceps, both across and within geographic regions, from 0.1% to 6.3% [5][6]. Vacuum extraction is used significantly more frequently, accounting for about 4.5% [7]. In the Russian Federation, the rate of fetal vacuum extraction is 1.23%, and that of obstetric forceps is 0.05% [8].
1.4 Features of Coding the Disease or Condition
O66.5 Failed vacuum extraction or forceps delivery – failed vacuum extraction or forceps application followed by delivery via forceps or Caesarean section, respectively.
O81 Single delivery with forceps or vacuum extractor.
O81.0 Low [outlet] forceps delivery.
O81.1 Mid-cavity [cavitary] forceps delivery.
O81.2 Mid-cavity forceps delivery with rotation.
O81.3 Other and unspecified forceps delivery.
O81.4 Vacuum extractor delivery.
O81.5 Delivery combining forceps and vacuum extractor.
1.5 Classification of the disease or condition
Classification of operative vaginal deliveries*
RCOG classification*, 2020 [9]. | Adapted classification taking into account terminology and practice adopted in the RF |
|---|---|
Outlet operation Fetal scalp is visible without separating the labia. The fetal skull has reached the pelvic floor. Rotation does not exceed 45°. | Outlet operation Fetal scalp is visible without separating the labia. The fetal skull bones have reached the pelvic floor. Sagittal suture is in the direct or oblique pelvic diameter (angle does not exceed 45°). |
Low cavity operation Fetal skull is at station +2, but does not reach the pelvic floor. Two options: Non-rotational £ 450 Rotational > 450 | Narrow pelvic cavity operation Fetal head occupies the landmarks of the narrow pelvic cavity. Leading point of the fetal head is at station +2 cm, but does not reach the pelvic floor. Sagittal suture is in the oblique pelvic diameter (angle does not exceed 45°) |
Mid-cavity operation No more than 1/5 of the head is palpable abdominally. Leading point of the skull is at station 0 or +1 cm. Two options: Non-rotational £ 450 Rotational > 450 | Wide pelvic cavity operation Fetal head occupies the landmarks of the wide pelvic cavity. Leading point of the fetal head is at station 0 or +1 cm (but not above the ischial spines). Sagittal suture is in the oblique pelvic diameter |
*RCOG classifies operative vaginal deliveries based on the fetal head station and the required angle of rotation during passage through the pelvis. Meanwhile, the head station (position relative to the pelvic planes) is measured in centimeters relative to the interspinous line connecting the ischial spines (narrow part of the pelvic cavity) (Fig. 1). When the leading point is at the level of this line, the position is considered zero (station 0); head levels above or below this line are designated from -1 to -5 cm and from +1 to +5 cm, respectively.
When the largest circumference of the fetal head is at station '0', the leading point is located at the level '+2', which, according to the terminology adopted in Russia, corresponds to the position of the head in the narrow part of the pelvic cavity. If the leading point is located at the level '0 or +1', the head is in the wide part of the pelvic cavity.
Taking into account the widespread practice in global medicine of determining the fetal head station in the pelvis in centimeters relative to the interspinous line, an adapted version of the classification of operative vaginal deliveries is presented, incorporating Russian terminology.
In Russia, obstetric forceps and fetal vacuum extraction are traditionally viewed as operations with 'traction' technique and spontaneous head rotation during the biomechanism of labor, while a head station above the narrow part of the pelvic cavity predominantly implies delivery via Caesarean section. Therefore, the adapted classification does not emphasize the degree of head rotation when situated above the level of the narrow part. Obstetric forceps operations with correction of head position (rotational) are not common in Russian practice and are performed only by physicians with sufficient experience using this method.
Fig. 1 Schematic representation of different fetal head stations in the lesser pelvis.
1.6 Clinical presentation of the disease or condition
Not applicable.
2. Diagnostics, medical indications and contraindications for diagnostic methods
2.1 Complaints and Anamnesis
It is recommended that the physician consider the results of examinations and consultations performed by related specialists when determining indications for operative delivery [10][11][12].
GPP CLEL 3Level of Evidence Recommendation C (Level of Evidence – 3)
Comments: a thorough history taking, evaluation of examination results, and consultations with related specialists help clarify the indications for operative delivery.
It is recommended that the physician take into account a history of operative vaginal delivery with birth trauma when assessing indications and choosing the method of operative delivery [13].
GPP BLEL 4Level of Evidence Recommendation B (Level of Evidence – 4)
Comments: women who underwent operative vaginal delivery in a previous pregnancy have a higher risk of repeat operative delivery and Caesarean section in subsequent pregnancies: 4.7% vs. 1.2% and 8.5% vs. 4.6% compared to women with a history of spontaneous delivery [13].
2.2 Physical Examination
It is recommended that the physician evaluate the general condition, heart and respiratory rate, and peripheral blood pressure in all parturients prior to operative vaginal delivery to correctly choose the method [14].
GPP CLEL 4Level of Evidence Recommendation C (Level of Evidence – 4)
Comment: assessment of the parturient's condition, hemodynamic parameters, and respiratory function ensures the correct choice of vaginal delivery method, taking into account the need to avoid pushing efforts (obstetric forceps) or, conversely, to ensure the active participation of the parturient in advancing the fetus through the birth canal (vacuum extraction).
It is recommended that the physician perform fetal auscultation in all parturients prior to operative vaginal delivery to assess fetal status [15].
GRC CLEL 4Grade of Recommendation C (Level of Evidence – 4)
Comments: the absence of fetal heart activity indicates fetal death, which is a contraindication to vaginal surgical delivery.
It is recommended that the physician perform a vaginal examination in all parturients prior to operative vaginal delivery to clarify maternal pelvic anatomic landmarks, fetal head station and position, their interrelationship, the type of presentation, to rule out fetopelvic disproportion, and to determine the direction of traction [16].
GCR ALEL 1Grade of Recommendations A (Level of Evidence – 1)
Comments: Clarifying the station, position, and orientation of the fetal head via vaginal examination is a prerequisite for determining the feasibility, method selection, and correct execution of vaginal surgical delivery (see Appendix B).
It is recommended that the physician evaluate the course of labor in accordance with the guidelines "Singleton delivery, spontaneous delivery in vertex presentation (normal labor)" to identify indications for operative delivery [17].
GPP CLEL 5 Level of Evidence Recommendation C (Level of Evidence – 5)
Comment: identifying deviations from the normal course of labor allows for timely determination of indications for operative delivery (see Appendix 2).
2.3 Laboratory Diagnostics
Following operative vaginal delivery, umbilical cord blood sampling is recommended for ABG determination (if available) [18].
GDR CLE 5Grade of recommendation C (level of evidence – 5)
Comment: in case of impaired neonatal adaptation in the first minutes of life, umbilical cord blood ABG determination will help clarify the cause and choose the correct management strategy [19].
2.4 Instrumental Diagnostics
It is recommended that the physician, in case of difficulty in determining the attitude, presentation, and position of the fetal head, perform clarification using ultrasound examination (if time, appropriate equipment, and a specialist are available in the delivery unit) [20][21].
GRC CLEL 4Grade of Recommendation C (Level of Evidence – 4)
Comment: sometimes determining the attitude, presentation, and position of the fetal head using clinical methods is difficult. Fetal ultrasound, using objective parameters (distance from the perineum to the fetal head, angle of progression, change in the angle of progression, etc.), makes it possible to clarify the conditions for operative vaginal delivery and to determine the choice and technique of execution [22][23][24].
2.5 Other Procedures
Not applicable
2.6. Criteria for Diagnosis/Condition Establishment:
Not applicable.
3. Treatment, including drug and non-drug therapies, diet therapy, and pain management
3.1. Pharmacological Treatment Methods
Not applicable.
3.2. Non-Pharmacological Treatment Methods
Recommended after operative vaginal delivery, women should be prescribed pelvic floor muscle training to normalize tone in order to reduce the incidence of urinary incontinence [25].
GCR ALeE 2Grade of Recommendation A (Level of Evidence - 2)
Comment: urinary incontinence of varying severity occurs in almost one third of cases following operative vaginal delivery. Pelvic floor muscle strengthening exercises reduce the frequency and severity of urinary incontinence in this group of women.
3.3. Pain management
Recommended to consider the possibility of pain relief for the parturient woman prior to operative vaginal delivery [26].
Level of Evidence AGrade of Evidence 2Level of Recommendations A (Grade of Evidence – 2)
Comment: in certain types of complications (e.g., hypertension, preeclampsia), pain relief is an important component of the delivery process. There is insufficient evidence to confirm that any specific analgesic or technique is the most effective for pain relief during operative vaginal deliveries [26]. If neuraxial analgesia is available, its extension is the optimal choice [27], using modern local anesthetics (ropivacaine**, bupivacaine**, lidocaine**, levobupivacaine**). Before starting general anesthesia, preoxygenation with 100% oxygen (O2) for 3 minutes is mandatory. Drugs used for general anesthesia: sodium thiopental** 4–5 mg/kg intravenously; propofol** may be used at a dose not exceeding 2.5 mg/kg. In case of hemorrhage, the drug of choice for general anesthesia is ketamine** 1 mg/kg) [28][29]. For endotracheal anesthesia, a 50:50 mixture of nitrous oxide** and oxygen or halogenated hydrocarbons up to 1.5 vol.% is used.
3.4. Indications and contraindications
It is recommended for all parturient women for whom pushing is contraindicated due to pregnancy complications or somatic diseases to timely determine the method and timeframe of scheduled surgical delivery [30].
GDR CLE 5Grade of recommendation C (level of evidence – 5)
Comment: in the presence of somatic diseases or pregnancy complications for which pushing is contraindicated in labor, the method of surgical delivery (cesarean section or obstetric forceps) should be discussed in the antenatal period and agreed upon with the pregnant woman.
It is recommended that the physician, upon detecting signs of fetal distress and in the absence of conditions for rapid spontaneous delivery, consider the possibility of emergency operative vaginal delivery [30].
GDR CLE 5Grade of recommendation C (level of evidence – 5)
It is recommended when choosing the method of operative vaginal delivery to take into account the clinical situation, assessing the fetal condition, the station of the fetal head, and the physician's experience [8], [31].
GDR CLE 5Grade of recommendation C (level of evidence – 5)
Comment: Vacuum extraction of the fetus and obstetric forceps have different advantages and disadvantages. A failed trial of operative vaginal delivery is more likely with fetal vacuum extraction, but perineal trauma is more likely with obstetric forceps [8]. In rapidly progressive fetal deterioration, one should strive for the most gentle delivery with the minimum possible interval from diagnosis to birth. Therefore, when the head is located in the wide pelvis, delivery by cesarean section is indicated; in the narrow pelvis, obstetric forceps are preferred; at the pelvic outlet, obstetric forceps or vacuum extraction of the fetus are preferred [31].
It is recommended in secondary labor dystocia unresponsive to conservative oxytocin** therapy to consider urgent operative vaginal delivery [30][32].
GCR CLEL 5Grade of Recommendation C (Level of Evidence – 5
Comment: labor dystocia and prolonged second stage of labor (more than 3 hours in nulliparous and 2 hours in multiparous women without epidural analgesia; more than 4 hours in nulliparous and 3 hours in multiparous women with epidural analgesia) with no effect from oxytocin** labor augmentation should be considered as a possible indication for surgical delivery [33]. When the fetal head is located in the wide part of the pelvic cavity (station 0/+1), the risks and benefits of operative vaginal delivery and second-stage cesarean section should be weighed. Second-stage cesarean section with a low-lying fetal head is associated with a higher incidence of maternal hemorrhage and the need for neonatal intensive care unit (NICU) admission, but operative vaginal delivery is associated with a higher incidence of maternal pelvic floor muscle dysfunction and fetal trauma [8]. Obstetric forceps rotation is not widespread in Russian practice and is used only by physicians with sufficient experience using this method.
It is recommended to rule out contraindications in all parturient women when indications for operative vaginal delivery are identified [34].
GCR CLEL 5Grade of Recommendation C (Level of Evidence – 5)
Comment: contraindications to operative vaginal delivery are: 2nd–3rd degree anatomical contracted pelvis and cephalopelvic disproportion; breech, brow (as well as face for vacuum extraction) presentation; head station above the wide part (narrow part for obstetric forceps); inability to determine head station and position; high probability of fetal skin trauma in the presence of active maternal viral infection. For vacuum extraction also: need to avoid pushing, known risk of fetal hemorrhage due to thrombocytopenia, hemophilia, or osteogenesis imperfecta, fetal distress with the head station above the pelvic outlet plane; prematurity less than 34 weeks (see Appendix B) [34]
It is recommended to determine the presence of conditions in all parturient women when indications for operative vaginal delivery are identified [35][36].
GCR CLEL 5Grade of Recommendation C (Level of Evidence – 5)
Comment: to ensure the maximum possible safety and efficacy of operative vaginal delivery, the following conditions must be met: absence of amniotic sac, full cervical dilation, live fetus, cephalic presentation, correspondence between maternal pelvic dimensions and the fetal head, emptied bladder, anesthesia (as indicated), and readiness to perform a cesarean section within 30 minutes in case of failure of the vaginal operation (see Appendix B).
It is recommended that the physician obtain voluntary informed consent from all parturient women prior to operative vaginal delivery [37].
GCR CLEL 5Grade of Recommendation C (Level of Evidence – 5)
Comment: informed consent must be obtained from the woman after a proper explanation of the procedure and its associated risks.
It is recommended that the physician decide on episiotomy during delivery by obstetric forceps and vacuum extraction, taking into account clinical data and the parturient woman's consent [8].
GDR CLE 5Grade of recommendation C (level of evidence – 5)
Comment: in operative vaginal deliveries, when the fetal head presses against the perineal tissues, mediolateral episiotomy at an angle of 60° can be used. Routine episiotomy increases the risk of anal sphincter and rectal injury [38]. However, there is evidence of a reduced risk of 3rd-4th degree perineal tears with episiotomy in nulliparous women and during delivery using obstetric forceps [8].
It is recommended during cesarean section to consider delivery using a vacuum extractor or obstetric forceps if delivery of the fetal head is difficult [39].
GDR CLE 5Grade of recommendation C (level of evidence – 5)
Comment: if during a cesarean section the widest circumference of the fetal head is above the level of the uterine incision, difficulties in its extraction may occur, which can lead to prolonged delay in birth and fetal hypoxia. At the same time, attempts at external fundal pressure increase the risk of fetal and uterine trauma. In such a situation, the use of vacuum extraction or obstetric forceps is safer (see Appendix B) [39].
It is recommended to provide for the possibility of converting to abdominal delivery in case of failure of the operative vaginal delivery [30].
GDR CLE 5Grade of recommendation C (level of evidence – 5)
Comment: When planning operative vaginal delivery, it is necessary to anticipate the possibility of changing the tactics in case of failure or deviation from the normal course. To this end, it is necessary to ensure a rapid transition to delivery by Cesarean section (operating room readiness; if the fetal head is located in the pelvic cavity, delivery can be performed directly in the operating room; readiness of the anesthesiology and neonatology teams).
When delivering via operative vaginal delivery, the physician is advised to consider the increased risk of fetal shoulder dystocia [40].
GRC CLEL 4Grade of Recommendation C (Level of Evidence – 4)
Comment: during delivery via forceps application, shoulder dystocia occurs with a frequency of up to 3.1%, and with vacuum extraction of the fetus, 2.7% [41][42]. If this complication occurs, treatment should be carried out in accordance with the clinical guidelines "Difficult labor [dystocia] due to fetal shoulder presentation. 2020" [43].
Routine sequential use of fetal vacuum extraction and obstetric forceps is not recommended to reduce the rate of maternal and perinatal complications [44].
GRC CLEL 4Grade of Recommendation C (Level of Evidence – 4)
Comment: the relative risk of sequential instrument use exceeds the sum of the individual relative risks of each instrument [45]. Thus, compared to spontaneous vaginal delivery, sequential instrument use (VE and OF) increases the rate of intracranial hemorrhage in the newborn (3.9%), brachial plexus injury (3.2%), facial nerve injury (13.3%), neonatal seizures (13.7%), low Apgar score at 5 minutes (3%), respiratory support (4.8%), as well as the rate of 4th-degree perineal lacerations (11.4%) and postpartum hemorrhage (1.6%) [46]. In addition, sequential instrument use compared to single instrument use is associated with an increased rate of anal sphincter rupture (17.4% vs. 8.4%) and umbilical artery pH <7.10 (13.8% vs. 5.0%) [44]. Therefore, sequential application of FVE and OF is possible only in isolated cases with a balanced risk assessment compared to emergency Cesarean section [44].
When delivering via application of obstetric forceps and fetal vacuum extraction, the physician is advised to administer a single dose of antibiotic prophylaxis [47].
GRC BLEL 2Grade of Recommendation B (Level of Evidence – 2)
Comment: due to the fact that the application of obstetric forceps and fetal vacuum extraction are surgical interventions that increase the risk of postpartum infectious complications, a single dose of antibiotic prophylaxis is indicated, which reduces the risk of infectious complications.
Drug | Dose | Administration |
Cefazolin** | 1 g | intravenously slowly |
Cefuroxime** | 1.5 g | intravenously slowly |
Amoxicillin+[Clavulanic acid]** | 1.2 g | intravenously, slowly |
Ampicillin+[Sulbactam]** | 1.5 g | intravenously slowly |
In case of allergic reactions to penicillins and/or cephalosporins, applicable erythromycin | ||
Erythromycin | 250 mg | orally |
After delivery via obstetric forceps and fetal vacuum extraction, the physician is recommended to assess risk factors for venous thromboembolic complications [48].
GDR CLE 5Grade of recommendation C (level of evidence – 5)
Comment: risk assessment should be performed in accordance with the clinical guidelines "Venous complications during pregnancy and the postpartum period. Obstetric embolism" [49].
4. Medical Rehabilitation and Sanatorium-Resort Treatment
Not applicable
5. Prevention and Dispensary Observation
Not applicable
6. Organization of Medical Care
Indications for hospital admission to a medical organization:
Presence of scheduled indications for operative delivery.
In the presence of scheduled indications for operative delivery, the patient should be referred to a level II or III medical obstetric inpatient facility based on routing schemes approved by regional healthcare management authorities.
In the event of urgent and emergent indications for delivery via
fetal vacuum extraction or application of obstetric forceps, the procedure is performed in the inpatient facility of the medical institution where the patient is located at the time of diagnosis.
Indications for discharging the patient from the medical organization: in accordance with the course of the postpartum period (see clinical guidelines "Postpartum care and examination"). The puerpera is discharged with recommendations for follow-up care in the postpartum period at the local antenatal clinic.
7. Additional Information
Not applicable
Criteria for Evaluating the Quality of Medical Care
№ | Quality criteria | Assessment of completion YES | Assessment of completion NO |
|---|---|---|---|
1 | When choosing the method of operative vaginal delivery, the station of the fetal head was taken into account | ||
2 | Conditions for operative vaginal delivery have been met. | ||
3 | Antibiotic prophylaxis was performed after operative vaginal delivery. | ||
4 | Risk factors for venous thromboembolic complications were assessed in accordance with the clinical guidelines "Venous complications during pregnancy and the postpartum period. Obstetric embolism" |
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54. World Health Organization U.N.P.F.& U.N.C.F. (UNICEF). Managing complications in pregnancy and childbirth: a guide for midwives and doctors, 2nd ed [Internet]. 2017. 492 p.
55. Ministry of Health of the Russian Federation. Provision of specialized medical care in operative vaginal delivery with a live fetus (using obstetric forceps or a vacuum extractor, or delivery using another obstetric aid). CLINICAL GUIDELINES (PROTOCOL).
Appendix A1. Working Group Composition
Baev Oleg Radomirovich – MD, PhD, Professor, Honored Doctor of the Russian Federation, Head of the Maternity Ward, Head of the Department of Obstetrics and Gynecology, National Medical Research Center for Obstetrics, Gynecology and Perinatology named after Academician V.I. Kulakov of the Russian Ministry of Health (Moscow). No conflict of interest.
Artymuk Natalia Vladimirovna - MD, PhD, Professor, Head of the Department of Obstetrics and Gynecology named after Professor G.A. Ushakova, Kemerovo State Medical University of the Russian Ministry of Health, Chief Freelance Specialist of the Russian Ministry of Health in Obstetrics and Gynecology in the Siberian Federal District (Kemerovo). No conflict of interest.
Bashmakova Nadezhda Vasilievna – MD, PhD, Professor, Chief Researcher, Ural Research Institute of Maternal and Infant Care of the Russian Ministry of Health, Chief Freelance Specialist of the Russian Ministry of Health in Obstetrics and Gynecology in the Ural Federal District (Yekaterinburg). No conflict of interest.
Bezhenar Vitaly Fedorovich - MD, PhD, Professor, Head of the Clinic of Obstetrics and Gynecology, Head of the Department of Obstetrics, Gynecology and Neonatology, Head of the Department of Obstetrics, Gynecology and Reproductology, First Saint Petersburg State Medical University named after Academician I.P. Pavlov of the Russian Ministry of Health, Chief Freelance Specialist in Obstetrics and Gynecology of the Russian Ministry of Health in the Northwestern Federal District (Saint Petersburg). No conflict of interest.
Belokrinitskaya Tatiana Evgenyevna – MD, PhD, 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 Doctor of the Russian Federation, Chief Freelance Specialist in obstetrics and gynecology of the Russian Ministry of Health in the Far Eastern Federal District (Chita). No conflict of interest.
Desyatnik Kirill Alexandrovich – obstetrician-gynecologist, organizational and methodological department, Yekaterinburg Clinical Perinatal Center (Yekaterinburg). No conflict of interest.
Dolgushina Nataliya Vitalievna – MD, PhD, Professor, Deputy Director – Head 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). No conflict of interest.
Karapetyan Anna Ovikovna – PhD in Medical Sciences, Assistant Professor at the Department of Obstetrics and Gynecology, obstetrician-gynecologist of the 1st Maternity Ward, 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.
Vladislav I. Krasnopolsky – Academician of the Russian Academy of Sciences, D.Sc. (Medicine), Professor, President of the Moscow Regional Research Institute of Obstetrics and Gynecology (Moscow). No conflict of interest.
Victoria A. Krutova – D.Sc. (Medicine), Professor, Chief Physician of the Clinic, Vice-Rector for Clinical Work at the Kuban State Medical University of the Russian Ministry of Health, Chief freelance specialist in obstetrics and gynecology of the Russian Ministry of Health in the Southern Federal District (Krasnodar). No conflict of interest.
Anna I. Malyshkina – D.Sc. (Medicine), Professor, Director of the V.N. Gorodkov Ivanovo Research Institute of Motherhood and Childhood of the Russian Ministry of Health, Chief freelance specialist in obstetrics and gynecology of the Russian Ministry of Health in the Central Federal District (Ivanovo). No conflict of interest.
Galina B. Malygina – D.Sc. (Medicine), Professor, Director of the Ural Research Institute of Maternal and Child Care of the Russian Ministry of Health (Yekaterinburg). No conflict of interest.
Sergey V. Martirosyan – Ph.D. (Medicine), Chief Physician of the Yekaterinburg Clinical Perinatal Center, Associate Professor at the Department of Obstetrics and Gynecology, Faculty of Medicine and Prevention, Ural State Medical University (Yekaterinburg). No conflict of interest.
Anton V. Mikhailov – Professor, Chief freelance specialist in obstetrics and gynecology of the Healthcare Committee of Saint Petersburg, Chief Physician of Saint Petersburg State Budgetary Healthcare Institution "Maternity Hospital No. 17". No conflict of interest.
Vitaly F. Nesterov – Ph.D. (Medicine), Senior Researcher, Head of the Anatomic and Physiological Department, Ural Research Institute of Maternal and Child Care of the Russian Ministry of Health (Yekaterinburg). No conflict of interest.
Igor M. Nesterov – Ph.D. (Medicine), Associate Professor, Department of Obstetrics, Gynecology and Reproductology, Pavlov First Saint Petersburg State Medical University of the Russian Ministry of Health (Saint Petersburg). No conflict of interest.
Anna A. Olina – D.Sc. (Medicine), Professor, Deputy Director of the Department of Medical Care for Children and Obstetrics Services, Ministry of Health of the Russian Federation (Moscow). No conflict of interest.
Olga V. Perevozokina – Ph.D. (Medicine), Head of the Organizational and Methodological Department, Yekaterinburg Clinical Perinatal Center (Yekaterinburg). No conflict of interest.
Vasily A. Petrukhin – D.Sc. (Medicine), Professor, Honored Doctor of the RF, Director of the Moscow Regional Research Institute of Obstetrics and Gynecology (Moscow). No conflict of interest.
Viktor E. Radzinsky - Corresponding Member of the RAS, D.Sc. (Medicine), Professor, Head of the Department of Obstetrics and Gynecology with a Course in Perinatology, Peoples' Friendship University of Russia (Moscow). No conflict of interest.
Galina M. Savelieva – Academician of the RAS, D.Sc. (Medicine), Professor, Honored Scientist, Head of the Department of Obstetrics and Gynecology, Pediatric Faculty, Pirogov Russian National Research Medical University (Moscow). No conflict of interest.
Vladimir N. Serov – Academician of the RAS, D.Sc. (Medicine), Professor, Honored Scientist of the RF, President of the Russian Society of Obstetricians and Gynecologists, 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 (Moscow). No conflict of interest.
Oleg V. Tysyachny – Ph.D. (Medicine), Physician of the 1st Maternity Department, Assistant at the Department of Obstetrics and Gynecology, National Medical Research Center for Obstetrics, Gynecology and Perinatology named after Academician V.I. Kulakov of the Russian Ministry of Health (Moscow). No conflict of interest.
Ildar F. Fatkullin – D.Sc. (Medicine), Professor, Head of the Prof. V.S. Gruздеv Department of Obstetrics and Gynecology, Kazan State Medical University, Chief freelance specialist of the Russian Ministry of Health in obstetrics and gynecology in the Volga Federal District (Kazan). No conflict of interest.
Elena V. Frederiks – Assistant at the Department of Obstetrics, Gynecology and Neonatology, Pavlov First Saint Petersburg State Medical University of the Russian Ministry of Health (Saint Petersburg). No conflict of interest.
Roman G. Shmakov – D.Sc. (Medicine), Professor of the RAS, 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.
Appendix A2. Methodology for Developing Clinical Guidelines
Target audience for these clinical guidelines:
1. obstetrician-gynecologists
2. obstetrics and gynecology residents
Table 1. Scale for assessing levels of evidence (LE) 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. Scale for assessing levels of reliable evidence (LRE) for prevention, treatment, and rehabilitation methods (preventive, therapeutic, rehabilitation interventions)
LoE | Definition |
|---|---|
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 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. Scale for assessing levels of recommendation credibility (LRC) for prevention, diagnostic, treatment and rehabilitation methods, diagnostic, therapeutic, and rehabilitation interventions)
LoE | 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) |
C | 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) |
Procedure for updating clinical guidelines.
The mechanism for updating clinical guidelines provides for their systematic revision at least once every three years, as well as upon the emergence of new evidence-based medicine data on the diagnosis, treatment, prevention, and rehabilitation of specific diseases, or in the presence of justified additions/comments to previously approved clinical guidelines, but no more frequently than once every 6 months.
Appendix A3. Reference Materials
Not acceptable
Appendix B. Physician Action Algorithms
Maternal pelvic anatomical landmarks depending on fetal head position [50][51].
Examples of indications for operative vaginal
delivery [50][2].
Contraindications to operative vaginal delivery [50][27].
Basic conditions for performing operative vaginal delivery [50][27].
Technique of fetal vacuum extraction surgery [50][52][53].
1. After assessing the obstetric situation, the physician uses two fingers to displace the posterior commissure downward, exposing the vaginal introitus, takes the vacuum extractor cup "like a pen" and inserts it into the birth canal with the inner side facing the fetal head.
2. The vacuum extractor cup is placed on the guiding point so that the sagittal suture divides it in half. The distance between the edge of the vacuum extractor cup and the posterior margin of the posterior fontanelle should be approximately 3 cm. Thus, the center of the device cup is located in the area of the guiding point of the fetal head (in occiput anterior presentation), which makes it possible to align the direction of traction with the pelvic axis, maintain fetal head flexion and synclitism, and thereby guarantee delivery of the fetal head in compliance with the biomechanism of labor.
3. Using the right hand, create negative pressure in the vacuum extractor system – the boundary between the green and red zones of the vacuum indicator scale (in accordance with the manufacturer's instructions, usually 500–600 mmHg or 0.8–0.9 bar).
4. Before starting traction, make sure that soft tissues of the birth canal are not trapped under the vacuum extractor cup.
5. The direction of traction is carried out in accordance with the pelvic curvature and the biomechanism of labor. The number of tractions depends on the station of the head. In 76–96% of cases, 4 pushes are sufficient. The duration of the procedure should not exceed 20 minutes.
· Hand positioning of the physician: pulling hand – distal phalanges of the 2nd or 4th fingers on the vacuum extractor handle (2 fingers when the head is at the pelvic outlet, 4 when the head is in the pelvic cavity), the forearm of the hand is a continuation of the "cable" connecting the vacuum extractor cup and the device handle. The distal phalanges of the controlling hand are positioned: thumb on the device cup, index finger on the fetal head near the edge of the vacuum extractor cup, fingers almost parallel.
· Tasks of the "pulling hand": performing traction during a uterine contraction, maintaining the direction of traction.
· Tasks of the "controlling hand": assessing the progressive movement of the fetal head, preventing the device cup from slipping — the thumb presses the cup against the head, counteracting the pulling force, maintaining axial traction control, monitoring the rotation of the head as it progresses down the birth canal.
· Determination of traction direction: this is the perpendicular from the center of the plane of the greatest pelvic circumference through the guiding point of the fetal head to the pelvic plane to be traversed. For a successful surgical outcome, correct selection of traction in accordance with the biomechanism of labor is essential.
The direction of all tractions is determined relative to a standing woman.
Traction when the fetal head is in the wide part of the pelvic cavity:
In occiput anterior presentation – backward until the plane of the greatest pelvic circumference passes through the plane of the narrow part of the pelvic cavity, downward until the suboccipital region of the fetal head is brought to the point of fixation – the lower edge of the symphysis, and forward, extending the fetal head and facilitating its crowning.
Traction when the fetal head is in the narrow part of the pelvic cavity:
Backward, considering that the ischial spines – the transverse diameter of the cavity – are located slightly higher than the longitudinal diameter of the cavity (the distance from the lower edge of the symphysis to the sacrococcygeal joint), then downward, which facilitates the descent of the fetal head until, in occiput anterior presentation, the suboccipital region of the fetal head touches the lower edge of the symphysis, and forward, extending the fetal head and facilitating its crowning.
Traction when the fetal head is in the pelvic outlet cavity in occiput anterior presentation:
If the suboccipital fossa of the fetal head is at the level of the lower margin of the symphysis, traction is directed solely anteriorly, extending the fetal head and facilitating its crowning; if the suboccipital fossa is slightly above the lower margin of the symphysis, downward traction will facilitate the descent of the fetal head, subsequently transitioning to anterior traction.
Traction when the fetal head is in the pelvic outlet cavity in the occiput posterior position:
internal rotation of the head is complete. The fetal head is on the pelvic floor. The sagittal suture is in the direct diameter of the outlet, the small fontanelle is located near the coccyx, the posterior margin of the large fontanelle is under the pubic symphysis; the small fontanelle is located lower than the large one. Traction is applied downward until the anterior margin of the large fontanelle touches the lower margin of the pubic symphysis (the first fixation point). Then, traction is applied anteriorly until the suboccipital fossa region is fixed at the tip of the coccyx (the second fixation point). After this, traction is applied posteriorly, resulting in extension of the head and delivery of the fetal forehead, face, and chin from beneath the pubic symphysis.
Traction in brow presentation when the large segment of the fetal head is in the wide part of the pelvic cavity:
posteriorly until the middle of the fetal forehead is brought to the lower margin of the symphysis, sharply anteriorly until the occipital tuber of the fetal head is brought to the lumbosacral joint region, downward and posteriorly, facilitating extension of the fetal head and its crowning through the soft tissues of the perineum.
After delivery of the fetal head, the cup is removed by pressing the pressure release button; delivery of the torso occurs via standard obstetric maneuvers.
Criteria for failed vacuum extraction of the fetus [50],[52],[53], [55].
· Absence of fetal head descent with correct placement of the vacuum extractor cup, moderate traction force, and traction directed along the axis of the birth canal.
· Failure to achieve descent of the fetal head within three tractions. Total operation duration must not exceed 20 min.
· Cup slippage occurring more than twice despite correct traction direction and maximum negative pressure.
Every application of the vacuum extractor should be considered an attempt. The procedure should not be continued if the head has not descended after three tractions.
Vacuum extraction of the fetus during Cesarean section
First, the position of the fetal head must be determined. Application of the cup to the fetal face and ear is strictly prohibited! If the head is located high, the cup is applied over the occiput. If the head has descended low, it is pulled upward manually along the uterine incision, and the cup is applied over the occiput. After establishing standard negative pressure, ensure that no other tissues are trapped under the cup. The fetal head is extracted through the uterine incision. After delivery of the head, the vacuum must be released using the valve on the device and the cup removed before proceeding to deliver the shoulders and torso.
Protocol for vacuum extractor application surgery (see Order of the Russian Ministry of Health No. 1130n dated 20.10.2020 on Approval of the Procedure for Providing Medical Care in the Profile "Obstetrics and Gynecology").
Technique for forceps delivery surgery [50][52][53].
1) Verification of the obstetric situation.
2) Assembly of the forceps blades.
3) Insertion of the forceps blades.
4) Locking the blades.
5) Trial traction.
6) Traction. The direction of all tractions is indicated relative to the standing woman.
7) Removal of the forceps. The "gold standard" for applying forceps in Russian-language literature consists of three triple rules:
1. Triple rule No. 1: "Three on the left – three on the right". The left blade of the forceps is inserted with the left hand into the left side of the pelvis, the right blade with the right hand into the right side;
2. Triple rule No. 2. Pertains to the insertion and positioning of the forceps. 1) The inserted forceps blades must be directed upward toward the guiding point; 2) The blades must lie biparietally, gripping the head along its largest circumference and extending past the parietal tubercles; 3) The guiding point and the axis of the head lie in the plane of the lock portion of the forceps.
3. Triple rule No. 3. "Three positions – three tractions". Helps determine the direction of traction. When the fetal head is in the wide part of the pelvic cavity, traction is directed posteriorly, downward, and anteriorly; in the narrow part – downward and anteriorly; at the outlet – anteriorly."
4. If the forceps branches lock without difficulty, the correctness of blade application should be checked by the following methods:
· the small fontanelle must be located midway between the forceps blades;
· the small fontanelle must be located at a distance of 1.5 cm from the surface of the forceps in the lock area. Otherwise, traction will lead to extension of the head;
· the sagittal suture must be perpendicular to the forceps lock.
5. After locking the forceps blades, a trial traction must be performed: the working hand grasps the forceps handles, the opposite hand fixes them, and the index finger of the left hand touches the fetal head; if this position is maintained during traction, the forceps are applied correctly.
6. Direction of traction:
· when the fetal head is in the wide or narrow parts of the pelvic cavity, traction is directed posteriorly.
· if the fetal head is in the pelvic cavity, when the diameter of the large segment of the head is between the plane of the narrow part of the pelvic cavity and the plane of the outlet, traction is directed downward.
· when the head is in the pelvic outlet, when the diameter of the large segment of the head is at the level of the plane of the direct diameter of the pelvic outlet – traction is directed anteriorly in occiput anterior presentation and posteriorly in occiput posterior and brow presentations.
In occiput presentation, when the large segment of the fetal head is in the wide part of the pelvic cavity, posterior traction is performed until the large segment of the fetal head reaches the level of the direct diameter of the narrow part of the pelvis (palpation of the ischial spine tips is impossible). Downward traction is performed until the fixation point—the suboccipital fossa—is at the level of the lower margin of the symphysis (approximately 7 cm along the fetal head from the guiding point). With subsequent anterior traction, the head will begin to extend and crown. If the fetal condition is satisfactory, tractions are performed in sync with pushing efforts, lasting 30–60 seconds with an interval of 1.5–2 minutes; the operation lasts from 3 to 8 minutes to allow the tissues of the birth canal to stretch during the progressive movement of the head and the fetal body to perform the rotations characteristic of the biomechanism of labor. In fetal distress, the operation is performed as quickly as possible. The forceps blades are removed after the delivery of the fetal head. Thereafter, labor is completed using standard obstetric maneuvers.
Criteria for failed forceps delivery surgery [54][55].
· Difficulty in inserting the forceps blades or locking their branches.
· Absence of fetal head descent with correct placement of the forceps blades, moderate traction force, and traction directed along the axis of the birth canal.
· Failure to achieve descent of the fetal head within three tractions.
Every application of forceps should be considered an attempt. The procedure should not be continued if the head has not descended after three tractions. If the forceps operation fails, delivery should be performed via Cesarean section.
Obstetric forceps during Cesarean section
The operation is performed to extract the fetal head when its position is unfavorable relative to the uterine incision. One or both forceps blades may be used. When the fetal head is positioned low, the forceps blade corresponding to the fetal position (according to the type of engagement) adjacent to the posterior wall of the uterus is inserted, and with an anterior movement combined with pressure on the uterine fundus through the anterior abdominal wall, the fetal head is delivered through the uterine and anterior abdominal wall incision. When the fetal head is located above the level of the uterine incision, the forceps blades are applied to the temporozygomatic regions of the fetal head in the direction from the occiput to the chin anterior to the auricles; meanwhile, the assistant fixes the mobile fetal head, the forceps are locked, and the fetal head is brought to the uterine incision area and delivered through the uterine and anterior abdominal wall incision.
Protocol for forceps delivery surgery (see Order of the Russian Ministry of Health No. 1130n dated 20.10.2020 on Approval of the Procedure for Providing Medical Care in the Profile "Obstetrics and Gynecology").
Complications in operative vaginal delivery [8].
For the mother:
Vaginal/perineal laceration 10-20%
3rd-4th degree perineal tear 1-4% to 8-12%
Postpartum hemorrhage 10-40%
Fecal or urinary incontinence (rare)
For the fetus/neonate:
Cephalhematoma 1-12%
Scalp or facial injury 10%
Retinal hemorrhage 17-38%
Hyperbilirubinemia or jaundice 5-15%
Subgaleal hemorrhage 0.3-0.6%
Intracranial hemorrhage 0.05-0.15%
Spinal cord injury (rare)
Skull fracture (rare)
Facial nerve palsy (rare)
Fetal death (very rare).
Appendix C. Patient Information
What is an operative vaginal delivery?
An operative vaginal delivery is a procedure in which a doctor uses specially designed instruments (obstetric forceps or a vacuum extractor) to help your baby be born.
Why might this procedure be needed?
There are many reasons why assistance during delivery may be necessary, for example:
· your baby's heart rate indicates that they may no longer be tolerating the labor process well.
· the baby is not descending through the birth canal despite contractions.
· other reasons (usually medical) that prevent unassisted vaginal delivery.
How to avoid the need for an operative vaginal delivery?
Not all births go according to plan, and although no one wishes for an operative vaginal delivery, if things do not go as expected, it may be the best option for you and your baby.
What procedures are performed before assisted delivery?
Before the procedure, the doctor will make sure that conditions are favorable for your baby to be born vaginally. To do this, the doctor will examine your abdomen and perform a vaginal examination to check the station and position of your baby's head.
Additional pain relief may be administered before the procedure. This may be a local anesthetic injection into the vagina or a regional anesthetic injection into the space around the nerves in your back (epidural or spinal anesthesia).
Your bladder may be emptied using a small tube called a catheter.
What is a vacuum extractor?
A vacuum extractor is an instrument that uses suction to attach a special sterile cup to your baby's head. The cup fits snugly against your baby's head. During a contraction, the doctor gently pulls on it to help deliver the baby.
What are obstetric forceps?
Obstetric forceps are metal instruments resembling large, curved spoons that fit around your baby's head. The forceps are carefully placed around the baby's head. During a contraction, the obstetrician pulls gently to assist in delivering the baby.
What happens after the procedure?
When your baby is born, you may need an incision of the perineum (episiotomy) to enlarge the vaginal opening. If you had a vaginal tear or a perineal incision, it will be repaired with sutures that dissolve within a few weeks.
A neonatologist (pediatrician) will be present during the birth and will check your baby's condition shortly after delivery to see if they need help with breathing and to ensure they are healthy.
The vacuum cup may leave a temporary swelling on the baby's head called a caput succedaneum, which resolves spontaneously within a few days (rarely weeks) and usually requires no treatment.
Forceps may leave minor marks on your baby's head. These usually disappear within a day or two.
Will I need an operative vaginal delivery in a future pregnancy?
Assisted delivery is most commonly needed in a first pregnancy. The majority of women who have had an operative vaginal delivery will not need one the next time.
Appendix G. Assessment Scales, Questionnaires, and Other Evaluation Tools
Appendix G1. Apgar score
Russian title: Apgar score
Original title: Apgar score
Source: Apgar V. A proposal for a new method of evaluation of the newborn infant. Curr. Res. Anesth. Analg. 1953;32:260-267
Type: rating scale
Purpose: assessment of the newborn's condition
Content:
Parameter / Score | 0 | 1 | 2 |
|---|---|---|---|
Heart rate | Absent | <100 bpm | ≥100 bpm |
Respiration | Absent | Bradypnea, irregular | Active, regular, loud cry |
Muscle tone | Absent, limbs limp | Decreased, some flexion of extremities | Active movement |
Reflex irritability (response to stimulation during airway suctioning) | No response | Weak response (grimace, movement) | Response in the form of movement, cough, sneezing, loud cry |
Skin coloration | Generalized pallor or generalized cyanosis | Body pink and extremities blue (acrocyanosis) | Entire body and extremities pink |
Key (interpretation):
A score of 4–7 points at 1 minute after birth corresponds to mild or moderate birth asphyxia (P21.1, ICD-10), while 0–3 points at 1 minute after birth corresponds to severe asphyxia (P21.0, ICD-10). Although according to ICD-10 a total of 7 points at 1 minute after birth corresponds to moderate to mild asphyxia, it is inappropriate to assign this diagnosis because a 1-minute Apgar score of 7 is not clinically and/or prognostically significant. The prognostic value of the first Apgar score is inherently extremely low. Adverse short- and long-term outcomes correlate with low Apgar scores at 5 and 10 minutes after birth.