"To get the baby out off the hook": a prospective, longitudinal, multicenter, observational study about decision making in vacuum-assisted operative vaginal delivery.

BACKGROUND: Since operative vaginal delivery may be risky for women and might cause neonatal complications, the aim of this study is to assess appropriateness of the procedure. This is a prospective, longitudinal, multicenter, observational study and it was conducted in three Italian Obstetric Units (Pisa, Massa Carrara and Prato). All term pregnant women, either nulliparous and multiparous, with singleton pregnancy and a cephalic fetus, with spontaneous or induced labour, requiring vacuum-assisted delivery were enrolled. Indications to operative vaginal delivery were grouped as alterations of fetal cardiotocography (CTG) patterns, delay/arrest of second stage of labour or elective shortening of second stage of labour. A board consisting of five among authors evaluated appropriateness of the procedure. RESULTS: Overall, 466 women undergoing operative vaginal deliveries were included. Cardiotocography, classified as ACOG category 2 or 3 was the indication for vacuum assisted delivery in 253 patients (54.29%). Among these, 66 women (26.1%) had an operative vaginal delivery which was then considered to be inappropriate, while in 114 cases (45.1%) CTG traces resulted to be unreadable. CONCLUSION: Decision making process, which leads clinicians to go for operative vaginal delivery, is often influenced by shortness of time and complexity of the situation. Therefore, clinicians tend to intervene performing vacuum delivery without adopting critical analysis and without adequately considering the clinical situation. Operative vaginal delivery might be a risky procedure and should be performed only when clinically indicated and after adequate critical analysis.

Operator experience affects the risk of obstetric anal sphincter injury in vacuum extraction deliveries.

INTRODUCTION: Delivery by vacuum extraction is a major risk factor for obstetric anal sphincter injury. The aim of this study was to assess risk factors for obstetric anal sphincter injury in vacuum extraction in nulliparous women, specifically operator-related factors. A secondary aim was to assess other complications of vacuum extraction that are dependent on operator experience. MATERIAL AND METHODS: A historical cohort study of nulliparous women with a live single fetus ≥34 weeks, delivered by vacuum extraction at a teaching hospital in Sweden in 1 year (2013), using data from medical records. Risk of obstetric anal sphincter injury was assessed for obstetricians (reference), gynecologists, and residents, and adjusted for maternal, fetal, procedure-related, and operator-related covariates using unconditional logistic regression. Results are presented as prevalence and crude and adjusted odds ratio (aOR) with 95% CI. RESULTS: In total, 323 nulliparous women delivered by vacuum extraction were included. Obstetric anal sphincter injury occurred in 57 (17.6%) women. Fifteen (11.5%) obstetric anal sphincter injuries occurred in vacuum extractions performed by obstetricians, 10 (13.5%) by gynecologists (aOR 1.84, 95% CI 0.72-4.70), and 32 (26.9%) by residents (aOR 5.13, 95% CI 2.20-11.95). Maternal height ≤155 cm (aOR 4.63, 95% CI 1.35-15.9) and conversion to forceps (aOR 19.4, 95% CI 1.50-252) increased the risk of obstetric anal sphincter injury. Operator gender, night shift work, or being a frequent operator did not affect the risk of obstetric anal sphincter injury. Postpartum hemorrhage and fetal complications did not differ between operator categories. CONCLUSIONS: The adjusted risk of obstetric anal sphincter injury in nulliparous women was five times higher in vacuum extractions performed by residents compared with those performed by obstetricians. Vacuum extractions performed by gynecologists did not carry an increased risk of obstetric anal sphincter injury. Experience in years of training, rather than frequency of the procedure, seemed to have the highest impact on reducing obstetric anal sphincter injury in vacuum extractions, which indicates a need for increased training and supervision.

Complications with vacuum delivery from a forceps-delivery perspective: Progress toward safe vacuum delivery.

AIM: To examine the rates of medical malpractice and cerebral palsy after vacuum delivery in comparison with forceps delivery and establish approaches for enabling safe vacuum delivery from the perspective of forceps delivery. METHODS: This study reviewed the Japan Obstetric Compensation System report data, which contains data from studies involving 188 cases through May 2013, including cases of emergency delivery. These cases included 118 cases of cesarean section (62.8%) and 70 cases of vaginal delivery (37.2%). Of the 188 patients, 145 required emergency delivery (77.1%), of which cesarean sections were performed in 117 patients (80.7%), vacuum delivery in 24 patients (16.6%) and forceps delivery in 4 patients (2.8%). RESULTS: In evaluating the contents of the report with a focus on vacuum delivery, it was found that vacuum delivery was attempted in 35 patients, and delivery was successful in 24 of these patients (68.6%); however, in 11 patients (31.4%), delivery was unsuccessful and cesarean section was required. Thus, vacuum delivery was unsuccessful in approximately one third of the cases. CONCLUSION: For delivery to be completed as successfully and quickly as possible, it is essential for obstetricians to have a good understanding of the process of vacuum delivery, and to have expertise in the relevant techniques. However, it is also necessary to modify the indications under which vacuum delivery is considered safe to perform, from fetal station ±0, that is, engagement of the fetal head, to station +2, or descent of the fetal head.

Delayed Infant Subaponeurotic (Subgaleal) Fluid Collections: A Case Series of 11 Infants.

BACKGROUND: Although subgaleal hemorrhage can present very soon after delivery with catastrophic consequences, subaponeurotic or subgaleal fluid collections are rare and clinically distinct causes of infant scalp swelling that present weeks to months after birth. Their exact etiology remains uncertain; however, they are frequently associated with instrumental and traumatic delivery. AIM & METHODS: To characterize 11 subaponeurotic fluid collections that presented to the Temple Street Children's University Hospital Emergency Department (TSCUHED) from July 2013 to July 2015 by a retrospective chart review. CASE REPORT: Eleven infants were identified with delayed subaponeurotic fluid collections. Of note, all infants were either successful vacuum delivery or failed vacuum delivery with subsequent forceps delivery or emergency caesarean section. All infants were otherwise well at presentation, and resolution of the scalp swelling occurred within weeks to months. WHY SHOULD AN EMERGENCY PHYSICIAN BE AWARE OF THIS?: This condition follows a benign course and conservative management is the treatment of choice.

Suboptimal care and metabolic acidemia is associated with neonatal encephalopathy but not with neonatal seizures alone: a population-based clinical audit.

OBJECTIVE: To determine the incidence of moderate to severe neonatal encephalopathy (NE) and neonatal seizures without encephalopathy, and the association with metabolic acidemia. Secondly, to investigate the occurrence of suboptimal intrapartum care and its impact on neonatal outcome. DESIGN: Clinical audit. SETTING: Two university hospitals in Sweden. POPULATION: Neonates ≥34 weeks with moderate or severe NE and neonatal seizures alone, i.e. without encephalopathy, from a population of 71 189 births, where umbilical blood gases were routinely analyzed. METHODS: Neonates were categorized depending on the presence of metabolic acidemia at birth by umbilical artery pH < 7.00, base deficit ≥12 mmol/L. Records were audited for suboptimal care and a decision was made on whether management was assessed to have impacted neonatal outcome. MAIN OUTCOME MEASURES: Encephalopathy and seizures alone. RESULTS: We identified 80 neonates with NE and 30 with seizures alone, of which 48 (60%) and none, respectively, had metabolic acidemia. Suboptimal care could be assessed in 77 and occurred in 28 (36%) NE cases and in one neonate with seizures alone (p < 0.001). In 47 NE cases with metabolic acidemia, suboptimal care occurred in 22 (47%) vs. 6/30 (20%) without metabolic acidemia (p = 0.02). Suboptimal care had an impact on outcome in 18/77 (23%) NE cases but in no cases with seizures alone. CONCLUSION: Suboptimal care was commonly seen with NE, particularly in neonates with metabolic acidemia, and also affected neonatal outcome. No such associations were found in neonates with seizures alone.

Vacuum extraction: development and test of a procedure-specific rating scale.

OBJECTIVES: To develop and validate an Objective Structured Assessment of Technical Skills (OSATS) scale for vacuum extraction. DESIGN: Two-part study design: Primarily, development of a procedure-specific checklist for vacuum extraction. Hereafter, validation of the developed OSATS scale for vacuum extraction in a prospective observational study. SETTING: Rigshospitalet, University Hospital of Copenhagen. POPULATION: For development, an obstetric expert from each labor ward in Denmark (28 departments) was invited to participate. For validation, nine first-year residents and 10 chief physicians with daily work in the obstetric field were tested. METHODS: The Delphi method was used for development of the scale. In a simulated vacuum extraction scenario, first-year residents and obstetric chief physicians were rated using the developed OSATS scale for vacuum extraction to test construct validity of the scale. MAIN OUTCOME MEASURES: Consensus for the content of the scale. To test the scale of Cronbach's alpha, interclass correlation and differential item function was calculated in the prospective study. RESULTS: 89% completed the first and 61% completed the second Delphi round. Hereafter, consensus was obtained. There was a significant difference between residents' and experts' performance for total score and for the score of the separate parts of the scale. Cronbach's alpha for total score and for the separate parts of the scale was 0.91-0.95 and interclass correlation 0.84-0.9. CONCLUSIONS: The OSATS scale for vacuum extraction is a reliable test for differentiating between competence levels in a simulated setting.

The effect of vacuum operator's experience on Apgar scores.

OBJECTIVE: To determine the effect of a vacuum operator's experience on Apgar scores. METHODS: A historical cohort study was conducted. All women who delivered by vacuum extraction between January 2003 and December 2007 at Songklanagarind Hospital were recruited. Vacuum operators were divided into two groups: staff doctors and residents. Comparisons of Apgar scores and rates of low Apgar scores (≤7) between the two groups were studied. A multivariate logistic regression analysis was used to control confounding variables for low Apgar scores. RESULTS: The percentages for the procedure performed by the staff doctors and residents were 76.9 and 23.1%. At 1 min, the rates of low Apgar scores in the staff and resident groups were 6.7 and 24.1% (p<0.001), and at 5 min, the rates of low Apgar scores were 0.6 and 5.2% (p<0.001). Multivariate logistic regression analysis showed that the operator's experience was an independent risk factor for low Apgar scores. The residents had a 2.9-fold increased risk of low Apgar scores at 1 min compared with the staff doctors (adjusted odds ratio 2.9; 95% confidence interval 1.7-6.8). In the resident group, the third year residents had the lowest risk of low Apgar scores. CONCLUSIONS: The vacuum operator's experience was an independent risk factor for low Apgar scores. Improvement of the residency training program is mandatory.

Second stage expedite delivery of low birth weight neonates: Emergent cesarean delivery versus vacuum assisted delivery.

OBJECTIVE: To determine maternal and neonatal outcomes among women undergoing second stage emergent cesarean delivery (ECD) versus vacuum-assisted delivery (VAD) of low birthweight neonates. MATERIALS AND METHODS: A retrospective cohort study from two tertiary medical centers. We included women who underwent either ECD or VAD during the second stage of labor, and delivered neonates with a birthweight of <2500 g during 2011-2019. Characteristics and outcomes were compared between the groups. The primary outcome was the rate of a composite adverse neonatal outcome, defined as the presence of ≥1 of the following: Apgar 5 min < 7, respiratory distress syndrome, neonatal intensive care unit admission, mechanical ventilation and intrapartum fetal death. RESULTS: The study cohort included 611 patients, of whom 46 had ECD and 565 had VAD. Baseline characteristics did not differ between the groups. The rate of Apgar score < 7 at 1 min was higher among the ECD group]10 (22%) vs. 29 (5%), OR (95% CI) 5.1 (2.3-11.3), p < 0.001[. Other neonatal and maternal outcomes were similar in both groups. CONCLUSIONS: Neonatal and maternal outcomes do not differ substantially between ECD and VAD of neonates weighing <2500 g. This information may be useful when contemplating the preferred mode of delivery in this setting.

Qualitative analysis by interviews and video recordings to establish the components of a skilled low-cavity non-rotational vacuum delivery.

OBJECTIVES: The objectives of this study were to define the components of a skilled low-cavity non-rotational vacuum delivery (occiput anterior, vertex at station +2 or below and less than 45-degree rotation from midline) and to facilitate the transfer of skills from expert to trainee obstetricians. DESIGN: Qualitative study using interviews and video recordings. SETTING: Two university teaching hospitals (St Michael's Hospital, Bristol, and Ninewell's Hospital, Dundee). PARTICIPANTS: Ten obstetricians and eight midwives identified as experts in conducting or supporting operative vaginal deliveries. METHODS: Semi-structured interviews were carried out using routine clinical scenarios. The experts were also video recorded conducting low-cavity vacuum deliveries in a simulation setting. The interviews and video recordings were transcribed verbatim and analysed using thematic coding. The anonymised data were independently coded by three researchers and compared for consistency of interpretation. The experts reviewed the coded interviews and video data for respondent validation and clarification. The themes that emerged following the final coding were used to formulate a list of skills. MAIN OUTCOME MEASURES: Key technical skills of a low-cavity non-rotational delivery. RESULTS: The final list included detailed technical skills required for conducting a low-cavity vacuum delivery. The combination of semi-structured interviews and simulation videos allowed the formulation of a comprehensive skills tool for future evaluation. CONCLUSION: This explicitly defined skills list could aid trainees understanding of the technique of low-cavity vacuum delivery. This is an important first step in evaluating clinical competence in intrapartum procedures.

[Learning curve of vacuum extraction in residency: a preliminary study]. / Courbe d'apprentissage de la ventouse obstétricale par les internes : étude préliminaire.

OBJECTIVES: The aim of this study was to assess the lurning curve of young residents for vacuum extraction. MATERIALS AND METHODS: All vacuum extractions performed in our department by five residents (< or =5th semester) during a study period of nine months were systematically supervised by a senior who fulfilled an assessment questionnaire from which was calculated a score reflecting the quality of the extraction. RESULTS: Fifty-four vacuum extractions were assessed with a mean of 10.8+/-2.9 (range, 10-13) procedures by resident. We compared the group including the six first procedures performed by each resident (group 1, n = 30) with the group including the following procedures (group 2, n = 24). We observed in the group 2 compared to the group 1, a significant improvement of the scores mean (12.3+/-5.4 vs 8.4+/-6.2, p = 0.016) and a significant reduction of the need for manual assistance by the senior (12.5% vs 40%, p = 0.034). CONCLUSION: We report a method for the learning and assessment of vacuum extraction feasible at "the bed" of the patient. This approach allows to observe a significant progression of the resident for the technique of vacuum extraction on a dozen of procedures.

Monitoring obstetricians' performance with statistical process control charts.

OBJECTIVE: The main objective of this study was to pave the way towards proactive, continuous assessment of individuals and hospitals by demonstrating the application of evidence-based competency standards in maternity care using statistical performance monitoring. DESIGN: Retrospective study using data routinely collected by a large maternity hospital. SETTING: A large teaching hospital. POPULATION: Clinicians who routinely perform either amniocentesis or ventouse deliveries. METHOD: As a 'proof of principle', we have used statistical process control (SPC) charts to compare the observed complication rates for amniocentesis and ventouse delivery with the expected complication rates based on published data. MAIN OUTCOME MEASURES: The recorded complication rates for amniocentesis and ventouse delivery. RESULTS: The SPC charts identified significant variation in complication rates within the team and showed the ways in which prospective data can be used to provide continuous feedback to individuals on their performance. CONCLUSION: The study shows that statistical performance monitoring and, in particular, the use of control charts can be a valuable tool in the continuous assessment of individuals and the healthcare service being provided. The control charts provide a more immediate indication of current performance and provide an alternative to performance-based league tables for the presentation of yearly performance data.

[Five questions about the Kiwi OmniCup vacuum extractor]. / Cinq questions à propos de la ventouse Kiwi OmniCup.

The vacuum extractor Kiwi OmniCup (Clinical Innovations, Muray, Utah, USA) has been developed to provide several advantages. This is a complete system with an integral hand-held vacuum operated by the obstetrician. This is also a single use instrument, which may reduce the risk of potential transmission of infections and the logistic of sterilization process. Further potential benefits of this system include the smaller overall equipment size and the ability to measure traction force. However, the data about its efficiency remain conflicting. The first works demonstrated very high successful rate of vaginal delivery, whereas two recent randomized studies showed that the Kiwi Omnicup was less efficient than currently used vacuum extractor. It appears to be as safe as conventional a device for both mother and newborn. However, further additional data remain necessary needed to complete its evaluation.

Obstetric management in vacuum-extraction deliveries.

OBJECTIVE: The aim of this observational study was to describe the obstetric management in vacuum extraction (VE) deliveries and to compare these findings to instructions in clinical guidelines on VE. METHODS: In 2013, detailed data on management of 600 VE cases were consecutively collected from six different delivery units in Sweden. Each unit also contributed their own clinical VE guideline. RESULTS: In total, 93% of the VEs ended with a vaginal delivery while 7% failed and were converted to an emergency cesarean section. In 2.3% extraction time exceeded 20 minutes, and in 6% more than six pulls were used to deliver the fetus. Cup detachment occurred in 14.6%, and fundal pressure was used in 11% of the deliveries. In 2.3%, fetal station was assessed as above the level of the maternal ischial spines. The clinical guidelines on VE varied in scope and content between units, and were often incomplete according to best practice. CONCLUSION: The vast majority of the VEs were conducted in accordance with safety recommendations. However, in a few extractions, safety rules were disregarded and more than six pulls or an extraction time of more than 20 minutes were used to complete the delivery.

Comparison of maternal and neonatal morbidity in midforceps delivery and midpelvis vacuum extraction.

The present study examines the incidence of maternal and neonatal morbidity associated with delivery from the midpelvis using the vacuum extractor when compared with obstetric forceps. Previous studies have failed to minimize the influence of confounding variables such as maternal and neonatal disease and indication for delivery on outcome when comparing determinants of maternal and neonatal morbidity in the two groups. Results indicate that there was significantly more maternal morbidity in forceps deliveries across most variables. There were no statistically significant differences in neonatal morbidity between the two groups except for a higher incidence of inconsequential cephalhematoma in the vacuum group. It is concluded that the vacuum extractor may be a valuable instrument in delivery from the midpelvis and that it should be more widely used in appropriate clinical situations.

Vacuum sources in obstetrics.

OBJECTIVE: To characterize the performance of vacuum equipment used in operative vaginal deliveries. STUDY METHOD: We measured wall suction in eight Cleveland area labor-and-delivery units. Additionally, we tested samples of hand-operated and electric vacuum pumps. For each apparatus we recorded vacuum in millimeters of mercury using a calibrated, diaphragm-type gauge. We calculated mean maximal vacuum. Work required to produce 500 mm Hg of vacuum was determined for the hand-operated pumps. At increments of vacuum, we compared the vacuum displayed by the gauge head included with the device to our standard. RESULTS: Mean wall suction was 494 mm Hg (range, 248-655). As compared to the Mity-vac, the CMI hand-operated pump needed significantly more work to generate 500 mm Hg of vacuum. Electric pumps produced a reliable and consistent vacuum. Gauges included with the pump had an average error of 4% over 400-600 mm Hg. CONCLUSION: Wall suction was an unreliable source of vacuum. The two hand-operated pumps tested required significantly different amounts of work to achieve an adequate vacuum. Addition of a fluid trap does not affect the vacuum, and head gauges supplied with vacuum pumps are accurate.

Foetal and maternal outcome of vacuum extraction.

In a prospective study, 167 vacuum extractions (VE) performed at the Kenyatta National Hospital, Nairobi, formed 6.3% of the total deliveries. Most patients were young and of low parity. There were no maternal deaths. The overall maternal morbidity rate was 22% and were mostly minor. Post partum haemorrhage was the most common maternal complication. There were 5 failed VEs. Perinatal morbidity and mortality rates were 16.2% and 4.8% respectively. Intrauterine asphyxia was the commonest cause of death. Several complications could have been avoided by more stringent use of the instrument. The place of VE in a busy obstetric unit is discussed.

PIP: A prospective study of all vacuum extraction deliveries in the maternity unit of the Kenyatta National Hospital, Nairobi, Kenya, in a 4-month period is presented. The vacuum extractions made up 167 (6.3%) of 2670 total deliveries, with 23.7% cesarean sections. The Bird's modified Malmstrom vacuum extractor was used, chiefly by residents (97%). In 97.% the maximum vacuum pressures ranged from 0.5-0.8 kg/sq. cm., developed over 5-10 minutes. Patients had local perineal anesthesia only (86.7%). 24% of patients had registered at the hospital for prenatal care. 88.4% of deliveries were at term. In 98.8% the head was less than 3/5 palpable per abdomen. The most common indications for vacuum extraction were prolonged 2nd stage (59.3%) and eclampsia (23.9%). 88.6% were done at full cervical dilatation. There were no maternal deaths; 21% of mothers experienced morbidity, most commonly hemorrhage .500 ml (8.4%), and lacerations (7.8%). There were 5 failed extractions, including 1 uterine rupture of a prior tear, and 1 procedural failure. Perinatal mortality was 4.8%, of which 6 were stillborn. Apgar scores ,7 occurred in 23.4% at 1 minute and 9% at 5 minutes. Since many of the mothers were young, of low parity, and referred in prolonged labor, the outcomes were to be expected. A concern was the high incidence of postpartum hemorrhage, now that transfusions should be avoided.

Instrumental (operative) vaginal deliveries: vacuum extraction compared with forceps delivery at Ilorin University Teaching Hospital, Nigeria.

In a four-year period (1984 to 1987) a total of 141 Nigerian women who had instrumental vaginal deliveries at term in the Obstetric unit of University of Ilorin Teaching Hospital, Ilorin, were studied. Out of this number 79 had forceps delivery while 62 had vacuum extraction. The forceps delivery rate had fluctuated between 0.11% and 0.46% while the vacuum extraction rate had steadily increased from 0.08% to 0.39% (Table 1) in our unit over the 4-year period. With the exception of fetal distress, there were no significant differences found in the indications for forceps delivery and vacuum extraction. The preapplication station, position and cervical dilatation differ in both groups (Table 4). There was less maternal trauma in vacuum extraction than forceps (Table 5). The vacuum extraction was more associated with cephalhaematoma and neonatal jaundice but less with neonatal mortality compared with forceps (Table 7). Vacuum extraction had gradually assumed more prominence as an alternative to midforceps delivery in our unit in the study period. There was no maternal mortality in the two groups.

Vacuum cup placement during delivery--a suggested obstetric quality assessment measure.

OBJECTIVE: To establish standards for the deviation of vacuum cup placement from the ideal location during operative delivery in an academic center. METHODS: Data on 92 vacuum deliveries were prospectively obtained. The actual point on the newborns head was determined and both midline and anterior-posterior line deviations from the ideal point of placement were calculated. RESULTS: The most common indication for vacuum extraction was a nonreassuring fetal heart rate (66.7%). The average deviation on the mid anterior-posterior line was 3.72 ± 1.46 cm; the average midline-lateral deviation was 1.92 ± 1.33 cm. There was no statistically significant difference in the cup placement deviations between deliveries performed by residents and consultants. The vacuum procedure failed in 8.6% of the cases. CONCLUSIONS: Accurate placement of the vacuum cup on the fetal head is considered to be clinically important. This assumption requires scientific clinical proof. Our local standard for deviation was established and will serve for audit. If safer neonatal and maternal outcomes are demonstrated, the deviation from the ideal placement location ought to become a universal quality measure for vacuum deliveries.

Operative vaginal delivery.

Operative vaginal delivery remains a valid option when problems arise in the second stage of labor. The most common indications are fetal compromise and failure to deliver spontaneously with maximum maternal effort. There is a clear trend to choose vacuum extraction over forceps to assist delivery, but the evidence supporting that trend is unconvincing. Recent literature confirms some advantages for forceps (eg, a lower failure rate) and some disadvantages for vacuum extraction (eg, increased neonatal injury), depending on the clinical circumstances. To preserve the option of forceps delivery, residency training programs must incorporate detailed instruction in forceps techniques and related skills into their curricula. Simulation training can enhance residents' understanding of mechanical principles and should logically precede clinical work.