Traction force profile in children with severe perinatal outcomes delivered with a digital vacuum extraction handle: A case-control study.

INTRODUCTION: During the second stage of labor, vacuum-assisted delivery is an alternative to forceps delivery and emergency cesarean section. Extensive research concerning perinatal outcomes has indicated that the risk of complications, although rare, is higher than with a spontaneous vaginal delivery. An important factor related to perinatal outcomes is the traction force applied. Our research group previously developed a digital extraction handle, the Vacuum Intelligent Handle-3 (VIH3), that measures and records traction force. The objective of this study was to compare traction force profiles in children with and without severe perinatal outcomes delivered with the digital handle. A secondary aim was to establish a safe force limit. MATERIAL AND METHODS: This was an observational case-control study at the delivery ward at Karolinska University Hospital, Sweden. In total, 573 children delivered with the digital handle between 2012 and 2018 were included. Cases were defined as a composite of severe perinatal outcomes, including subgaleal hematoma, intracranial hemorrhage, hypoxic ischemic encephalopathy 1-3, seizures or death. The cases in the cohort were matched 1:3 based on five matching variables. Traction profiles were analyzed using the MATLAB® software and conditional logistic regression. RESULTS: The incidence of severe perinatal outcomes was 2.3%. The 13 cases were matched with three controls each (n = 39). A statistically significant increased odds for higher total traction forces was seen in the case group (odds ratio [OR] 1.004; 95% confidence interval [CI] 1.001-1.007) and for the peak force (OR 1.022; 95% CI 1.004-1.041). Several procedure-related parameters were significantly increased in the case group. As expected, some neonatal characteristics also differed significantly. An upper force limit of 343 Newton minutes (Nmin) revealed an 86% reduction in severe perinatal outcomes (adjusted OR 0.14; 95% CI 0.04-0.5). CONCLUSIONS: Children with severe perinatal outcomes had traction force profiles with significantly higher forces. The odds for severe perinatal outcomes increased for every increase in Nmin and Newton used during the extraction procedure. A calculated total force level of 343 Nmin is suggested as an upper safety limit, but this must be tested prospectively to provide validity.

Perinatal outcome after vacuum assisted delivery with digital feedback on traction force; a randomised controlled study.

BACKGROUND: Low and mid station vacuum assisted deliveries (VAD) are delicate manual procedures that entail a high degree of subjectivity from the operator and are associated with adverse neonatal outcome. Little has been done to improve the procedure, including the technical development, traction force and the possibility of objective documentation. We aimed to explore if a digital handle with instant haptic feedback on traction force would reduce the neonatal risk during low or mid station VAD. METHODS: A two centre, randomised superiority trial at Karolinska University Hospital, Sweden, 2016-2018. Cases were randomised bedside to either a conventional or a digital handle attached to a Bird metal cup (50 mm, 80 kPa). The digital handle measured applied force including an instant notification by vibration when high levels of traction force were predicted according to a predefined algorithm. Primary outcome was a composite of hypoxic ischaemic encephalopathy, intracranial haemorrhage, seizures, death and/or subgaleal hematoma. Three hundred eighty low and mid VAD in each group were estimated to decrease primary outcome from six to 2 %. RESULTS: After 2 years, an interim analyse was undertaken. Meeting the inclusion criteria, 567 vacuum extractions were randomized to the use of a digital handle (n = 296) or a conventional handle (n = 271). Primary outcome did not differ between the two groups: (2.7% digital handle vs 2.6% conventional handle). The incidence of primary outcome differed significantly between the two delivery wards (4% vs 0.9%, p < 0.05). A recalculation of power revealed that 800 cases would be needed in each group to show a decrease in primary outcome from three to 1 %. This was not feasible, and the study therefore closed. CONCLUSIONS: The incidence of primary outcome was lower than estimated and the study was underpowered. However, the difference between the two delivery wards might reflect varying degree of experience of the technical equipment. An objective documentation of the extraction procedure is an attractive alternative in respect to safety and clinical training. To demonstrate improved safety, a multicentre study is required to reach an adequate cohort. This was beyond the scope of the study. TRIAL REGISTRATION: ClinicalTrials.gov NCT03071783 , March 1, 2017, retrospectively registered.

Long-term neurodevelopmental outcome in children born after vacuum-assisted delivery compared with second-stage caesarean delivery and spontaneous vaginal delivery: a cohort study.

OBJECTIVE: To evaluate long-term neurodevelopment in children born after low-or mid-station vacuum-assisted delivery (VAD) compared with children delivered by second-stage caesarean delivery (SSCD) or spontaneous vaginal delivery (SVD). DESIGN: Cross-sectional cohort study. SETTING: Two delivery wards, Karolinska University Hospital, Sweden. PATIENTS: 253 children born by low-station or mid-station VAD, 247 children born after an SVD, and 86 children born via an SSCD accepted to participate. INTERVENTIONS: The Five-to-Fifteen questionnaire was used as a validated screening method for neurodevelopmental difficulties, assessed by parents. MAIN OUTCOMES MEASURES: Results in the Five-to-Fifteen questionnaire. In addition, registered neurodevelopmental ICD-10 diagnoses were collected. Regression analyses estimated associations between delivery modes. RESULTS: Children born after VAD exhibited an increased rate of long-term neurodevelopmental difficulties in motor skills (OR 2.2, 95% CI 1.3 to 3.8) and perception (OR 1.7, 95% CI 1.002 to 2.9) compared with SVD. Similar findings were seen in the group delivered with an SSCD compared with SVD (motor skills: OR 3.3, 95% CI 1.8 to 6.4 and perception: OR 2.3, 95% CI 1.2 to 4.4). The increased odds for motor skills difficulties after VAD and SSCD remained after adjusting for proposed confounding variables. There were significantly more children in the VAD group with registered neurodevelopmental ICD-10 diagnoses such as attention deficit/hyperactivity disorders. CONCLUSIONS: The differences in long-term neurodevelopmental difficulties in children delivered with a VAD or SSCD compared with SVD in this study indicate the need for increased knowledge in the field to optimise the management of second stage of labour.

Role of tumor-associated macrophages and angiogenesis in desmoid-type fibromatosis.

Desmoid-type fibromatosis (DTF) is a rare soft tissue tumor with fibroblastic features affecting two to four individuals per million population per year. Despite its bland microscopic appearance, the tumor behaves aggressively. Although unable to metastasize, DTF tends to recur and local recurrences in anatomically critical sites can be fatal. Tumor-associated macrophages (TAM) play an important role in tumor development through the activation of angiogenesis, particularly in cases of epithelial malignancies. The aim of this study is to investigate the prognostic significance of TAMs and the number of microvessels in DTF. Tumor macrophages (CD163), microvessel density (CD31), and beta-catenin were investigated on 69 primary DTF cases with follow-up information. CTNNB1 mutations were also studied. High density of tumor macrophages and high number of microvessels were associated with a significantly worse recurrence-free survival (P = 0.03 and P = 0.007, respectively). There was a significant correlation between microvessel density and CD163 macrophages (P = 0.02). Furthermore, combination of high number of tumor macrophages and high microvessel density greatly improved the statistical significance (P = 0.000005). Macrophages and microvessels may play an important role in the biologic behavior of DTF. This finding could help in the clinical management of patients with DTF.