Effect of team training and monitoring on the rate of failed mid and low cavity vacuum extraction: a hospital based intervention study

Pettersson, Kristina; Westgren, Magnus; Götze-Eriksson, Rebecca; Ajne, Gunilla

doi:10.1186/s12884-019-2257-z

Cited by 1 publication

(1 citation statement)

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“…A digital vacuum extraction handle has been developed by our research group at the Division of Obstetrics and Gynaecology, KI, in collaboration with the Royal Institute of Technology in Stockholm, Sweden [ 17 ]. It monitors real time traction forces and provides objective documentation on the procedure, which seems to increase adherence to existing guidelines [ 18 ]. A predictive algorithm for high level of traction force is incorporated in the handle.…”

Section: Introductionmentioning

confidence: 99%

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

Romero¹,

Pettersson²,

Yousaf³

et al. 2021

BMC Pregnancy Childbirth

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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.

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Section: Introductionmentioning

confidence: 99%