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

BMC Pregnancy and Childbirth

Kristina Pettersson¹  Gunilla Ajne¹  Stefhanie Romero¹  Magnus Westgren¹  Khurram Yousaf² 

[1] Pregnancy Care & Delivery K57, Karolinska University Hospital, 141 86, Stockholm, Sweden;Division of Obstetrics and Gynecology, Clintec, Karolinska Institutet, 141 86, Stockholm, Sweden;School of Technology and Health, Royal Institute of Technology, Stockholm, Sweden;

关键词: Vacuum assisted delivery;    Traction force;    Haptic feedback;    Neonatal outcome;   

DOI  :  10.1186/s12884-021-03604-z

来源: Springer

【 摘 要 】

BackgroundLow 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.MethodsA 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 %.ResultsAfter 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.ConclusionsThe 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 registrationClinicalTrials.gov NCT03071783, March 1, 2017, retrospectively registered.

【 授权许可】

CC BY