Strengths and limitations
A major strength of this research is the use of comprehensive prospectively collected patient data within the context of a RCT, and the concurrently provided costing data. It is also the first RCT on STan as an adjunct to CTG in a region with a relatively higher CS rate, and hence, if there was adequate power, differences in the primary outcome, if they existed, were more likely to be demonstrated.
COVID-19 pandemic restrictions affected recruitment with limitations on non-critical activity mandated from March 2020. There was reluctance of midwives to recruit, and concerns from the women themselves, due to perceived invasiveness of the FSE and impairment of mobility resulting from the necessary use of a scalp clip if STan was randomised. This resulted in women 970 women completing the study, which was only 53% of the planned sample size. Thus, the study was underpowered to detect absolute differences </= 5% and the lack of a significant finding in the primary outcome (caesarean section) may have been due to a Type 2 error. Additionally, this failure to achieve the required power for clinical outcomes would may have adversely affected the power to detect differences in the economic outcomes.