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.