Clinical study
A single-centre, RCT was conducted from January 2017 to July 2021) at the largest tertiary care centre in South Australia (Women’s and Children’s Hospital , North Adelaide) (Australian Clinical Trial register number ACTRN12615001308583; Womens and Childrens Health Network Human Research Ethics Committee approval (HREC/14/WCHN/145). Eligibility for the trial included: being aged 18 years or older with a singleton pregnancy; a fetus in cephalic presentation; a gestational age >36weeks and an indication for CEFM based on RANZCOG guidelines(9). Women were randomly allocated (1:1 ratio with stratification for parity) to monitoring either by CTG+STan or CTG alone(. The primary hypothesis was that the proportion of EmCS for women on CTG+STan is not equal to that for women on CTG monitoring alone. Our secondary hypotheses included that CTG+STan monitoring is cost-effective compared to CTG alone (8).
For women assigned to CTG+STan, a fetal scalp electrode (FSE) was applied to the fetal head and connected to a STAN® fetal heart monitor (STAN, Neoventa Medical, Mölndal, Sweden)(10), which allowed both conventional CTG interpretation and ST analysis of the fetal ECG. Further clinical management was made using the STan clinical guidelines [STAN2007 CTG classification system] (11), in addition to CTG classification and interpretation according to the RANZCOG clinical guidelines (9). In women assigned to CTG alone, either an external doppler transducer was utilised, or a FSE was applied to the fetal head and a conventional fetal heart rate monitor (Philips or Neoventa) was used. The CTG was classified and interpreted according to the RANZCOG clinical guidelines (9) Clinical decisions were based on overall clinical assessment combined with STan and/or CTG interpretation, as described in further detail in the study protocol (8).