Swedish randomized controlled trial of cardiotocography only versus cardiotocography plus ST analysis of fetal electrocardiogram revisited: analysis of data according to standard versus modified intention‐to‐treat principle

Abstract

Re-analysis of data according to the ITT principle showed that regardless of the method of analysis, the Swedish randomized controlled trial maintained its ability to demonstrate a significant reduction in metabolic acidosis rate when using CTG+ST analysis for fetal surveillance in labor.

ST waveform analysis versus cardiotocography alone for intrapartum fetal monitoring: a systematic review and meta‐analysis of randomized trials

“…The CTG method has low specificity and high false-positive rates; therefore, ª 2015 Nordic Federation of Societies of Obstetrics and Gynecology, Acta Obstetricia et Gynecologica Scandinavica 95 (2016) [16][17][18][19][20][21][22][23][24][25][26][27] its introduction into clinical practice was associated with increased incidences of cesarean section and operative vaginal delivery (1). Hence, a test with higher diagnostic accuracy is needed to identify truly hypoxic fetuses.…”

FIGO consensus guidelines on intrapartum fetal monitoring: Adjunctive technologies

“…Six RCTs were published that compared CTG + ST monitoring with isolated CTG, for a total of more than 26 000 enrolled women [41][42][43][44][45][46][47][48]. The first trial used an earlier version of the technology, the first five trials were conducted in Europe using FBS as an adjunctive technique, and the most recent trial was performed in the USA, where a simplified threetier CTG classification was used and FBS was not available.…”

ST Analysis of the Fetal Electrocardiogram in Intrapartum Fetal Monitoring

“…For the studies of Westerhuis et al and Amer-Wahlin et al, the corrected data after retrospective quality control were used. 21,22 In the Swedish trial, the corrections were related to present standards of intention-to-treat analysis that lead to renewed extraction from the original database and renewed quality control in relation to a more clinically relevant definition of metabolic acidosis. Furthermore, in the study of Ojala et al, 8 analyses were performed according to the intention-to-treat principle for the delivery data (ie, number of cesarean deliveries, number of vaginal operative deliveries, and number of fetal blood sampling).…”