Comparing the effect of STan (cardiotocographic electronic fetal monitoring (CTG) plus analysis of the ST segment of the fetal electrocardiogram) with CTG alone on emergency caesarean section rates: study protocol for the STan Australian Randomised controlled Trial (START)

Abstract

Background Cardiotocography is almost ubiquitous in its use in intrapartum care. Although it has been demonstrated that there is some benefit from continuous intrapartum fetal monitoring using cardiotocography, there is also an increased risk of caesarean section which is accompanied by short-term and long-term risks to the mother and child. There is considerable potential to reduce unnecessary operative delivery with up to a 60% false positive diagnosis of fetal distress using cardiotocography alone. ST analysis of the fetal electrocardiogram is a promising adjunct to cardiotocography alone, and permits detection of metabolic acidosis of the fetus, potentially reducing false positive diagnosis of fetal distress. Methods This study will be a single-centre, parallel-group, randomised controlled trial, conducted over 3 years. The primary hypothesis will be that the proportion of women with an emergency caesarean section on ST analysis will not equal that for women on cardiotocography monitoring alone. Participants will be recruited at the Women’s and Children’s Hospital, a high-risk specialty facility with approximately 5000 deliveries per annum. A total of 1818 women will be randomised to the treatment or conventional arm with an allocation ratio of 1:1, stratified by parity. The primary outcome is emergency caesarean section (yes/no). Statistical analysis will follow standard methods for randomised trials and will be performed on an intention-to-treat basis. Secondary maternal and neonatal outcomes will also be analysed. Additional study outcomes include psychosocial outcomes, patient preferences and cost-effectiveness. Discussion Approximately 20% of Australian babies are delivered by emergency caesarean section. This will be the first Australian trial to examine ST analysis of the fetal electrocardiogram as an adjunct to cardiotocography as a potential method for reducing this proportion. The trial will be among the first to comprehensively examine ST analysis, taking into account the impact on psychosocial well-being as well as cost-effectiveness. This research will provide Australian evidence for clinical practice and guideline development as well as for policy-makers and consumers to make informed, evidence-based choices about care in labour. Trial registration ANZCTR, ACTRN1261800006268 . Registered on 19 January 2018. Electronic supplementary material The online version of this article (10.1186/s13063-019-3640-9) contains supplementary material, which is available to authorized users.

Cardiotocography and Clinical Risk Factors in Early Term Labor: A Retrospective Cohort Study Using Computerized Analysis With Oxford System

“…During the 10-year study period, there were 32,743 singleton deliveries (excluding elective cesarean sections) with gestational age ≥ 36 weeks of cephalic presentation and normally formed fetuses with intrapartum CTG recorded as per standard care at the John Radcliffe Hospital, Oxford ( Figure 1 ). The selected gestational age of 36 completed weeks is in line with the threshold used in our previous work and in large randomized controlled trials on intrapartum CTG ( 23 – 25 ). We only included cases with at least 20 min of CTG recordings of acceptable signal quality for analysis, taken only at maternity admission or delivery units.…”

Evidence-based intrapartum care during vaginal births: Direct observations in a tertiary care hospital in Central Sri Lanka

“…Continuous CTG during labour is associated with a decrease in neonatal seizures but no significant difference in infant mortality, cerebral palsy, or other standard measures of neonatal wellbeing [ [64] , [65] , [66] , [67] , [68] ]. In addition, continuous CTG monitoring restricts a woman's movements during labour and may limit her choice of birthing position [ 67 , 69 ].…”

A Performance Evaluation of Computerised Antepartum Fetal Heart Rate Monitoring: The Dawes-Redman Algorithm at Term

“…To circumvent potential bias stemming from pregnancies with multiple FHR traces within a particular data group, lower numbers of traces at different gestational ages or imbalance in specific adverse outcomes, stratified bootstrapping was employed for each analysis. 47 A balanced, random sample consisting of normal healthy pregnancies and adverse outcome pregnancies was drawn from each gestational age and time before delivery (in the case of adverse pregnancy outcomes), ensuring a fair representation. Performance metrics were then computed for each random sample.…”