@article{ed099955058d45bea822e820a71a72eb,
title = "Comparison of effect of CTG + STan with CTG alone on emergency Cesarean section rate: STan Australian Randomized controlled Trial (START)",
abstract = "Objective: To investigate whether use of ST analysis of the fetal electrocardiogram (STan) as an adjunct to continuous cardiotocography (CTG) reduces the rate of emergency Cesarean section (EmCS) compared with CTG alone. Methods: This was a randomized controlled trial of patients with a singleton fetus in cephalic presentation at ≥ 36 weeks' gestation, requiring continuous electronic fetal monitoring during labor at a tertiary maternity hospital in Adelaide, Australia, between January 2018 and July 2021. Participants were randomized to undergo CTG + STan or CTG alone. The calculated sample size was 1818 participants. The primary outcome was EmCS. Secondary outcomes included metabolic acidosis, a composite adverse perinatal outcome, and other maternal and neonatal morbidity and safety outcomes. Results: The present study enrolled 970 women, of whom 967 were included in the primary analysis. EmCS occurred in 107/482 (22.2%) deliveries in the CTG + STan arm and in 107/485 (22.1%) in the CTG arm (adjusted relative risk, 1.02 (95% CI, 0.81–1.27); P = 0.89). There was no difference in the rate of adverse maternal or neonatal outcomes between arms. Conclusions: The addition of STan as an adjunct to continuous CTG did not reduce the EmCS rate. The smaller-than-anticipated sample size meant that this study was underpowered to detect absolute differences of ≤ 5% and, therefore, this negative finding could be due to a Type-2 error.",
keywords = "CTG, Cesarean section, RCT, ST analysis, STan, cardiotocography, fetal ECG, fetal electrocardiography, intrapartum fetal monitoring, randomized controlled trial",
author = "S. Kuah and B. Simpson and A. Salter and G. Matthews and J. Louise and J. Bednarz and E. Chandraharan and I. Symonds and A. McPhee and Mol, {B. W.} and D. Turnbull and C. Wilkinson",
note = "Funding Information: We thank the women and their babies for participating. We also thank the staff at the Women's and Children's Hospital (WCH), North Adelaide, SA, Australia, in particular Priya Umapathysivam, Denise Cheetham and Cecilia Heitmann, for their assistance in recruiting participants for the STan Australian Randomized controlled Trial (START). We also thank the members of the Data Safety Monitoring Committee, Diogo Ayres-de-Campos, Scott Morris and Katherine Lee, for their oversight of START and the Clinical Information Service team at the WCH for providing comparative hospital data. This study was funded by the National Health and Medical Research Council (NHMRC; project grant 1129648). The NHMRC had no involvement in the study design, collection, analysis and interpretation of data, writing of the report or decision to submit the article for publication. Open access publishing facilitated by The University of Adelaide, as part of the Wiley – University of Adelaide agreement via the Council of Australian University Librarians. Neoventa Medical AB (M{\"o}lndal, Sweden) provided training, education and engineering support for installation and use of STAN S31 machines, when STan was first introduced to the WCH as a standard of care in 2015, prior to and independent of START. E.C. conducted masterclasses in cardiotocography, fetal electrocardiography and postpartum hemorrhage for the Baby Lifeline charity, Neoventa Academy and Baby Lifeline Training until March 2022, but has had no financial or managerial interests at any of these organizations. From March 2022, he has conducted these masterclasses through the Global Academy of Medical Education & Training, London, UK. Funding Information: We thank the women and their babies for participating. We also thank the staff at the Women's and Children's Hospital (WCH), North Adelaide, SA, Australia, in particular Priya Umapathysivam, Denise Cheetham and Cecilia Heitmann, for their assistance in recruiting participants for the STan Australian Randomized controlled Trial (START). We also thank the members of the Data Safety Monitoring Committee, Diogo Ayres‐de‐Campos, Scott Morris and Katherine Lee, for their oversight of START and the Clinical Information Service team at the WCH for providing comparative hospital data. This study was funded by the National Health and Medical Research Council (NHMRC; project grant 1129648). The NHMRC had no involvement in the study design, collection, analysis and interpretation of data, writing of the report or decision to submit the article for publication. Open access publishing facilitated by The University of Adelaide, as part of the Wiley – University of Adelaide agreement via the Council of Australian University Librarians. Publisher Copyright: {\textcopyright} 2023 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology.",
year = "2023",
month = oct,
doi = "10.1002/uog.26279",
language = "English",
volume = "62",
pages = "462--470",
journal = "Ultrasound in Obstetrics and Gynecology",
issn = "0960-7692",
publisher = "John Wiley and Sons Ltd",
number = "4",
}