Please use this identifier to cite or link to this item: http://hdl.handle.net/2440/121460
Citations
Scopus Web of Science® Altmetric
?
?
Type: Journal article
Title: 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)
Author: Turnbull, D.
Salter, A.
Simpson, B.
Mol, B.
Chandraharan, E.
McPhee, A.
Symonds, I.
Benton, M.
Kuah, S.
Matthews, G.
Howard, K.
Wilkinson, C.
Citation: Trials, 2019; 20(1):539
Publisher: Springer Nature
Issue Date: 2019
ISSN: 1745-6215
1745-6215
Statement of
Responsibility: 
D. Turnbull, A. Salter, B. Simpson, B. W. Mol, E. Chandraharan, A. McPhee, I. Symonds, M. Benton, S. Kuah, G. Matthews, K. Howard and C. Wilkinson
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.
Keywords: Caesarean section; Cardiotocography; Continuous electronic fetal monitoring; Randomised controlled trial; ST analysis; START
Rights: © The Author(s). 2019. Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
RMID: 0030134520
DOI: 10.1186/s13063-019-3640-9
Grant ID: http://purl.org/au-research/grants/nhmrc/1129648
Appears in Collections:Medicine publications

Files in This Item:
File Description SizeFormat 
hdl_121460.pdfPublished version1.76 MBAdobe PDFView/Open


Items in DSpace are protected by copyright, with all rights reserved, unless otherwise indicated.