School of Psychology, University of Adelaide, Adelaide, South Australia, Australia.
School of Public Health, University of Adelaide, Adelaide, South Australia, Australia.
Trials. 2019 Aug 29;20(1):539. doi: 10.1186/s13063-019-3640-9.
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.
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.
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.
ANZCTR, ACTRN1261800006268 . Registered on 19 January 2018.
胎心监护在分娩过程中的应用几乎无处不在。虽然已经证明，使用胎心监护进行连续的分娩期胎儿监测有一定的益处，但这也增加了剖宫产的风险，而剖宫产对母婴都有短期和长期的风险。仅使用胎心监护，就有可能将高达 60%的胎儿窘迫假阳性诊断率降低，从而降低不必要的手术分娩率。胎儿心电图 ST 分析是胎心监护的一种很有前途的辅助手段，它可以检测胎儿代谢性酸中毒，从而降低胎儿窘迫的假阳性诊断率。
本研究将是一项为期 3 年的单中心、平行组、随机对照试验。主要假设是，在 ST 分析的女性中，紧急剖宫产的比例将不等于仅行胎心监护监测的女性。参与者将在妇女儿童医院招募，这是一家高危专科医疗机构，每年约有 5000 例分娩。总共将有 1818 名妇女随机分为治疗组或常规组，分配比例为 1:1，并按产次分层。主要结局是紧急剖宫产（是/否）。统计分析将遵循随机试验的标准方法，并基于意向治疗进行分析。次要的产妇和新生儿结局也将进行分析。其他研究结果包括社会心理结局、患者偏好和成本效益。
大约 20%的澳大利亚婴儿是通过紧急剖宫产分娩的。这将是澳大利亚首个检验胎儿心电图 ST 分析作为降低这一比例的潜在方法的试验。该试验将是第一个全面检验 ST 分析的试验之一，将考虑到对社会心理健康的影响以及成本效益。这项研究将为澳大利亚的临床实践和指南制定提供证据，也为决策者和消费者提供信息，以便他们在分娩时做出明智的、基于证据的选择。
澳大利亚新西兰临床试验注册中心，ACTRN1261800006268。于 2018 年 1 月 19 日注册。
