A Multicentre Randomised Controlled Trial of an Intelligent System to Support Decision Making in the Management of Labour Using the Cardiotocogram
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 47,062
- 试验地点
- 21
- 主要终点
- Admissions to higher level of care
研究概览
简要总结
In women judged to require continuous electronic fetal heart rate monitoring (EFM) during their labour, does the addition of decision support software to aid the interpretation of the intrapartum cardiotocogram (CTG) reduce the number of 'poor neonatal outcomes'? This study is not introducing a new form of labour monitoring; it is evaluating the addition of decision-support to CTGs displayed on the Guardian™ system. Specifically comparing: "No decision-support" - CTGs with no additional interpretation (UK standard care), compared with: "Decision-support" - CTGs with the decision support software running that will alert clinicians to the presence of abnormalities in the CTG in real time. How the labour is managed is entirely up to the recruiting unit and the woman; however the allocation of decision-support or no decision-support is determined randomly by the Guardian™ system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Require continuous electronical fetal monitoring during labour
- •they have a singleton or twin pregnancy
- •they are ≥ 35 weeks' gestation (≥ 245 days)
- •there is no known gross fetal abnormality, including any known fetal heart arrhythmia such as heart block
- •they are 16 years of age or older
- •they are able to give consent to participate in the trial as judged by the attending clinicians.
排除标准
- •• triplets or higher order pregnancy
- •criteria for EFM not met, including elective caesarean section prior to the onset of labour
研究组 & 干预措施
Decison support
"Decision-support" - CTGs with the decision support software running that will alert clinicians to the presence of abnormalities in the CTG in real time.
干预措施: INFANT software (Device)
No Decision Support
"No decision-support" - CTGs with no additional interpretation (UK standard care),
结局指标
主要结局
Admissions to higher level of care
时间窗: within 48 hours and for longer than 48 hours
A composite of 'poor perinatal outcome' to include (a) all deaths (intrapartum stillbirths plus neonatal deaths i.e. deaths up to 28 days after birth) except deaths due to congenital anomalies, (b) significant morbidity: neonatal encephalopathy (moderate and severe); (c) admissions to the neonatal unit within 48 hours of birth for ≥ 48 hrs with evidence of feeding difficulties, respiratory illness or encephalopathy.
次要结局
- Neuro Development(2 years)