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临床试验/NCT04584281
NCT04584281Unknown不适用

Introduction of Artificial Intelligence (AI) and Machine Learning in Cardiotocography (CTG) Interpretation to Improve Clinical Use

Insel Gruppe AG, University Hospital Bern1 个研究点 分布在 1 个国家目标入组 15,000 人开始时间: 2020年10月最近更新:
适应症

试验速览

阶段
不适用
入组人数
15,000
试验地点
1
主要终点
Superior prediction of fetal morbidity through the self-learning CDS system than if performed by obstetricians alone, especially in regards to specificity.

研究概览

简要总结

The project leaders plan to create a clinical decision support (CDS) system by programming a self-learning software to analyze the cardiotocography (CTG) traces in the - already existing - database from the maternity department of the Inselspital Berne. The project leaders will process and analyze all clinical outcomes of the estimated 10000-15000 eligible patient records. CSEM will design, develop, and validate several AI architectures with the intend to create the CDS system. The AI would learn to assist on this task by training machine learning (ML) algorithms. The main purpose of the AI-CDS will be to determine the best fetal extraction moment during labor, based on a self-learning approach, as a "superhuman" support tool for obstetricians in decision making during labor.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • CTG-registrations of patients with singleton pregnancies during labour from 01.01.2006 to 31.12.2019
  • Gestational age ≥ 24+0 weeks
  • Age ≥ 18 years
  • Written informed consent

排除标准

  • Documented refusal
  • Multiple pregnancies
  • CTG-registrations of planned caesarean sections

结局指标

主要结局

Superior prediction of fetal morbidity through the self-learning CDS system than if performed by obstetricians alone, especially in regards to specificity.

时间窗: 3 months

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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