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临床试验/NCT02835417
NCT02835417终止不适用

Fetal Evaluation at Term Using Statistical ECG Signal Processing (FETUSES)

Hospices Civils de Lyon0 个研究点目标入组 3,563 人开始时间: 2012年1月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
3,563
主要终点
P-leader comes from multifractal analysis

研究概览

简要总结

Background

The fetal heart rate (FHR) is commonly monitored during labor to detect early fetal acidosis. FHR variability is traditionally investigated using Fourier transform, however, fetal conditions differ from adults (higher frequency, widely instable signal) modifying spectrum repartition along frequencies, making this approach inappropriate. New mathematic approach, including Multifractal analysis, adaptative multiscale complexity analysis, nearest-neighbor based wavelet entropy rate measures, scattering transform, may identify parameters associated with fetal acidosis. Modern classification system, driven by the data, based on these relevant parameters should help to dsiccriminate the fetus at risk for acidosis and help the clinician in decision making for the management and termination of labor. Analysing 20 to 30 minutes sliding windows with these different methods in a limited number of cases (foetus born with acidosis) and controls (foetus without acidosis) should lead to identify relevant parameters, which will be submitted to these classification tools. For external validation, a large database, including more than 4500 FHR recording documented with foetal outcomes, will be used to evaluate the performance of the combination of parameters identify and classification system used to discriminate foetuses at risk for short term acidosis or not, in order to give a relevant information to the clinician before acidosis occurs, to make the appropriate decision.

研究设计

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

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • women with singleton pregnancy and fetal ECG recording using a scalp electrode, with recording lasting more than 60 minutes, with less than 20 % of missing data and less than 20 minutes between the end of recording and birth.

排除标准

  • Women with recirdin lasting less than 60 minutes, with more than 20 % of missing data, or more than 20 minutes between the end of recording and birth.

结局指标

主要结局

P-leader comes from multifractal analysis

时间窗: Day 0 (during 20 to 30 minutes sliding windows during labor)

Hurst parameter and P-leader comes from multifractal analysis of fetal ECG that quantify fetal heart rate variability.

Hurst parameter comes from multifractal analysis

时间窗: Day 0 (during 20 to 30 minutes sliding windows during labor)

Hurst parameter and P-leader comes from multifractal analysis of fetal ECG that quantify fetal heart rate variability.

次要结局

  • Support vector machine (SVM) classification(Day 0 (during 20 to 30 minutes sliding windows during labor))
  • Entropy rate(Day 0 (during 20 to 30 minutes sliding windows during labor))
  • adaptative multiscale complexity analysis(Day 0 (during 20 to 30 minutes sliding windows during labor))
  • Scattering transform(Day 0 (during 20 to 30 minutes sliding windows during labor))

研究者

申办方类型
Other
责任方
Sponsor

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