NCT04323865已完成不适用
Non-invasive Fetal Electrocardiography (NI-FECG); Repeatability of Time-domain and Spectral Analyses
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Root mean square of successive RR-interval differences (RMSSD)
研究概览
简要总结
Need statement
- a new way to distinguish between a healthy small fetus and a small fetus suffering from deprivation of nutrition and oxygen to prevent unnecessary induction of preterm birth and improve neonatal outcome.
Aim - to characterize fetal heart rate variability (fHRV) based on fetal ECG in the normal fetus and in the fetus suffering from growth retardation to evaluate its value and applicability as a supplementary tool in fetal surveillance.
Aim of current study
- To evaluate the feasibility of NI-FECG from gestational week 20 and onwards and investigate if important factors as length and heart rate pattern affects repeatability of time domain and spectral analyses in fetuses.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy singleton pregnancies
排除标准
- •Fetal malformations, multiple pregnancy, obstetric complications, maternal chronic disease and labor.
结局指标
主要结局
Root mean square of successive RR-interval differences (RMSSD)
时间窗: 01.04.2020
Time domain analysis, measured in ms
Low frequency power (LF-power)
时间窗: 01.04.2020
Spectral analysis, measured in ms\^2
Standard deviation of normal to normal RR-interval (SDNN)
时间窗: 01.04.2020
Time domain analysis, measured in ms
LF-power/HF-power
时间窗: 01.04.2020
Spectral analysis, ratio
High frequency power (HF-power)
时间窗: 01.04.2020
Spectral analysis, measured in ms\^2
次要结局
未报告次要终点
研究者
研究点 (1)
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