NCT01681498终止不适用
Fetal Electrocardiogram Extraction-Pilot Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Beat-to-beat fetal heart rate will be compared to the Doppler result.
研究概览
简要总结
This is a pilot study utilizing trans-abdominal ECG and Doppler Ultrasounds to assess the feasibility of extracting fECGs in a volunteer population.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Subjects must be pregnant women at least 18 years of age.
- •Subject's fetus must be between the gestational ages of 16 weeks and term.
- •Subjects must be able to tolerate 20 minutes (per fetus for which trans-abdominal ECG and Doppler ultrasounds will be performed) in the supine position.
- •Subjects are willing to provide informed consent and are willing to participate in all procedures necessary to complete the study.
排除标准
- •Subjects must not have a physical or mental condition, in the opinion of the investigator, which will limit their ability to provide adequate consent.
结局指标
主要结局
Beat-to-beat fetal heart rate will be compared to the Doppler result.
时间窗: 2 years
Beat-to-beat fetal heart rate will be compared to the Doppler result using Pearson Correlation. Timing of PR, QT, and QS, if visible, will be compared with published normative values from the neonatology literature as these values are not otherwise obtainable in an ongoing pregnancy.
次要结局
- Evaluate the presence of other fECG intervals.(2 years)
研究者
研究点 (1)
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