NCT02320279Unknown不适用
The Fetal EKG Study
Mindchild Medical Inc.1 个研究点 分布在 1 个国家目标入组 900 人开始时间: 2013年10月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 900
- 试验地点
- 1
- 主要终点
- Quantitative FHR
研究概览
简要总结
The objective is to contribute data to ongoing research activities focused on identification of EKG waveform changes in the context of clinical conditions and maternal medication use. Additionally, to develop the capacity to measure contractions more accurately and more reliably using skin-surface electrodes.
详细描述
Specific Aim 1: To develop a technique for the quantitative analysis of fetal heart-rate (FHR) data recorded during labor using advanced mathematical techniques, including pattern-recognition analysis.
- Specific Aim 2: To develop the capacity to measure fetal cardiac data using EKG sensors applied to the maternal abdomen during labor.
- Specific Aim 3: To validate prenatal non-invasive measurement of the fetal QTc interval.
- Specific Aim 4: To develop and validate the capacity to measure uterine contractions using the uterine EMG signal recorded from maternal skin-surface electrodes.
- Specific Aim 5: Collect clinical data related to medication usage and hypoxia.
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
- 否
入选标准
- •Women who are pregnant or in labor who are having their fetus' heart rate monitored continuously and able to consent
- •18 years old or older.
- •Gestational age of 24-42 weeks.
- •Any method of fetal heart rate monitoring.
- •Pregnant women in labor as well as women who are not in labor.
- •Pregnant women who are admitted to labor and delivery for scheduled c-sections.
排除标准
- •Women unable to consent
- •Women under sedation or systemic anesthesia, and women who have diminished cognitive capacity
- •Women in extremis (in severe pain, etc.)
- •Women who are using the Mindchild device for clinical monitoring.
结局指标
主要结局
Quantitative FHR
时间窗: During Labor
Quantitative analysis of fetal heart-rate data recorded during labor using advanced mathetmatical techniques, including pattern-recognition analysis using EKG electrodes applied to the maternal abdomen.
次要结局
- Uterine contractions(During labor)
研究者
研究点 (1)
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