Feasibility of a Non-invasive, Trans-abdominal, Low Cost Fetal Oximetry Probe on Pregnant Human Subjects
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Fetal Photoplethysmogram
研究概览
简要总结
Three non-invasive, trans-abdominal fetal oximetry probes will be tested on pregnant human subjects, in order to obtain fetal heart rate.
We want to determine if this device can accurately measure a baby's oxygen level when placed on your abdomen.
Current technology to measure a baby's oxygen levels requires a probe to be inserted into the vagina.
详细描述
The study subject will have a brief trans-abdominal ultrasound examination.
3 trans-abdominal fetal oximetry probes will be tested for 5 minutes per probe. No probes will be placed into the vagina.
It is anticipated that 6 months will be required to recruit, consent and study 25 participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Greater than 36 weeks pregnant
- •Singleton fetus
排除标准
- •Prisoners
研究组 & 干预措施
Administration of Fetal Oximetry Probe
Administration of Raydiant Oximetry Sensor System on 36 weeks or greater pregnant women
干预措施: Raydiant Oximetry Sensor System (Device)
结局指标
主要结局
Fetal Photoplethysmogram
时间窗: 6 months
The primary outcome measure will be if a fetal photoplethysmogram is obtained in the time domain that correlates to the fetal heart rate.
次要结局
- Fetal Heart Rate(6 months)