Trans-abdominal Fetal Pulse Oximetry: Signal Integrity
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Fetal signal integrity
研究概览
简要总结
This project is set up to advance and integrate the established mathematical principles of oxygen saturation to model with increasing accuracy the "body in a body" problem of fetus in mother; similar to existing pulse oximeters,
详细描述
The investigational device is a non-invasive fetal pulse oximeter that measures fetal arterial pulse signal using safe, noninvasive, transabdominal near-infrared spectroscopy. The optical sensor will obtain fetal pulse oximetry signals. Women will also undergo sonographic evaluation to assess distance from maternal skin to fetal tissue and to confirm fetal presentation and position. There is no change to standard of care procedures for fetal heart rate monitoring. The fetal heart rate that will be monitored with the investigational device will be used for research purposes only. Results will not be used to guide or alter patient management.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Pregnant women with singleton pregnancies, vertex presentation
- •Age ≥ 18 years
- •Healthy women ≥ 28 weeks gestation undergoing either Non-Stress test (NST) or Biophysical profile (BPP) OR
- •Healthy women ≥ 37 weeks in labor
- •Vertex presentation
排除标准
- •Age <18 years
- •Multiple gestation ( twins, triplets)
- •Presentation other than vertex
- •< 28 weeks of gestation
结局指标
主要结局
Fetal signal integrity
时间窗: During NST, BPP, or active labor
Integrity of the fetal signal relative to background maternal signal and biologic/electronic noise, and related to fetal position, presentation and the depth of the fetus from maternal skin.
次要结局
未报告次要终点