Fetal Heart Rate Characterization Using Innovative Advanced Non-invasive Technology
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- fetus pulse
研究概览
简要总结
The purpose of the study is to examine the effectiveness and reliability of fetal heart rate monitoring by the Oxitone device.
Today, fetal monitoring is carried out with an external approach using a Doppler transducer placed on the mother's abdomen or with an internal approach only after water breaks and during active labor by connecting an electrode to the head of the fetus.
Oxyton's technology collects various physiological indicators and calculates an estimation of the fetal pulse. This monitoring method has a wide potential for use as part of pregnancy monitoring and perhaps even during childbirth.
Fetal heart rate will be measured in pregnant women in the third trimester of pregnancy with one fetus. The patients will wear the Oxitone device at the same time as Doppler monitoring in the hospital. An analysis of the data will be performed in comparison to the current accepted fetal monitor.
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 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy individuals between the age of 18-50
排除标准
- •Clotting disorders, diabetes, currently taking psychotropic medications
结局指标
主要结局
fetus pulse
时间窗: through study completion, an average of 1 year
fetus pulse calculated by a new algorithm
次要结局
未报告次要终点