Clinical Study Evaluating the Safety of PregSense and Comparative Performance of PregSense Versus CTG in Prenatal Monitoring of Pregnant Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 151
- 试验地点
- 6
- 主要终点
- Maternal Heart Rate
研究概览
简要总结
This clinical study will evaluate the safety of PregSense™ and Comparative Performance of PregSense™ versus CTG in Prenatal Monitoring of Pregnant subjects.
详细描述
PregSense™ is a maternal-fetal monitor that non-invasively measures and displays fetal heart rate, maternal hear rate and uterine contractions. This study will be performed to collect and digitally record data from PregSense™ and the standard of care (CTG) in order to provide evidence of safety and agreement between PregSense™ and the gold standard NST device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female age between 18-50
- •Gestational age > 32 + 0 weeks
- •Singleton gestation
- •Ability to understand and sign informed consent
排除标准
- •BMI (Body Mass Index) ≥ 45 and ≤15 prior pregnancy
- •Multiple gestation
- •Uncontrolled Hypertension
- •Fetal Anomaly
- •Subjects with skin problems in the abdominal area (such as flesh wounds, cuts in the skin, skin rashes, etc.)
- •Subjects with implanted electronic devices (pacemaker, defibrillator, etc.)
- •Subjects who, in the judgement of the investigator, are likely to be non-compliant or uncooperative during the study
结局指标
主要结局
Maternal Heart Rate
时间窗: 30 MInutes
Provide evidence of safety and agreement between MHR collected via the PregSense™ and the standard of care devices (i.e. CTG)
Fetal Heart Rate
时间窗: 30 Minutes
Provide evidence of safety and FHR agreement between PregSense™ and the standard of care devices (i.e. CTG)
次要结局
- Uterine Contractions(30 Minutes)