Maternal Fetal Device Performance Testing During Antepartum Twin Monitoring
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Collection of Distinct Fetal Heart Rate
研究概览
简要总结
Maternal Fetal Monitoring devices assist the health care professional in acquiring, monitoring, and storing fetal and maternal physiologic data which support clinical decision making for pregnant women and assesses the overall fetal health status during pregnancy and delivery. This study aims to support a new maternal fetal monitoring device with clinical data by collecting simultaneous, continuous, external, distinguishable FHRs from twin pregnancies using ultrasound Doppler transducers from the new maternal fetal monitoring investigational device and a marketed ultrasound imaging device.
详细描述
This study aims to support a new maternal fetal monitoring device with clinical data by collecting distinguishable FHRs from twin pregnancies using ultrasound Doppler transducers from the investigational device and a marketed ultrasound imaging device. This study will collect twin fetal heart rate data from the new monitor on twin gestations.
Funding for this study will be provided by GE HealthCare. This study does not include patient advisors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Able and willing to provide written informed consent.
- •Twin pregnancy.
- •Greater than or equal to 30 0/7 weeks gestation.
- •Patient has none of the
排除标准
- •Exclusion Criteria:
- •Non-twin pregnancy.
- •Involvement in another clinical trial currently or previously in this pregnancy that, in the investigator's opinion, would affect the conduct of this study.
- •Medical or obstetric problem that in investigator's opinion would make the patient incapable of taking part in the study.
- •Inability to understand the consent information due to medical illness, diminished intellectual capacity, or insurmountable language barrier.
研究组 & 干预措施
Twin Monitoring - All Subjects
Pregnant women of ≥30 0/7 weeks gestation will undergo one 40-minute monitoring session utilizing the investigational device with two Doppler transducers (FHR 1 and FHR 2) following M- mode fetal ultrasound imaging confirming fetal presentation, fetal lie, visualization of fetal heart rates of each fetus and documentation. During the monitoring sessions, maternal pulse rate (MPR) will be monitored using a SpO2 sensor and the investigator shall be present to adjust the transducers as needed to maintain a continuous FHR tracing.
干预措施: Investigational Fetal Monitor (Device)
Twin Monitoring - All Subjects
Pregnant women of ≥30 0/7 weeks gestation will undergo one 40-minute monitoring session utilizing the investigational device with two Doppler transducers (FHR 1 and FHR 2) following M- mode fetal ultrasound imaging confirming fetal presentation, fetal lie, visualization of fetal heart rates of each fetus and documentation. During the monitoring sessions, maternal pulse rate (MPR) will be monitored using a SpO2 sensor and the investigator shall be present to adjust the transducers as needed to maintain a continuous FHR tracing.
干预措施: Ultrasound Imaging Device (Device)
结局指标
主要结局
Collection of Distinct Fetal Heart Rate
时间窗: 40 minutes
Number of participants from whom the required data were successfully collected
Collection of Maternal Pulse Rate
时间窗: 40 minutes
Number of participants from whom the required data were successfully collected
次要结局
- Incidence of Safety Events(40 Minutes)