Maternal Fetal Device Performance Testing During Antepartum Singleton Monitoring
概览
- 阶段
- 不适用
- 干预措施
- Investigational Fetal Monitoring Device
- 疾病 / 适应症
- Pregnancy
- 发起方
- GE Healthcare
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Success Rate Calculated Based on Collection of Fetal Heart Rate Data From Investigational Devices on Subjects Enrolled in Each Gestational Age Group
- 状态
- 已完成
- 最后更新
- 3个月前
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 supports the decision making for pregnant women and the overall fetal health status during pregnancy and delivery. This study aims to support a new maternal fetal monitoring device with clinical data to demonstrate the equivalent performance against the currently marketed Corometrics 259cx. The fetal heart rate and will be collected during antenatal monitoring using standard of care Doppler ultrasound.
详细描述
This study aims to compare a maternal fetal monitoring device to the currently marketed Corometrics 259cx. Fetal heart rate and Fetal Movement Detection data will be collected during antenatal monitoring using standard of care Doppler Ultrasound transducers. The new Maternal/Fetal Monitor is capable of monitoring heart rates (maternal/ fetal), maternal uterine contractions, as well as maternal blood pressure and maternal pulse oximetry. This study will compare clinical data between the current and the new monitor on non-laboring singleton gestation women. Funding for this study will be provided by GE HealthCare. This study does not include patient advisors.
研究者
入排标准
入选标准
- •Able and willing to provide written informed consent.
- •Singleton pregnancy.
- •Greater than or equal to 22 0/7 weeks gestation.
- •Patient has none of the
排除标准
- •Exclusion Criteria:
- •Multiple 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
Group 3: Greater than or equal to 32 0/7 Weeks
All subjects will undergo the same interventions as part of the study procedures but will be divided into groups based on gestational age groups. Each study subject will undergo two 30-minute monitoring sessions (60 minutes total). One with FDA approved device and one with the investigational device. During both monitoring sessions, maternal pulse rate (MPR) will be monitored using SpO2 and the investigator shall be present to adjust the transducer placement as needed.
干预措施: Investigational Fetal Monitoring Device
Group 1: 22 0/7 - 24 6/7 Weeks
All subjects will undergo the same interventions as part of the study procedures but will be divided into groups based on gestational age groups. Each study subject will undergo two 30-minute monitoring sessions (60 minutes total). One with FDA approved device and one with the investigational device. During both monitoring sessions, maternal pulse rate (MPR) will be monitored using SpO2 and the investigator shall be present to adjust the transducer placement as needed
干预措施: Fetal Monitoring Device
Group 1: 22 0/7 - 24 6/7 Weeks
All subjects will undergo the same interventions as part of the study procedures but will be divided into groups based on gestational age groups. Each study subject will undergo two 30-minute monitoring sessions (60 minutes total). One with FDA approved device and one with the investigational device. During both monitoring sessions, maternal pulse rate (MPR) will be monitored using SpO2 and the investigator shall be present to adjust the transducer placement as needed
干预措施: Investigational Fetal Monitoring Device
Group 2: 25 0/7 - 31 6/7 Weeks
All subjects will undergo the same interventions as part of the study procedures but will be divided into groups based on gestational age groups. Each study subject will undergo two 30-minute monitoring sessions (60 minutes total). One with FDA approved device and one with the investigational device. During both monitoring sessions, maternal pulse rate (MPR) will be monitored using SpO2 and the investigator shall be present to adjust the transducer placement as needed.
干预措施: Fetal Monitoring Device
Group 2: 25 0/7 - 31 6/7 Weeks
All subjects will undergo the same interventions as part of the study procedures but will be divided into groups based on gestational age groups. Each study subject will undergo two 30-minute monitoring sessions (60 minutes total). One with FDA approved device and one with the investigational device. During both monitoring sessions, maternal pulse rate (MPR) will be monitored using SpO2 and the investigator shall be present to adjust the transducer placement as needed.
干预措施: Investigational Fetal Monitoring Device
Group 3: Greater than or equal to 32 0/7 Weeks
All subjects will undergo the same interventions as part of the study procedures but will be divided into groups based on gestational age groups. Each study subject will undergo two 30-minute monitoring sessions (60 minutes total). One with FDA approved device and one with the investigational device. During both monitoring sessions, maternal pulse rate (MPR) will be monitored using SpO2 and the investigator shall be present to adjust the transducer placement as needed.
干预措施: Fetal Monitoring Device
结局指标
主要结局
Success Rate Calculated Based on Collection of Fetal Heart Rate Data From Investigational Devices on Subjects Enrolled in Each Gestational Age Group
时间窗: 30 minutes with investigational device over the course of 1 visit.
Collection of the presence of fetal heart rate rhythm data from the investigational device on subjects enrolled in each gestational age group to evaluate non-Inferiority in terms success rate which was defined as percentage of time in which the device gave FHR reading during the study monitoring period.
Success Rate Calculated Based on Collection of Fetal Heart Rate Data From Coro 259cx Devices on Subjects Enrolled in Each Gestational Age Group
时间窗: 30 minutes with Coro 259cx over the course of 1 visit.
Collection of the presence of fetal heart rate rhythm data from the Coro 259cx device on subjects enrolled in each gestational age group to evaluate non-Inferiority in terms success rate which was defined as percentage of time in which the device gave FHR reading during the study monitoring period.
Difference in Success Rate Calculated Based on Collection of Fetal Heart Rate Data From Investigational and Coro 259cx Devices on Subjects Enrolled in Each Gestational Age Group
时间窗: 30 minutes with Coro 259cx and 30 minutes of investigational over the course of 1 visit.
Collection of the difference in the presence of fetal heart rate rhythm data sets from the Investigational and Coro 259cx devices on subjects enrolled in each gestational age group to evaluate non-Inferiority in terms success rate which was defined as percentage of time in which the device gave fetal heart rate reading during the study monitoring period. Difference in success rate was calculated as investigation minus Coro 259cx.
次要结局
- Number of Raw Datasets of the Presence of Fetal Heart Rate During Continuous Monitoring Data From Investigational Device(30 minutes with investigational device over the course of 1 visit.)
- Number of Raw Datasets of Automated Fetal Movement Detection and Remote Event Marks Data Sets on Investigational Device(30 minutes with investigational device over the course of 1 visit.)
- Number of Adverse Safety Events With Investigational Device(30 minutes with investigational device over the course of 1 visit.)
- Number of Adverse Safety Events With Coro259 cx, FDA Approved Device(30 minutes with FDA approved device over the course of 1 visit.)
- The Number of Raw Datasets of Automated Fetal Movement Detection and Remote Event Marks Data Sets on Coro 259cx Device(30 minutes with Coro 259cx, FDA approved device over the course of 1 visit.)