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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
30
Fetal monitoring device is a multi-parameter maternal fetal monitor that is intended to monitor, store, display, transmit, and generate alarms for non-invasive and invasive clinical parameters of pregnant women and fetuses (singleton and twin), during the antepartum, intrapartum, and postpartum period.
Fetal monitoring device is a multi-parameter maternal fetal monitor that is intended to monitor, store, display, transmit, and generate alarms for non-invasive and invasive clinical parameters of pregnant women and fetuses (singleton and twin), during the antepartum, intrapartum, and postpartum period.
Element Materials Technology
Louisville, Colorado, United States
Success Rate Calculated Based on Collection of Fetal Heart Rate Data From Investigational Devices on Subjects Enrolled in Each Gestational Age Group
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.
Time frame: 30 minutes with investigational device over the course of 1 visit.
Success Rate Calculated Based on Collection of Fetal Heart Rate Data From Coro 259cx Devices on Subjects Enrolled in Each Gestational Age Group
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.
Time frame: 30 minutes with Coro 259cx over the course of 1 visit.
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
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.
Time frame: 30 minutes with Coro 259cx and 30 minutes of investigational over the course of 1 visit.
Number of Raw Datasets of the Presence of Fetal Heart Rate During Continuous Monitoring Data From Investigational Device
Collection of the number of raw data sets of fetal heart rate data sets for each group for internal testing purposes. No additional analysis was performed outside the success rate described in primary outcome.
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Time frame: 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
The collection of the number of raw data sets of automated fetal movement detection and remote event marks data sets per subject during continuous fetal monitoring from the investigational device on enrolled subjects for device validation. No analysis was performed on this data and it was collected for future testing purposes.
Time frame: 30 minutes with investigational device over the course of 1 visit.
Number of Adverse Safety Events With Investigational Device
The collection of the number of adverse events, serious adverse events, and/or device deficiencies reported on all enrolled subjects in the study using the investigational device.
Time frame: 30 minutes with investigational device over the course of 1 visit.
Number of Adverse Safety Events With Coro259 cx, FDA Approved Device
The collection of the number of adverse events, serious adverse events, and/or device deficiencies reported on all enrolled subjects in the study using the FDA approved device.
Time frame: 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
The collection of the number of raw data sets of automated fetal movement detection and remote event marks data sets per subject during continuous fetal monitoring from the investigational device on enrolled subjects for device validation. No analysis was performed on this data and it was collected for future testing purposes.
Time frame: 30 minutes with Coro 259cx, FDA approved device over the course of 1 visit.