Pregnancy
Conditions
Keywords
Pregnancy, Singleton
Brief summary
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.
Detailed description
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.
Interventions
DEVICEFetal Monitoring Device
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.
DEVICEInvestigational Fetal Monitoring Device
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.
Sponsors
GE Healthcare
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Pregnant women of ≥22 weeks gestation will undergo two 30-minute monitoring sessions (60 minutes total). One with currently approved Corometrics 259cx and one with the investigational device. During both monitoring sessions, maternal pulse rate will be monitored using SpO2 and the investigator shall be present to adjust the transducer placement as needed.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Able and willing to provide written informed consent. 2. Singleton pregnancy. 3. Aged 18+. 4. Greater than or equal to 22 0/7 weeks gestation. 5. Patient has none of the
Exclusion criteria
.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Success Rate Calculated Based on Collection of Fetal Heart Rate Data From Investigational Devices on Subjects Enrolled in Each Gestational Age Group | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Adverse Safety Events With Coro259 cx, FDA Approved Device | 30 minutes with FDA approved device over the course of 1 visit. | 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. |
| 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. | 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. |
| 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. | 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. |
| 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. | 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. |
| Number of Adverse Safety Events With Investigational Device | 30 minutes with investigational device over the course of 1 visit. | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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
Fetal Monitoring Device: 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.
Investigational Fetal Monitoring Device: 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. | 10 |
| 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.
Fetal Monitoring Device: 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.
Investigational Fetal Monitoring Device: 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. | 10 |
| 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.
Fetal Monitoring Device: 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.
Investigational Fetal Monitoring Device: 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. | 10 |
| Total | 30 |
Baseline characteristics
| Characteristic | Total | Group 3: Greater Than or Equal to 32 0/7 Weeks | Group 1: 22 0/7 - 24 6/7 Weeks | Group 2: 25 0/7 - 31 6/7 Weeks |
|---|---|---|---|---|
| Age, Continuous | 31.07 years STANDARD_DEVIATION 3.76 | 31.7 years STANDARD_DEVIATION 3.65 | 31.2 years STANDARD_DEVIATION 4.08 | 30.3 years STANDARD_DEVIATION 3.8 |
| BMI | 28.83 kg/m^2 STANDARD_DEVIATION 6.56 | 29.86 kg/m^2 STANDARD_DEVIATION 4.64 | 26.69 kg/m^2 STANDARD_DEVIATION 3.88 | 29.94 kg/m^2 STANDARD_DEVIATION 9.71 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 1 Participants | 1 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 26 Participants | 9 Participants | 9 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Height | 64.8 centimeters STANDARD_DEVIATION 2.61 | 64.5 centimeters STANDARD_DEVIATION 2.68 | 64.6 centimeters STANDARD_DEVIATION 1.96 | 65.3 centimeters STANDARD_DEVIATION 3.23 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 29 Participants | 10 Participants | 10 Participants | 9 Participants |
| Region of Enrollment United States | 30 participants | 10 participants | 10 participants | 10 participants |
| Sex: Female, Male Female | 30 Participants | 10 Participants | 10 Participants | 10 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Weight | 171.43 pounds STANDARD_DEVIATION 36.67 | 176.2 pounds STANDARD_DEVIATION 25.04 | 157.8 pounds STANDARD_DEVIATION 18.96 | 180.3 pounds STANDARD_DEVIATION 55.02 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 0 / 10 | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 | 0 / 10 |
Outcome results
Primary
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.
Population: The test was performed using two-sided 95% CI of the difference in Mean Success Rate (SR) for each gestational age group. Success rate is defined as percentage of time in which the device gave FHR reading during the study monitoring period.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Group 1: 22 0/7 - 24 6/7 Weeks | 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 | 1.23 percentage |
| Group 2: 25 0/7 - 31 6/7 Weeks | 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 | 3.20 percentage |
| Group 3: Greater Than or Equal to 32 0/7 Weeks | 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 | 5.82 percentage |
Primary
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.
Population: The test was performed using two-sided 95% CI of the difference in Mean Success Rate (SR) for each gestational age group. Success rate is defined as percentage of time in which the device gave FHR reading during the study monitoring period.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Group 1: 22 0/7 - 24 6/7 Weeks | Success Rate Calculated Based on Collection of Fetal Heart Rate Data From Coro 259cx Devices on Subjects Enrolled in Each Gestational Age Group | 83.77 percentage |
| Group 2: 25 0/7 - 31 6/7 Weeks | Success Rate Calculated Based on Collection of Fetal Heart Rate Data From Coro 259cx Devices on Subjects Enrolled in Each Gestational Age Group | 89.07 percentage |
| Group 3: Greater Than or Equal to 32 0/7 Weeks | Success Rate Calculated Based on Collection of Fetal Heart Rate Data From Coro 259cx Devices on Subjects Enrolled in Each Gestational Age Group | 92.62 percentage |
Primary
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.
Population: The test was performed using two-sided 95% CI of the difference in Mean Success Rate (SR) for each gestational age group. Success rate is defined as percentage of time in which the device gave FHR reading during the study monitoring period.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Group 1: 22 0/7 - 24 6/7 Weeks | Success Rate Calculated Based on Collection of Fetal Heart Rate Data From Investigational Devices on Subjects Enrolled in Each Gestational Age Group | 85.01 percentage |
| Group 2: 25 0/7 - 31 6/7 Weeks | Success Rate Calculated Based on Collection of Fetal Heart Rate Data From Investigational Devices on Subjects Enrolled in Each Gestational Age Group | 92.27 percentage |
| Group 3: Greater Than or Equal to 32 0/7 Weeks | Success Rate Calculated Based on Collection of Fetal Heart Rate Data From Investigational Devices on Subjects Enrolled in Each Gestational Age Group | 98.43 percentage |
Secondary
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.
Population: No AEs occurred during this study with the FDA approved device.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1: 22 0/7 - 24 6/7 Weeks | Number of Adverse Safety Events With Coro259 cx, FDA Approved Device | 0 safety events |
| Group 2: 25 0/7 - 31 6/7 Weeks | Number of Adverse Safety Events With Coro259 cx, FDA Approved Device | 0 safety events |
| Group 3: Greater Than or Equal to 32 0/7 Weeks | Number of Adverse Safety Events With Coro259 cx, FDA Approved Device | 0 safety events |
Secondary
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.
Population: No AEs occurred during this study with the investigational device.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1: 22 0/7 - 24 6/7 Weeks | Number of Adverse Safety Events With Investigational Device | 0 safety events |
| Group 2: 25 0/7 - 31 6/7 Weeks | Number of Adverse Safety Events With Investigational Device | 0 safety events |
| Group 3: Greater Than or Equal to 32 0/7 Weeks | Number of Adverse Safety Events With Investigational Device | 0 safety events |
Secondary
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.
Population: No subgroup analysis was performed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1: 22 0/7 - 24 6/7 Weeks | Number of Raw Datasets of Automated Fetal Movement Detection and Remote Event Marks Data Sets on Investigational Device | 10 data sets |
| Group 2: 25 0/7 - 31 6/7 Weeks | Number of Raw Datasets of Automated Fetal Movement Detection and Remote Event Marks Data Sets on Investigational Device | 10 data sets |
| Group 3: Greater Than or Equal to 32 0/7 Weeks | Number of Raw Datasets of Automated Fetal Movement Detection and Remote Event Marks Data Sets on Investigational Device | 10 data sets |
Secondary
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.
Time frame: 30 minutes with investigational device over the course of 1 visit.
Population: No subgroup analysis was performed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1: 22 0/7 - 24 6/7 Weeks | Number of Raw Datasets of the Presence of Fetal Heart Rate During Continuous Monitoring Data From Investigational Device | 10 data sets |
| Group 2: 25 0/7 - 31 6/7 Weeks | Number of Raw Datasets of the Presence of Fetal Heart Rate During Continuous Monitoring Data From Investigational Device | 10 data sets |
| Group 3: Greater Than or Equal to 32 0/7 Weeks | Number of Raw Datasets of the Presence of Fetal Heart Rate During Continuous Monitoring Data From Investigational Device | 10 data sets |
Secondary
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.
Population: No subgroup analysis was performed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1: 22 0/7 - 24 6/7 Weeks | The Number of Raw Datasets of Automated Fetal Movement Detection and Remote Event Marks Data Sets on Coro 259cx Device | 10 data sets |
| Group 2: 25 0/7 - 31 6/7 Weeks | The Number of Raw Datasets of Automated Fetal Movement Detection and Remote Event Marks Data Sets on Coro 259cx Device | 10 data sets |
| Group 3: Greater Than or Equal to 32 0/7 Weeks | The Number of Raw Datasets of Automated Fetal Movement Detection and Remote Event Marks Data Sets on Coro 259cx Device | 10 data sets |