Trial Outcomes & Findings for Maternal Fetal Device Performance Singleton (NCT NCT06726343)
NCT ID: NCT06726343
Last Updated: 2026-01-07
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
30 minutes with investigational device over the course of 1 visit.
Results posted on
2026-01-07
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Maternal Fetal Device Performance Singleton
Baseline characteristics by cohort
| Measure |
Group 1: 22 0/7 - 24 6/7 Weeks
n=10 Participants
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.
|
Group 2: 25 0/7 - 31 6/7 Weeks
n=10 Participants
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.
|
Group 3: Greater Than or Equal to 32 0/7 Weeks
n=10 Participants
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.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
31.2 years
STANDARD_DEVIATION 4.08 • n=37 Participants
|
30.3 years
STANDARD_DEVIATION 3.8 • n=56 Participants
|
31.7 years
STANDARD_DEVIATION 3.65 • n=95 Participants
|
31.07 years
STANDARD_DEVIATION 3.76 • n=61 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=37 Participants
|
10 Participants
n=56 Participants
|
10 Participants
n=95 Participants
|
30 Participants
n=61 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=61 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=37 Participants
|
2 Participants
n=56 Participants
|
1 Participants
n=95 Participants
|
4 Participants
n=61 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=37 Participants
|
8 Participants
n=56 Participants
|
9 Participants
n=95 Participants
|
26 Participants
n=61 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=61 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=61 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=61 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=61 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=37 Participants
|
1 Participants
n=56 Participants
|
0 Participants
n=95 Participants
|
1 Participants
n=61 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=37 Participants
|
9 Participants
n=56 Participants
|
10 Participants
n=95 Participants
|
29 Participants
n=61 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=61 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=61 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=37 Participants
|
10 participants
n=56 Participants
|
10 participants
n=95 Participants
|
30 participants
n=61 Participants
|
|
Height
|
64.6 centimeters
STANDARD_DEVIATION 1.96 • n=37 Participants
|
65.3 centimeters
STANDARD_DEVIATION 3.23 • n=56 Participants
|
64.5 centimeters
STANDARD_DEVIATION 2.68 • n=95 Participants
|
64.8 centimeters
STANDARD_DEVIATION 2.61 • n=61 Participants
|
|
Weight
|
157.8 pounds
STANDARD_DEVIATION 18.96 • n=37 Participants
|
180.3 pounds
STANDARD_DEVIATION 55.02 • n=56 Participants
|
176.2 pounds
STANDARD_DEVIATION 25.04 • n=95 Participants
|
171.43 pounds
STANDARD_DEVIATION 36.67 • n=61 Participants
|
|
BMI
|
26.69 kg/m^2
STANDARD_DEVIATION 3.88 • n=37 Participants
|
29.94 kg/m^2
STANDARD_DEVIATION 9.71 • n=56 Participants
|
29.86 kg/m^2
STANDARD_DEVIATION 4.64 • n=95 Participants
|
28.83 kg/m^2
STANDARD_DEVIATION 6.56 • n=61 Participants
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Group 1: 22 0/7 - 24 6/7 Weeks
n=10 Participants
Subjects with gestational ages between 22 weeks and 0/7 days and 24 weeks and 6/7 days.
|
Group 2: 25 0/7 - 31 6/7 Weeks
n=10 Participants
Subjects with gestational ages between 25 weeks and 0/7 days and 31 weeks and 6/7 days.
|
Group 3: Greater Than or Equal to 32 0/7 Weeks
n=10 Participants
Subjects with gestational age greater than 32 weeks and 0/7 days.
|
|---|---|---|---|
|
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
Interval 77.51 to 92.5
|
92.27 percentage
Interval 86.51 to 98.03
|
98.43 percentage
Interval 97.3 to 99.57
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Group 1: 22 0/7 - 24 6/7 Weeks
n=10 Participants
Subjects with gestational ages between 22 weeks and 0/7 days and 24 weeks and 6/7 days.
|
Group 2: 25 0/7 - 31 6/7 Weeks
n=10 Participants
Subjects with gestational ages between 25 weeks and 0/7 days and 31 weeks and 6/7 days.
|
Group 3: Greater Than or Equal to 32 0/7 Weeks
n=10 Participants
Subjects with gestational age greater than 32 weeks and 0/7 days.
|
|---|---|---|---|
|
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
Interval 74.41 to 93.13
|
89.07 percentage
Interval 77.06 to 100.0
|
92.62 percentage
Interval 88.27 to 96.96
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Group 1: 22 0/7 - 24 6/7 Weeks
n=10 Participants
Subjects with gestational ages between 22 weeks and 0/7 days and 24 weeks and 6/7 days.
|
Group 2: 25 0/7 - 31 6/7 Weeks
n=10 Participants
Subjects with gestational ages between 25 weeks and 0/7 days and 31 weeks and 6/7 days.
|
Group 3: Greater Than or Equal to 32 0/7 Weeks
n=10 Participants
Subjects with gestational age greater than 32 weeks and 0/7 days.
|
|---|---|---|---|
|
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
Interval -7.74 to 10.2
|
3.20 percentage
Interval -4.66 to 11.06
|
5.82 percentage
Interval 2.14 to 9.5
|
SECONDARY outcome
Timeframe: 30 minutes with investigational device over the course of 1 visit.Population: No subgroup analysis was performed.
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.
Outcome measures
| Measure |
Group 1: 22 0/7 - 24 6/7 Weeks
n=10 Participants
Subjects with gestational ages between 22 weeks and 0/7 days and 24 weeks and 6/7 days.
|
Group 2: 25 0/7 - 31 6/7 Weeks
n=10 Participants
Subjects with gestational ages between 25 weeks and 0/7 days and 31 weeks and 6/7 days.
|
Group 3: Greater Than or Equal to 32 0/7 Weeks
n=10 Participants
Subjects with gestational age greater than 32 weeks and 0/7 days.
|
|---|---|---|---|
|
Number of Raw Datasets of the Presence of Fetal Heart Rate During Continuous Monitoring Data From Investigational Device
|
10 data sets
|
10 data sets
|
10 data sets
|
SECONDARY outcome
Timeframe: 30 minutes with investigational device over the course of 1 visit.Population: No subgroup analysis was performed.
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.
Outcome measures
| Measure |
Group 1: 22 0/7 - 24 6/7 Weeks
n=10 Participants
Subjects with gestational ages between 22 weeks and 0/7 days and 24 weeks and 6/7 days.
|
Group 2: 25 0/7 - 31 6/7 Weeks
n=10 Participants
Subjects with gestational ages between 25 weeks and 0/7 days and 31 weeks and 6/7 days.
|
Group 3: Greater Than or Equal to 32 0/7 Weeks
n=10 Participants
Subjects with gestational age greater than 32 weeks and 0/7 days.
|
|---|---|---|---|
|
Number of Raw Datasets of Automated Fetal Movement Detection and Remote Event Marks Data Sets on Investigational Device
|
10 data sets
|
10 data sets
|
10 data sets
|
SECONDARY outcome
Timeframe: 30 minutes with investigational device over the course of 1 visit.Population: No AEs occurred during this study with the 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.
Outcome measures
| Measure |
Group 1: 22 0/7 - 24 6/7 Weeks
n=10 Participants
Subjects with gestational ages between 22 weeks and 0/7 days and 24 weeks and 6/7 days.
|
Group 2: 25 0/7 - 31 6/7 Weeks
n=10 Participants
Subjects with gestational ages between 25 weeks and 0/7 days and 31 weeks and 6/7 days.
|
Group 3: Greater Than or Equal to 32 0/7 Weeks
n=10 Participants
Subjects with gestational age greater than 32 weeks and 0/7 days.
|
|---|---|---|---|
|
Number of Adverse Safety Events With Investigational Device
|
0 safety events
|
0 safety events
|
0 safety events
|
SECONDARY outcome
Timeframe: 30 minutes with FDA approved device over the course of 1 visit.Population: No AEs occurred during this study with the 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.
Outcome measures
| Measure |
Group 1: 22 0/7 - 24 6/7 Weeks
n=10 Participants
Subjects with gestational ages between 22 weeks and 0/7 days and 24 weeks and 6/7 days.
|
Group 2: 25 0/7 - 31 6/7 Weeks
n=10 Participants
Subjects with gestational ages between 25 weeks and 0/7 days and 31 weeks and 6/7 days.
|
Group 3: Greater Than or Equal to 32 0/7 Weeks
n=10 Participants
Subjects with gestational age greater than 32 weeks and 0/7 days.
|
|---|---|---|---|
|
Number of Adverse Safety Events With Coro259 cx, FDA Approved Device
|
0 safety events
|
0 safety events
|
0 safety events
|
SECONDARY outcome
Timeframe: 30 minutes with Coro 259cx, FDA approved device over the course of 1 visit.Population: No subgroup analysis was performed.
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.
Outcome measures
| Measure |
Group 1: 22 0/7 - 24 6/7 Weeks
n=10 Participants
Subjects with gestational ages between 22 weeks and 0/7 days and 24 weeks and 6/7 days.
|
Group 2: 25 0/7 - 31 6/7 Weeks
n=10 Participants
Subjects with gestational ages between 25 weeks and 0/7 days and 31 weeks and 6/7 days.
|
Group 3: Greater Than or Equal to 32 0/7 Weeks
n=10 Participants
Subjects with gestational age greater than 32 weeks and 0/7 days.
|
|---|---|---|---|
|
The Number of Raw Datasets of Automated Fetal Movement Detection and Remote Event Marks Data Sets on Coro 259cx Device
|
10 data sets
|
10 data sets
|
10 data sets
|
Adverse Events
Group 1: 22 0/7 - 24 6/7 Weeks
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 2: 25 0/7 - 31 6/7 Weeks
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 3: Greater Than or Equal to 32 0/7 Weeks
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place