Pregnancy
Conditions
Keywords
Fetal monitoring, Prenatal monitoring
Brief summary
This clinical study will evaluate the safety of PregSense™ and Comparative Performance of PregSense™ versus CTG in Prenatal Monitoring of Pregnant subjects.
Detailed description
PregSense™ is a maternal-fetal monitor that non-invasively measures and displays fetal heart rate, maternal hear rate and uterine contractions. This study will be performed to collect and digitally record data from PregSense™ and the standard of care (CTG) in order to provide evidence of safety and agreement between PregSense™ and the gold standard NST device.
Interventions
DEVICEPregSense™
PregSense™ wearable device will be applied for maternal-fetal monitoring
DEVICECardiotocopraphy (CTG)
Cardiotocopraphy (CTG) will be applied for maternal-fetal monitoring
Sponsors
Nuvo-Group, Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Open Label
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Female age between 18-50 * Gestational age \> 32 + 0 weeks * Singleton gestation * Ability to understand and sign informed consent
Exclusion criteria
* BMI (Body Mass Index) ≥ 45 and ≤15 prior pregnancy * Multiple gestation * Uncontrolled Hypertension * Fetal Anomaly * Subjects with skin problems in the abdominal area (such as flesh wounds, cuts in the skin, skin rashes, etc.) * Subjects with implanted electronic devices (pacemaker, defibrillator, etc.) * Subjects who, in the judgement of the investigator, are likely to be non-compliant or uncooperative during the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fetal Heart Rate | 30 Minutes | Provide evidence of safety and FHR agreement between PregSense™ and the standard of care devices (i.e. CTG) |
| Maternal Heart Rate | 30 MInutes | Provide evidence of safety and agreement between MHR collected via the PregSense™ and the standard of care devices (i.e. CTG) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Uterine Contractions | 30 Minutes | Compare uterine contractions from Pregsense™ versus CTG. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Safety Measures | Through study completion, an average of 1 hour | Evaluate device related adverse events |
Countries
Germany, Israel, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PregSense™ PregSense™ wearable device and the standard of care CTG (cardiotocography) will be applied for maternal-fetal monitoring
PregSense™: PregSense™ wearable device will be applied for maternal-fetal monitoring
Cardiotocopraphy (CTG): Cardiotocopraphy (CTG) will be applied for maternal-fetal monitoring | 147 |
| Total | 147 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Device Failure | 2 |
| Overall Study | Screening Failure | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | PregSense™ |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 147 Participants |
| Age, Continuous | 31.8 years STANDARD_DEVIATION 6.89 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 140 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Region of Enrollment Germany | 31 Participants |
| Region of Enrollment Israel | 49 Participants |
| Region of Enrollment United States | 69 Participants |
| Sex: Female, Male Female | 147 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 147 |
| other Total, other adverse events | 0 / 147 |
| serious Total, serious adverse events | 0 / 147 |
Outcome results
Primary
Fetal Heart Rate
Provide evidence of safety and FHR agreement between PregSense™ and the standard of care devices (i.e. CTG)
Time frame: 30 Minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PregSense™ and Cardiotocopraphy (CTG) | Fetal Heart Rate | 140.3 bpm | Standard Deviation 11.9 |
| Cardiotocopraphy (CTG) | Fetal Heart Rate | 140.4 bpm | Standard Deviation 11.65 |
Primary
Maternal Heart Rate
Provide evidence of safety and agreement between MHR collected via the PregSense™ and the standard of care devices (i.e. CTG)
Time frame: 30 MInutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PregSense™ and Cardiotocopraphy (CTG) | Maternal Heart Rate | 89.3 bpm | Standard Deviation 12.54 |
| Cardiotocopraphy (CTG) | Maternal Heart Rate | 89.1 bpm | Standard Deviation 12.5 |
Secondary
Uterine Contractions
Compare uterine contractions from Pregsense™ versus CTG.
Time frame: 30 Minutes
Population: Uterine Contraction information was eventually not collected AT ALL, therefore no population to describe.
Other Pre-specified
Safety Measures
Evaluate device related adverse events
Time frame: Through study completion, an average of 1 hour
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PregSense™ and Cardiotocopraphy (CTG) | Safety Measures | 0 Participants |