Pregnancy
Conditions
Keywords
antenatal monitoring, fetal monitoring
Brief summary
The objective of this study is to demonstrate the safety and performance of the M•care™ System for use in antenatal monitoring of pregnant women ≥ 32 weeks' gestation.
Interventions
DEVICEM•care™ System
The M•care™ System will be applied for monitoring of fetal heart rate (FHR), maternal heart rate (MHR) and uterine activity (UA)
DEVICECardiotocography (CTG)
A standard of care CTG device will be applied for monitoring of fetal heart rate (FHR), maternal heart rate (MHR) and uterine activity (UA)
Sponsors
Marani Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Able to provide informed consent and follow study instructions * 18 years of age or older * Pregnant subjects ≥ 32 weeks' gestation * Singleton pregnancy * BMI ≥15, pre-pregnancy * BMI ≤45, pre-pregnancy * Belly circumference ≥80 cm and ≤ 130 cm
Exclusion criteria
* Known major fetal malformation or chromosome abnormality * Abdominal medical skin conditions, including surgical incisions, open wounds with our without infections, edema, or irritation * Participants with implanted electronic devices (pacemakers, defibrillator, etc.) * 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 the investigator's opinion would make the participant incapable of taking part in the study * In the investigator's opinion, the participant is not likely to be available for the minimum 60 minutes of the monitoring session * History of skin allergies to cosmetics and lotions * Known allergies to silver, nylon, or polyester
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fetal Heart Rate (FHR) | Up to 120 minutes | FHR as measured by the M•care System versus standard of care CTG device |
| Maternal Heart Rate (MHR) | Up to 120 minutes | MHR as measured by the M•care System versus standard of care CTG device |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Uterine Contractions (UC) | Up to 120 minutes | UC sensitivity as measured by the M•care System versus standard of care CTG device, where sensitivity is defined as the proportion of UC events identified by standard of care that are simultaneously identified by the M•care System (positive agreement). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| M•Care™ System + CTG The M•care System and standard of care CTG (cardiotocography) will be applied for fetal and maternal monitoring
M•care™ System: The M•care™ System will be applied for monitoring of fetal heart rate (FHR), maternal heart rate (MHR) and uterine activity (UA)
Cardiotocography (CTG): A standard of care CTG device will be applied for monitoring of fetal heart rate (FHR), maternal heart rate (MHR) and uterine activity (UA) | 80 |
| Total | 80 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Did not complete 5-minute monitoring session | 15 |
| Overall Study | Did not have ≥ 1 minute of concurrent data | 19 |
| Overall Study | Physician Decision | 2 |
| Overall Study | Progressed to active labor | 1 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | M•Care™ System + CTG |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 80 Participants |
| Age, Continuous | 31.7 years STANDARD_DEVIATION 4.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 72 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants |
| Race (NIH/OMB) Asian | 4 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 7 Participants |
| Race (NIH/OMB) White | 62 Participants |
| Region of Enrollment United States | 80 participants |
| Sex: Female, Male Female | 80 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 120 |
| other Total, other adverse events | 1 / 120 |
| serious Total, serious adverse events | 0 / 120 |
Outcome results
Primary
Fetal Heart Rate (FHR)
FHR as measured by the M•care System versus standard of care CTG device
Time frame: Up to 120 minutes
Population: The performance evaluable population was defined as the population of subjects who had at least one minute of concurrent data collection with both devices (M•care and CTG) and did not have any major protocol violations. Of the 80 subjects in the performance evaluable population, no FHR data are available for one subject.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| M•Care™ System | Fetal Heart Rate (FHR) | 140.1 BPM | Standard Deviation 11.4 |
| Cardiotocography (CTG) | Fetal Heart Rate (FHR) | 140.0 BPM | Standard Deviation 10.7 |
Primary
Maternal Heart Rate (MHR)
MHR as measured by the M•care System versus standard of care CTG device
Time frame: Up to 120 minutes
Population: The performance evaluable population was defined as the population of subjects who had at least one minute of concurrent data collection with both devices (M•care and CTG) and did not have any major protocol violations. Of the 80 subjects in the performance evaluable population, no MHR data are available for one subject.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| M•Care™ System | Maternal Heart Rate (MHR) | 83.4 BPM | Standard Deviation 12 |
| Cardiotocography (CTG) | Maternal Heart Rate (MHR) | 83.1 BPM | Standard Deviation 12.1 |
Secondary
Uterine Contractions (UC)
UC sensitivity as measured by the M•care System versus standard of care CTG device, where sensitivity is defined as the proportion of UC events identified by standard of care that are simultaneously identified by the M•care System (positive agreement).
Time frame: Up to 120 minutes
Population: Of the 80 subjects in the performance evaluable population, no uterine contraction (UC) data are available for two subjects.~To compare sensitivity (positive agreement) in UC events between M•care and standard of care, bootstrap resampling techniques were used to account for the correlation among repeated UC measurements within subjects. Results for the M•care System and CTG are combined due to the outcome measure of UC sensitivity (positive agreement).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| M•Care™ System | Uterine Contractions (UC) | 0.57 proportion of true positives |