Fetal Monitoring
Conditions
Brief summary
Bloomlife MFM-Pro is a non-invasive, wireless, external monitoring system used to measure fetal heart rate and maternal heart rate on pregnant women with a singleton pregnancy, starting from 32 weeks of gestation. The purpose of this study is to validate that the Bloomlife MFM-Pro is equivalent to clinical standard-of-care for fetal heart rate and maternal heart rate when performing antepartum fetal monitoring.
Detailed description
The study consisted of 2 phases: a pilot phase and a pivotal phase. The pilot phase of the study was aimed at testing the Bloomlife MFM-Pro device prior to validation in the pivotal phase of the study. The pivotal phase of the study was aimed at validating that the Bloomlife MFM-Pro is equivalent to clinical standard-of-care for fetal heart rate and maternal heart rate when performing antepartum fetal monitoring.
Interventions
DEVICEBloomlife MFM-Pro
Bloomlife MFM-Pro is a non-invasive, wireless, external monitoring system used to measure fetal heart rate and maternal heart rate on pregnant women with a singleton pregnancy. The system acquires biopotential signals from abdominal surface electrodes.
Sponsors
Bloom Technologies
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
Yes
Inclusion criteria
* Pregnant woman ≥ 18 years old * Gestational age ≥ 32 weeks and 0 days * Singleton pregnancy * Ability to read and understand English or Spanish * Willingness to participate in the study
Exclusion criteria
* Implanted pacemaker or any other implanted electrical device * Plurality higher than 1 * History of allergies to skin adhesives * Irritated or lesioned skin at the Bloomlife MFM-Pro electrodes locations * Contraindication to the use of CTG
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Extent of Agreement Between Bloomlife MFM-Pro and CTG in Fetal Heart Rate | 5 minutes |
| Extent of Agreement Between Bloomlife MFM-Pro and CTG in Maternal Heart Rate | 5 minutes |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bloomlife MFM-Pro, Pilot Phase The pilot phase of the study was aimed at testing the Bloomlife MFM-Pro device prior to validation in the pivotal phase of the study. | 60 |
| Bloomlife MFM-Pro, Pivotal Phase The pivotal phase of the study was aimed at validating that the Bloomlife MFM-Pro is equivalent to clinical standard-of-care for fetal heart rate and maternal heart rate when performing antepartum fetal monitoring. | 61 |
| Total | 121 |
Baseline characteristics
| Characteristic | Total | Bloomlife MFM-Pro, Pivotal Phase | Bloomlife MFM-Pro, Pilot Phase |
|---|---|---|---|
| Age, Continuous | 30.1 years STANDARD_DEVIATION 6.01 | 30.4 years STANDARD_DEVIATION 5.69 | 29.9 years STANDARD_DEVIATION 6.31 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 43 Participants | 19 Participants | 24 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 76 Participants | 40 Participants | 36 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 2 Participants | 0 Participants |
| Gestational Age | 35.65 weeks STANDARD_DEVIATION 2.04 | 35.51 weeks STANDARD_DEVIATION 2.102 | 35.8 weeks STANDARD_DEVIATION 1.96 |
| Pre-pregnancy Body Mass Index (BMI) | 31.96 kg/m^2 STANDARD_DEVIATION 7.89 | 33.19 kg/m^2 STANDARD_DEVIATION 7.776 | 30.7 kg/m^2 STANDARD_DEVIATION 7.81 |
| Race (NIH/OMB) American Indian or Alaska Native | 4 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 6 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 26 Participants | 13 Participants | 13 Participants |
| Race (NIH/OMB) More than one race | 18 Participants | 10 Participants | 8 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 3 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) White | 61 Participants | 30 Participants | 31 Participants |
| Sex: Female, Male Female | 121 Participants | 61 Participants | 60 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 60 | 0 / 61 |
| other Total, other adverse events | 1 / 60 | 1 / 61 |
| serious Total, serious adverse events | 0 / 60 | 0 / 61 |
Outcome results
Primary
Extent of Agreement Between Bloomlife MFM-Pro and CTG in Fetal Heart Rate
Time frame: 5 minutes
Population: The Analysis Population includes all enrolled patients without major protocol deviations or technical failure
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Bloomlife MFM-Pro, Pilot Phase | Extent of Agreement Between Bloomlife MFM-Pro and CTG in Fetal Heart Rate | Lower Limit of Agreement | -5.46 BPM |
| Bloomlife MFM-Pro, Pilot Phase | Extent of Agreement Between Bloomlife MFM-Pro and CTG in Fetal Heart Rate | Upper Limit of Agreement | 6.04 BPM |
| Bloomlife MFM-Pro, Pivotal Phase | Extent of Agreement Between Bloomlife MFM-Pro and CTG in Fetal Heart Rate | Lower Limit of Agreement | -5.57 BPM |
| Bloomlife MFM-Pro, Pivotal Phase | Extent of Agreement Between Bloomlife MFM-Pro and CTG in Fetal Heart Rate | Upper Limit of Agreement | 6.04 BPM |
Primary
Extent of Agreement Between Bloomlife MFM-Pro and CTG in Maternal Heart Rate
Time frame: 5 minutes
Population: Analysis Population includes all enrolled patients without major protocol deviation or technical failure.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Bloomlife MFM-Pro, Pilot Phase | Extent of Agreement Between Bloomlife MFM-Pro and CTG in Maternal Heart Rate | Lower Limit of Agreement | -2.27 BPM |
| Bloomlife MFM-Pro, Pilot Phase | Extent of Agreement Between Bloomlife MFM-Pro and CTG in Maternal Heart Rate | Upper Limit of Agreement | 3.56 BPM |
| Bloomlife MFM-Pro, Pivotal Phase | Extent of Agreement Between Bloomlife MFM-Pro and CTG in Maternal Heart Rate | Lower Limit of Agreement | -1.84 BPM |
| Bloomlife MFM-Pro, Pivotal Phase | Extent of Agreement Between Bloomlife MFM-Pro and CTG in Maternal Heart Rate | Upper Limit of Agreement | 2.67 BPM |