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Bloomlife has developed a wearable system (Bloomlife MFM-Pro) that can allow fetal monitoring to be conveniently performed in healthcare settings under supervision of a healthcare professional.
Bloomlife MFM-Pro is a non-invasive, wireless, external monitoring system used to measure fetal heart rate, maternal heart rate, and uterine activity during antepartum (non-stress) testing on pregnant women with a singleton pregnancy.
The purpose of this study is to validate that the Bloomlife MFM-Pro is equivalent to clinical standard-of-care for routine non-stress test (NST) performed at the hospital.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bloomlife MFM-Pro | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bloomlife MFM-Pro | Device | Bloomlife MFM-Pro is a non-invasive, wireless, external monitoring system used to measure fetal heart rate, maternal heart rate, and uterine activity during antepartum (non-stress) testing on pregnant women with a singleton pregnancy. The system acquires biopotential signals from abdominal surface electrodes and measures the fetal electrocardiography, maternal electrocardiography, electrohysterography, as well as accelerometer data. |
| Measure | Description | Time Frame |
|---|---|---|
| Extent of agreement between Bloomlife MFM-Pro and CTG in fetal heart rate | Bland-Altman analysis, based on a 95% limits of agreement | 1 hour |
| Extent of agreement between Bloomlife MFM-Pro and CTG in maternal heart rate | Bland-Altman analysis, based on a 95% limits of agreement | 1 hour |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wilfried Gyselaers | Ziekenhuis Oost-Limburg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ziekenhuis Oost-Limburg | Genk | Limburg | 3600 | Belgium |
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