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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
121
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.
Valley Perinatal Services
Phoenix, Arizona, United States
Ochsner
New Orleans, Louisiana, United States
Extent of Agreement Between Bloomlife MFM-Pro and CTG in Fetal Heart Rate
Time frame: 5 minutes
Extent of Agreement Between Bloomlife MFM-Pro and CTG in Maternal Heart Rate
Time frame: 5 minutes
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