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A Clinical Study for Validating the Equivalence of Bloomlife MFM-Pro to Clinical Standard-of-care for Performing Antepartum Fetal Monitoring — NST  

Fetal Monitoring Clinical Trial

Official title:
A Cross-sectional, Interventional, Single-arm Clinical Study for Validating the Equivalence of Bloomlife MFM-Pro to Clinical Standard-of-care for Fetal Heart Rate and Maternal Heart Rate When Performing Antepartum Fetal Monitoring

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04915131
Study type Interventional
Source Bloom Technologies
Contact
Status Completed
Phase N/A
Start date April 6, 2021
Completion date May 5, 2022
View Details
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