CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 121 enrolled
Drug / intervention
Bloomlife MFM-Prodevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04915131
NCT04915131N/ACompleted
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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

Bloom Technologies·interventional·Posted Jun 7, 2021·Updated Oct 18, 2023

In Brief

A clinical study evaluating Bloomlife MFM-Pro for Fetal Monitoring. Completed, enrolled 121 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFetal Monitoring
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20222023202420252026
First PostedJun 7, 2021
Enrollment StartApr 6, 2021
Primary CompletionApr 28, 2022
Study CompletionMay 5, 2022
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 5.1 years ago

Interventions

Bloomlife MFM-Prodevice

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.