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NCT04915131 Clinical Trial

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

Fetal Monitoring Clinical Trial

— NST  

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 Details — Status: Completed

Administrative data
NCT number NCT04915131
Other study ID # NST-01-2021-US
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 6, 2021
Est. completion date May 5, 2022

Study information
Verified date September 2023
Source Bloom Technologies
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 121
Est. completion date May 5, 2022
Est. primary completion date April 28, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Bloomlife 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.

Locations
Country Name City State
United States Ochsner New Orleans Louisiana
United States Valley Perinatal Services Phoenix Arizona

Sponsors (1)
Lead Sponsor Collaborator
Bloom Technologies

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Extent of Agreement Between Bloomlife MFM-Pro and CTG in Fetal Heart Rate 5 minutes
Primary Extent of Agreement Between Bloomlife MFM-Pro and CTG in Maternal Heart Rate 5 minutes
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