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
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Fetal Monitoring

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