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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05060172
• Other study ID #: NST-01-2020-EU
• Status: Completed
• Phase: N/A
• Start date: June 25, 2021
• Est. completion date: November 25, 2021

Study information

• Verified date: January 2022
• Source: Bloom Technologies
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Bloomlife has developed a wearable system (Bloomlife MFM-Pro) that can allow fetal monitoring to be conveniently performed in healthcare settings under supervision of a healthcare professional.

Bloomlife MFM-Pro is a non-invasive, wireless, external monitoring system used to measure fetal heart rate, maternal heart rate, and uterine activity during antepartum (non-stress) testing on pregnant women with a singleton pregnancy.

The purpose of this study is to validate that the Bloomlife MFM-Pro is equivalent to clinical standard-of-care for routine non-stress test (NST) performed at the hospital.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: November 25, 2021
• Est. primary completion date: November 9, 2021
• 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 Dutch or English

• 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

• Contraindication to the use of the 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, maternal heart rate, and uterine activity during antepartum (non-stress) testing on pregnant women with a singleton pregnancy. The system acquires biopotential signals from abdominal surface electrodes and measures the fetal electrocardiography, maternal electrocardiography, electrohysterography, as well as accelerometer data.

Locations

Country	Name	City	State
Belgium	Ziekenhuis Oost-Limburg	Genk	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Bloom Technologies

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Extent of agreement between Bloomlife MFM-Pro and CTG in fetal heart rate	Bland-Altman analysis, based on a 95% limits of agreement	1 hour
Primary	Extent of agreement between Bloomlife MFM-Pro and CTG in maternal heart rate	Bland-Altman analysis, based on a 95% limits of agreement	1 hour