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

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.

Completed

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Key information

Conditions

Fetal Monitoring

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ziekenhuis Oost-Limburg

Genk, Limburg, 3600, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bloomlife MFM-Pro

Device

The system acquires biopotential signals from abdominal surface electrodes and measures the fetal electrocardiography, maternal electrocardiography, electrohysterography, as well as accelerometer data.

Primary outcomes

Extent of agreement between Bloomlife MFM-Pro and CTG in fetal heart rate

Time frame: 1 hour

Bland-Altman analysis, based on a 95% limits of agreement
Extent of agreement between Bloomlife MFM-Pro and CTG in maternal heart rate

Time frame: 1 hour

Bland-Altman analysis, based on a 95% limits of agreement

Sponsors and collaborators

Lead sponsor

Bloom Technologies

Industry

Registry information

Official study 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

Acronym: NST

Important dates

Study start: 2021
Primary completion: 2021
Study completion: 2021
First posted: Sep 29, 2021
Registry last updated: Jan 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed