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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05060172

Acronym

NST

Enrollment

Registered

2021-09-29

Start date

2021-06-25

Completion date

2021-11-25

Last updated

2022-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fetal Monitoring

Brief 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.

Interventions

DEVICEBloomlife 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026