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

Bloom Technologies

Status: Completed

Conditions: Fetal Monitoring

Treatments: Device: Bloomlife MFM-Pro

Study type: Interventional

Funder types: Industry

Identifiers

NCT05060172

NST-01-2020-EU

Details and patient eligibility

About

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.

Enrollment: 96 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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96 participants in 1 patient group

Bloomlife MFM-Pro

Experimental group

Treatment:

Device: Bloomlife MFM-Pro