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

Bloom Technologies

Status: Completed

Conditions: Fetal Monitoring

Treatments: Device: Bloomlife MFM-Pro

Study type: Interventional

Funder types: Industry

Identifiers

NCT04915131

NST-01-2021-US

Details and patient eligibility

About

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.

Full 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.

Enrollment: 121 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 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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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121 participants in 1 patient group

Bloomlife MFM-Pro

Other group

Treatment:

Device: Bloomlife MFM-Pro

Sponsor of this trial

Lead Sponsor

Bloom Technologies