A Clinical Study for Validating the Equivalence of Bloomlife MFM-Pro to Clinical Standard-of-care for Antepartum Fetal Monitoring
NCT ID: NCT05060172
Last Updated: 2022-01-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
96 participants
INTERVENTIONAL
2021-06-25
2021-11-25
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Bloomlife MFM-Pro
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Plurality higher than 1
* History of allergies to skin adhesives
* Contraindication to the use of the CTG
18 Years
FEMALE
Yes
Sponsors
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Bloom Technologies
INDUSTRY
Responsible Party
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Principal Investigators
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Wilfried Gyselaers
Role: PRINCIPAL_INVESTIGATOR
Ziekenhuis Oost-Limburg
Locations
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Ziekenhuis Oost-Limburg
Genk, Limburg, Belgium
Countries
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Other Identifiers
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NST-01-2020-EU
Identifier Type: -
Identifier Source: org_study_id
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