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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Fetal Monitoring
- Sponsor
- Bloom Technologies
- Enrollment
- 96
- Locations
- 1
- Primary Endpoint
- Extent of agreement between Bloomlife MFM-Pro and CTG in maternal heart rate
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
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
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