A Clinical Study for Validating the Equivalence of Bloomlife MFM-Pro to Clinical Standard-of-care for Antepartum Fetal Monitoring
- Conditions
- Fetal Monitoring
- Interventions
- Device: Bloomlife MFM-Pro
- Registration Number
- NCT05060172
- Lead Sponsor
- Bloom Technologies
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 96
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Bloomlife MFM-Pro Bloomlife MFM-Pro -
- Primary Outcome Measures
Name Time Method 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
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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Ziekenhuis Oost-Limburg
🇧🇪Genk, Limburg, Belgium