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

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

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.

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