A Clinical Study for Validating the Equivalence of Bloomlife MFM-Pro to Clinical Standard-of-care for Performing 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 Fetal Heart Rate and Maternal Heart Rate When Performing Antepartum Fetal Monitoring

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.

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.

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