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

Measurement time + 7-day follow-up period

Bloomlife MFM-Pro is a safe, non-invasive device that measures standard physiological parameters. Risk assessment and management was performed in compliance with ISO 14791 standard. The anticipated adverse device effects involved with the use of the device include skin irritations and sensitization, which is considered a minor physical risks directly related to the use of Bloomlife MFM-Pro. The risk of mortality and serious adverse events is considered negligible.