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

Completed · Not applicable

Conditions studied: Fetal Monitoring

In brief

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.

Key facts

Study ID

NCT04915131

Run by

Bloom Technologies

People needed

121

Starts

2021-04-06

Expected to finish

2022-05-05

Last updated by the study team

2023-10-18

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Valley Perinatal Services — Phoenix, Arizona, United States
• Ochsner — New Orleans, Louisiana, United States

Full record on ClinicalTrials.gov

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