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OpenTrials
Completed

NCT Number: NCT04915131

A Clinical Study for Validating the Equivalence of Bloomlife MFM-Pro to Clinical Standard-of-care for 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.

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Key information

Conditions

Fetal Monitoring

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Valley Perinatal Services, Phoenix, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bloomlife MFM-Pro

Device

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.

The system acquires biopotential signals from abdominal surface electrodes.

Primary outcomes

  1. Extent of Agreement Between Bloomlife MFM-Pro and CTG in Fetal Heart Rate

    Time frame: 5 minutes

  2. Extent of Agreement Between Bloomlife MFM-Pro and CTG in Maternal Heart Rate

    Time frame: 5 minutes

Sponsors and collaborators

Lead sponsor

Bloom Technologies

Industry

Registry information

Official study title

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

Acronym: NST

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 7, 2021
Registry last updated
Oct 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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