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

Not Applicable

Completed

• Conditions: Fetal Monitoring
• Interventions: Device: Bloomlife MFM-Pro

• Registration Number: NCT04915131
• Lead Sponsor: Bloom Technologies

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2021-04-06
• Study First Submitted: 2021-04-10
• Study First Submitted QC: 2021-05-31
• Study First Posted: 2021-06-07
• Primary Completion: 2022-04-28
• Study Completion: 2022-05-05
• Results First Submitted: 2023-08-16
• Status Verified: 2023-09
• Results First Submitted QC: 2023-09-25
• Last Update Submitted: 2023-09-25
• Results First Posted: 2023-10-18
• Last Update Posted: 2023-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 121

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bloomlife MFM-Pro	Bloomlife MFM-Pro	-

Primary Outcome Measures

Name	Time	Method
Extent of Agreement Between Bloomlife MFM-Pro and CTG in Fetal Heart Rate	5 minutes
Extent of Agreement Between Bloomlife MFM-Pro and CTG in Maternal Heart Rate	5 minutes

Trial Locations

Locations (2)

Valley Perinatal Services; 🇺🇸 Phoenix, Arizona, United States

Ochsner; 🇺🇸 New Orleans, Louisiana, United States