NCT05060172

Brief Summary

Bloomlife has developed a wearable system (Bloomlife MFM-Pro) that can allow fetal monitoring to be conveniently performed in healthcare settings under supervision of a healthcare professional. Bloomlife MFM-Pro is a non-invasive, wireless, external monitoring system used to measure fetal heart rate, maternal heart rate, and uterine activity during antepartum (non-stress) testing on pregnant women with a singleton pregnancy. The purpose of this study is to validate that the Bloomlife MFM-Pro is equivalent to clinical standard-of-care for routine non-stress test (NST) performed at the hospital.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 31, 2021

Completed
25 days until next milestone

Study Start

First participant enrolled

June 25, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 29, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 9, 2021

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 25, 2021

Completed
Last Updated

January 25, 2022

Status Verified

January 1, 2022

Enrollment Period

5 months

First QC Date

May 31, 2021

Last Update Submit

January 10, 2022

Conditions

Fetal Monitoring

Outcome Measures

Primary Outcomes (2)

  • Extent of agreement between Bloomlife MFM-Pro and CTG in fetal heart rate

    Bland-Altman analysis, based on a 95% limits of agreement

    1 hour

  • Extent of agreement between Bloomlife MFM-Pro and CTG in maternal heart rate

    Bland-Altman analysis, based on a 95% limits of agreement

    1 hour

Study Arms (1)

Bloomlife MFM-Pro

EXPERIMENTAL
Device: Bloomlife MFM-Pro

Interventions

Bloomlife MFM-ProDEVICE

Bloomlife MFM-Pro is a non-invasive, wireless, external monitoring system used to measure fetal heart rate, maternal heart rate, and uterine activity during antepartum (non-stress) testing on pregnant women with a singleton pregnancy. The system acquires biopotential signals from abdominal surface electrodes and measures the fetal electrocardiography, maternal electrocardiography, electrohysterography, as well as accelerometer data.

Bloomlife MFM-Pro

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pregnant woman ≥ 18 years old
  • Gestational age ≥ 32 weeks and 0 days
  • Singleton pregnancy
  • Ability to read and understand Dutch or English
  • 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
  • Contraindication to the use of the CTG

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ziekenhuis Oost-Limburg

Genk, Limburg, 3600, Belgium

Location

Study Officials

  • Wilfried Gyselaers

    Ziekenhuis Oost-Limburg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 31, 2021

First Posted

September 29, 2021

Study Start

June 25, 2021

Primary Completion

November 9, 2021

Study Completion

November 25, 2021

Last Updated

January 25, 2022

Record last verified: 2022-01

Locations

BE(1)