NCT04915131

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
121

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 6, 2021

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

April 10, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 7, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 28, 2022

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 5, 2022

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

October 18, 2023

Completed
Last Updated

October 18, 2023

Status Verified

September 1, 2023

Enrollment Period

1.1 years

First QC Date

April 10, 2021

Results QC Date

August 16, 2023

Last Update Submit

September 25, 2023

Conditions

Fetal Monitoring

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (1)

Bloomlife MFM-Pro

OTHER
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 and maternal heart rate on pregnant women with a singleton pregnancy. The system acquires biopotential signals from abdominal surface electrodes.

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 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Valley Perinatal Services

Phoenix, Arizona, 85004, United States

Location

Ochsner

New Orleans, Louisiana, 70115, United States

Location

Results Point of Contact

Title
Managing Director
Organization
Bloom Technologies NV
julien@bloomlife.com
+14156038067

Study Officials

  • Avinash Patil

    Valley Perinatal Services

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

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

April 10, 2021

First Posted

June 7, 2021

Study Start

April 6, 2021

Primary Completion

April 28, 2022

Study Completion

May 5, 2022

Last Updated

October 18, 2023

Results First Posted

October 18, 2023

Record last verified: 2023-09

Locations

US(2)