Longitudinal Study for the Development of Innovative Wearable Tools for Foetal Wellbeing Monitoring

The purpose of this study is to support the development of a new generation of the Bloomlife sensor, enabling continuous monitoring of foetal wellbeing.

Data is collected in four Phases, with different experimental setups. Recordings with investigational and reference devices are performed on the subjects, at different gestational ages.

The collected data is used for developing algorithms for the extraction of parameters descriptive of foetal wellbeing.

Clinical information related to subjects' pregnancy and foetal health is also collected.

Study Overview

• Status: Completed
• Conditions: Foetal Wellbeing
• Intervention / Treatment: Device: TMSi Porti; Device: Bloomlife sensor

• Study Type: Interventional
• Enrollment (Actual): 231
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Limburg
    • Genk, Limburg, Belgium, 3600
      • Ziekenhuis Oost-Limburg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Pregnant
• Gestational age of at least 20 weeks
• Singleton pregnancy
• Willingness to participate in the study

Exclusion Criteria:

• Multiple pregnancy
• Implanted pacemaker or any other implanted electrical device
• History of allergies to silicone-based adhesives

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Phase I; Data collections are performed with TMSi Porti system and CTG (reference)	Device: TMSi Porti; Data collections
EXPERIMENTAL: Phases II-III-IV; Data collections are performed with the Bloomlife sensor and CTG (reference)	Device: Bloomlife sensor; Data collections

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy and reliability in the detection of foetal heart rate	Foetal heart rate is extracted from the collected electrophysiological data and compared to the reference	Throughout the subject's participation in the study, from inclusion until delivery
Accuracy and reliability in the detection of foetal movements	Foetal movements are detected from the collected sensor data and compared to the reference	Throughout the subject's participation in the study, from inclusion until delivery

Collaborators and Investigators

• Sponsor: Bloom Technologies

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 5, 2018
• Primary Completion (ACTUAL): June 24, 2021
• Study Completion (ACTUAL): July 1, 2021

Study Registration Dates

• First Submitted: May 28, 2019
• First Submitted That Met QC Criteria: May 28, 2019
• First Posted (ACTUAL): May 31, 2019

Study Record Updates

• Last Update Posted (ACTUAL): January 25, 2022
• Last Update Submitted That Met QC Criteria: January 10, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: BEATLE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No