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

Foetal Wellbeing Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03969433
• Other study ID #: BEATLE
• Status: Completed
• Phase: N/A
• Start date: March 5, 2018
• Est. completion date: July 1, 2021

Study information

• Verified date: January 2022
• Source: Bloom Technologies
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 231
• Est. completion date: July 1, 2021
• Est. primary completion date: June 24, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Foetal Wellbeing

Intervention

Device:
• TMSi Porti
Data collections
• Bloomlife sensor
Data collections

Locations

Country	Name	City	State
Belgium	Ziekenhuis Oost-Limburg	Genk	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Bloom Technologies

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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