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

Not Applicable

Completed

• Conditions: Foetal Wellbeing
• Interventions: Device: TMSi Porti; Device: Bloomlife sensor

• Registration Number: NCT03969433
• Lead Sponsor: Bloom Technologies

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-03-05
• Study First Submitted: 2019-05-28
• Study First Submitted QC: 2019-05-28
• Study First Posted: 2019-05-31
• Primary Completion: 2021-06-24
• Study Completion: 2021-07-01
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-10
• Last Update Posted: 2022-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 231

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Phase I	TMSi Porti	Data collections are performed with TMSi Porti system and CTG (reference)
Phases II-III-IV	Bloomlife sensor	Data collections are performed with the Bloomlife sensor and CTG (reference)

Primary Outcome Measures

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

Trial Locations

Locations (1)

Ziekenhuis Oost-Limburg; 🇧🇪 Genk, Limburg, Belgium