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

Bloom Technologies

Status: Completed

Conditions: Foetal Wellbeing

Treatments: Device: TMSi Porti; Device: Bloomlife sensor

Study type: Interventional

Funder types: Industry

Identifiers

NCT03969433

BEATLE

Details and patient eligibility

About

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.

Enrollment: 231 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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231 participants in 2 patient groups

Phase I

Experimental group

Description:

Data collections are performed with TMSi Porti system and CTG (reference)

Treatment:

Device: TMSi Porti

Phases II-III-IV

Experimental group

Description:

Data collections are performed with the Bloomlife sensor and CTG (reference)

Treatment:

Device: Bloomlife sensor