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

NCT03969433 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 231

Last updated 2022-01-25

No results posted yet for this study

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.

Conditions

  • Foetal Wellbeing

Interventions

DEVICE

TMSi Porti

Data collections

DEVICE

Bloomlife sensor

Data collections

Sponsors & Collaborators

  • Bloom Technologies

    lead INDUSTRY

Principal Investigators

  • Wilfried Gyselaers, MD, PhD · Ziekenhuis Oost-Limburg

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-03-05
Primary Completion
2021-06-24
Completion
2021-07-01

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03969433 on ClinicalTrials.gov