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OpenTrials
Completed

NCT Number: NCT03969433

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.

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Key information

Conditions

Foetal Wellbeing

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ziekenhuis Oost-Limburg

Genk, Limburg, 3600, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TMSi Porti

Device

Data collections

Bloomlife sensor

Device

Data collections

Primary outcomes

  1. Accuracy and reliability in the detection of foetal heart rate

    Time frame: 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

  2. Accuracy and reliability in the detection of foetal movements

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Bloom Technologies

Industry

Registry information

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
May 31, 2019
Registry last updated
Jan 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.