NCT03969433

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
231

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 5, 2018

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

May 28, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 31, 2019

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 24, 2021

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

January 25, 2022

Status Verified

January 1, 2022

Enrollment Period

3.3 years

First QC Date

May 28, 2019

Last Update Submit

January 10, 2022

Conditions

Foetal Wellbeing

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (2)

Phase I

EXPERIMENTAL

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

Device: TMSi Porti

Phases II-III-IV

EXPERIMENTAL

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

Device: Bloomlife sensor

Interventions

TMSi PortiDEVICE

Data collections

Phase I
Bloomlife sensorDEVICE

Data collections

Phases II-III-IV

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pregnant
  • Gestational age of at least 20 weeks
  • Singleton pregnancy
  • Willingness to participate in the study

You may not qualify if:

  • Multiple pregnancy
  • Implanted pacemaker or any other implanted electrical device
  • History of allergies to silicone-based adhesives

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ziekenhuis Oost-Limburg

Genk, Limburg, 3600, Belgium

Location

Study Officials

  • Wilfried Gyselaers, MD, PhD

    Ziekenhuis Oost-Limburg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2019

First Posted

May 31, 2019

Study Start

March 5, 2018

Primary Completion

June 24, 2021

Study Completion

July 1, 2021

Last Updated

January 25, 2022

Record last verified: 2022-01

Locations

BE(1)