NCT03982654

Brief Summary

The purpose of the study is to collect data to support the development and validation of a machine learning model for the automatic detection, prediction and monitoring of labour, through the use of a wearable sensor (Bloomlife sensor) that can be easily used at home. Women participating in the study will be asked to regularly record data with the Bloomlife sensor, from inclusion in the study until delivery. In addition, clinical information related to their pregnancy and delivery will be collected.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
145

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

2 active sites

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 30, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 26, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 5, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 20, 2019

Completed
22 days until next milestone

First Posted

Study publicly available on registry

June 11, 2019

Completed
Last Updated

June 11, 2019

Status Verified

June 1, 2019

Enrollment Period

8 months

First QC Date

May 20, 2019

Last Update Submit

June 10, 2019

Conditions

Labour Onset

Outcome Measures

Primary Outcomes (1)

  • Accuracy

    Accuracy of the machine learning model for the automatic detection of labor, measured in terms of sensitivity and specificity in detecting labour

    At delivery

Secondary Outcomes (1)

  • Labour probability

    At delivery

Study Arms (1)

Bloomlife

EXPERIMENTAL
Device: Bloomlife

Interventions

BloomlifeDEVICE

Women use the Bloomlife sensor to collect data throughout their pregnancy. The collected data is stored locally in the device, but it is not used to provide any feedback to the patients or to the clinical team. Therefore the use of the device doesn't have an impact on clinical decision making and patients' care.

Bloomlife

Eligibility Criteria

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

You may qualify if:

  • Pregnant
  • Gestational age between 20 weeks and 0 days and 30 weeks and 0 days
  • Willingness to participate in the study

You may not qualify if:

  • Implanted pacemaker or any other implanted electrical device
  • History of allergies to silicone-based adhesives
  • Any health condition resulting in higher chance of C-section (meeting one of these criteria is sufficient to be excluded): previous history of C-section, placental abnormality, being primipara and older than 40

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ziekenhuis Oost-Limburg

Genk, 3600, Belgium

Location

CHR de la Citadelle

Liège, 4000, Belgium

Location

Study Officials

  • Wilfried Gyselaers, MD, PhD

    Ziekenhuis Oost-Limburg

    PRINCIPAL INVESTIGATOR

  • Frederic Chantraine, MD, PhD

    CHR de la Citadelle

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 20, 2019

First Posted

June 11, 2019

Study Start

March 30, 2018

Primary Completion

November 26, 2018

Study Completion

March 5, 2019

Last Updated

June 11, 2019

Record last verified: 2019-06

Locations

BE(2)