Investigating the Physiology of Labour and Labour Onset Through Longitudinal Measurements Performed With a Wearable Sensor

Investigating the Physiology of Labour, Labour Onset and Pregnancy Outcomes in Pregnant Women, Through Longitudinal Measurements Performed With a Wearable Sensor

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.

Study Overview

• Status: Completed
• Conditions: Labour Onset
• Intervention / Treatment: Device: Bloomlife

• Study Type: Interventional
• Enrollment (Actual): 145
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Genk, Belgium, 3600
    • Ziekenhuis Oost-Limburg
  • Liège, Belgium, 4000
    • Chr de La Citadelle

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bloomlife	Device: Bloomlife; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Labour probability	Probability of being in labour, computed using electrophysiological signals collected with the Bloomlife sensor	At delivery

Collaborators and Investigators

• Sponsor: Bloom Technologies
• Investigators: Principal Investigator: Frederic Chantraine, MD, PhD, Chr de La Citadelle

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2018
• Primary Completion (Actual): November 26, 2018
• Study Completion (Actual): March 5, 2019

Study Registration Dates

• First Submitted: May 20, 2019
• First Submitted That Met QC Criteria: June 10, 2019
• First Posted (Actual): June 11, 2019

Study Record Updates

• Last Update Posted (Actual): June 11, 2019
• Last Update Submitted That Met QC Criteria: June 10, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: WISH01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No