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

Labour Onset Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03982654
• Other study ID #: WISH01
• Status: Completed
• Phase: N/A
• Start date: March 30, 2018
• Est. completion date: March 5, 2019

Study information

• Verified date: June 2019
• Source: Bloom Technologies
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 145
• Est. completion date: March 5, 2019
• Est. primary completion date: November 26, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Labour Onset

Intervention

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.

Locations

Country	Name	City	State
Belgium	Ziekenhuis Oost-Limburg	Genk
Belgium	CHR de la Citadelle	Liège

Sponsors (1)

Lead Sponsor	Collaborator
Bloom Technologies

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Labour probability	Probability of being in labour, computed using electrophysiological signals collected with the Bloomlife sensor	At delivery