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

Bloom Technologies

Status: Completed

Conditions: Labour Onset

Treatments: Device: Bloomlife

Study type: Interventional

Funder types: Industry

Identifiers

NCT03982654

WISH01

Details and patient eligibility

About

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.

Enrollment: 145 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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145 participants in 1 patient group

Bloomlife

Experimental group

Treatment:

Device: Bloomlife