Investigating the Physiology of Labour and Labour Onset Through Longitudinal Measurements Performed With a Wearable Sensor
- Conditions
- Labour Onset
- Interventions
- Device: Bloomlife
- Registration Number
- NCT03982654
- Lead Sponsor
- Bloom Technologies
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 145
- Pregnant
- Gestational age between 20 weeks and 0 days and 30 weeks and 0 days
- Willingness to participate in the study
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Bloomlife Bloomlife -
- Primary Outcome Measures
Name Time Method Accuracy At delivery Accuracy of the machine learning model for the automatic detection of labor, measured in terms of sensitivity and specificity in detecting labour
- Secondary Outcome Measures
Name Time Method Labour probability At delivery Probability of being in labour, computed using electrophysiological signals collected with the Bloomlife sensor
Trial Locations
- Locations (2)
CHR de la Citadelle
🇧🇪Liège, Belgium
Ziekenhuis Oost-Limburg
🇧🇪Genk, Belgium