NCT03982654

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 145 (actual)
• Sponsor: Bloom Technologies · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Labour Onset

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-03-30
• Primary completion: 2018-11-26
• Completion: 2019-03-05
• First posted: 2019-06-11
• Last updated: 2019-06-11

Locations

2 sites across 1 country: Belgium