Completed

NCT Number: NCT03982654

Investigating the Physiology of Labour and Labour Onset 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.

Completed

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Key information

Conditions

Labour Onset

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ziekenhuis Oost-Limburg, Genk, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bloomlife

Device

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.

Primary outcomes

Accuracy

Time frame: 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 outcomes

Labour probability

Time frame: At delivery

Probability of being in labour, computed using electrophysiological signals collected with the Bloomlife sensor

Sponsors and collaborators

Lead sponsor

Bloom Technologies

Industry

Registry information

Official study title

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

Important dates

Study start: 2018
Primary completion: 2018
Study completion: 2019
First posted: Jun 11, 2019
Registry last updated: Jun 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.