A Clinical Study for the Development of a Device (Lovelace) for Antepartum Fetal Monitoring

A Cross-sectional, Interventional, Exploratory Clinical Study for the Development of a Device (Lovelace) for Antepartum Fetal Monitoring

Bloomlife Lovelace FT is a non-invasive, wireless, external measurement system used to measure accelerometer and electrophysiological signals on pregnant women with a singleton pregnancy, by acquiring biopotential signals from abdominal surface electrodes.

In this study, Bloomlife Lovelace FT is used to collect the dataset needed for the development of a future product (Bloomlife Lovelace) for the monitoring of fetal heart rate, maternal heart rate and uterine activity.

Inclusion Criteria:

• Pregnant woman ≥ 18 years old
• Gestational age greater or equal to 24 weeks and 0 days
• Singleton pregnancy
• Ability to read and understand Dutch
• Willingness to participate in the study

Exclusion Criteria:

• Implanted pacemaker or any other implanted electrical device
• History of allergies to skin adhesives
• Irritated or lesioned skin at the Bloomlife Lovelace FT electrodes locations
• Contraindication to the use of CTG based on physician's decision (e.g. due to preterm contractions)