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NCT05665400
A Clinical Study for the Development of a Device (Lovelace) for Antepartum Fetal Monitoring
Conditions: Fetal Monitoring
Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: 1
Phase: NA
Enrollment: 100
Sponsor: Bloom Technologies
Location: Belgium
Summary
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.
Eligibility Criteria
Inclusion Criteria:Pregnant woman ≥ 18 years oldGestational age greater or equal to 24 weeks and 0 daysSingleton pregnancyAbility to read and understand DutchWillingness to participate in the studyExclusion Criteria:Implanted pacemaker or any other implanted electrical deviceHistory of allergies to skin adhesivesIrritated or lesioned skin at the Bloomlife Lovelace FT electrodes locationsContraindication to the use of CTG based on physician's decision (e.g.
due to preterm contractions)
Source: ClinicalTrials.gov (NCT05665400). StuddyBuddy aggregates publicly available trial information.