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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05665400
Enrollment
68
Registered
2022-12-27
Start date
2022-07-13
Completion date
2023-11-30
Last updated
2024-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fetal Monitoring

Brief 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.

Interventions

DEVICEBloomlife Lovelace FT

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.

Sponsors

Bloom Technologies
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Extent of agreement between Bloomlife Lovelace FT and CTG in fetal heart rate1 hourBland-Altman analysis, based on a 95% limits of agreement.
Extent of agreement between Bloomlife Lovelace FT and CTG in maternal heart rate1 hourBland-Altman analysis, based on a 95% limits of agreement.
Performance metrics of Contraction Detection with Bloomlife Lovelace FT1 hourSensitivity, False Event Rate, Positive Percentage Agreement, Negative Percentage Agreement.

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026