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Completed

NCT Number: NCT05665400

A 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.

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Key information

Conditions

Fetal Monitoring

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ziekenhuis Oost-Limburg

Genk, Limburg, 3600, Belgium

Who can participate

Healthy volunteers accepted: Yes

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

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)

Treatment and study plan

Bloomlife Lovelace FT

Device

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.

Primary outcomes

  1. Extent of agreement between Bloomlife Lovelace FT and CTG in fetal heart rate

    Time frame: 1 hour

    Bland-Altman analysis, based on a 95% limits of agreement.

  2. Extent of agreement between Bloomlife Lovelace FT and CTG in maternal heart rate

    Time frame: 1 hour

    Bland-Altman analysis, based on a 95% limits of agreement.

  3. Performance metrics of Contraction Detection with Bloomlife Lovelace FT

    Time frame: 1 hour

    Sensitivity, False Event Rate, Positive Percentage Agreement, Negative Percentage Agreement.

Sponsors and collaborators

Lead sponsor

Bloom Technologies

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 27, 2022
Registry last updated
Jul 3, 2024

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.

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