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

Fetal Monitoring Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05665400
• Other study ID #: LOV-01-2022-EU
• Status: Recruiting
• Phase: N/A
• Start date: July 13, 2022
• Est. completion date: May 2023

Study information

• Verified date: December 2022
• Source: Bloom Technologies
• Contact: Elisa Rossetti
• Phone: +32483653848
• Email: elisa[@]bloom-life.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 2023
• Est. primary completion date: May 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Fetal Monitoring

Intervention

Device:
• Bloomlife 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.

Locations

Country	Name	City	State
Belgium	Ziekenhuis Oost-Limburg	Genk	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Bloom Technologies

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Extent of agreement between Bloomlife Lovelace FT and CTG in fetal heart rate	Bland-Altman analysis, based on a 95% limits of agreement.	1 hour
Primary	Extent of agreement between Bloomlife Lovelace FT and CTG in maternal heart rate	Bland-Altman analysis, based on a 95% limits of agreement.	1 hour
Primary	Performance metrics of Contraction Detection with Bloomlife Lovelace FT	Sensitivity, False Event Rate, Positive Percentage Agreement, Negative Percentage Agreement.	1 hour