A Clinical Study to Investigate the Reliability of Fetal Heart Rate and Maternal Heart Rate Signals Extracted From Biopotential Data

Pregnancy Related Clinical Trial

Official title:

A Cross-sectional, Interventional, Exploratory Clinical Study to Investigate the Reliability of Fetal Heart Rate and Maternal Heart Rate Signals Extracted From Biopotential Data

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05498298
• Other study ID #: LOV-02-2022-US
• Status: Completed
• Phase: N/A
• Start date: August 3, 2022
• Est. completion date: December 7, 2022

Study information

• Verified date: December 2022
• Source: Bloom Technologies
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Bloom Technologies is developing a wearable device for monitoring pregnancy.

In this study, Bloom Technologies wants to investigate the reliability of this new technology.

For this reason, a device that records very high-quality data (g,Hlamp) was chosen. The study device is attached to the body by means of electrodes (up to 32) that can be safely attached to the skin. Most of the electrodes are placed on the abdomen, and a few on the chest and back.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: December 7, 2022
• Est. primary completion date: December 7, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Pregnant woman = 18 years old

• Gestational age = 30 weeks and 0 days

• Singleton pregnancy

• Ability to read and understand English or Spanish

• 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 electrodes locations

Related Conditions & MeSH terms

• Pregnancy Related

Intervention

Device:
• Biopotentials measurement with gtec device
A measurement of 40 minutes is performed with the gtec g.Hlamp to collect biopotential signals. 32 electrodes are attached to the body (abdomen, thorax and back).

Locations

Country	Name	City	State
United States	Valley Perinatal Services	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Bloom Technologies

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reliability in fetal heart rate extraction	Percentage of a recording with a fetal heart rate signal extracted	40 minutes
Primary	Reliability in maternal heart rate extraction	Percentage of a recording with a maternal heart rate signal extracted	40 minutes