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NCT04941534 Clinical Trial

This Clinical Study Evaluates the Performance and Safety of Biorithm Research Kit Versus CTG in Prenatal Monitoring of Pregnant Participants.

Pregnancy Clinical Trial

Official title:
AMBulatory Fetal ECG Monitoring in High Risk Pregnancies

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04941534
Other study ID # AMBER
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 4, 2021
Est. completion date July 30, 2022

Study information
Verified date February 2023
Source Biorithm Pte Ltd
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This clinical study will evaluate the safety and comparative performance of Biorithm Research Kit vs CTG (gold standard) in prenatal monitoring of pregnant participants.

Description:

The Biorithm Research Kit system used in this study consists of femom fetal monitor (known as fetal monitor), a digital gateway and a cloud storage. It's intended for monitoring of maternal and fetal physiological parameters. It includes non-invasive fetal monitor or device, that monitors fetal heart rate (FHR), maternal heart rate (MHR), and uterine activity (UA) in the antepartum period.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date July 30, 2022
Est. primary completion date June 22, 2022
Accepts healthy volunteers
Gender Female
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria: - Have a singleton pregnancy - Should be at and above 28 weeks of pregnancy - Should have a valid indication for antenatal FHR monitoring as part of their pregnancy management, as per local hospital policy - Able to speak English or have access to an interpreter and provide Informed Consent Exclusion Criteria: - Participants with an intellectual or mental impairment - Participants with a known allergy or hypersensitivity to ECG gel electrodes - Participants in pain, with contractions or in labour - Known fetal cardiac or genetic abnormality - Participant with a pacemaker

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United Kingdom St George's University Hospital London

Sponsors (1)
Lead Sponsor Collaborator
Biorithm Pte Ltd

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Fetal Heart Rate (FHR) FHR agreement between Biorithm Research Kit and standard of care (CTG) 60 minutes
Primary Maternal Heart Rate (MHR) MHR agreement between Biorithm Research Kit and standard of care (CTG) 60 minutes
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