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

Sponsor
Biorithm Pte Ltd (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04941534
Collaborator
(none)
100
Enrollment
1
Location
17.9
Anticipated Duration (Months)
5.6
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Detailed 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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    AMBulatory Fetal ECG Monitoring in High Risk Pregnancies
    Actual Study Start Date :
    Jun 4, 2021
    Anticipated Primary Completion Date :
    Dec 1, 2022
    Anticipated Study Completion Date :
    Dec 1, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Fetal Heart Rate (FHR) [60 minutes]

      FHR agreement between Biorithm Research Kit and standard of care (CTG)

    2. Maternal Heart Rate (MHR) [60 minutes]

      MHR agreement between Biorithm Research Kit and standard of care (CTG)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    Female
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 St George's University Hospital London United Kingdom SW17ORE

    Sponsors and Collaborators

    • Biorithm Pte Ltd

    Investigators

    • Principal Investigator: Baskaran Thilaganathan, St-George's University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Biorithm Pte Ltd
    ClinicalTrials.gov Identifier:
    NCT04941534
    Other Study ID Numbers:
    • AMBER
    First Posted:
    Jun 28, 2021
    Last Update Posted:
    Feb 10, 2022
    Last Verified:
    Jan 1, 2022
    Keywords provided by Biorithm Pte Ltd
    antepartum monitoring

    Study Results

    No Results Posted as of Feb 10, 2022