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OpenTrials
Completed

NCT Number: NCT04941534

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

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

Completed

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Key information

Conditions

Pregnancy

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

St George's University Hospital

London, SW17ORE, United Kingdom

About this study

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.

Who can participate

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

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

Treatment and study plan

Primary outcomes

  1. Fetal Heart Rate (FHR)

    Time frame: 60 minutes

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

  2. Maternal Heart Rate (MHR)

    Time frame: 60 minutes

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

Sponsors and collaborators

Lead sponsor

Biorithm Pte Ltd

Industry

Registry information

Official study title

AMBulatory Fetal ECG Monitoring in High Risk Pregnancies

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 28, 2021
Registry last updated
Feb 8, 2023

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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