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

February 7, 2023 updated by: Biorithm Pte Ltd

AMBulatory Fetal ECG Monitoring in High Risk Pregnancies

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

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, SW17ORE
        • St George'S University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Participants would be recruited at the Day Assessment Unit who require CTG monitoring and meet the inclusion criteria

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fetal Heart Rate (FHR)
Time Frame: 60 minutes
FHR agreement between Biorithm Research Kit and standard of care (CTG)
60 minutes
Maternal Heart Rate (MHR)
Time Frame: 60 minutes
MHR agreement between Biorithm Research Kit and standard of care (CTG)
60 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biorithm Pte Ltd

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 4, 2021

Primary Completion (ACTUAL)

June 22, 2022

Study Completion (ACTUAL)

July 30, 2022

Study Registration Dates

First Submitted

June 22, 2021

First Submitted That Met QC Criteria

June 22, 2021

First Posted (ACTUAL)

June 28, 2021

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2023

Last Update Submitted That Met QC Criteria

February 7, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • AMBER

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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