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

Biorithm Pte Ltd100 enrolled

Overview

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

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

100

Conditions

Pregnancy

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

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

Locations (1)

St George's University Hospital

London, United Kingdom

Outcomes

Primary Outcomes

Fetal Heart Rate (FHR)

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

Time frame: 60 minutes

Maternal Heart Rate (MHR)

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

Time frame: 60 minutes

Data from ClinicalTrials.gov

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