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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-04

Study Completion Date

2022-07-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Pregnancy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No