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

Pregnancy Clinical Trial

Official title:
AMBulatory Fetal ECG Monitoring in High Risk Pregnancies

Clinical Trial 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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04941534
Study type Observational
Source Biorithm Pte Ltd
Contact
Status Completed
Phase
Start date June 4, 2021
Completion date July 30, 2022
View Details
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