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

Biorithm

Status: Completed

Conditions: Pregnancy

Study type: Observational

Funder types: Industry

Identifiers

NCT04941534

AMBER

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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