This Clinical Study Evaluates the Performance and Safety of Biorithm Research Kit Versus CTG in Prenatal Monitoring of Pregnant Participants.
- Conditions
- Pregnancy
- Registration Number
- NCT04941534
- Lead Sponsor
- Biorithm Pte Ltd
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 100
- 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
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Maternal Heart Rate (MHR) 60 minutes MHR agreement between Biorithm Research Kit and standard of care (CTG)
Fetal Heart Rate (FHR) 60 minutes FHR agreement between Biorithm Research Kit and standard of care (CTG)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
St George's University Hospital
🇬🇧London, United Kingdom