Pregnancy
Conditions
Keywords
antepartum monitoring
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.
Interventions
None listed
Sponsors
Biorithm Pte Ltd
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fetal Heart Rate (FHR) | 60 minutes | FHR agreement between Biorithm Research Kit and standard of care (CTG) |
| Maternal Heart Rate (MHR) | 60 minutes | MHR agreement between Biorithm Research Kit and standard of care (CTG) |
Countries
United Kingdom
Outcome results
None listed