Trials / Completed
CompletedNCT04941534
This Clinical Study Evaluates the Performance and Safety of Biorithm Research Kit Versus CTG in Prenatal Monitoring of Pregnant Participants.
AMBulatory Fetal ECG Monitoring in High Risk Pregnancies
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 100 (actual)
- Sponsor
- Biorithm Pte Ltd · Industry
- Sex
- Female
- Age
- 18 Years – 50 Years
- Healthy volunteers
- —
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.
Conditions
Timeline
- Start date
- 2021-06-04
- Primary completion
- 2022-06-22
- Completion
- 2022-07-30
- First posted
- 2021-06-28
- Last updated
- 2023-02-08
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT04941534. Inclusion in this directory is not an endorsement.