RecruitingNCT06497205

AMBulatory Fetal ECG Monitoring in Low and High-Risk Pregnancies


Sponsor

Biorithm Pte Ltd

Enrollment

180 participants

Start Date

Mar 19, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

This study is a planned research project to test and demonstrate the feasibility of using the Femom device for monitoring fetal heart rate remotely. The main goal is to learn if the remote recordings using Femom provide reliable information about the baby's heart rate. We will also establish reference standards of heart rate variability in uncomplicated pregnancies at different stages of pregnancy. Additionally, we will compare the heart rate variability in FGR and diabetic pregnancies to normal pregnancies.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 50 Years

Inclusion Criteria3

  • Singleton live pregnancy
  • > 26 weeks gestational age
  • Able to speak English or available NHS interpreter

Exclusion Criteria6

  • Women below 18 years of age
  • Women with an intellectual or mental impairment
  • Women with a known allergy or hypersensitivity to ECG gel electrodes
  • Known fetal cardiac or genetic abnormality.
  • Patient with existing dependent or unequal relationships with any member of the research team, the researchers(s) and/or the person undertaking the recruitment/consent process.
  • Inability to access interpreter.

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Locations(1)

St Georges University Hospital

London, Tooting, United Kingdom

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NCT06497205


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