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Search / Trial NCT06497205

AMBulatory Fetal ECG Monitoring in Low and High-Risk Pregnancies

Launched by BIORITHM PTE LTD · Jul 4, 2024

Trial Information

Current as of August 22, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial, titled "AMBulatory Fetal ECG Monitoring in Low and High-Risk Pregnancies," is exploring a new way to monitor a baby's heart rate using a device called Femom. The main goal is to find out if the heart rate recordings taken at home are accurate and reliable. The study will also help establish normal heart rate patterns during different stages of pregnancy and compare these patterns in pregnancies that have certain risks, like fetal growth restriction or diabetes, to those that are considered normal.

To participate in this study, women must be at least 18 years old, be pregnant with a single baby, and be more than 26 weeks along in their pregnancy. They should also be able to speak English or have access to an interpreter. Participants will be asked to use the Femom device to record their baby's heart rate and will help researchers gather important information about fetal heart health. If you're interested and meet the eligibility criteria, this study could provide valuable insights into your pregnancy and contribute to better monitoring methods for the future.

Gender

FEMALE

Eligibility criteria

  • Inclusion Criteria:
  • Singleton live pregnancy
  • \> 26 weeks gestational age
  • Able to speak English or available NHS interpreter
  • Exclusion Criteria:
  • 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.

About Biorithm Pte Ltd

Biorithm Pte Ltd is a pioneering clinical trial sponsor specializing in the advancement of innovative therapeutics and medical technologies. Committed to enhancing patient outcomes, Biorithm focuses on conducting rigorous and ethically sound clinical trials across various therapeutic areas. With a team of experienced professionals and a robust infrastructure, the company leverages cutting-edge methodologies and data analytics to streamline trial processes, ensuring compliance and efficiency. Biorithm aims to bridge the gap between scientific research and clinical application, fostering partnerships with stakeholders to facilitate the successful development and commercialization of transformative healthcare solutions.

Locations

London, Tooting, United Kingdom

Patients applied

0 patients applied

Trial Officials

Amarnath Bhide, MBBS, PHD

Principal Investigator

St Georges University Hospitals

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported