AMBulatory Fetal ECG Monitoring in Low and High-Risk Pregnancies

Recruiting

• Conditions: Pregnancy Related

• Registration Number: NCT06497205
• Lead Sponsor: Biorithm Pte Ltd

Brief 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.

Detailed Description

The Femom device is a non-invasive fetal ECG (NIFECG) device which has been developed for self application and remote monitoring. Women from three different cohort groups (controls, FGR and insulin dependent diabetes) will be approached and asked to monitor their baby at home once a day. Women in the control group will be asked to do this once a day for one week, the FGR pregnancies until delivery and the insulin dependent diabetics just from 36 weeks until delivery.

The data will be collected and analysed retrospectively to assess compliance of the participants with the study protocol, signal quality and establish reference standards in relation to gestation within the control group. Heart rate variability measures in the FGR and diabetes arm will be compared to the reference standards in the control group. Outcomes of the pregnancy.

Feedback regarding the usability of the device will also be collected using a feedback questionnaire to assess the feasibility of home antenatal monitoring.

Study Timeline

• Study Start: 2024-03-19
• Status Verified: 2024-07
• Study First Submitted: 2024-07-04
• Study First Submitted QC: 2024-07-04
• Last Update Submitted: 2024-07-04
• Study First Posted: 2024-07-11
• Last Update Posted: 2024-07-11
• Primary Completion: 2025-04-30
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 180

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
FHR	60 minutes	FHR agreement between Femom system and standard of care (CTG)
MHR	60 minutes	MHR agreement between Femom system and standard of care (CTG)

Trial Locations

Locations (1)

St Georges University Hospital; 🇬🇧 London, Tooting, United Kingdom