Ambulatory foetal ECG monitoring in low and high-risk pregnancies (AMBER2): a prospective cohort study protocol.
Claire Pegorie, Becky Liu, Basky Thilaganathan...
https://pubmed.ncbi.nlm.nih.gov/41022451Actively Recruiting
Age: 18Years - 50Years
FEMALE
Healthy Volunteers
ID06497205
AMBulatory Fetal ECG Monitoring in Low and High-Risk Pregnancies
Led by Biorithm Pte Ltd · Updated on 2024-07-11
180
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of the Femom device, a non-invasive fetal ECG tool designed for self-application and remote monitoring, to track fetal heart rate in both low and high-risk pregnancies. The study aims to determine if remote recordings from Femom provide reliable information about the baby's heart rate and to establish reference standards for heart rate variability during uncomplicated pregnancies at various stages. It will also compare heart rate variability in pregnancies affected by fetal growth restriction (FGR) and insulin-dependent diabetes to normal pregnancies. Participants are divided into three groups: low-risk controls, FGR pregnancies, and insulin-dependent diabetic pregnancies. Women in the control group will monitor their baby's heart rate once a day for one week. Those in the FGR group will monitor daily until delivery, while women with insulin-dependent diabetes will monitor daily from 36 weeks until delivery. Data collected will be analyzed to assess participant adherence, signal quality, and heart rate variability, along with usability feedback from questionnaires. During the study, participants will monitor their baby's heart rate at home using the Femom device. Researchers will collect and analyze fetal heart rate (FHR) and maternal heart rate (MHR) recordings over 60-minute periods. The study will also gather feedback on the device's ease of use and monitor pregnancy outcomes. Participants' involvement duration varies by group, with ongoing monitoring until delivery for high-risk groups. The study is observational and led by Biorithm Pte Ltd.
CONDITIONS
Brief Title
AMBulatory Fetal ECG Monitoring in Low and High-Risk Pregnancies
Who Can Participate
Age: 18Years - 50Years
FEMALE
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Singleton live pregnancy
- More than 26 weeks gestational age
- Able to speak English or have access to an NHS interpreter
- Female aged between 18 and 50 years
You will not qualify if you...
- Women below 18 years of age
- Women with intellectual or mental impairment
- Women with known allergy or hypersensitivity to ECG gel electrodes
- Known fetal cardiac or genetic abnormality
- Existing dependent or unequal relationships with research team members
- Inability to access an interpreter
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Monitoring
Duration - Varies by group: 1 week for low risk controls, until delivery for FGR pregnancies, and from 36 weeks until delivery for insulin dependent diabetics.
Participants monitor their baby at home once a day using the Femom non-invasive fetal ECG device.
Daily monitoring at home
Trial Site Locations
Total: 1 location
1
St Georges University Hospital
London, Tooting, United Kingdom, SW17 0QT
Actively Recruiting
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Research Team
V
Vilasini Nair
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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