AMBER 2
Research type
Research Study
Full title
Ambulatory Fetal ECG Monitoring in Low and High-Risk Pregnancies: Proof of concept study.
IRAS ID
330204
Contact name
Amarnath Bhide
Contact email
Sponsor organisation
Biorithm Pte Ltd
Duration of Study in the UK
0 years, 11 months, 30 days
Research summary
Monitoring the baby's heart rate is an important way to check the baby's health during pregnancy. Currently, this is done using a machine called cardiotocography (CTG) in the hospital, and it helps guide decisions about interventions like delivering the baby early in high-risk pregnancies with fetal growth restriction (FGR).
A big study called TRUFFLE found that in high-risk pregnancies with FGR, monitoring the baby's heart rate twice a week might not be enough. They suggested that more frequent monitoring, like daily, could help reduce complications.
The Femom device is a safe and non-invasive monitor that goes on the pregnant woman's abdomen to measure the baby's heart signals. A pilot study called AMBER1 showed that it's comparable to CTG in a hospital for checking the baby's heart rate variability which is an important indicator of fetal wellbeing.
AMBER2 is the next step and will explore using Femom remotely. The study will include 120 women with low-risk pregnancies (control group) and 30-50 women with FGR pregnancies or insulin-dependent diabetes (FGR and Diabetes groups). The women in the control group will monitor their babies for at least 60 minutes a day for one week. The other two groups will monitor their pregnancies for at least 60 minutes a day until delivery.
The collected data will be analysed in retrospect. The main goal is to see 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.
This study is a planned research project to test and demonstrate the feasibility of using the Femom device for monitoring fetal heart rate remotely.
REC name
London - Stanmore Research Ethics Committee
REC reference
23/LO/0744
Date of REC Opinion
17 Oct 2023
REC opinion
Further Information Favourable Opinion