AMBulatory Fetal ECG Monitoring in Low and High-Risk Pregnancies
This research project is testing a new device called Femom, which helps monitor a baby's heart rate remotely during pregnancy. The main goal is to find out if this device gives accurate information about the baby's heart. We also want to understand what a normal baby's heart rate looks like at different stages of pregnancy. Additionally, the study will compare baby heart rates in pregnancies with growth concerns or diabetes to those without these issues. Women will use the device at home, and their feedback will help us understand if this type of home monitoring is practical and helpful for future antenatal care.
At a glance
What is this study about?
Imagine being able to check your baby's heartbeat from the comfort of your own home during pregnancy. That's exactly what this study is exploring! Researchers are looking at a new, easy-to-use device called Femom. This device helps keep an eye on your baby's heart rate without needing a trip to the hospital. The main idea is to see if this home monitoring gives reliable information about your baby's health.
We also want to learn what a typical baby's heart rate pattern looks like as they grow inside the womb. This helps us create a 'normal range' that we can compare against. Then, for pregnancies where the baby might not be growing as expected (called FGR) or where the mother has diabetes, we will look at their babies' heart rates. By comparing these to the normal range, we hope to understand more about how these conditions affect a baby's heart.
Ultimately, this research could open the door to more convenient ways for pregnant women to monitor their babies, potentially reducing the need for hospital visits and giving parents more peace of mind. We'll also be asking for feedback on how easy the device is to use, which is really important for making sure it's helpful in the real world.
Key takeaways
- You'll use a home device to monitor your baby's heart rate.
- The study aims to see if home monitoring is reliable.
- It will help understand baby heart rates in different pregnancies.
- Participation involves daily home monitoring for a set period.
- Your feedback on the device's usability is important.
- You can stop participating at any time without affecting your care.
Who may be eligible?
To join this study, you need to be pregnant with one baby and be at least 26 weeks into your pregnancy. You also need to be 18 years old or older, and either speak English or have access to an NHS interpreter to make sure you understand everything.
There are some reasons why you might not be able to take part. For example, if you are under 18, or if you have a known brain or mental health condition that would make it difficult to follow the study instructions. We also can't include you if you're allergic to the gel used with heart rate monitors, or if your baby has a known heart problem or genetic condition.
Finally, if you have a close relationship with any of the research team that might make it hard to be completely objective, or if you can't get an interpreter when needed, you wouldn't be able to join. The most important thing is that everyone taking part can safely and clearly understand their role in the study.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you pregnant with one baby?
- Are you at least 26 weeks pregnant?
- Are you 18 years old or older?
- Do you speak English or have an NHS interpreter available?
- Does your baby not have a known heart problem or genetic issue?
- Are you not allergic to the gel used with heart rate monitors?
What does participation involve?
If you decide to join this study, you'll be asked to use the Femom device to monitor your baby's heart rate at home. The device is designed to be easy for you to use yourself. Depending on which group you're in, you'll record your baby's heart rate once a day.
If your pregnancy is uncomplicated (the 'control group'), you'll do this for one week. If your baby has growth concerns (FGR), you'll continue monitoring until your baby is born. If you have diabetes that requires insulin, you'll monitor from 36 weeks until your baby is born. After your baby is born, the research team will look back at all the recordings. You'll also be asked to complete a short questionnaire about your experience using the device and how easy it was. There are no extra hospital visits specifically for this study, as all monitoring will happen at home.
Potential risks and benefits
Locations (1)
- St Georges University HospitalVerified postcodeLondon, United Kingdom· Recruiting
Common questions
What is the Femom device?
The Femom device is a special monitor that helps check your baby's heart rate from your home. It's safe and doesn't go inside your body.
How often would I need to use the device?
You'd be asked to use the device once a day, but the total time you monitor depends on your specific pregnancy situation, from one week to until your baby is born.
Is the device safe for my baby?
Yes, the device is non-invasive, meaning it doesn't enter your body, and it's designed to be safe for both you and your baby.
Do I have to go to the hospital more often for this study?
No, all the monitoring for this study happens at home. There are no extra hospital visits specifically because of this research.
What happens to the information collected?
The information about your baby's heart rate will be collected and looked at by the researchers. It will help them understand more about baby heart rates during pregnancy.
How to find out more
Vilasini Nair
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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