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RecruitingNAINTERVENTIONAL

Remote Cardiotocography Telemonitoring Within High-risk Pregnancy Care

This research is exploring a new way for pregnant women with specific health needs to monitor their baby’s heart rate from home. The main goal is to find out if using a special device at home (cardiotocography or CTG) is practical and comfortable for pregnant women, and if healthcare professionals find it useful. Fifty women will use this device once a week for an hour, for up to six weeks or until their baby is born, alongside their usual clinic visits. We want to see if the device can record a baby’s heart rate for at least 20 continuous minutes. The study also looks at how easy it is to use, if women stick to the schedule, and if it’s safe.

At a glance

Status
Recruiting
Phase
NA
Sponsor
Birmingham Women's NHS Foundation Trust
Enrolment target
50
Start
11 Jun 2025
Estimated completion
01 Apr 2026

What is this study about?

This study is looking at a new way to monitor a baby's heart rate during pregnancy, especially for mums who need a bit of extra care. Normally, these checks happen in the hospital or at a clinic. This research is testing if we can do some of these important checks at home using a special device. It's called "telemonitoring" because it uses technology to send information remotely.

The main aim is to see if this home monitoring is practical and comfortable for pregnant women. Researchers also want to know if doctors and midwives find it helpful. If successful, this could mean fewer trips to the hospital for some mums, making their pregnancy journey a little bit easier and less stressful.

Fifty women who are already having regular fetal monitoring for different reasons (like high blood pressure in pregnancy, if the baby is growing a bit slowly, or if the baby’s movements are reduced) will be invited to take part. They will use the home device once a week for an hour. The study will check if the device works well and if it's safe to use at home.

Key takeaways

  • Tests a new device for monitoring baby's heart rate at home.
  • Aimed at pregnant women needing extra checks for conditions like high blood pressure.
  • Could mean fewer hospital visits for some monitoring.
  • Involves using a device once a week for an hour.
  • Your usual care will continue alongside the study.
  • You must be able to go to hospital quickly if the device shows a concern.

Who may be eligible?

To take part in this study, you need to be at least 18 years old and at least 32 weeks pregnant with one baby. You should be able to speak English and already be receiving extra check-ups for your baby due to certain health conditions. These conditions could include high blood pressure during pregnancy, if your baby is growing slowly, liver problems in pregnancy (obstetric cholestasis), your waters breaking early, a previous stillbirth, or if you've noticed fewer baby movements.

There are some reasons why you wouldn't be able to join. These include if you’re pregnant with more than one baby, if your baby has known health problems, or if you have a BMI of 35 or higher. You also can't take part if you have a pacemaker or similar heart device, if you’re allergic to skin adhesives or latex, or if you have any skin problems or wounds where the monitoring device would be placed.

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.

  1. Are you at least 18 years old?
  2. Are you at least 32 weeks pregnant with one baby?
  3. Do you already have extra baby check-ups due to a specific health condition?
  4. Can you speak English?
  5. Do you have a medical condition that might stop you from joining (like twins, a pacemaker, or a very high BMI)?
  6. Are you willing and able to go to the hospital immediately if the device shows something unexpected?
Answer every question to see your result.

What does participation involve?

If you join this study, you'll be asked to use a special device at home to check your baby’s heart rate once a week. Each session will last for one hour. You will do this for up to six weeks, or until your baby is born, whichever happens first. This home monitoring will be in addition to your usual antenatal care and clinic appointments. The main goal for each session is to get at least 20 minutes of continuous monitoring.

During the study, you'll be taught how to use the home device. You'll also need to be prepared to go to the hospital straight away if the device shows anything unexpected during a home monitoring session. The research team will also want to chat with you about how you found using the device, if it was easy to stick to the schedule, and if you felt safe using it.

Potential risks and benefits

Taking part in this study might mean you have fewer trips to the hospital for some of your baby's heart rate checks, which could be more convenient for you. It also gives you a chance to be part of research that could improve care for other pregnant women in the future. The risks are expected to be low; the device is similar to ones used in hospitals. However, there's always a chance of mild skin irritation from the adhesive or very rarely, a strong emotional reaction if the device shows something unusual. You will be asked to go to the hospital immediately if anything unexpected shows up. You are free to withdraw from the study at any time, for any reason, without it affecting your usual care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Birmingham Women's and Children's NHS Foundation Trust
    Verified postcode
    Birmingham, United Kingdom· Recruiting

Common questions

What is cardiotocography (CTG)?

CTG is a way to monitor your baby's heart rate and your contractions. It helps doctors check on your baby's wellbeing.

What does 'high-risk pregnancy' mean in this study?

It means you have certain health conditions during pregnancy that require closer monitoring for your baby, such as high blood pressure or if your baby is growing a bit slowly.

How often would I use the home device?

You would use it once a week for one hour, for up to 6 weeks or until your baby is born.

What if the device shows something concerning?

You would need to go to the hospital immediately for further checks, as instructed by the study team.

Will using the home device replace all my hospital visits?

No, it's meant to be used *in addition* to your regular antenatal care. It won't replace all your usual clinic appointments.

How to find out more

Jack Hamer, MBChB

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Remote Cardiotocography Telemonitoring Within High-risk Preg…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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