RecruitingObservational

Can eye imaging in pregnancy help predict stillbirth?

This study aims to understand why some babies are stillborn and find new ways to identify those at risk during pregnancy. Currently, our monitoring with blood tests, blood pressure, and scans doesn't always give a complete picture. Changes in blood vessels throughout the body, including those at the back of the eye, can be linked to complications like pre-eclampsia and stillbirth. Taking pictures of the eye's blood vessels is a quick, simple, and painless test, similar to ones you might have at an optician. Researchers are hoping to find out if regularly monitoring these changes in pregnant women could become a new way to spot potential problems early. The results could help improve future care for pregnant women and their babies.

At a glance

Status

Recruiting

Sponsor

Accord (United Kingdom)

Enrolment target

650

Start

01 Dec 2023

Estimated completion

01 Mar 2027

Stillbirth and pregnancy complications linked to stillbirth risk (pre-eclampsia and fetal growth restriction)

What is this study about?

Each year, millions of babies are stillborn, and for many, the reason isn't clear. Doctors and researchers are always trying to find better ways to understand why this happens and to identify babies who might be at risk during pregnancy. Current checks like blood tests, blood pressure measurements, and ultrasound scans are very helpful, but they don't always show the full picture.

During pregnancy, a woman's body goes through many changes, including in the tiny blood vessels that carry blood around. Sometimes, these changes can lead to complications such as high blood pressure, a condition called pre-eclampsia, or even stillbirth. Interestingly, the blood vessels at the back of your eye can act as a kind of window to what's happening with blood vessels elsewhere in your body. Taking pictures of these eye blood vessels is a simple, quick, and comfortable test that you may have even experienced at a routine eye check-up.

The main goal of this study is to see if regularly checking these eye blood vessel changes throughout pregnancy could be a new and effective way to spot women who might be at a higher risk of complications. Ultimately, the researchers hope their findings will lead to better ways to support pregnant women and help prevent stillbirths in the future.

Key takeaways

This study hopes to find new ways to predict stillbirth using eye scans.
It's a research study, so there are no direct benefits for participants.
The eye scan is quick, painless, and similar to an optician's check.
Participation involves 1-2 visits during pregnancy and one follow-up after birth.
The study aims to improve future care for pregnant women.
You can withdraw at any time without affecting your medical care.

Who may be eligible?

This study is looking for pregnant women living in the Lothian area of Scotland who are between 16 and 50 years old. You should be expecting just one baby (not twins or more) to take part.

You can join if you are either 12 weeks into your pregnancy (give or take 3 weeks) or 20 weeks into your pregnancy (give or take 3 weeks). There's also a group for women who are more than 23 weeks pregnant.

Unfortunately, you can't take part if you are not pregnant, are outside the age range, are pregnant with more than one baby, or if a healthcare professional decides you are unable to understand and agree to 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 currently pregnant with one baby?
Are you between 16 and 50 years old?
Do you live in the Lothian area of Scotland?
Are you currently around 12 weeks, 20 weeks, or more than 23 weeks pregnant?
Can you give informed consent (understand and agree to take part)?
Are you able to attend appointments at The University of Edinburgh?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll have either one or two study visits during your pregnancy. If you have two visits, they'll happen around 12 or 20 weeks, and then again at 36 weeks. If you have one visit, it will be around 36 weeks.

During these visits, a special camera will be used to take pictures of the back of each of your eyes – this is quick and painless. At the 36-week visit, you'll also have an ultrasound scan to check your womb, placenta, and baby, and a blood sample will be taken.

After your baby is born, you'll be invited for one final follow-up visit. This will be sometime between 6 and 18 months after the birth. At this visit, more eye pictures will be taken, and some non-invasive (meaning they don't go inside your body) measurements will be taken of your heart and blood vessels. You'll also provide a blood and urine sample. The whole study, from your first visit to your follow-up, could last between 9 months and just over 2 years.

Potential risks and benefits

There won't be any direct medical benefits for you or your baby from taking part in this study, but your contribution could greatly help future pregnant women by leading to better ways of predicting and preventing stillbirth. The tests are generally very safe; the eye pictures are non-invasive and the ultrasound scans are standard pregnancy checks. While blood tests can sometimes cause a small bruise, none of the measurements are expected to harm you or your pregnancy. The main inconvenience might be the time and travel needed for the study visits. It's also possible, though unlikely, that a hidden health issue might be found during the tests. If this happens, you will be promptly referred to a doctor for advice and treatment. Remember, you are free to withdraw from the study at any time without giving a reason, and this will not affect your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Royal Infirmary of Edinburgh at Little France
City only
Lothian, Scotland

Common questions

What is stillbirth?

Stillbirth is when a baby is born without signs of life after 24 completed weeks of pregnancy in the UK. It's a very sad event, and this study aims to understand it better.

Will taking part help me personally?

While you won't get direct personal benefits from taking part, the information gathered from you and others could significantly help improve care for pregnant women and reduce stillbirths in the future.

Is the eye test like going to the optician?

Yes, taking pictures of the back of your eye is a simple, quick, and painless procedure, much like what you might experience during a routine eye check-up at an optician.

What if they find something wrong with my health during the study?

In the rare event that the measurements show a health problem you weren't aware of, the study team will let you know and arrange for you to see a doctor for further advice and treatment.

Can I stop taking part if I change my mind?

Absolutely. You are free to withdraw from the study at any time, for any reason, without affecting your standard care or relationship with your healthcare providers.

How to find out more

Rebecca Reynolds

R.Reynolds@ed.ac.uk +44 (0)131 242 6762 Official trial record

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