RecruitingNot ApplicableInterventional

Fetal ultrasound randomised trial of AI-assisted workflow for anomaly detection with health economic assessment

This study explores how new computer tools could make ultrasound scans during pregnancy better. In the UK, pregnant women usually have a detailed scan halfway through their pregnancy to check on their baby’s development. Sometimes, serious health issues can be missed. Researchers have developed new artificial intelligence (AI) tools to help spot problems during the scan and support expert review afterwards. The study aims to see if using these AI tools helps detect more health problems earlier and makes scan clinics run more smoothly and efficiently. Taking part could help improve future pregnancy scans and potentially lead to quicker detection of health problems in babies.

At a glance

Status

Recruiting

Phase

Not Applicable

Sponsor

King's College London

Enrolment target

9,566

Start

01 Oct 2025

Estimated completion

01 Oct 2026

Ultrasound screening of prenatal abnormalities

What is this study about?

Imagine getting a super-detailed picture of your baby during pregnancy, where spotting any tiny concerns is made easier and faster. That's what this study, called 'Fetal ultrasound randomised trial of AI-assisted workflow for anomaly detection with health economic assessment', is trying to achieve. In the UK, most pregnant women have a routine ultrasound scan around the middle of their pregnancy. This scan is really important for checking how the baby is growing and developing, but sometimes, even with expert eyes, some health conditions can be missed.

Researchers have created new computer-based tools that use something called Artificial Intelligence (AI). Think of AI as smart computer programs that can quickly analyse images and patterns. These particular AI tools are designed to help sonographers (the people who do the scans) and doctors spot potential issues more easily during the scan itself, and also to help experts review the scan results afterwards. The main goal of this study is to find out if using these AI tools, alongside the usual care, can help detect health problems in babies more often and at an earlier stage. It also wants to see if using these tools helps scan clinics run more efficiently.

This research is important because finding concerns earlier can sometimes mean babies get the care they need sooner, potentially leading to better outcomes. The study is run by King’s College London and funded by the National Institute for Health and Care Research (NIHR), which is a major UK research funder. By taking part, you could be helping to shape how pregnancy scans are done for future generations of expectant parents.

Key takeaways

New AI tools are being tested to improve routine pregnancy ultrasound scans.
The study aims to detect potential health problems in babies earlier and make clinics more efficient.
Around 9,500 pregnant people will be invited to participate in this UK-based study.
Participation involves your routine mid-pregnancy scan; there are no extra tests or visits.
There are no known risks beyond those of a standard, safe ultrasound scan.
Taking part could help improve future pregnancy care for everyone.

Who may be eligible?

This study is looking for around 9,500 pregnant people to take part. To be eligible, you need to be booked for a routine NHS ultrasound scan around the middle of your pregnancy (between 18 and 22 weeks). You also need to be pregnant with one baby and your pregnancy must generally be considered low-risk, meaning you're not already under the care of specialist doctors for complex fetal conditions.

There are a few reasons why you might not be able to take part. For example, if you are under 18 years old, if you are pregnant with more than one baby (like twins or triplets), or if your baby has already been diagnosed with a structural or genetic health problem. You also need to have sufficient English language skills to understand the study information and give your consent.

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 booked for your routine NHS mid-pregnancy ultrasound (around 18-22 weeks)?
Is your pregnancy considered low-risk (not under specialist care for severe conditions)?
Are you 18 years old or older?
Can you understand information about the study in English?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, it simply means your routine pregnancy scan will be part of the research. You will be randomly put into one of two groups. One group will have their scan done as usual, which is the standard high-quality care you would expect. The other group will have their scan supported by the new AI tools, and then an expert will also review the results with the help of AI. Apart from this, your scan experience will generally be the same.

Crucially, taking part will not change the care you receive. Your scan will still be performed by qualified professionals, and if any concerns are found, they will be handled through the usual NHS procedures. Some participants might also be asked to complete a short survey or have an interview to share their thoughts and experiences, but this would be entirely optional.

Potential risks and benefits

Taking part in this study could offer several benefits. You would be contributing to important research that aims to improve pregnancy scans for future expectant parents, potentially helping more babies get earlier detection of health problems. Regarding risks, there are no known risks beyond those associated with a standard pregnancy ultrasound scan, which is a very safe procedure. Your decision to participate is completely voluntary, and you are free to withdraw from the study at any time without your medical care being affected.

Locations (5)

Guys and St Thomas's NHS Foundation Trust
City only
London, England
Lewisham and Greenwitch NHS Trust
City only
London, England
Liverpool Women's NHS Foundation Trust
City only
Liverpool, England
William Harvey Hospital
Approximate
Ashford, England
Queen Elizabeth the Queen Mother Hospital
Approximate
Margate, England

Common questions

What is AI and how is it used in this study?

AI stands for Artificial Intelligence. In this study, it's a smart computer program designed to help scan technicians and doctors spot potential issues in your baby's ultrasound images more easily and quickly.

Will my scan be different if I'm in the AI group?

The scan itself will feel very similar to a standard scan. The AI tools work in the background to help the professionals doing and reviewing your scan. Your care will not change.

Do I have to do extra visits or have more tests?

No, you don't. Your participation is part of your routine mid-pregnancy scan. Some people might be asked to complete a survey or interview, but this would be optional and separate from the scan itself.

What if a problem is found during my scan?

If any concerns are found during your scan, whether you're in the AI group or not, they will be handled in the usual way by your healthcare team, just as with any standard NHS pregnancy scan.

Who is paying for this study?

The study is funded by the National Institute for Health and Care Research (NIHR), which is a major government body in the UK that supports health research.

How to find out more

Reza Razavi

reza.razavi@kcl.ac.uk +44 20 784 89587 Official trial record

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