Is everyone invited to take part?
If you are attending a routine pregnancy ultrasound scan (between 18–22 weeks) at a participating hospital you may be invited to take part in the Friaya study. No everyone is invited because only two ultrasound rooms per hospital are being used for the study.
How many people will take part in the study?
How many people will take part in the study?
We’re inviting around 9,500 pregnant people to take part over one year.
Do I have to take part?
No, it’s completely your choice. If you decide to take part, you’ll be given more information and asked to sign a consent form. You can change your mind and withdraw at any time. This won’t affect your care or your legal rights.
What information will I receive and how do I consent?
You may have received some information at your 12-week scan. A member of the team will usually email the formal study participant information sheet at least 4 weeks before your scan. They will also send email guidance to complete an eConsent form online. They may call you before your scan appointment or speak to you in person at your scan. If you agree to take part, you’ll need to have signed an online or paper consent form.
English is not my first language, are there translations of the formal documents?
Yes, translated versions of the study documents are available in multiple languages commonly requested in NHS settings. Please contact the study team to request more information.
What what will be different with my care if I take part?
Your scan will still go ahead as planned in line with NHS standards. The researcher at the ultrasound clinic will use software connected to our clinical trials unit at King's College London to let the hospital know which group you will be in (this is random).
Group 1 – Standard Care: You’ll have your scan as usual.
Group 2 – AI-supported Scan: Your sonographer will be supported by trusted computer tools (AI). An expert may also review your scan images remotely, again with AI support, within a few days to double check the results.
What’s different with the AI-supported scan?
The sonographer will use the AI software to help capture and measure standard images.
An expert sonographer or specialist doctor may review your scan images afterwards — this is an extra check and doesn’t replace your usual care.
What are the surveys and interviews about?
The one-to-one interview (which lasts about 45 minutes) is optional and will be offered to up to 30 people. We hope to understand what you think about the use of the new computer software and if it impacted your scan experience at all. It will usually be a video call, but in-person interviews are possible, if needed. We’ll reimburse travel costs and offer a small gift voucher for your time.In the surveys we want to hear about your experience of the scan.
In addition, you may also be offered a short online survey by email, to understand from more people what they thought of the scans.
How will I let researchers know I want to take part in a survey or interview?
You will have the opportunity to consent to sharing your contact details with the King's College London Research team who are doing the surveys and interviews. In addition, you can contact the study team using email (FraiyaStudy@kcl.ac.uk).
Do I need to do anything special to take part?
No. Just attend your scan as usual. If you’re invited to take part you will receive some information by email. We may also speak to you at the time of your scan to see if you are still interested in taking part. On the day of your scan, if there room in available to perform the research study you will be told what group you are in so you can inform your sonographer.
Will this affect my care or my baby’s care?
No. Your care will not be affected by whether you take part or which group you’re in. If anything unexpected is found during your scan, it will be followed up as normal.
Are there any benefits to taking part?
There may be no direct benefit to you or your baby. Your scan and care will follow normal NHS procedures. However, you’ll be helping researchers improve pregnancy care for others in the future. The study may help make ultrasound scans better at spotting serious conditions earlier, which could lead to better outcomes for babies and families.
Are there any risks or downsides?
There are no serious risks involved in the research, as the ultrasound is performed with technology that meets clinical safety standards. However, there are some things to consider:
Time and inconvenience: Reading the study information and giving consent takes a little extra time. Surveys and interviews are optional but may take up to 15–45 minutes. If you’re in the AI-supported scan group, your appointment will usually take the same time — or may be quicker. In rare cases, you may be asked to return for a follow-up scan if the images need to be checked again.
Emotional impact: As with any scan, there’s a small chance something unexpected may be found. This can be upsetting. If this happens, you’ll be supported and referred for follow-up care. If you take part in an interview, you can skip any questions or stop at any time.
Confidentiality: We collect some personal and health information for the study. It will be stored securely and kept confidential. There’s a very small risk of a data breach, but we have strong safeguards in place to protect your information.
No medical risks: The scan is the same as those used in routine NHS care. There’s no exposure to radiation, no treatments or blood tests, and no risk to pregnancy or breastfeeding.
Can I change my mind?
Yes. You can withdraw at any time without giving a reason. This won’t affect your care. We’ll still use any information already collected (because it will be already anonymised).
What happens with the study results?
The results will help us understand if AI tools can improve pregnancy scans. We’ll share findings in journals, conferences, and public summaries. Updates will be available in the News and Updates section of the website or shared by email (if you give permission).
Have patients helped design the study?
Yes. We’ve worked with members of the public who have experience of pregnancy, NHS care and health research. They’ve helped shape the study and will continue to advise us. A trained public involvement researcher will lead interviews to make sure participants’ voices are heard.
What happens to my data?
Your data will be stored securely and kept confidential. It will only be used for this study unless you give permission for future use. Any reports will use anonymised data.
Will my GP be informed?
Yes. Your GP will be told you’re taking part. We may contact them after your baby is born (up to 6 weeks later) to check scan findings.
What if new information comes up?
If we learn anything that might affect your decision to take part, the research team will let you know as soon as possible.
How can I share my experience after the scan?
Some participants will be invited to complete a survey or interview. You may also be asked to share health updates about you and your baby in a short postnatal email survey, text or phone call. If you’d like to share anything else, you can contact the team at fraiyastudy@kcl.ac.uk.
Will I receive any financial benefit?
No. If the study leads to new technologies or services, they may be sold in future, but you won’t receive any financial benefit.