Research Centre: The Newcastle Upon Tyne Hospitals NHS Foundation Trust
Chief Investigator: Nicola Heslehurst, Newcastle University
Principal Investigator: Raya Vinogradov, Newcastle upon Tyne NHS Foundation Trust,
Reproductive Health Research Team, The Royal Victoria Infirmary (RVI)
0191 2820362 nuth.rhnresearch@nhs.net

We would like to invite you to take part in a research study. Before you decide if you want to take part it is important that you understand what it will involve. Please take time to read this document and discuss it with others if you wish. You will have the opportunity to discuss the research with a member of the team when you attend for your 12-week scan appointment and we encourage you to do this if there is anything you are unsure of. If you have received this information sheet before your scan appointment, you can contact us directly if you would like to discuss anything in advance.

• Part one of this document tells you about the purpose of the study and what would happen if you decided to take part.
• Part two provides information about optional extras, which are extra parts of this research that you can choose whether or not you want to take part in.
• Part three gives more details about the conduct of the research.
• Further contact details are on the last page of this document.

Part One

What is the purpose of the research? This research will explore body shape in early pregnancy and how it impacts on the health of women and babies. The NHS uses Body Mass Index (BMI) to identify who might need extra care in pregnancy. However, there may be more accurate measures than BMI to understand who would most benefit from extra pregnancy care. We will look at body shape in early pregnancy, and need women with a whole range of BMIs to take part. This research will inform how maternity services provide care to improve health of women and babies.

Why have I been invited? The study is being carried out at the RVI. We are inviting pregnantwomen attending this hospital for a 12-week scan, and aim to include 1400 women in this study.

What will happen to me if I take part? A member of the research team will discuss the research with you at your 12-week scan appointment. If you decide to take part, you will be asked to sign a consent form. We will take some extra body shape measurements on the same day as your scan appointment. The sonographer who is doing your 12-week scan will take some extra ultrasound measurements. A female researcher will then take all the extra measurements in a private room.

These will include your waist size, hip size, upper arm size, neck size, skinfold measurements of fat stored underneath the skin, height and weight. We will need to draw some lines on your arms, stomach and back using an erasable pen. It would be helpful if you could wear a loose-fitting top and lightweight clothing on the day. Most of the measurements will be taken using a tape measure. The skinfold measurements will use callipers to compress the skin, but this should not cause any pain.

You will also be asked to fill in a short questionnaire to get some extra information about you, for example your age, ethnic group and postcode. We will review your routine maternity notes after you have had your baby so that we can get information about your pregnancy, for example, how you delivered your baby.

You don’t need to do anything else for this research after your 12-week scan appointment.

Will I learn more about my own body shape measurements or health? No. We don’t yet know which body shape measurements are most accurate, so we can’t give you any feedback on this.

What will happen to the results of the research study? The results from this study will be used to see how well body shape measurements relate to health during pregnancy. This will give us a better idea of which women and babies would benefit the most from extra care during pregnancy. The results will be published in a scientific journal so that other researchers and health professionals can learn from this research. You would not be identified in any results we present or publish. If you would like to receive a summary of results from the study, then we can share these with you.

What are the possible benefits and disadvantages of taking part? Your hospital ultrasound scan appointment will take up to 45 minutes longer than normal. There are no direct benefits for you during this pregnancy but taking part in this research could help to improve care of for women and their babies during pregnancy in the future.

To say thank you for taking part you will receive a photograph mount with three printed pictures of your baby from your 12-week scan which will be given to you on the day of your scan appointment. You can also take part in a research prize draw which will be drawn at the end of the research. There are 40 prizes of £100 shopping vouchers to be won.

Do I have to take part? No. Participation is voluntary, and it is up to you to decide if you want to participate in the study. If you do not want to take part, you do not have to give a reason and your care will not be affected in any way. If you have received this document before your scan appointment and you decide that you don’t want to take part in the study, you can either contact us to let us know before attending for your appointment or turn up and let us know on the day. Your scan appointment will go ahead as planned whether you decide to take part in this research or not.

What if I change my mind? You are free to withdraw from the study at any time, without giving a reason. If you change your mind, your care will not be affected in any way. If you want to withdraw from the study, please use the contact details on page 1 of this document.

Part Two: Optional Extras

There are three optional extras for this research.
You can still take part in the research without agreeing to any of these optional extras, or you can choose to agree to one, two or all three of them.

SHAPES Study Interviews: You will be asked by the research team if you are happy to share your contact details with the research team at Newcastle University for a second study related to SHAPES. The second study involves being interviewed about your experiences of having the extra body shape measurements taken. If you agree to share your contact details now, this does not mean that you are agreeing to be interviewed, you are only agreeing to share your contact details with the research team. Not all women who share their details will be contacted as there will be 1400 women in SHAPES and only around 30 women will be interviewed. If you are contacted about the interview study, you will receive detailed written information and have the opportunity to discuss with the researchers before deciding whether to take part. If you don’t want to take part, you do not have to give a reason and your care won’t be affected in any way.

Future research about long-term health and well-being of women and their children: We would like to explore whether body shape in early pregnancy is linked to the future health and well-being of women and their children. An example of the type of research question we would be asking would be “can waist size measured at 12-weeks in pregnancy identify which women or children develop diabetes later in life?” If pregnancy measurements are useful, then we could plan ways to support women and children after pregnancy to try and improve long-term health and well-being.

To do this future research, we would need your consent to store your NHS number, name and date of birth, and your baby’s NHS number and date of birth, linked to your SHAPES Study ID number. This is needed so that we can link the SHAPES data with routinely collected health data in the future, through organisations such as NHS Digital, hospital attendance data and GP records. For example, we could link to medical records to see if you or your child has been diagnosed with diabetes at any point after pregnancy. This extra research will only involve accessing routine electronic data and not any further contact with you. Any researcher who wants to access your health records can only do so if you consent to the use of your data in this way, and will follow best ethical and legal practice.

Future research using routine blood samples: you may have a routine blood test at your dating scan appointment if you opt into first trimester combined screening for Down’s, Edwards’ and Patau’s syndromes. After your routine blood tests have been carried out, any leftover blood is stored in a freezer at the hospital until 3-6 months after your baby is born. This is in case there are more tests needed after your baby is born linked to the first trimester screening. Once the blood samples are no longer needed, they are destroyed. However, other blood tests can provide valuable information for research. For example, there are tests we can do for certain chemicals in your blood, known as “biomarkers”. Hormones, fats and cholesterol are examples of biomarkers that can be measured in blood tests to check people’s health. These blood tests may be useful to help identify which women and babies go on to develop certain health conditions during pregnancy.

We would like to use these types of blood tests in a research project to help us to find out who would benefit most from extra care during pregnancy. If you sign up to this optional extra, we are not asking for you to do another blood test. We are asking for your permission to keep the blood that is already being stored by Newcastle NHS Trust instead of this blood sample being destroyed. Your personal details, such as your name and date of birth will be removed and the blood sample will only have your SHAPES ID number on it. Your blood samples will be kept in the freezers at Newcastle NHS Trust until we are ready to use them for the research.

We will need to apply for more research funding to do this extra analysis. The research project will explore whether there are any biomarkers that could be used instead of, or alongside, other SHAPES measurements to identify which women and babies would benefit from extra pregnancy care. If we don’t receive the funding needed for this research, then your blood samples will be destroyed by Newcastle NHS Trust in the same way that they would have been destroyed when your baby is 3-6 months old. If we do receive the funding needed for this research, we will apply for new ethics approval to use your blood samples in an ethical and legal way. We will then transfer your blood samples from the Newcastle NHS Trust freezers to a university laboratory where the analysis will take place. We expect the samples to be stored and analysed by 31 st July 2026, and any remaining samples will be destroyed by incineration following the completion of the analysis.

If you agree to this optional extra, you are able to change your mind at any time without giving a reason and without your care or legal rights being affected, until 31 st July 2025. To do this, you will need to contact the Principal Investigator for this research study (contact details on page 1) requesting to withdraw, and giving them your SHAPES participant ID number. If you withdraw from the study then your sample will be destroyed and your data will not be included in any future research project.

Part Three

Will my taking part in the study be kept confidential? Yes. Newcastle upon Tyne Hospitals NHS Foundation Trust, based in the United Kingdom, is the sponsor for this study and will act as the data controller for it. This means they are responsible for looking after your information and using it properly. Newcastle upon Tyne Hospitals NHS Foundation Trust will keep identifiable information about you for 5 years after the study has finished. Newcastle upon Tyne Hospitals NHS Foundation Trust will collect information from you and/or your medical records for this research study in accordance with our instructions. Only trained clinical-research team members will have access to your information.

Your rights to access, change, or move your information is limited, as we need to manage your information in specific ways in order for the research to be reliable and accurate. If you withdraw from the study, we will keep the information about you that we have already obtained. To safeguard your rights, we will use the minimum personal identifiable information possible.

Individuals from Newcastle upon Tyne Hospitals NHS Foundation Trust (NuTH) and regulatory organisations may look at your medical and research records to check the accuracy of the research study. The research team will pass these details to individuals at NuTH along with the information collected from you and/or your medical records upon request for audit purposes. The only people in NuTH who will have access to information that identifies you will be people who need to contact you to discuss this study or audit the data collection process. People outside the NuTH will have no access to your identifiable information and will not be able to access your medical notes, find out your name, NHS number or contact details.

If you give consent to participate in the study, we would use non-identifiable personal information (through allocating a study ID number) to analyse the data and report the findings. Any paper documents will be stored in a locked fire-resistant cupboard at the RVI. To allow us to analyse the anonymised data it will be transferred to a secure server on the Newcastle University system and stored in accordance with the regulations of the Data Protection Act 2018 and the Newcastle upon Tyne Hospitals NHS Foundation Trust Caldicott guidelines. You can find out more about how we use your information at:

• www.hra.nhs.uk/information-about-patients/
• https://newcastlejro.com/research/new-study/data-security
• Email the NUTH Data Protection Officer, Richard Oliver: richard.oliver2@nhs.net

Future research: If you consent to us keeping your data for future research, it will be stored on a secure server at Newcastle University. Newcastle University will be the data controller for the future research. All data protection regulations will be followed. Even if you agree to us storing this data, we will still need to get ethical approval to access your data again for future research. This would be to make sure we are using the data in the way we have told you about in this document, and that you have consented to. If you consent to us storing your data, we will not share it with anyone else or use it for any other purpose than described in this document. If you consent to us storing this data for future research, you are free to withdraw at any time, without giving a reason. Any information already collected can be destroyed if you wish. If you change your mind, your care will not be affected in any way. To withdraw from this future research, please contact the chief investigator (contact details on the last page of this document).

What will happen to information collected about me for the research study? The information we collect during the study will be analysed (or processed) to enable us to explore if body shape measurements in early pregnancy relate to the health of women and babies.

Who is organising and funding the research? This project is funded by the Department of Health via the National Institute for Health Research. It is being led by Dr Nicola Heslehurst who is a researcher at Newcastle University.

Who has reviewed the study? This study has been reviewed and given a favourable opinion by North East - Newcastle & North Tyneside 1 Research Ethics Sub-Committee. The study design has been reviewed by Sponsor (NuTH). Members of the public were involved in review of a scope (lay summary), design and incentives for this research.

Extra Contact Details

Where can I get further information about the study? If you have any questions or concerns about participating in the study please contact the Principle Investigator for this research at the RVI
(Raya Vinogradov, 0191 2820362 nuth.rhnresearch@nhs.net), or the Chief Investigator from Newcastle University (Nicola Heslehurst, 0191 2083823, nicola.heslehurst@ncl.ac.uk).

What if there is a problem? If you are not satisfied with any aspect of the way you have been approached or treated during the course of this study, you should first speak to the research team (please see contact details on page 1) who will do their best to answer your questions. If you remain unhappy and wish to complain formally, the normal National Health Service complaints mechanisms are available to you: please ask to speak to the complaints manager for the Hospital.

If you have any concerns about how you are treated in relation to this research study, you can raise these with the Patient Advice and Liaison Service (PALS). This service is confidential and can be contacted on Freephone: 0800 032 0202. Alternatively, if you wish to make a formal complaint you can contact the Patient Relations Department, Tel: 0191 2231382 or 0191 2231454, Email: nuth.patient.relations@nhs.net
Address: Patient Relations Department, Newcastle upon Tyne Hospitals NHS Foundation Trust
Thank you for taking the time to read this participant information sheet.