Frequently Asked Questions
What is the purpose of the study?
The purpose of the study is to find out more about the pattern of normal growth among healthy babies both before and after birth. Currently, your baby’s growth before birth is assessed by comparing ultrasound measurements of the size of your baby’s head and tummy with reference charts obtained from the growth of a small number of babies from selected hospitals. Unfortunately, most of these ultrasound charts of size by gestational age were obtained from very small studies of growth of babies in the USA or Europe, and may not be appropriate for use internationally. This project will be conducted in eight different countries simultaneously over a five year period. We aim to recruit 4000 participants internationally. To the best of our knowledge, this project is unique because of its size and because it studies healthy mothers and babies in different parts of the world. We hope that this study will shed light on the growth pattern of healthy unborn babies and newborns across the world and can be used to set a new “gold” standard internationally: How fetuses should grow!
Why have I been invited?
You have been invited to take part because you are aged between 18 and 35, are fit and healthy, have regular menstrual cycles, have conceived spontaneously and have a gestational age of less than 14 weeks now.
What will I be asked to do?
If you agree to take part in the study, you would be offered, after this dating scan, 6 further scans scheduled at 5 weekly intervals: 14-18 weeks, 19-23 weeks, 24-28 weeks, 29-33weeks, 34-38 weeks and 39-42 weeks. At each of these visits, you would have an ultrasound scan. Apart from the additional scans, you would receive the standardized antenatal care. If your baby is born early (less than 37 weeks) we will monitor the growth of your baby for 8 months. This would include measuring your baby’s weight, length and head circumference every 2 weeks for the first eight weeks and then monthly until eight months after birth.
Do I have to take part?
It is entirely up to you to decide whether or not to take part. Your decision will not affect the care you receive. If, after reading this information, you have questions about the study, name of research midwife (to be appointed) would be happy to answer them. Her contact details can be found at the end of this information sheet.
What are the possible disadvantages or side effects of taking part?
We do not foresee any disadvantages to you as a result of participating in this study other than the extra visits to the Hospital.
What are the possible benefits of taking part?
Taking part in this study would not benefit you directly. However you have the opportunity to have 5 extra scans during your pregnancy, for which all travel expenses can be reimbursed. The information obtained from this study will enable us to create for the first time unique fetal and newborn growth charts which can be used internationally and potentially save the lives of many babies and newborns.
What if there is a problem?
Because the study only involves additional ultrasound scans and external measurements of your newborn baby; the likelihood of harm to you or your baby from the study is negligible. If you have concerns about the way you have been approached or treated during the course of the study, you can contact the study unit coordinator.
Will my taking part in the study be kept confidential?
Only the system administrator (who has a duty of confidentiality to you) would be able to identify you. Your results and pictures would be held anonymously in a database to which only the research team will have access. Authorised representatives from the University of Oxford may look at the anonymised results to check that the study is being performed correctly. Anonymised data will be stored on a computer database in the secure servers of the Oxford University Computing Service. No individual participants will be identified when the results of the study are published. In clinical research such as this, it is our responsibility to inform your GP that you have agreed to take part in this study. This is to ensure that you are fit and healthy at the time of participation and remain well during the course of the study.
What will happen if I don’t want to carry on with the study?
You may withdraw from the study at any time. This would not affect the care you get in any way. Any stored data that identifies you would be destroyed.
What will happen to the results of the research study?
The results will be written up for worldwide distribution, publication in scientific journals and presentation at international meetings. We would be happy to provide you with a copy of the papers after publication if you wished. You personally would not be identifiable in any report or publication. Some of the data from the study will also contribute to the PhD thesis of one or more of the researchers.
Who is organising and funding the research?
The research is being carried out by the Nuffield Department of Obstetrics and Gynaecology. The study is funded by the Bill and Melinda Gates Foundation.
Who has reviewed the study protocol?
Research is reviewed by an independent group of people called a Research Ethics Committee to protect your safety, rights, well being and dignity. This study has been reviewed and approved by Oxfordshire Clinical Research Ethics Committee C.
Contact for further information
If you have any further questions please do not hesitate to contact the Chief Investigator: Jose Villar, Nuffield Department of Obstetrics and Gynaecology, University of Oxford, John Radcliffe Hospital, Women’s Centre, Level 3, Headington, Oxford, OX39DU. Tel. +44 1865 740885