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PATIENT INFORMATION SHEET
Title: About Teenage Eating (ATE)
22/3/2006 Version 3
You are invited to take part in this project. Before you decide it is important for you to understand why the study is being done and what it involves. Please read this information sheet carefully and feel free to discuss it with your partner, friends and family. We can answer any questions you may have. Take time to decide whether or not you wish to take part.
What is the purpose of this study?
We want to find out what we should be telling young pregnant women about their diet, and whether this information is especially important for certain teenagers (such as those who are still growing when pregnant). We hope that this project will help us to improve the future health of young women and their babies.
Why have I been chosen?
You have been invited to take part because you are a young pregnant woman between the ages of 14 and 18.
Do I have to take part?
It is up to you. If you decide to take part you are still free to withdraw at any time without giving a reason. This will not affect your care in any way.
What will happen if I take part?
A midwife involved in the project will meet with you 2 times during the pregnancy although there might be a need for a third visit if some of the measurements are not taken on the second visit. 2 telephone questionnaires take place between 32 to 36 weeks.
When will I see this Midwife?
The first visit is before you are 20 weeks pregnant. The second will be some time between 28 and 32 weeks. If a third visit is necessary, it will be between 34 and 36 weeks. The research midwife will try to meet you when you would normally be attending your antenatal appointments, or whenever is easiest for you.
photo to be inserted
London Participant Thalita Batista Ostermann and baby Joao Pedro born October 4, 2005
What will I need to do?
During the visits you will be asked questions about what you eat and drink. There are no right or wrong answers. Do not worry if you cannot answer all the questions. We will also take some measurements to find out if you are still growing.
At the second visit we will take a sample of blood. This can be taken with your routine blood tests. During this visit a doppler scan will also be done. This test is a special scan and looks at the blood flow from your placenta to your baby.
After your baby has been born we will collect information from your maternity notes about your pregnancy, birth and baby.
We are also interested in looking at how the placenta works during pregnancy. Once your baby is born the placenta (after birth) is delivered. Usually this is thrown away. We would like your permission to use this in the laboratory, to examine how the placenta forms, how nutrients cross it and how it ages through your pregnancy. You will be asked whether you agree to us having your placenta at your last visit with the research midwife, and will be asked to sign another consent form if you are happy with this.
If you don’t want to give us your placenta you can still take part in the other parts of this project. If you have any questions at any time, please ask.
What are the possible disadvantages of taking part?
Each visit will take about 30 minutes. This is in addition to routine antenatal care. Some extra blood will be taken at the time of routine samples.
What are the possible benefits of taking part?
You will be part of a project that will tell us how to advise young women about eating during pregnancy.
What happens when the study stops?
The information we have collected from you will be analysed in confidence and only by researchers directly linked to this study. Some of the information will be stored on computer and only accessed by these researchers with confidential passwords. You will be given a patient identification number and instead of using your name, this number is used at all times. If the results of the study are published in a report, you will not be identified in any way.
Who has reviewed the study?
The Central Manchester Local Research Ethics Committee.
How can I find out more about the project?
You can read more about the project on the website www.medscinet.com/teen or contact the research midwives below:
Manchester:
Georgina Bennett and Gemma Wild
Tel: 0161 276 5470, Mobile 07716 010 588
London:
Cindy Hutchinson
Tel 020 7188 3634, Mobile 07960 065 473
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