| Patient information leaflet - VIPS |
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[1/7/00 version 3] Vitamins In Pre-Eclampsia Study, a Multicentre Research Study You are being invited to take part in a research study. Before you decide whether to take part it is important for you to understand why we are doing this research and what is involved. Please take time to read this leaflet. If you want to, please discuss it with your doctor or midwives. Please feel free to ask us if anything is not clear, or if you would like more information. Thank you for taking the time to read this. What are we trying to find out? We want to see if taking vitamin C and E in pregnancy helps
prevent pre-eclampsia. What happens in pre-eclampsia? The mother may get high blood pressure and protein in her urine. The baby may grow slowly. A few women with pre-eclampsia may become very ill and the baby may need to be delivered early.When does it happen This illness can happen at any time during the second half of pregnancy. Sometimes it starts in labour or even just after the baby is born.What happens to the mother? Most women who get pre-eclampsia do not get any symptoms. Some may get a headache, blurred vision, and/or stomach pain. Sometimes women may get swollen fingers, face and ankles (although these do not necessarily mean you have pre-eclampsia). Doctors and Midwives may give the mother drugs to lower her blood pressure for a while. But the best way to make the mother get better is to deliver the baby. This is why women with pre-eclampsia may have their babies delivered early.Why have I been chosen? This condition can effect anyone and in many cases there is no obvious cause. We know that some women are more at risk of getting pre-eclampsia. These include those expecting their first baby, those who have had it before, and those who have high blood pressure before they become pregnant. Some women with underlying medical conditions, such as diabetes, kidney disease, and vascular disease may also be at increased risk. An abnormal Doppler scan (before 22 weeks) of your blood vessels feeding the placenta may also indicate increased risk. This is why you have been asked to help.We are testing a new treatment for pre-eclampsia. We believe it is better to start the treatment before the woman gets ill. If we wait until she gets high blood pressure it may be too late to help. The new treatment is simply vitamins C and E taken together. We have already conducted a small study (283 women at high risk of getting pre-eclampsia) and this new treatment looks very promising. Now it is important to see if this treatment works on much larger numbers of women. Do I have to take part? It is entirely your choice whether or not you decide to take part. If you agree to join the study you will keep a copy of this information sheet and be asked to sign a consent form. You are free to change your mind and withdraw from the study at any time without giving a reason. The care you receive will not be effected by this decision.What will happen to me if I take part? You will be asked to take 2 tablets every day until you have your baby. These will either be vitamin C and E or identical looking dummy tablets. We do not know if the vitamins will help and that is why we need to compare women who take vitamins with others who do not. Whether you get the vitamins or the placebo will be decided by a computer. You will not know which tablets you will be taking and neither will the doctors and midwives looking after you (although they will be able to find out if they need to). You should not take any supplementary vitamins other then those prescribed by your GP (such as folic acid).You will be given sufficient packets of tablets to last you till the end of pregnancy. When you finish each packet we would be grateful if you could post back the empty packet in the freepost envelope provided. The research midwife at your local hospital will also contact you each month to make sure everything is OK. A few women will also be asked to have an additional blood test at the start of the study and on 2 other occasions; this will be done with routine antenatal blood tests whenever possible. What do I have to do? All you have to do is take the tablets every day, and when each packet is finished post it back to us in the Freepost envelope provided.What is the drug being tested? The vitamins are an essential part of a normal healthy diet. We are giving them in larger doses than you would normally get from your diet.What are the side effects of taking part? Side effects to these vitamins are extremely rare. In the previous study we gave 141 women the same vitamins we are using now, there were no reported side-effects. We do not anticipate any problems for those taking part in this study.If you have any concerns please contact your
research midwife, pager number ………………, What are the possible benefits of taking part? The information we get from this study may help us to treat future pregnant women to prevent pre-eclampsia.What if new information becomes available? If new information about the drug/ treatment being studied comes to light your research midwife/ doctor will tell you about it and discuss whether or not you want to continue in the study. Your doctor may decide it would be in your best interest to stop. He/she will explain the reasons and make arrangements for your continuing care.What happens if something goes wrong? In the unlikely event that you are harmed by taking part in a research project, there are no special compensation arrangements. If you are harmed due to someone’s negligence you may have grounds for a legal action, but you may have to pay for it. Regardless of this, if you wish to complain about any aspect of the way you have been approached or treated during the course of this study, the normal National Health Service complaints mechanisms will be available to you.Will my taking part in this study be kept confidential? All information collected about you during the course of study will be kept strictly confidential. Any information about you that leaves the hospital will have your name and address deleted, so that you can not be recognised by it. This includes data that is transmitted electronically. Details about the trial and your participation will be kept in your hand held notes, so that any clinician caring for you, (GP, midwife or obstetrician) will be aware of the treatment you may be receiving. In an emergency they can find out whether you are on vitamins or dummy tablets. If you or your baby have a serious illness in the future we may be informed by the office for national statistics, and this information will remain confidential.What will happen to the results of the research study? The results of this study should be available from the middle of 2003. Your local co-ordinating midwife can be contacted after this time if you want to know the results and which tablets you were taking.Who is organising and funding the research? The midwives running the study are paid for by the sponsors of the research. The hospital and other clinicians do not receive anything if you participate in the project.Who has reviewed the study? The Research Ethics Committee in your area has reviewed and agreed to this study.Contact for Further information Your local research midwife for this study can be contacted via her pager number ..................... Or please ring the trial answerphone on ....................... Consumers in Ethics in Research (CERES) publish a leaflet called “Medical Research and You”, this leaflet explains more about medical research and answers some of the questions you may want to ask. You can get a copy of the leaflet from CERES, PO Box 1365, London N16 0BW. You will be given a copy of this form and a signed consent form to keep if you take part. |
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