Preterm birth is birth that happens before 37 weeks of pregnancy. It affects around seven out of every 100 babies born in the UK. We do not fully understand why some babies are born too early and at present there are few effective treatments to prevent this from happening. Research shows it is likely that early labour may occur in some pregnancies because of inflammation in the mother’s body. Taking a medication that reduces inflammation, such as Pravastatin, could therefore reduce the number of babies being born too early.
Pravastatin is a statin, and statins are a group of medicines which are commonly taken to help lower the risk of heart disease and stroke. Statins work by protecting blood vessels and lowering inflammation in the body. During the past couple of decades, Pravastatin has been used during pregnancy in studies which have investigated whether Pravastatin prevents or treats other problems/complications of pregnancy. In total 1,303 pregnant women took part in these studies, which showed that there were no safety concerns or problems regarding the baby’s development.
Do I have to take part?
Before you decide whether to take part in this study, it is important that you understand why the research is being done and what it will involve for you. You do not have to take part.
If you do choose to take part but later change your mind, you are free to withdraw at any time. You do not have to give a reason for your decision. The standard of care you receive will remain the same.
If you are interested in joining the study, the local research team at your hospital will speak with you and answer any questions at the time of your first Preterm Birth Prevention Clinic (PTBPC) appointment. Please take time to read this information sheet carefully. If anything is not clear, or you would like more information, please don’t hesitate to ask a member of the research team. Talk
to others about the study if you wish, such as friends or relatives, and take time to decide whether you would like to take part.