The PROTEA Study

Bleeding in the earliest stages of an ongoing pregnancy is known as threatened miscarriage. It affects 1 in 5 pregnant women, a third of whom will ultimately go on to lose their baby. The hormone progesterone has been shown to reduce the risk of pregnancy loss in women who have had one or more previous miscarriages. Although this treatment has recently been recommended by the National Institute of Clinical Excellence (NICE), progesterone is not equally effective in all women and appears to be more beneficial to those who have had several previous miscarriages. In addition, as with any medication used in pregnancy, the benefits of treatment need to be balanced against any possible unforeseen effects on babies. NICE guidance is gradually being rolled out across Scotland in the next few years with some hospitals offering the treatment earlier than others. In this proposed research, we aim to use hospital records from all Scottish hospitals to study how well progesterone works in terms of preventing miscarriage and what additional NHS resources are needed to support this service. The information collected will also help us to understand whether progesterone treatment affects the risk of other complications in pregnancy such as pre-eclampsia and if it has any effect on babies. We believe it is critical that this research is started soon and that much-needed information on the benefits, safety, and consequences of progesterone use is made available before this treatment becomes part of normal care.