Researchers from the Universities of Aberdeen and Edinburgh are looking into the use of progesterone for early pregnancy bleeding in Scotland.
Bleeding in the earliest stages of pregnancy is known as threatened miscarriage. It affects 1 in 5 pregnant women and whilst many pregnancies will continue normally, up to a third of women with early pregnancy bleeding may go on to lose the pregnancy. The hormone progesterone has been shown to reduce the risk of pregnancy loss in women experiencing bleeding who have had one or more previous miscarriages.
In 2021, the National Institute for Health and Care Excellence (NICE) made the decision to recommend that women with early pregnancy bleeding, who have had an ultrasound scan confirming ongoing pregnancy, and have had at least one miscarriage should be offered progesterone to protect against early miscarriage. However, research shows that 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.
The PROTEA Study, funded by the Scottish Government’s Chief Scientist Office, and led by Dr Andrea Woolner, Senior Clinical Lecturer at the University of Aberdeen who is also an Honorary Consultant Obstetrician and Early Pregnancy Lead at NHS Grampian, is now underway across all Scottish health boards to fully evaluate this approach. The team will find whether the current ‘blanket’ approach is the most appropriate and understand how progesterone treatment is implemented in practice.
As well as looking at whether miscarriage is prevented, the team will also look at any impact in later pregnancy and early neonatal life as well as the costs associated with the current approach.
They will use routinely collected NHS data to study what happens to pregnancies for women who present with early pregnancy bleeding and are appealing to all early pregnancy unit staff in all 14 Scottish Health Boards to keep helping them collect data on early pregnancy information until the study closes in 2027.
Dr Andrea Woolner, Senior Clinical Lecturer at the University of Aberdeen
The information collected will explore whether progesterone treatment affects the risk of other complications in pregnancy such as pre-eclampsia and if it has any effect on babies.
Professor Colin Duncan, from the Centre for Reproductive Health at the University of Edinburgh who is collaborating with Dr Woolner on the project, said: “We all want to ensure the best possible outcomes for women and babies.
“This study allows us to explore the uptake, effectiveness and impacts of progesterone supplementation in threatened miscarriage in the real world by looking outcomes from the whole of Scotland.
“The impressive record system within Scotland means we are ideally placed to carry out this important research.”
Dr Woolner said: “We believe it is critical that this research is undertaken to follow up on the important findings from the clinical trials investigating this treatment to understand how progesterone may work in real-world settings and provide much-needed information on the benefits, safety, and consequences of progesterone use is made available as this treatment becomes part of normal care.
“We will use routine data collected within Scottish hospitals to observe how well progesterone works in terms of preventing miscarriage when used across the population and what additional NHS resources are needed to support this service. We will monitor for any other effects progesterone might have, be that beneficial or potentially harmful, on the rest of the pregnancy and babies.”
Vicki Robinson, chief executive officer at the Miscarriage Association, said: “Miscarriage can be an incredibly painful and isolating experience, and research like this is vital to ensuring that care and treatment are grounded in strong, evidence-based guidance.
“We’re pleased to be working alongside researchers and patients on this important study.”