Developing a new screening test for a life-threatening maternal condition
In countries with well-developed healthcare systems, dying as a direct result of a condition brought on by pregnancy is a remote and shocking possibility. Nevertheless, one such condition, pre-eclampsia, affects 2% of all first-time mothers, and, moreover, to date no viable screening test has been developed.
Without an effective test for this little known or understood condition, clinicians are unable to offer preventive measures to lower the risk of it developing.
Pre-eclampsia, which causes high blood pressure in the second half of pregnancy, accounts for up to a quarter of maternal deaths in Europe and more than 500 000 infant deaths annually worldwide.
But this situation is on the verge of changing. For the past 12 years, the University College Cork in Ireland has been one of the pioneering institutes in the emerging science of metabolomics, the study of the chemical processes of the small molecules involved in metabolism. The university has now developed a prototype test consisting of a panel of biomarker metabolisers, which it believes can predict pre-eclampsia at an early stage of pregnancy (15 weeks).
According to Professor Louise Kenny, the project coordinator of IMPROvED, data from a pilot study shows that the test offers “an unprecedented degree of specificity and sensitivity”.
Thanks to European Union (EU) funding of €6 million, Prof Kenny will be able to lead a consortium of researchers and clinicians in conducting a phase II trial of this prototype test.
The project is one of 26 research projects focusing on rare diseases that the European Commission announced on Rare Disease Day 2013 would receive funding worth a total of €144 million.
Under the IMPROvED project (IMproved Pregnancy Outcomes by Early Detection), 5 000 first-time pregnant women from across Europe will provide blood samples at four points during pregnancy.
Charles Garvey from the project’s partner Metabolomic Diagnostics, a Cork-based SME, says that “metabolomics offers a breakthrough in the discovery of effective screening tests by providing a window into what is actually happening in the metabolism at any moment in time”.
Along with the metabolomics-based test, the IMPROvED project will also trial a protein-based test. “At the end of the study, we’ll know which test works best. We’ll also be able to see whether combining the tests will give rise to a super test,” says Prof Kenny.
The research team hopes to demonstrate an effective test that in a few years’ time can be licenced around the world.
If this ultimate goal is not reached, however, the study will have at least enabled researchers to further refine their test, and furthermore, it will have created a ‘bio-bank’ of data from the participating women that researchers can build on to continue to improve screening tests in general.
While proven interventions for pre-eclampsia are also at an early stage, screening is still beneficial, according to Prof Kenny. “If you can pick out women at risk, you can push them into a different pattern of antenatal care, including increased maternal and foetal surveillance, which means that the disease can be picked up early, and mothers and babies can be saved,” she argues.
Moreover, some innovative preventive measures have been shown to be quite effective – for example, giving aspirin to women at high-risk of pre-eclampsia at low doses can decrease the risk of the condition developing by about 30%.
The development of a reliable screening test will also lead to significant healthcare savings. Women who are shown to not be at risk of developing pre-eclampsia can safely remain on less expensive low-risk care, while large savings will result from the reduced incidence of this disease.