IMPROvED: Preventing preeclampsia from day zero

IMPROvED is an inter-European research consortium that will screen thousands of mothers to find hidden signs of pregnancy complications.

Last October, a little baby came to life in Karolinska Institute’s Huddinge Hospital with the help of the midwife Boel Niklasson. This baby is not just one of the 110.000 newborns in the Sweden every year: we know more about this baby’s mother and father than any other baby ever born in Sweden, as scientists have been closely monitoring them since the first weeks of pregnancy.

This is a lucky baby too: it was born without complications. But in Europe, one in every twenty pregnancies are at risk due to preeclampsia, a medical condition where high blood pressure precedes kidney and liver dysfunction, stroke and eclampsia (the involuntary contraction of muscles) in the mother. If undetected, pre-eclampsia may compromise the fetus normal development, and a baby may need to be delivered before its full development.

Pre-eclampsia usually arise in the second half of pregnancy, and together with fetal growth restriction and spontaneous preterm birth, it is the leading cause of illness and death in mothers and babies in Europe.

To detect signs of the disease before it manifests is the mission of IMproved Pregnancy Outcomes by Early Detection (IMPROvED), an inter-European research consortium sponsored by the 7th Framework Programme (7FP). IMPROvED has the ambitious goal to recruit and monitor 5.000 first-time mothers across Europe, and to collect blood samples at different time during their pregnancy.

"We try to bring science closer"

This was the first baby born by a mother who volunteered to help researches with the IMPROvED project in Sweden. With the use of state-of-the-art mass spectrometry, important molecules running in the blood of the mothers will be identified, and by comparing safe and complicated pregnancies, scientists at NOVUM hope to identify factors that can predict pre-eclampsia.

Ireland, UK, The Netherlands, Germany and Sweden host seven, highly specialised medical centres for women recruitment and monitoring. In Sweden, the recruitment is ongoing at Karolinska Institutet, supervised by principal investigator and associate professor Karolina Kublickiene, Head of Unit of Centre for Gender Medicine. “The recruitment at Karolinska is going very well, with already 120 women involved in the study” says Dr. Kublickiene. “Such high number of women would have never been possible without our excellent recruitment collaborators: the clinic Ultajudsbarmorskor, the Midwifes Team at the Centre for Fetal Medicine at Karolinska Hospital, the midwife project coordinator Boel Niklasson and many more. I am so pleased to have these enthusiastic teams on board”.

Karolinska aims to recruit 750 first time moms by the end of 2015, a goal that may seem far away. “We must communicate to mothers and patient organisations about the importance of our research" says Dr. Kublickiene, "we try to bring science closer to those who needs it most”.

The idea of IMPROvED is to develop a small, inexpensive and sensitive test that can be used in all healthcare setting to also detect small or vulnerable babies for which a normal delivery may be a risk. IMPROvED is among the first international consortium to spin off personalized medicine for women’s health. "Karolinska is involved into an innovative project that not only will help future mothers, but will also strengthen research collaboration with other European partners" says Dr. Kublickiene.

IMPROvED BioBank & Big data

A key factor that will determine the success of IMPROvED is the collection, organisation and storage of blood samples. Dr. Monica Eriksson is responsible for the BioBanking at Karolinska Institutet, where -82C freezers currently preserve 25.000 tubes.

"For IMPROvED we have allocated 500.000 new slots" says Dr Eriksson "We think that BioBanking is a key tool that will lead to more personalised medicine in the next future, granting researchers access to a number of samples once inconceivable to imagine. This is why Karolinska has invested in developing these ‘libraries’".

BioBanks are exactly like libraries, with human samples that store information instead of books. But some people may be worry about privacy. “Every appropriate safeguards is in place to protect mothers confidentiality: only researchers with special approval can gain access to the resources stored in BioBank, all the information stored in BioBanks follow the EU regulation on privacy, and tubes are labelled anonymously” says Dr Eriksson. "I do not think that privacy will be a concern for anyone who wish to join the study".

Collecting blood is just the beginning. The consortium will produces thousands of samples which will give rise to twice as many metabolomic and proteomic datasets, for a total of several million numbers. To make sense of these massive amount of information, the Swedish company MedSciNet AB will develop software to handle and organise whatever comes out from the study. "We are an Application Service Provider" says Sten Marthinsson, Sales Manager of MedSciNet which build complex software, tailored after the needs of the project. We will make the software available to all the participants in Europe via the web browser. All researchers involved will have access to the data according to their defined access rights”.

The research project will run the full circle: from bed to bench, to bed again. IMPROvED not only will predict biomarkers for women and children's health, but will also to put in motion the necessary regulatory approval to bring the test into the clinical arena. “It is the partnership between academia, health care providers, industries and patient organizations that gives true value to IMPROvED” says Dr Kublickiene. “I would call our network ‘a roadmap’ towards innovation for women’s health, where we gathered all the necessary partners to impact on people health”.

text by Riccardo Guidi