Karolinska Institutet & IMPROvED fighting Pre- Eclampsia, the leading cause of maternal death in Europe

Karolinska Institutet and the KI Centre for Gender Medicine are hosting an international expert meeting on the pregnancy disorder pre-eclampsia next Monday and Tuesday, the 11th and 12th of May . Over the two days top-class obstetric clinicians, midwives, scientists and industry partners from 8 European countries are meeting to discuss exciting progress in the large European funded study IMPROvED.

IMPROvED – standing for IMproved PRegnancy Outcomes by Early Detection – has set out to develop a non-invasive, sensitive, specific, and clinically robust blood-screening test for pre-eclampsia, using novel metabolite and protein biomarkers, to achieve better outcomes for mums and babies. There are currently no tests for pre-eclampsia, IMPROvED, co-ordinated by Professor Louise Kenny, is the first prospective trial anywhere ever to test two new prototypes for early pregnancy screening.

Science with the help of mothers

First-time pregnant women who have never before given birth are being recruited in Ireland, the United Kingdom, Germany, Sweden and the Netherlands to take part in the study. The study involves two compulsory visits with two additional optional visits. Eligible women who meet the selection criteria – less than 17 weeks pregnant, in good health (i.e., no high blood pressure, no diabetes, no kidney disease) – are seen by a research midwife and undergo routine clinical evaluations, such as weight, height, blood pressure, and pulse readings, and also give urine, hair, and blood samples. The patient –midwife relationship is critical to the success of recruitment. As research midwife, Boel Niklasson, notes: “Women who agree to participate are not only helping make pregnancy safer in the future, but being in our programme also provides first-time mums with a little extra quality time with a midwife which is always nice in a first pregnancy”.

The help of first-time mothers is vital to the success of IMPROvED. Hanna Hellström, the first women recruited to the project in Stockholm noted: “Pre-eclampsia can have a devastating outcome for both mums and babies. By joining IMPROvED I feel that I am contributing to a better and more personalised approach to understanding the cause of this disease”.

Supported by €6m in funding from the European Union’s Seventh Framework Programme, IMPROvED (IMproved PRegnancy Outcomes by Early Detection) has recently reached an important recruitment milestone with over 1700 women recruited and is now more than a third of the way to reaching its target of including 5000 first time mothers in the study.

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 clinicUltraljudsbarnmorskorna, the Midwifes Team at the Centre for Fetal Medicine at Karolinska Hospital, team at Ultragyn, Odenplan, the midwife project coordinator Boel Niklasson and many more. I am so pleased to have these enthusiastic teams on board”.

IMPROvED: Revolutionising maternal and fetal health care

Collecting blood is just the beginning. The study will generate hundreds of thousands of samples, and a vast amount of patient data. The Swedish company MedSciNet AB has developed software to manage and protect all the data generated in 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: “Researchers at all European recruiting hospitals can access the software “via the web browser to input clinical and sample data”.

Tangible benefits of IMPROvED include:

• A reduction in the overall disease burden on mums and babies
• Reduced healthcare costs
• High-calibre research will be facilitated
• increased European competitiveness in this research fiel

Pre-eclampsia the leading cause of maternal death in Europe

Pre-eclampsia, a common late-stage pregnancy complication is the leading cause of maternal death in Europe and is responsible for 70,000-80,000 maternal deaths and more than 500,000 infant deaths worldwide annually. The objective of the IMPROvED project is to assess and refine two innovative screening tests for the early detection of this complex disorder.

Associated Professor Karolina Kublickiene, IMPROvED Primary Investigator at Karolinska Institutet says, “our goal is to save the lives of affected mums and babies by reducing and eventually preventing the life-threatening complications associated with pre-eclampsia.” Professor Louise Kenny (Cork Ireland) adds that “Mums-to-be can be confident that they are in excellent hands as all participating obstetric recruitment centres have well-established track records and outstanding reputations for the research and management of pre-eclampsia”.