IMproved Pregnancy Outcomes by Early Detection; personalised medicine for pregnant women: novel metabolomic and proteomic biomarkers to detect pre-eclampsia and improve outcome.

1 in 20 first time pregnancies are complicated by pre-eclampsia, the leading
cause of maternal death in Europe. No clinically useful screening test exists;
consequently clinicans are unable to offer targeted suveillance or
known/emerging preventative strategies.

IMPROvED Consortium members have pioneered a personalised medicine approach to
identifying blood-borne biomarkers through recent technological advancements,
especially in the field of mass spectrometry and the comprehensive mapping of
the blood metabolome and proteome.

The application of new technologies to identify 'at risk' patients in early
pregnancy will allow stratified care with personalised fetal and maternal
surveillance, early diagnosis and timely intervention. This will lead to
significant health economic saving and moreover an accurate predictive test
would be a crucial step in reducing the life-threatening complications of the
disease.

The prime objective of the IMPROvED project is to develop a clinically robust
predictive blood test for pre-eclampsia, using innovative technologies and
utilising novel metabolite and protein biomarkers.

This blood test is targeted to all first time mothers during early pregnancy to
determine their risk for this major pregnancy complication.

The IMPROvED study will:
1. Determine whether prototype predictive assays and algorithms translate to
the clinical environment
2. Establish a residual biobank that can be accessed by the European scientific
communtiy for high quality research into the cause and prevention of adverse
pregnancy outcomes

5000 first time mothers will be recruited over the course of 2 years to
academic medical centres across Europe (Ireland, UK, the Netherlands, Sweden,
and Germany), in a phase IIa prognostic multicentre hospital-based clinical
study.

Six recruitment sites (all with high patient-throughput) have been selected on
the basis of investigator expertise and background in pre-eclampsia research.

Pertinent and detailed clinical data will be collected, and blood samples taken
in the first trimester, at 15, 20 and 34 weeks* gestation. Women will then be
followed throughout their pregnancies and pertinent outcomes will be recorded.

Four times venipuncture during pregnancy. This will be combined with the blood
sample in the context of the clinical care if possible. This procedure has a
minimal risk to the participant.