title: A multi-centre phase IIa clinical study of predictive testing for pre-eclampsia. IMproved PRegnancy Outcomes Via Early Detection (IMPROVED).
abstract: 1 in 20 first time pregnancies is complicated by pre-eclampsia, the leading cause of maternal death in Europe. No clinically useful early pregnancy screening test exists, consequentially clinicians are unable to offer targeted surveillance or preventative strategies. IMPROVED Consortium members have pioneered a personalised medicine approach in identifying blood-borne biomarkers through recent technological advancements, involving mapping of the blood metabolome and proteome. The Consortium recently received funding under the auspices of the 7th Framework Programme of the European Union under the call: HEALTH- 2012-INNOVATION-1.2-1 (Grant Agreement no. Health-F5-2012-305169). The objective is to develop a sensitive, specific, high-throughput and economically viable early pregnancy screening test for pre-eclampsia. We report the design of a multicentre, phase IIa clinical study to assess and refine innovative prototype tests based on emerging metabolomic and proteomic technologies. Participation involves serial maternal phlebotomy, collection of clinical data, and pregnancy outcome data. Participants will attend essential visits at 15 and 20 weeks' gestation, with optional 11 and 34 weeks' gestation. Blood samples will undergo a combination of proteomic and metabolomic tests, and diagnostic performance will be assessed in accord with a pre-approved statistical analysis plan which will report Receiver Operating Curves, and Positive Predictive Values. The study is expected to refine proteomic and metabolomic panels, combined with clinical parameters, and evaluate clinical applicability as an early pregnancy predictive test for pre-eclampsia. If 'at risk' patients can be identified, this will allow stratified care with personalised fetal and maternal surveillance, early diagnosis, timely intervention, and significant health economic savings. The IMPROVED biobank will be accessible to the European scientific community for high quality research into the cause and prevention of adverse pregnancy outcome.
authors.forename: Louise
authors.initials: L
authors.lastname: Kenny