A multi-centre phase IIa clinical study of predictive testing for preeclampsia: improved pregnancy outcomes via early detection (IMPROvED)
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Published Version
Date
2013-12-07
Authors
Navaratnam, Kate
Alfirevic, Zarko
Baker, Philip N.
Gluud, Christian
Grüttner, Berthold
Kublickiene, Karolina
Zeeman, Gerda
Kenny, Louise C.
Journal Title
Journal ISSN
Volume Title
Publisher
BioMed Central Ltd.
Published Version
Abstract
Background: 5% of first time pregnancies are complicated by pre-eclampsia, the leading cause of maternal death in Europe. No clinically useful screening test exists; consequentially clinicians are unable to offer targeted surveillance or preventative strategies. IMPROvED Consortium members have pioneered a personalised medicine approach to identifying blood-borne biomarkers through recent technological advancements, involving mapping of the blood metabolome and proteome. The key objective is to develop a sensitive, specific, high-throughput and economically viable early pregnancy screening test for pre-eclampsia. Methods/Design: We report the design of a multicentre, phase IIa clinical study aiming to recruit 5000 low risk primiparous women to assess and refine innovative prototype tests based on emerging metabolomic and proteomic technologies. Participation involves maternal phlebotomy at 15 and 20 weeks’ gestation, with optional testing and biobanking at 11 and 34 weeks. Blood samples will be analysed using two innovative, proprietary prototype platforms; one metabolomic based and one proteomic based, both of which outperform current biomarker based screening tests at comparable gestations. Analytical and clinical data will be collated and analysed via the Copenhagen Trials Unit. Discussion: The IMPROvED 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.
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Keywords
Pre-eclampsia , Screening , Proteomics , Metabolomics , Preterm birth , Small for gestational age
Citation
NAVARATNAM, K., ALFIREVIC, Z., BAKER, P. N., GLUUD, C., GRÜTTNER, B., KUBLICKIENE, K., ZEEMAN, G. & KENNY, L. C. 2013. A multi-centre phase IIa clinical study of predictive testing for preeclampsia: improved pregnancy outcomes via early detection (IMPROvED). BMC Pregnancy and Childbirth, 13:226, 1-7. http://dx.doi.org/10.1186/1471-2393-13-226