A multi-centre phase IIa clinical study of predictive testing for preeclampsia: improved pregnancy outcomes via early detection (IMPROvED)

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dc.contributor.authorNavaratnam, Kate
dc.contributor.authorAlfirevic, Zarko
dc.contributor.authorBaker, Philip N.
dc.contributor.authorGluud, Christian
dc.contributor.authorGrüttner, Berthold
dc.contributor.authorKublickiene, Karolina
dc.contributor.authorZeeman, Gerda
dc.contributor.authorKenny, Louise C.
dc.contributor.funderEuropean Commission
dc.date.accessioned2016-02-08T13:06:35Z
dc.date.available2016-02-08T13:06:35Z
dc.date.issued2013-12-07
dc.description.abstractBackground: 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.en
dc.description.sponsorshipEuropean Commission (7th Framework Programme HEALTH- 2012-INNOVATION-1.2-1)en
dc.description.statusPeer revieweden
dc.description.versionPublished Versionen
dc.format.mimetypeapplication/pdfen
dc.identifier.articleid226
dc.identifier.citationNAVARATNAM, 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/10.1186/1471-2393-13-226en
dc.identifier.doi10.1186/1471-2393-13-226
dc.identifier.endpage7en
dc.identifier.issn1471-2393
dc.identifier.journaltitleBMC Pregnancy and Childbirthen
dc.identifier.startpage1en
dc.identifier.urihttps://hdl.handle.net/10468/2259
dc.identifier.volume13en
dc.language.isoenen
dc.publisherBioMed Central Ltd.en
dc.rights© Navaratnam et al.; licensee BioMed Central Ltd. 2013. This article is published under license to BioMed Central Ltd. This is an open access article distributed under the terms of the Creative Commons Attribution License (http://​creativecommons.​org/​licenses/​by/​2.​0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.en
dc.rights.urihttp://​creativecommons.​org/​licenses/​by/​2.​0en
dc.subjectPre-eclampsiaen
dc.subjectScreeningen
dc.subjectProteomicsen
dc.subjectMetabolomicsen
dc.subjectPreterm birthen
dc.subjectSmall for gestational ageen
dc.titleA multi-centre phase IIa clinical study of predictive testing for preeclampsia: improved pregnancy outcomes via early detection (IMPROvED)en
dc.typeArticle (peer-reviewed)en
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