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

BMC Pregnancy and Childbirth

Louise C Kenny²  Gerda Zeeman⁴  Karolina Kublickiene⁷  Berthold Grüttner³  Christian Gluud⁵  Philip N Baker⁶  Zarko Alfirevic¹  Kate Navaratnam¹ 

[1] Centre for Womens Health Research, University of Liverpool, First Floor, Liverpool Women's Hospital, Crown Street, Liverpool L8 7SS, UK;University College Cork, Cork, Ireland;The University of Cologne, Cologne, Germany;Erasmus University, Rotterdam, Netherlands;Copenhagen Trial Unit, Copenhagen, Denmark;Keele University School of Medicine, Stoke-on-Trent, UK;Karolinska Institute, Stockholm, Sweden

关键词: Small for gestational age;    Preterm birth;    Metabolomics;    Proteomics;    Screening;    Pre-eclampsia;   

Others  :  1131943
DOI  :  10.1186/1471-2393-13-226

 received in 2013-08-20, accepted in 2013-12-03,  发布年份 2013

【 摘 要 】

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.

Trial registration

Trial registration number NCT01891240

The IMPROvED project is funded by the seventh framework programme for Research and Technological development of the EU. http://www.fp7-improved.eu/ webcite

【 授权许可】

   
2013 Navaratnam et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

Figure 2.

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