A multi-centre phase IIa clinical study of predictive testing for preeclampsia: improved pregnancy outcomes via early detection (IMPROvED)
Authors: Karolina Kublickiene
Philip N Baker
Christian Gluud
Louise C Kenny
Gerda Zeeman
Kate Navaratnam
Berthold Grüttner
Zarko Alfirevic
Journal: BMC Pregnancy and Childbirth (2013)
Discipline: CLINICAL MEDICINE
Keywords: pre-eclampsia; screening test; blood-borne biomarkers; metabolome; proteome
Affiliations: Centre for Womens Health Research, University of Liverpool, First Floor, Liverpool Women's Hospital, Crown Street, Liverpool L8 7SS, UK. .

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. Trial registration: Trial registration number NCT01891240The IMPROvED project is funded by the seventh framework programme for Research and Technological development of the EU. http://www.fp7-improved.eu/ 

Retracted: No

PubPeer comments:
 Figures 2, 3, and 6 have several image overlaps with other images in this paper and [another with the same first author](http: pubpeer.com publications B00AC97C35BDA0267A1D0C7E61AF6F). ![file] ![file] ![file] ![file] ![file] , 
 Figure 3 has an additional overlap with [yet another paper](http: pubpeer.com publications 470F62FC5EADC48D9D3134BD2F7D9B): ![file] ![file] , 
 Figure 6 has two additional overlaps with [another paper (different from those mentioned above)](http: pubpeer.com publications 09372199F668DC8D4A2828899366C8): ![file] ![file] To help people keep track, there is a total of 5 papers that share images all by Jie Li. https: pubpeer.com publications AEA8F680DF2B92BA9380932C779BE0 https: pubpeer.com publications B00AC97C35BDA0267A1D0C7E61AF6F https: pubpeer.com publications 470F62FC5EADC48D9D3134BD2F7D9B https: pubpeer.com publications 09372199F668DC8D4A2828899366C8 ,