IMPROvED
Research type
Research Study
Full title
The IMPROvED Study: Personalised medicine for pregnant women: novel metabolomic and proteomic biomarkers to detect pre-eclamplsia and improve outoome.
IRAS ID
130291
Contact name
Phil Baker
Contact email
Sponsor organisation
Keele University School of Medicine
Research summary
Research Summary
The three major problems in late pregnancy are pre-eclampsia, small babies, and babies who are born prematurely which affect one in five first time mothers and cause most of the complications and deaths that occur in newborn babies. It is very difficult to know early in pregnancy which women will develop these problems. The purpose of this study is to develop effective screening tests. This will allow a first time mother’s risk for these complications to be calculated in early pregnancy. We will invite 1000 women to attend the hospital at 4 points during their pregnancy: 11 /15 /20/34 weeks (the 11 and 34 week visits are optional). First visit will include an explanation of the study and consent and all visits will include the following: blood pressure , height, weight, urinalysis and blood glucose. The research midwife will then take 35mls (approximately 2 tablespoons) of blood for study purposes. After the women give birth, the research midwives will obtain further data from the participants health records.
Summary of Results
Identification of women at risk of pre-eclampsia is the first step to effective intervention and prevention. Current screening is based on the presence of clinical features, however, the majority of women who develop pre-eclampsia are first-time mothers, who commonly have no identifiable clinical risk factors in early pregnancy.
Prompted by the current absence of a clinically useful screening test for pre-eclampsia, the IMPROvED consortium aimed to develop a robust predictive blood test suitable for use in a clinical environment, employing innovative technologies and utilising novel metabolite biomarkers. Project partner Metabolomics Diagnostics (Ireland) had developed a prototype screening test (MetTest) for pre-eclampsia which was to be further refined and validated in IMPROvED, with the aim of ultimately progressing to regulatory approval and clinical use.
4063 first time mothers were found to be eligible and consented into the study in four European countries, Ireland, United Kingdom, the Netherlands and Sweden. Of those, 4005 completed the study by attending at least two appointments at 15 and 20 weeks’ gestation. A subset of these attended up to four visits, with additional optional time points at 9-11 weeks’ and/or 32 weeks’ gestation, with an IMPROvED midwife. At each visit, comprehensive clinical data, blood, urine and hair samples were collected. A customised IMPROvED Clinical Data and Biobank Management Database, specifically designed for data management in clinical trials and cohort studies was developed by project partner MedSciNet. In parallel to participant recruitment and validation of the MetTest, project partner University of Groningen in the Netherlands, provided expertise to support the assessment of the health economic benefits of screening tests.
Metabolomic Diagnostics finalised its translational research work and prepared its test, PrePsia,™ for clinical validation with biobanked samples collected during the IMPROvED study. Metabolomic Diagnostics was subsequently being awarded €2 million in EU Funding under the Horizon2020 SME Instrument call in March 2018, as part of a plan to introduce PrePsia™ into the European market and beyond.
Initial assessment of the performance of PrePsia in the IMPROvED cohort indicated that the biomarkers did not have the same stand-alone pre-eclampsia risk prediction as observed earlier. However the metabolites in PrePsia were selected based on their ability to improve on prediction of pre-eclamspia by the protein biomarker placental growth factor (PlGF) (increasingly incorporated into screening strategies for pre-eclampsia). Full assessment of the PrePsia biomarkers can only be made upon availability of PlGF data for the same patients, and funding to perform PlGF measurements on the IMPROvED cohort is awaited
In Summary
The IMPROvED project was imagined as a unique public-private collaboration to overcome the historic underinvestment in maternal health diagnostics and an opportunity for a European Consortium to make a significant global impact.
The promise and potential of IMPROvED is still intact and we remain committed to leveraging the unique IMPROvED resource, as selflessly enabled by pregnant women across Europe and by a group of committed academic and commercial stakeholders, to deliver innovation for the prediction of pregnancy complications to European women as fast as feasible.
Much endeavour has been undertaken to pursue the development of a metabolite based test. The metabolite assays have been run and the data analysed, however, funding to perform the necessary placenta growth factor analyses (that would be a key component to a clinical test) is still being sought.REC name
West Midlands - Solihull Research Ethics Committee
REC reference
13/WM/0268
Date of REC Opinion
29 Jul 2013
REC opinion
Further Information Favourable Opinion