5000 first time mothers will be recruited over the course of 2 years to academic medical centres across Europe (Ireland, UK, the Netherlands, Sweden, and Germany), in a phase IIa prognostic multicentre hospital-based clinical study.
Seven recruitment sites (all with high patient-throughput) have been selected on the basis of investigator expertise and background in pre-eclampsia research; the different centres will facilitate assessment of the screening test in different models of healthcare delivery.
Pertinent and detailed clinical data will be collected, and blood samples taken in the first trimester, at 11, 15, 20 and 34 weeks’ gestation. Women will then be followed throughout their pregnancies and clinical outcomes will be recorded.
Establishing a high calibre biobank, augmented by accurate clinical metadata, will enable the development of predictive screening tests for pre-eclampsia and will also provide a vital resource for pregnancy researchers across Europe.
MedSciNet will deliver a sophisticated web-based informatics platform, already widely used internationally for data management in clinical trials and cohort studies, to create biobank management software augmented with clinical metadata.
The IMPROvED programme will create a cadre of highly trained midwives, clinical academics, PhD students and postdoctoral fellows, who will be accustomed to working across national and disciplinary boundaries. The three groups of medical professionals who will be comprehensively trained by the IMPROvED programme are as follows:
- Research midwives and laboratory technicians: will undergo extensive training in clinical data collection, database management, phenotypic assessment, sample pro-cessing and biobank curation. Much of these training will be condensed into an intensive three month period prior to the initiation of patient recruitment. However, workshops will continue throughout the duration of the programme. Midwives employed through the IMPROvED programme will be encouraged to register for higher research qualifications (such as Masters in Research Methodology).
- Clinical academics: Each of the six academic recruiting partners will identify a junior clinical academic who will undergo training in all aspects of our multidisciplinary, multicentre, hospital-based study. Each junior clinical academic will be mentored by one of the senior investigators, and will be involved in every facet of the study, from design, through to analysis of samples and interpretation of results. They will be involved in the ethical discussions, interact with patient groups, and spend time with SME (Small and Medium Enterprises) partners.
- PhD students and postdoctoral fellows: several PhD students and postdoctoral fellows will be employed and trained through the IMPROvED programme. Although each will be working on specific, focused projects, they will be co-supervised by investigators from different centres and different disciplines. For example, a PhD student will be employed between UCC and KI, and, utilizing the IMPROVeD biobank and database, will search for and validate biomarkers for spontaneous pre-term birth (incidence of 9% as with equally compelling health and economic arguments for screening). These students and fellows will receive high calibre scientific training but will also facilitate enhanced synergy and collaboration between partners.