Study completed and recruitment closed
What is Pre-eclampsia?
Pre-eclampsia is a disorder that occurs only during pregnancy and the postpartum period, affecting both the mother and the unborn baby. Experienced in at least 5-8% of all pregnancies, it is a rapidly progressive condition characterized by high blood pressure and the presence of protein in the urine. Swelling, sudden weight gain, headaches and changes in vision are important symptoms; however, some women with rapidly advancing disease report few symptoms.
Typically, pre-eclampsia occurs after 20 weeks gestation (in the late 2nd or 3rd trimesters or middle to late pregnancy) and up to six weeks postpartum (after delivery), though in rare cases it can occur earlier than 20 weeks. Proper prenatal care is essential in order to diagnose and manage pre-eclampsia. Pregnancy Induced Hypertension (PIH) and toxemia are other, outdated terms for preeclampsia. HELLP syndrome and eclampsia (seizures) are other variants of pre-eclampsia.
Globally, pre-eclampsia and other hypertensive disorders of pregnancy are a leading cause of maternal and infant illness and death. By conservative estimates, these disorders are responsible for 76,000 maternal and 500,000 infant deaths each year.
What is the IMPROvED Project?
The main aim of the IMPROvED consortium is to develop and validate two prototype early pregnancy screening tests for the pregnancy complication pre-eclampsia. Using a multi-centre hospital-based approach, representative of different healthcare models, we are building a high calibre pregnancy biobank for European pregnancy researchers.
How does IMPROvED work?
The goal of IMPROvED is to develop two prototype screening tests for pre-eclampsia.
We measure metabolomic and proteomic biomarkers, which we have identified as predictors of disease, and compare these measurements with clinical data from mothers. The result will be a simple algorithm which will determine risk status in mothers and babies.
On the basis of our work to date, the two blood tests we have created have the potential to predict pre-eclampsia risk with an unprecedented accuracy.
Continued Storage, Processing and Analysis of Data and Samples
In 2018 the Health Research Consent Declaration Committee (HRCDC) was established as part of the Health Research Regulations made under the Data Protection Act, 2018.
The purpose of those Regulations is to support health research and promote necessary and desirable public confidence in such research.
The Regulations make explicit consent the default position for processing personal data for health research. In other words, a health researcher planning to use an individual’s information for health research must obtain the explicit consent of the individual to do so. This is about empowering the patient in relation to his or her medical records.
However, it is recognised – as it is in other countries – that sometimes, in limited situations, obtaining consent will not be possible and that the public interest of doing the research significantly outweighs the need for explicit consent. It is in cases like this that HRCDC has a decision-making role.
In 2019 the INFANT centre at UCC (responsible for continued storage, processing and analysis of IMPROvED data and samples) applied for a Consent Declaration from the HRCDC. This declaration, granted in 2021 permits the INFANT centre to continue to store biosamples and personal data from the study and to continue processing and analysing the samples and data for the purpose of the IMPROvED study. The data and biosamples are stored securely for future related research which can only be undertaken subject to Ethics Committee approval.
We are continuing to carry out important secondary data analysis of the stored data and biosamples collected from the IMPROvED study, for example data from the IMPROvED study is now being used in the IDEA study.
If you would like more information about your rights (including the right to withdraw) please visit our Data Protection page.