Toxemia Clinical Trial
Official title:
PIERS (Pre-eclampsia Integrated Estimate of RiSk) Model: Predicting Adverse Maternal Outcomes in Pre-eclampsia
At present, the management of pre-eclampsia is guided by expert opinions that are not well-based on firm evidence. What is required is a clinical tool that can accurately determine a women's risk for adverse outcomes, and thereby reduce the risk for women while safely prolonging pregnancies remote from term (to improve fetal outcomes). This research project, 'a severity score for pre-eclampsia,' will develop such a clinical tool that is specific to the condition. This severity score will be used clinically (to guide management) and in research (in both clinical trials and basic science research), and will provide an evidence base on which to build future practice, improving outcomes for pregnant women and their babies. In addition, this project is part of a three part strategy to better understand the mechanisms of disease in pre-eclampsia and to investigate a potential disease-modifying therapy, namely, recombinant human activated protein C.
In North America, pre-eclampsia ('toxaemia of pregnancy') is the most common cause for women
to die during or shortly after pregnancy. It is also the most common reason for babies who
are otherwise doing well to be delivered prematurely; this is with the intent purpose of
protecting maternal health and safety. In many ways it is similar to the systemic
inflammatory response syndrome ('septicaemia').
This project is part of a three part strategy to better understand the mechanisms of disease
in pre-eclampsia and to investigate a potential disease-modifying therapy, namely,
recombinant human activated protein C. We have surveyed Canadian practice, and undertaken
both feasibility and pilot studies for this project.
At present, the management of pre-eclampsia is guided by expert opinions that are not
well-based on firm evidence. What is required is a clinical tool that can accurately
determine a women's risk for adverse outcomes, and thereby reduce the risk for women while
safely prolonging pregnancies remote from term (to improve fetal outcomes). This research
project, 'a severity score for pre-eclampsia,' will develop such a clinical tool that is
specific to the condition. To develop and validate the tool we will recruit 3000 women in
Canada, the UK, and Australasia who are admitted to a hospital with either pre-eclampsia or
one of its variants. At the same time, because the majority of deaths associated with
pre-eclampsia occur in low and middle income countries, we will recruit 3000 women from
Uganda, China, Fiji, South Africa and Pakistan with pre-eclampsia. We will use this cohort
to test the model and ensure it accurately predicts risk in this new population.
This severity score will be used clinically (to guide management) and in research (in both
clinical trials and basic science research), and will provide an evidence base on which to
build future practice, improving outcomes for pregnant women and their babies.
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Observational Model: Case-Only, Time Perspective: Prospective
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