Predicting Complications in Women With Toxaemia
Condition: Toxemia
MeSH terms: Toxemia; Sepsis
Study type: Observational

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): preeclampsia
Intervention type(s): Behavioral
Intervention description(s): 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 w
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Women with pre-eclampsia ('toxaemia of pregnancy') which is the most common cause for women
        to die during or shortly after pregnancy.