Predicting Complications in Women With Toxaemia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00175526|
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : June 1, 2016
|Condition or disease||Intervention/treatment|
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.
|Study Type :||Observational|
|Actual Enrollment :||650 participants|
|Official Title:||PIERS (Pre-eclampsia Integrated Estimate of RiSk) Model: Predicting Adverse Maternal Outcomes in Pre-eclampsia|
|Study Start Date :||September 2005|
|Actual Primary Completion Date :||December 2010|
|Actual Study Completion Date :||December 2010|
- To identify the maternal and fetal variables predictive of a combined adverse maternal outcome occurring within one week of hospital admission for pre-eclampsia [ Time Frame: Unknown at this time ]
- To identify whether these also predict the combined adverse maternal outcome at any time following admission ii to identify whether these variables can predict a combined adverse perinatal outcome both (a) within one week and (b) at any time foll [ Time Frame: Unknown at this time ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00175526
|Canada, British Columbia|
|Children's and Women's Health Centre of BC|
|Vancouver, British Columbia, Canada, V5Z 1L8|
|Kingston General Hospital|
|Kingston, Ontario, Canada|
|Ottawa Hospital-General Campus|
|Ottawa, Ontario, Canada|
|le Centre hospitalier universitaire de Sherbrooke|
|Sherbrook, Quebec, Canada|
|Christchurch Women's Hospital|
|Christchurch, New Zealand|
|Leeds Teaching Hospitals NHS Trust|
|Leeds, United Kingdom|
|Principal Investigator:||Peter von Dadelszen, MD||University of British Columbia|