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Sponsored by: |
University of British Columbia |
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Information provided by: | University of British Columbia |
ClinicalTrials.gov Identifier: | NCT00175526 |
Short description of the primary purpose of the protocol intended for the lay public. Include brief statement of study hypothesis
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.
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.
Condition | Intervention |
---|---|
Toxemia |
Behavioral: preeclampsia |
Study Type: | Observational |
Study Design: | Case-Only, Prospective |
Official Title: | PIERS (Pre-Eclampsia Integrated Estimate of RiSk) Model: Predicting Adverse Maternal Outcomes in Pre-Eclampsia. |
Estimated Enrollment: | 2000 |
Study Start Date: | September 2005 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 16 Years to 45 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Probability Sample |
Women with pre-eclampsia ('toxaemia of pregnancy') which is the most common cause for women to die during or shortly after pregnancy.
Inclusion Criteria:
These criteria reflect the evidence that pre-eclampsia is more than hypertension and proteinuria, particularly at onset:
Exclusion Criteria:
Contact: Dr. Peter von Dadelszen | pvd@cw.bc.ca |
Canada, British Columbia | |
Children's and Women's Health Centre of BC | Recruiting |
Vancouver, British Columbia, Canada, V5Z 1L8 | |
Contact: Dr. Peter vonDadelszen, MD pvd@cw.bc.ca | |
Canada, Ontario | |
Ottawa Hospital-General Campus | Recruiting |
Ottawa, Ontario, Canada | |
Contact: Unavailable at this time ????@uottawa.ca | |
Kingston General Hospital | Recruiting |
Kingston, Ontario, Canada | |
Contact: Unavailable at this time ????@kingston.ca | |
Canada, Quebec | |
le Centre hospitalier universitaire de Sherbrooke | Recruiting |
Sherbrook, Quebec, Canada | |
Contact: Unavailable at this time ????@sherbrooke.ca | |
New Zealand | |
Christchurch Women's Hospital | Recruiting |
Christchurch, New Zealand | |
Contact: Unavailable at this time ????@christchurch.nz | |
United Kingdom | |
Leeds Teaching Hospitals NHS Trust | Recruiting |
Leeds, United Kingdom | |
Contact: Unavailable at this time ????@leeds.uk |
Principal Investigator: | Peter von Dadelszen, MD | University of British Columbia |
Responsible Party: | University of British Columbia ( Dr. Peter von Dadelszen ) |
Study ID Numbers: | C03-0137 |
Study First Received: | September 12, 2005 |
Last Updated: | August 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00175526 |
Health Authority: | Canada: Health Canada |
Eclampsia Pregnancy toxemia /hypertension Pre-Eclampsia Preeclampsia Toxemia |
Infection |