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| Sponsor: | University of British Columbia |
|---|---|
| Information provided by (Responsible Party): | University of British Columbia |
| ClinicalTrials.gov Identifier: | NCT00175526 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Toxemia |
Behavioral: preeclampsia |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: 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: | September 2015 |
| Estimated Primary Completion Date: | September 2015 (Final data collection date for primary outcome measure) |
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.
Eligibility| 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:
Contacts and Locations| Contact: Beth Payne | 604-875-2424 ext 7917 | bpayne@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 | |
| Kingston General Hospital | Recruiting |
| Kingston, Ontario, Canada | |
| Contact: Unavailable at this time ????@kingston.ca | |
| Ottawa Hospital-General Campus | Recruiting |
| Ottawa, Ontario, Canada | |
| Contact: Unavailable at this time ????@uottawa.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 |
More Information
| Responsible Party: | University of British Columbia |
| ClinicalTrials.gov Identifier: | NCT00175526 History of Changes |
| Other Study ID Numbers: | H03-70137 |
| Study First Received: | September 12, 2005 |
| Last Updated: | September 26, 2011 |
| Health Authority: | Canada: Health Canada |
|
Pre-Eclampsia Toxemia Sepsis Hypertension, Pregnancy-Induced Pregnancy Complications |
Infection Systemic Inflammatory Response Syndrome Inflammation Pathologic Processes |