Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00175526
Status:
COMPLETED
Last Update Posted:
2016-06-01
First Post:
2005-09-12
Brief Title:
Predicting Complications in Women With Toxaemia
Sponsor:
University of British Columbia
Organization:
University of British Columbia
Study Overview
Official Title:
PIERS Pre-eclampsia Integrated Estimate of RiSk Model Predicting Adverse Maternal Outcomes in Pre-eclampsia
Status:
COMPLETED
Status Verified Date:
2016-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 womens 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 womens 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
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 womens 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None