Predicting Complications in Women With Toxaemia

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 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 or disease	Intervention/treatment
Toxemia	Behavioral: preeclampsia

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.

Study Design

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Study Type :	Observational
Actual Enrollment :	650 participants
Observational Model:	Case-Only
Time Perspective:	Prospective
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

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Intervention Details:

Behavioral: preeclampsia
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

Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. 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 ]

Secondary Outcome Measures :

1. 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 ]

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	16 Years to 45 Years (Child, Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes
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.

Criteria

Inclusion Criteria:

These criteria reflect the evidence that pre-eclampsia is more than hypertension and proteinuria, particularly at onset:

• Hypertension. sBP >140mmHg and/or dBP >90mmHg, twice, >4h apart after 20 weeks' gestation. sBP will be included to reflect international guidelines.
• Proteinuria. 24h urinary protein >0.3g/d3, or in the absence of a 24h urine collection: >2+ dipstick proteinuria after 20wk or a random protein:creatinine ratio >30mg protein/mmol creatinine106-108.
• HELLP syndrome that is non-hypertensive and non-proteinuric, using Sibai's criteria109,
• One eclamptic seizure without preceding hypertension or proteinuria ('BEST' definition of eclampsia38).
• Women admitted with suspected 'superimposed pre-eclampsia' will also be included (e.g., those with a history of pre-existing hypertension with new proteinuria (>2+) or accelerated hypertension3;23;24).

Exclusion Criteria:

• Occurrence of the maternal outcome (e.g., recurrent eclampsia) prior to collection of the predictors.
• Admission to hospital in spontaneous labour (as clinicians will not attempt to stop these labours).

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Canada, British Columbia
Children's and Women's Health Centre of BC
Vancouver, British Columbia, Canada, V5Z 1L8
Canada, Ontario
Kingston General Hospital
Kingston, Ontario, Canada
Ottawa Hospital-General Campus
Ottawa, Ontario, Canada
Canada, Quebec
le Centre hospitalier universitaire de Sherbrooke
Sherbrook, Quebec, Canada
New Zealand
Christchurch Women's Hospital
Christchurch, New Zealand
United Kingdom
Leeds Teaching Hospitals NHS Trust
Leeds, United Kingdom

Sponsors and Collaborators

University of British Columbia

Investigators

Principal Investigator:	Peter von Dadelszen, MD	University of British Columbia

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	University of British Columbia
ClinicalTrials.gov Identifier:	NCT00175526 History of Changes
Other Study ID Numbers:	H03-70137
First Posted:	September 15, 2005
Last Update Posted:	June 1, 2016
Last Verified:	May 2016

Additional relevant MeSH terms:

Toxemia; Sepsis; Infection	Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes