Predicting Complications in Women With Toxaemia

Toxemia Clinical Trial

Official title:

PIERS (Pre-eclampsia Integrated Estimate of RiSk) Model: Predicting Adverse Maternal Outcomes in Pre-eclampsia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00175526
• Other study ID #: H03-70137
• Status: Completed
• Phase: N/A
• First received: September 12, 2005
• Last updated: May 30, 2016
• Start date: September 2005
• Est. completion date: December 2010

Study information

• Verified date: May 2016
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 650
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years to 45 Years

Eligibility

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).

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Toxemia

Intervention

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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Countries where clinical trial is conducted

Canada,  New Zealand,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To identify the maternal and fetal variables predictive of a combined adverse maternal outcome occurring within one week of hospital admission for pre-eclampsia		Unknown at this time	No
Secondary	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		Unknown at this time	No