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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00175526




Registration number
NCT00175526
Ethics application status
Date submitted
12/09/2005
Date registered
15/09/2005
Date last updated
1/06/2016

Titles & IDs
Public title
Predicting Complications in Women With Toxaemia
Scientific title
PIERS (Pre-eclampsia Integrated Estimate of RiSk) Model: Predicting Adverse Maternal Outcomes in Pre-eclampsia
Secondary ID [1] 0 0
H03-70137
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Toxemia 0 0
Condition category
Condition code
Injuries and Accidents 0 0 0 0
Poisoning
Blood 0 0 0 0
Other blood disorders
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
BEHAVIORAL - preeclampsia

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
Intervention code [1] 0 0
BEHAVIORAL
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To identify the maternal and fetal variables predictive of a combined adverse maternal outcome occurring within one week of hospital admission for pre-eclampsia
Timepoint [1] 0 0
Unknown at this time
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
Unknown at this time

Eligibility
Key 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).
Minimum age
16 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key 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
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2010
Sample size
Target
Accrual to date
Final
650
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
British Columbia
Country [2] 0 0
Canada
State/province [2] 0 0
Ontario
Country [3] 0 0
Canada
State/province [3] 0 0
Quebec
Country [4] 0 0
New Zealand
State/province [4] 0 0
Christchurch
Country [5] 0 0
United Kingdom
State/province [5] 0 0
Leeds

Funding & Sponsors
Primary sponsor type
Other
Name
University of British Columbia
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Peter von Dadelszen, MD
Address 0 0
University of British Columbia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00175526