Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000225213
Ethics application status
Approved
Date submitted
16/04/2009
Date registered
5/05/2009
Date last updated
10/03/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Estimation of a clot end-product called D-Dimer in different stages of pregnancy with establishment of a normal value for Tasmanian women.
Scientific title
Estimation of D-Dimer in different stages of pregnancy with establishment of a reference range for Tasmanian women and investigation of a possible association with high risk pregnancy, disseminated intravascular coagulation (DIC), venous thromboembolic (VTE) disease and pregnancy loss.
Secondary ID [1] 288735 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
The association of D-Dimer levels with normal pregnancy and also high risk pregnancy, DIC, venous thromboembolic (VTE) and pregnancy loss. 4610 0
Condition category
Condition code
Reproductive Health and Childbirth 237042 237042 0 0
Normal pregnancy

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Observational study of D-Dimer levels in pregnancy and the possible association between D-Dimer levels and high risk pregnancy, disseminated intravascular coagulation, venous thomboembolism and pregnancy loss. Observation to continue into the postpartum period until D-Dimer levels return to normal, non-pregnant levels.
Intervention code [1] 4373 0
Not applicable
Comparator / control treatment
Not applicable as it is an observational study.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 5755 0
The statistical establishment of normal D-dimer levels in each trimester of pregnancy supported by haematological evaluation and well-being questionnaires.
Timepoint [1] 5755 0
Blood sample once per trimester of pregnancy.
Secondary outcome [1] 241707 0
The seconday outcome will be to determine and evaluate the optimum diagnostic thresholds for D-Dimer levels as predictors of adverse pregnancy outcomes. This will be done by monitoring D-Dimer levels whilst assessing patients for indicators of adverse pregnancy outcomes. This will be acheived through the use of haematological assessment, the use of well-being questionnaires and hospital records of patients' admission for treatment of pathology during pregnancy.
Timepoint [1] 241707 0
Blood sampled once per trimester in pregnancy, with monthly blood samples from women whose D-Dimer level was higher than the estimated average normal range inpregnancy.

Eligibility
Key inclusion criteria
Pregnant women 18 years old and above.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Age less than 18 years.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
22/03/2007
Actual
22/03/2007
Date of last participant enrolment
Anticipated
Actual
31/01/2009
Date of last data collection
Anticipated
Actual
Sample size
Target
700
Accrual to date
Final
632
Recruitment in Australia
Recruitment state(s)
TAS

Funding & Sponsors
Funding source category [1] 4794 0
Charities/Societies/Foundations
Name [1] 4794 0
Clifford Craig Medical Research Trust
Country [1] 4794 0
Australia
Funding source category [2] 4795 0
Hospital
Name [2] 4795 0
Launceston General Hospital
Country [2] 4795 0
Australia
Primary sponsor type
Hospital
Name
Assoc Professor Alhossain Khalafallah
Address
C/- Pathology Department
Launceston General Hospital
Charles St, Launceston
Tasmania 7250
Country
Australia
Secondary sponsor category [1] 4328 0
None
Name [1] 4328 0
Address [1] 4328 0
Country [1] 4328 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6843 0
Human Research Ethics Committee (Tasmania) Network
Ethics committee address [1] 6843 0
Ethics committee country [1] 6843 0
Australia
Date submitted for ethics approval [1] 6843 0
Approval date [1] 6843 0
20/09/2006
Ethics approval number [1] 6843 0
H0008950

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

Contacts
Principal investigator
Name 29497 0
Prof Alhossain Khalafallah
Address 29497 0
Pathology Department Launceston General Hospital Charles St, Launceston Tasmania 7250
Country 29497 0
Australia
Phone 29497 0
+61367776777
Fax 29497 0
Email 29497 0
[email protected]
Contact person for public queries
Name 12744 0
Assoc. Professor Alhossain Khalafallah
Address 12744 0
C/- Pathology Department
Launceston General Hospital
Charles St, Launceston
Tasmania 7250
Country 12744 0
Australia
Phone 12744 0
+61 417 324 623
Fax 12744 0
+61 363487695
Email 12744 0
[email protected]
Contact person for scientific queries
Name 3672 0
Assoc Professor Alhossain Khalafallah
Address 3672 0
C/- Pathology Department
Launceston General Hospital
Charles St, Launceston
Tasmania 7250
Country 3672 0
Australia
Phone 3672 0
+61 417 324 623
Fax 3672 0
+61 363487695
Email 3672 0
[email protected]

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.