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Trial registered on ANZCTR


Registration number
ACTRN12610001007022
Ethics application status
Approved
Date submitted
12/10/2010
Date registered
18/11/2010
Date last updated
18/11/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Hemolysis, elevated liver functions and low platelets (HELLP syndrome): Does the use of dexamethasone in the postpartum period improve maternal outcome?
Scientific title
Hemolysis, elevated liver functions and low platelets (HELLP syndrome): Does the use of dexamethasone in the postpartum period improve maternal hospital stay and complications?
Secondary ID [1] 252853 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HELLP syndrome 258374 0
Condition category
Condition code
Reproductive Health and Childbirth 258547 258547 0 0
Fetal medicine and complications of pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients with HELLP syndrome was randomised to receive either dexamethasone or no dexamethasone in postpartum peroid. the dose of dexamethasone was 24 mg on day 1, 16mg on day2 and 12 mg on day 3 and it was given intravenously.
Intervention code [1] 257371 0
Treatment: Drugs
Comparator / control treatment
Routine postpartum care, including Magnesium sulphate and antihypertensive therapy
Control group
Active

Outcomes
Primary outcome [1] 259383 0
Days in hospital
Timepoint [1] 259383 0
till discharge from hospital
Primary outcome [2] 259657 0
Days till platelet count more than 100 000/mm3
Timepoint [2] 259657 0
till discharge from hospital
Primary outcome [3] 259658 0
Intensive care admissions
Timepoint [3] 259658 0
Till discharge from hospital
Secondary outcome [1] 265913 0
Neonatal morbidity and mortality
Timepoint [1] 265913 0
till discharge from hospital

Eligibility
Key inclusion criteria
HELLP syndrome according to Tennessee criteria
Haptoglobin in all cases to confirm hemolysis
Minimum age
18 Years
Maximum age
45 Years
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Partial hemolysis, elevated liver functions and low platelet (HELLP) syndrome
Thrombotic thrombocytopenic purpura (TTP)
Ideopatic thrombocytopenic purpura (ITP)
Hemolytic uremic syndrome (HUS)
Acute fatty liver of pregnancy
Cholestasis of pregnancy

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
After diagnosis of HELLP syndrome, patients were randomised to either receive dexametasone or no dexamethasone in postpartum peroid.
Randomisation was done by consecutively number opaque sealed envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation was done according to randomisation list provided by the department of Biostatistics, University of Free State, Bloemfontein, South Africa
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 2965 0
South Africa
State/province [1] 2965 0

Funding & Sponsors
Funding source category [1] 257821 0
Hospital
Name [1] 257821 0
Universitas Hospital
Address [1] 257821 0
20 Paul Kruger Avenue
Bloemfontein
9300
Country [1] 257821 0
South Africa
Primary sponsor type
Hospital
Name
Universitas Hospital
Address
20 Paul Kruger Avenue
Bloemfontein
9300
Country
South Africa
Secondary sponsor category [1] 257023 0
None
Name [1] 257023 0
Address [1] 257023 0
Country [1] 257023 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259851 0
Ethics Review Board, University of Free State
Ethics committee address [1] 259851 0
University of Free State
20 Paul Kruger Avenue
Bloemfontein
9300
Ethics committee country [1] 259851 0
South Africa
Date submitted for ethics approval [1] 259851 0
Approval date [1] 259851 0
Ethics approval number [1] 259851 0
ETOVS 30/07

Summary
Brief summary
To establish if the use of corticosteroids improve the outcome of patients with HELLP syndrome
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31757 0
Address 31757 0
Country 31757 0
Phone 31757 0
Fax 31757 0
Email 31757 0
Contact person for public queries
Name 15004 0
Jacobus du Plessis
Address 15004 0
Royal Womens Hospital
20 Flemington Road
Parkville
Victoria
3052
Country 15004 0
Australia
Phone 15004 0
+ 61 3 8345 2000
Fax 15004 0
Email 15004 0
Jacobus.DuPlessis@thewomens.org.au
Contact person for scientific queries
Name 5932 0
Jacobus du Plessis
Address 5932 0
Royal Womens Hospital
20 Flemington Road
Parkville
Victoria
3052
Country 5932 0
Australia
Phone 5932 0
+61 3 8345 2000
Fax 5932 0
Email 5932 0
Jacobus.DuPlessis@thewomens.org.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary