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Trial registered on ANZCTR


Registration number
ACTRN12609000177257
Ethics application status
Approved
Date submitted
19/03/2009
Date registered
17/04/2009
Date last updated
10/03/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
A prospective study of the effect of two different forms of iron therapy for women, who diagnosed with iron deficiency anaemia during pregnancy with the aim to achieve a normal haemoglobin level at the time of delivery.
Scientific title
A prospective randomised trial to study the effect of intravenous iron therapy versus the standard treatment with oral iron for women diagnosed with iron deficiency anaemia in pregnancy.
Secondary ID [1] 288732 0
nil known
Universal Trial Number (UTN)
Trial acronym
Anaemia in pregnancy
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Iron deficiency anaemia in pregnancy 4502 0
Condition category
Condition code
Blood 4783 4783 0 0
Anaemia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intravenous iron polymaltose in a dose according body weight once. Iron dose calculated in mg (50 mg per 1 ml)= body weight in kg x (Target haemoglobin (Hb)-actual haemoglobin (Hb) in g/L) x constant factor (0.24) + iron store immediately after randomisation
Intervention code [1] 4252 0
Treatment: Drugs
Comparator / control treatment
Oral iron therapy with ferrous sulphate 250 mg once daily start from day of randomization until delivery (for approximately 28-40 weeks)
Control group
Active

Outcomes
Primary outcome [1] 5643 0
Haemoglobin (Hb) level pre-delivery via full blood count test
Timepoint [1] 5643 0
Haemoglobin (Hb) level at 4 weeks after treatment
Secondary outcome [1] 241528 0
To assess quality of life of pregnant women via regular questionnaires designed for the purpose of study at the Launceston General Hospital
Timepoint [1] 241528 0
after 4 weeks of treatment and pre as well as Post delivery follow up
Secondary outcome [2] 241529 0
Amount of blood transfusion. Via reviewing hospital records.
Timepoint [2] 241529 0
40 weeks gestation and post delivery.
Secondary outcome [3] 241541 0
Estimate any additional cost versus benefit of intravenous iron over oral iron.
Timepoint [3] 241541 0
by delivery time (40 weeks)

Eligibility
Key inclusion criteria
This trial will be available to all women planning confinement at the Launceston General Hospital (LGH) over a period of 18-24 months. Pregnant women who are anaemic with Hb level <116g/L and 18 year old and above are eligible for this study.
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Cause of anaemia other than Iron deficiency: Malabsorption syndrome affecting uptake of oral iron Condition associated with iron overload e.g. Haemochromatosis

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)
It is proposed that pregnant women noted to be anaemic will be invited to participate in the study after the first trimester by the midwife, who will explain in details the aims and objectives of the study. If the patient agree to be enrolled in the study, a written consent form contain all information about the study will be given to the patients to sign and retain a copy for themselves as a reference. Patients can withdraw from the study at anytime without any adverse impact of any kind on their treatment at the Launceston General Hospital (LGH). Central randomisation by computer will follow thereafter.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
If the patients agree to participate in the trial, randomisation will follow in different department by the Pharmacy clinical trial personnel where a special computer programme will assign the treatment in random fashion without influence of treating team. This is usually conducted in blocks until full recruitment occurs.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
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 in Australia
Recruitment state(s)
TAS

Funding & Sponsors
Funding source category [1] 4689 0
Hospital
Name [1] 4689 0
Launceston General Hospital
Address [1] 4689 0
Charles Street, Launceston, TAS 7250
Country [1] 4689 0
Australia
Primary sponsor type
Hospital
Name
Launceston General Hospital
Address
Charles Street, Launceston, TAS 7250
Country
Australia
Secondary sponsor category [1] 4234 0
Charities/Societies/Foundations
Name [1] 4234 0
Clifford Craig Research Foundation
Address [1] 4234 0
Charles Street, Launceston Tasmania, 7250
Country [1] 4234 0
Australia
Other collaborator category [1] 616 0
University
Name [1] 616 0
School of Human Life Sciences, University of Tasmania (UTAS)
Address [1] 616 0
School of Human Life Sciences, University of Tasmania, Alandale street, Launceston 7250 Tasmania
Country [1] 616 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6728 0
Human Research Ethics Committee (Tasmania) Network
Ethics committee address [1] 6728 0
Human Research Ethics Committee (HREC) Administration
University of Tasmania
Private Bag 01
HOBART TAS 7001
Ethics committee country [1] 6728 0
Australia
Date submitted for ethics approval [1] 6728 0
Approval date [1] 6728 0
26/09/2006
Ethics approval number [1] 6728 0
H0008952

Summary
Brief summary
To date, limited data is available regarding the prevalence of iron deficiency anaemia (IDA) during pregnancy in Australia, or the comparative efficacy of intravenous (IV) iron versus oral iron therapy in pregnant women.

Patients and Method: At the Launceston General Hospital we prospectively investigating pregnant women with full blood count (FBC) and iron studies at the first or second antenatal visit.

Among those, patients with iron deficiency anaemia, will be recruited to a prospective randomised trial to determine whether intravenous iron therapy (iron polymaltose) is superior to oral iron (ferrous sulphate 250 mg) for the management of IDA associated with pregnancy.

Our perliminary data indicate that iron deficiency is a common finding during pregnancy in the northern Tasmanian population, and intravenous iron therapy appears a safe and effective treatment in this cohort of patients.
Trial website
NA
Trial related presentations / publications
Khalafallah A, Dennis A, Bates J, Bates G, Robertson IK, Smith L, Ball MJ, Seaton D, Brain T, Rasko JE. A prospective randomized, controlled trial of intravenous versus oral iron for moderate iron deficiency anaemia of pregnancy. J Intern Med. 2010 Sep;268(3):286-95. doi: 10.1111/j.1365-2796.2010.02251.x. Epub 2010 May 19. PMID:20546462

http://www.ncbi.nlm.nih.gov/pubmed/20546462
http://onlinelibrary.wiley.com/doi/10.1111/j.1365-2796.2010.02251.x/abstract;jsessionid=FE3714A96859FCC7713E2D01F2BD55C3.f01t03
Public notes

Contacts
Principal investigator
Name 29416 0
Prof Alhossain Khalafallah
Address 29416 0
Launceston General Hospital, Launceston, Tasmania
Country 29416 0
Australia
Phone 29416 0
+61363487111
Fax 29416 0
Email 29416 0
khalafallah@dhhs.tas.gov.au
Contact person for public queries
Name 12663 0
Prof Alhossain Khalafallah
Address 12663 0
The Launceston General Hospital
Charles Street
Launceston, TAS 7250
Country 12663 0
Australia
Phone 12663 0
+61363487111
Fax 12663 0
+61363487695
Email 12663 0
khalafallah@dhhs.tas.gov.au
Contact person for scientific queries
Name 3591 0
Prof A/Professor Alhossain A. Khalafallah
Address 3591 0
The Launceston General Hospital
Charles Street
Launceston, TAS 7250
Country 3591 0
Australia
Phone 3591 0
+6136348-7111
Fax 3591 0
+61363487695
Email 3591 0
khalafallah@dhhs.tas.gov.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