ANZCTR - Registration

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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]

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

Condition category

Condition code

Blood

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]

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]

Haemoglobin (Hb) level pre-delivery via full blood count test

Timepoint [1]

Haemoglobin (Hb) level at 4 weeks after treatment

Secondary outcome [1]

To assess quality of life of pregnant women via regular questionnaires designed for the purpose of study at the Launceston General Hospital

Timepoint [1]

after 4 weeks of treatment and pre as well as Post delivery follow up

Secondary outcome [2]

Amount of blood transfusion. Via reviewing hospital records.

Timepoint [2]

40 weeks gestation and post delivery.

Secondary outcome [3]

Estimate any additional cost versus benefit of intravenous iron over oral iron.

Timepoint [3]

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

Sex

Females

Can healthy volunteers participate?

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

1/04/2007

Actual

31/03/2007

Date of last participant enrolment

Anticipated

Actual

31/01/2009

Date of last data collection

Anticipated

Actual

Sample size

Target

200

Accrual to date

Final

200

Recruitment in Australia

Recruitment state(s)

TAS

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Launceston General Hospital

Address [1]

Charles Street, Launceston, TAS 7250

Country [1]

Australia

Primary sponsor type

Hospital

Name

Launceston General Hospital

Address

Charles Street, Launceston, TAS 7250

Country

Australia

Secondary sponsor category [1]

Charities/Societies/Foundations

Name [1]

Clifford Craig Research Foundation

Address [1]

Charles Street, Launceston Tasmania, 7250

Country [1]

Australia

Other collaborator category [1]

University

Name [1]

School of Human Life Sciences, University of Tasmania (UTAS)

Address [1]

School of Human Life Sciences, University of Tasmania, Alandale street, Launceston 7250 Tasmania

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Human Research Ethics Committee (Tasmania) Network

Ethics committee address [1]

Human Research Ethics Committee (HREC) Administration
University of Tasmania
Private Bag 01
HOBART TAS 7001

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

26/09/2006

Ethics approval number [1]

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

Prof Alhossain Khalafallah

Address

Launceston General Hospital, Launceston, Tasmania

Country

Australia

Phone

+61363487111

Fax

khalafallah@dhhs.tas.gov.au

Contact person for public queries

Name

Alhossain Khalafallah

Address

The Launceston General Hospital
Charles Street
Launceston, TAS 7250

Country

Australia

Phone

+61363487111

Fax

+61363487695

khalafallah@dhhs.tas.gov.au

Contact person for scientific queries

Name

A/Professor Alhossain A. Khalafallah

Address

The Launceston General Hospital
Charles Street
Launceston, TAS 7250

Country

Australia

Phone

+6136348-7111

Fax

+61363487695

khalafallah@dhhs.tas.gov.au

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

Source	Title	Year of Publication	DOI
Dimensions AI	A prospective randomized, controlled trial of intravenous versus oral iron for moderate iron deficiency anaemia of pregnancy	2010	https://doi.org/10.1111/j.1365-2796.2010.02251.x
Dimensions AI	Three-year follow-up of a randomised clinical trial of intravenous versus oral iron for anaemia in pregnancy	2012	https://doi.org/10.1136/bmjopen-2012-000998
Embase	Intravenous iron therapy for treatment of anemia during pregnancy is associated with improved maternal quality of life, less postnatal depression and longer breastfeeding.	2013

N.B. These documents automatically identified may not have been verified by the study sponsor.

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