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Trial registered on ANZCTR


Registration number
ACTRN12613000853741
Ethics application status
Approved
Date submitted
20/07/2013
Date registered
2/08/2013
Date last updated
10/03/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of a single iron infusion versus oral iron tablets in the treatment of pregnancy anaemia among Tasmanian women
Scientific title
Treatment of Iron Deficiency Anaemia of Late pregnancy with a single intravenous iron versus oral iron sulphate: A Prospective Randomized Controlled Study (TIDAL)
Secondary ID [1] 282901 0
http://apps.who.int/trialsearch/trial.aspx?trialid=ACTRN12613000853741
Universal Trial Number (UTN)
None
Trial acronym
TIDAL: Treatment of Iron Deficiency Anaemia of Late pregnancy with a single intravenous iron versus oral iron sulphate: A Prospective Randomized Controlled Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pregnancy anaemia 289679 0
Condition category
Condition code
Public Health 289996 289996 0 0
Health service research
Blood 290038 290038 0 0
Anaemia
Reproductive Health and Childbirth 290052 290052 0 0
Antenatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1 and 2 a single iron ifusion either with carboxymaltose infusion 15mg/Kg body weight once only or 1000 mg iron polymaltose followed by oral iron maintenance. Arm 3 oral iron sulphate will be given with elemental iron of 100 mg daily from enrolment until delivery. All treatments will be given at enrolment once the patients have been randomised.

Compliance will be measured by drug return and also by picking up the monthly script at the Pharmacy Department.
Intervention code [1] 287563 0
Treatment: Drugs
Comparator / control treatment
The control group will receive treatment as per standard care at the LGH (Arm 3) encompasses iron treatment tablet.
Control group
Active

Outcomes
Primary outcome [1] 290046 0
assess the improvement in haemoglobin (Hb) and ferritin levels after treatment with the standard care of oral iron or IV iron polymaltose versus newly available intravenous iron carboxymaltose therapy in Australia.

By Hb check and serum iron studies
Timepoint [1] 290046 0
Hb level and iron studies 4 weeks post treatment and immediate pre-delivery as well as 3 months post delivery
Primary outcome [2] 290047 0
To assess the practical benefits of a new shorter intravenous iron therapy regime in treating iron deficiency anaemia in pregnancy.

This will be measured through cost effectivness analysis.
Timepoint [2] 290047 0
To assess cost effective of all treatments after the treatment until delivery
Primary outcome [3] 290048 0
To assess the prevalence of pregnancy anaemia among Tasmanian population

By screening pregnant women at their first antenatal visit with Hb and iron studies
Timepoint [3] 290048 0
At first antenatal visit
Secondary outcome [1] 303842 0
To assess patient outcome and quality of life via SF-36 Quality of Life Questionnaire
Timepoint [1] 303842 0
at baseline, 4 weeks after treatment pre-delivery and psot delivery at 3,6 and 12 months
Secondary outcome [2] 303844 0
To obtain additional information on the blood transfusion needs of pregnant women during and after pregnancy in relation to their iron status.

by assessing the hospital case notes of the patients and blood bank data at our institution.
Timepoint [2] 303844 0
by post delivery time
Secondary outcome [3] 303845 0
To assess other complications of pregnancy anaemia such as tiredness, lethargy and downheartiness.

This will be assessed by quality of life suervy (SF36)
Timepoint [3] 303845 0
By end of pregnancy up to 42 weeks gestation

Eligibility
Key inclusion criteria
Pregnant women who are 18 years old and above and found to have Hb less than 120 and greater than 85 g/L with ferritin level less than 100mcg/L.

Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Megaloblastic anaemia
Myelodysplasia
Aplastic Anaemia
Haemolysis
Bone marrow diseases
Malignancy
First trimester of pregnancy
Other disorders as documented by clinician that may be affected by iron therapy.
Documented iron overload status.
Allergic reaction to iron.


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)
This study is aiming to recruit patients with iron deficiency anaemia according to the trial criteria from the LGH Antenatal Clinic.
randomisation occurs with a simple computer program through pharmacy department, which will be given in sealed opaque envelopes. The professional and ethical actions of the investigators along with detailed participant information sheet and study consent form will enable patients to understand the implications of becoming a participant and ensure that potential participants are fully informed.
The patients who will be asked should understand clearly that their voluntary participation will not affect their relationship with the treating physician or hospital by any means.
Subjects will be provided with the contact details of the research team with concise directions to contact them if they wish to discuss any aspect of the project.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation). this will be given to the research assistant in sealed opaque envelopes.
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
The results will be reported on an intention-to-treat basis. Effectiveness of randomisation to the treatment groups will be assessed by: (i) general linear modelling for continuous variables, (ii) ordinal logistic regression for number of live births, and (iii) logistic regression for binary variables. The mean levels of Hb and serum ferritin (with standard deviations) and the differences [with 95% confidence intervals (CI) and P values] between the IV and the oral iron only groups at trial entry, subsequent intermediate time points, and at delivery, will be estimated by mixed methods linear regression with correction for repeated measures, and adjustment for maternal age, weight, gestational age and corresponding iron status value at trial entry. Further testing strategy will be implemented with sequential hierarchical approach to analysis. P-values will be corrected for multiple comparisons by the Holm method. All analyses will be performed using Stata / IC 10.1 for Windows (Stata Corp LP, College Station, TX,USA). The primary end points will be Hb and Ferritin levels 4 weeks after treatment pre-delivery. The study design is a randomised controlled trial. Multivariate analyses will be conducted to compare the outcomes in the three treatment groups, unadjusted and adjusted for actual and potential confounding variables (e.g. age, gender, initial Hb, body weight, final post-delivery Hb and iron studies where relevant): pre-delivery Hb levels by repeated measures ANOVA using general linear modelling; postnatal blood transfusion volumes by Poisson regression. It is estimated that we would screen about 2000 patients over a 12 month period, and that 20% of these would fit the inclusion criteria. Sample size calculations indicate a requirement for 52 completed patients per treatment group for both outcomes based on assumptions: i) a minimum effect size detection of 2g/l increase in pre-delivery Hb and a 45% reduction in units of blood transfused; ii) an untreated rise in Hb of 0g/l and SD 2.8g/l, and an expected untreated transfusion rate of 2.2 units per patient SD 1.8g/l iii) alpha value of 0.05 and power of 80%.


Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
7/08/2013
Actual
25/09/2013
Date of last participant enrolment
Anticipated
31/12/2014
Actual
7/08/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
156
Accrual to date
Final
246
Recruitment in Australia
Recruitment state(s)
TAS
Recruitment hospital [1] 1349 0
Launceston General Hospital - Launceston
Recruitment postcode(s) [1] 7184 0
7250 - Launceston

Funding & Sponsors
Funding source category [1] 287651 0
Charities/Societies/Foundations
Name [1] 287651 0
Clifford Craig Medical Trust Fund


Country [1] 287651 0
Australia
Primary sponsor type
Hospital
Name
Launceston General Hospital
Address
Charles Street, Launceston, 7250
Tasmania
Country
Australia
Secondary sponsor category [1] 286394 0
Charities/Societies/Foundations
Name [1] 286394 0
Clifford Craig Medical Trust Fund


Address [1] 286394 0
Address: Level 5
Launceston General Hospital
Charles street
Launceston, Tasmania 7250
Country [1] 286394 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289620 0
Tasmanian Human Research Ethics Committee
Ethics committee address [1] 289620 0
Ethics committee country [1] 289620 0
Australia
Date submitted for ethics approval [1] 289620 0
Approval date [1] 289620 0
08/07/2013
Ethics approval number [1] 289620 0
H0013323

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

Contacts
Principal investigator
Name 41558 0
Prof A/Professor Alhossain A. Khalafallah
Address 41558 0
Launceston General Hospital Charles Street, Launceston, TAS 7250
Country 41558 0
Australia
Phone 41558 0
+61373487111
Fax 41558 0
+61373487695
Email 41558 0
khalafallah@dhhs.tas.gov.au
Contact person for public queries
Name 41559 0
A/Professor Alhossain A. Khalafallah
Address 41559 0
Launceston General Hospital Charles Street, Launceston, TAS 7250
Country 41559 0
Australia
Phone 41559 0
+61373487111
Fax 41559 0
+61373487695
Email 41559 0
khalafallah@dhhs.tas.gov.au
Contact person for scientific queries
Name 41560 0
A/Professor Alhossain A. Khalafallah
Address 41560 0
Launceston General Hospital, Charles Street, Launceston, TAS 7250
Country 41560 0
Australia
Phone 41560 0
+61373487111
Fax 41560 0
+61373487695
Email 41560 0
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
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