Evaluation of a single iron infusion versus oral iron tablets in the treatment of pregnancy anaemia among Tasmanian women

Treatment of Iron Deficiency Anaemia of Late pregnancy with a single intravenous iron versus oral iron sulphate: A Prospective Randomized Controlled Study (TIDAL)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613000853741

Acronym

TIDAL: Treatment of Iron Deficiency Anaemia of Late pregnancy with a single intravenous iron versus

Enrollment

246

Registered

2013-08-02

Start date

2013-09-25

Completion date

2014-08-07

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study is aiming to show that by having normal haemoglobin and iron studies at the time of delivery, the patients will not only feel better, but will perform better during and after pregnancy. It is hoped that their pregnancy will be less eventful without any complications. By improving antenatal haemoglobin, we expect to reduce the incidence or necessity for blood transfusions in this cohort of patients thereby relieving the strain on the supply of blood from an already stretched Blood Blank and also to avoid the risks/complications of transfusion. Because of its national and global significance, this project merits significant health improvement for pregnant women. To identify the best treatment approach to iron deficiency anaemia in pregnancy. Effective management of iron deficiency anaemia has a major impact on the health, educational and economic potential of populations in Tasmania and Australia. This and future work may lead to replacement of iron as first line therapy of the world’s most common nutritional disorder, affecting more than 2 billion people.

Interventions

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

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.

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.

Outcome results