CompletedPhase 3Phase 4ACTRN12613000853741

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)


Sponsor

Launceston General Hospital

Enrollment

156 participants

Start Date

Sep 25, 2013

Study Type

Interventional

Conditions

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.


Eligibility

Sex: FemalesMin Age: 18 Yearss

Inclusion Criteria1

  • 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 Criteria10

  • 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.

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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 give

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.


Locations(1)

Launceston General Hospital - Launceston

TAS, Australia

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ACTRN12613000853741