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

Phase 3

Completed

• Conditions: Pregnancy anaemia; Public Health - Health service research; Blood - Anaemia; Reproductive Health and Childbirth - Antenatal care

• Registration Number: ACTRN12613000853741
• Lead Sponsor: aunceston General Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-08-02
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 156

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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. <br><br>By Hb check and serum iron studies[Hb level and iron studies 4 weeks post treatment and immediate pre-delivery as well as 3 months post delivery];To assess the practical benefits of a new shorter intravenous iron therapy regime in treating iron deficiency anaemia in pregnancy. <br><br>This will be measured through cost effectivness analysis.[To assess cost effective of all treatments after the treatment until delivery];To assess the prevalence of pregnancy anaemia among Tasmanian population <br><br>By screening pregnant women at their first antenatal visit with Hb and iron studies[At first antenatal visit ]

Secondary Outcome Measures

Name	Time	Method
To assess patient outcome and quality of life via SF-36 Quality of Life Questionnaire[at baseline, 4 weeks after treatment pre-delivery and psot delivery at 3,6 and 12 months];To obtain additional information on the blood transfusion needs of pregnant women during and after pregnancy in relation to their iron status.<br><br>by assessing the hospital case notes of the patients and blood bank data at our institution. [by post delivery time];To assess other complications of pregnancy anaemia such as tiredness, lethargy and downheartiness.<br><br>This will be assessed by quality of life suervy (SF36)[By end of pregnancy up to 42 weeks gestation]