The investigator's study is going to compare effectiveness of single dose intravenous iron in combination with oral iron versus oral iron monotherapy in correcting haemoglobin deficit, replenishing iron stores and improving clinical symptoms in women with post-partum anaemia after postpartum hemorrhage without increasing the rate of adverse outcomes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
single dose of 1000 mg iron isomaltoside diluted in 100 ml of 0.9% sodium chloride, infused intravenously over ≥ 20 minutes. \- infusion set will be covered for blinding
100 ml of 0.9% sodium chloride, infused intravenously over ≥ 20 minutes. \- infusion set will be covered for blinding
once a day dose, to start 5 days after the intervention
University of Malaya Medical Centre
Petaling Jaya, Kuala Lumpur, Malaysia
RECRUITINGHemoglobin concentration (g/dL)
To evaluate the increase in hemoglobin level
Time frame: Six weeks after intervention
Serum iron concentration
To evaluate the increase in serum iron concentration (µmol/L)
Time frame: Six weeks after intervention
Serum ferritin concentration
serum ferritin levels (µg/L)
Time frame: six weeks after intervention
General fatigue score
Using the Multidimensional Fatigue Inventory (MFI) which will be answered by the participants, scores will be taken ranging from lowest 4, till the highest of 20. A higher score will indicate higher levels of fatigue.
Time frame: Six weeks after intervention
Number of participants that had adverse effects to intravenous iron
Any adverse effects experienced by the participant arising from the administration of intravenous iron isomaltoside will be documented and managed as per protocol.
Time frame: Up to six weeks after intervention
Blood transfusion requirement
Number of blood transfusions required after intervention
Time frame: Up to six weeks after intervention
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