Single Dose Intravenous Iron Isomaltoside in Combination With Oral Iron vs Oral Iron Monotherapy in Patients With Anemia After Postpartum Haemorrhage

Study Overview
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Brief Summary
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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.

Official Title
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Single Dose Intravenous Iron Isomaltoside in Combination With Oral Iron vs Oral Iron Monotherapy in Patients With Anemia After Postpartum Haemorrhage: A Single-blinded, Randomised Controlled Trial

Conditions
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Anemia, Post Partum Hemorrhage

Intervention / Treatment
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* Drug: Iron Isomaltoside 1000
* Drug: Placebo
* Drug: Iberet-Folic-500


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: women who underwent spontaneous vaginal delivery with Post partum hemorrhage (PPH) ≥ 500ml OR women who underwent lower segment caesarean section with PPH ≥ 1000 ml post PPH haemoglobin level ≤ 10.0 g/dl measured within 48hrs after delivery and stabilisation & resuscitation. ≥ 18 years of age Proficient in Malaysian language or English language Willingness to consent for blood taking and attending follow-up at 2 weeks and 6 weeks Exclusion Criteria: refused consent to participate in trial history of hemolytic anemia, Thalassemia , and sickle cell anemia women with signs of sepsis (clinical or laboratory evidence-intrapartum fever >38.5 degrees with abnormal vital signs, positive blood culture) clinical or laboratory evidence of hepatic or renal, cardiovascular and hemolytic abnormalities history of active severe acid peptic disorder, esophagitis or hiatus hernia and malabsorption syndrome. Severe symptoms of anemia including dyspnoea at rest, angina pectoris, syncope or transient ischemic attacks. history of severe asthma, eczema or other atopic allergy known allergy to iron patients with known immune or inflammatory conditions (e.g. systemic lupus erythematosus, rheumatoid arthritis).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intravenous Iron Group<br> | Drug: Iron Isomaltoside 1000<br>* 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<br>Drug: Iberet-Folic-500<br>* once a day dose, to start 5 days after the intervention<br>|
| Active Comparator: Oral Iron Group<br> | Drug: Placebo<br>* 100 ml of 0.9% sodium chloride, infused intravenously over ≥ 20 minutes. - infusion set will be covered for blinding<br>Drug: Iberet-Folic-500<br>* once a day dose, to start 5 days after the intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin concentration (g/dL) | To evaluate the increase in hemoglobin level | Six weeks after intervention | 
| Serum iron concentration | To evaluate the increase in serum iron concentration (µmol/L) | Six weeks after intervention | 
| Serum ferritin concentration | serum ferritin levels (µg/L) | six weeks after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Up to six weeks after intervention | 
| Blood transfusion requirement | Number of blood transfusions required after intervention | Up to six weeks after intervention |