Intravenous Iron Isomaltoside Versus Oral Iron Supplementation for Treatment of Iron Deficiency in Pregnancy.

Study Overview
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Brief Summary
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Intravenous iron isomaltoside versus oral iron supplementation for treatment of iron deficiency in pregnancy

Detailed Description
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Iron deficiency (ID) in pregnant women can cause iron deficiency anaemia (IDA). ID is defined by low iron stores, measured by a low level of s-ferritin. Iron is essential for the synthesis of haemoglobin (Hb). Anaemia is defined by a low Hb level (<11.0 g/dL in 1st trimester, <10.5 g/dL in 2nd, and <10.5 - 11.0 g/dL in 3rd trimesters). In Danish pregnant women, who do not take iron supplementation approximately 50 % have ID and 21 % have IDA. According to WHO anaemia, defined as Hb <11.0 g/dL, regardless the cause is estimated to occur in 24 % of Danish pregnant women. This trial is designed to evaluate and compare the effect of IV iron isomaltoside to a fixed dose of oral iron administered as tablet ferrous fumarate with ascorbic acid as correction of IDA in pregnant women after 4 weeks of standard treatment.

Official Title
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Intravenous Iron Isomaltoside Versus Oral Iron Supplementation for Treatment of Iron Deficiency in Pregnancy: a Randomised, Comparative, Open-label Trial

Conditions
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Iron Deficiency Anemia of Pregnancy

Intervention / Treatment
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* Drug: Iron Isomaltoside 1000
* Drug: ferrous fumarate with ascorbic acid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women aged ≥18 years Pregnancy at GA 14+0 - 19+0 Ferritin <30 μg/L after 4 weeks of standard treatment in a clinical setting Willingness to participate and attend all planned follow-up visits, and signing the in-formed consent form Exclusion Criteria: History of anaemia caused by e.g. thalassemia, hypersplenism or haemolytic anaemia (known haematologic disorder other than iron deficiency) Iron overload or disturbances in utilisation of iron (e.g. haemochromatosis and haemosiderosis) Drug hypersensitivity (i.e. previous hypersensitivity to IV iron) Known hypersensitivity to any excipients in the investigational drug products History of active asthma within the last 5 years History of multiple allergies Known decompensated liver cirrhosis or active hepatitis Active acute or chronic infections (assessed by clinical judgement) Rheumatoid arthritis with symptoms or signs of active inflammation Treated with IV iron products or blood transfusion within 4 weeks prior to inclusion Treated with erythropoietin (EPO) within 4 weeks prior to inclusion Participation in any other interventional trial where the trial drug has not passed 5 half-lives prior to inclusion Any other medical condition that, in the opinion of the Investigator, may cause the subject to be unsuitable for the completion of the trial or place the subject at potential risk from being in the trial Meeting RBC-transfusion criteria (Hb ≤6.9 g/dL= 4.3 mmol/L with intolerable symptoms of anaemia like severe palpitations, severe dizziness, shortness of breath at rest or syncope or an Hb ≤6.4 g/dL (4.0 mmol/L) without intolerable symptoms of anaemia) Multiple pregnancies Inability to read and understand the Danish language

Ages Eligible for Study
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Minimum Age: 18 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IV administration<br>Iron isomaltoside (Monofer) Administered iv | Drug: Iron Isomaltoside 1000<br>* Administered iv<br>|
| Active Comparator: Oral administration<br>Ferrous fumarate with ascorbic acid Administered oral | Drug: ferrous fumarate with ascorbic acid<br>* Oral administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome measure is the achievement of an hemoglobin equal or above 11 g/dL |  | from baseline to 18 weeks after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Achievement of an hemoglobin equal to or above 11 g/dL |  | T=3 weeks, T=6 weeks, T=12 weeks, and T=18 weeks | 
| Change in iron biomarkers |  | From baseline to T=3 weeks, T=6 weeks, T=12 weeks, and T=18 weeks |