Iron Deficiency Anemia of Pregnancy
Conditions
Brief summary
Intravenous iron isomaltoside versus oral iron supplementation for treatment of iron deficiency in pregnancy
Detailed description
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.
Interventions
Administered iv
DRUGferrous fumarate with ascorbic acid
Oral administration
Sponsors
Pharmacosmos A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Women aged ≥18 years 2. Pregnancy at GA 14+0 - 19+0 3. Ferritin \<30 μg/L after 4 weeks of standard treatment in a clinical setting 4. Willingness to participate and attend all planned follow-up visits, and signing the in-formed consent form
Exclusion criteria
1. History of anaemia caused by e.g. thalassemia, hypersplenism or haemolytic anaemia (known haematologic disorder other than iron deficiency) 2. Iron overload or disturbances in utilisation of iron (e.g. haemochromatosis and haemosiderosis) 3. Drug hypersensitivity (i.e. previous hypersensitivity to IV iron) 4. Known hypersensitivity to any excipients in the investigational drug products 5. History of active asthma within the last 5 years 6. History of multiple allergies 7. Known decompensated liver cirrhosis or active hepatitis 8. Active acute or chronic infections (assessed by clinical judgement) 9. Rheumatoid arthritis with symptoms or signs of active inflammation 10. Treated with IV iron products or blood transfusion within 4 weeks prior to inclusion 11. Treated with erythropoietin (EPO) within 4 weeks prior to inclusion 12. Participation in any other interventional trial where the trial drug has not passed 5 half-lives prior to inclusion 13. 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 14. 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) 15. Multiple pregnancies 16. Inability to read and understand the Danish language
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
Denmark
Outcome results
None listed