Intravenous iron isomaltoside versus oral iron supplementation for treatment of iron deficiency in pregnancy
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
201
Administered iv
Oral administration
Phamacosmos Investigational site
Hvidovre, Sjaeland, Denmark
The primary outcome measure is the achievement of an hemoglobin equal or above 11 g/dL
Time frame: from baseline to 18 weeks after treatment
Achievement of an hemoglobin equal to or above 11 g/dL
Time frame: T=3 weeks, T=6 weeks, T=12 weeks, and T=18 weeks
Change in iron biomarkers
Time frame: From baseline to T=3 weeks, T=6 weeks, T=12 weeks, and T=18 weeks
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