A Phase 4 interventional study of Iron Isomaltoside 1000 and ferrous fumarate with ascorbic acid in Iron Deficiency Anemia of Pregnancy, sponsored by Pharmacosmos A/S. Completed at 1 site in Denmark. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-11-13.
Sponsored by Pharmacosmos A/S · Phase 4, Interventional, and Treatment
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.
644 studies on the registry are indexed under Anemia, Iron-Deficiency; 105 are open to participants now.
This study's enrollment of 201 is above the median of 100 across 503 interventional studies indexed under Anemia, Iron-Deficiency.
Browse Anemia, Iron-Deficiency studies →Pharmacosmos A/S is the lead sponsor of 36 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Iron isomaltoside (Monofer) Administered iv
Drug: Iron Isomaltoside 1000
Ferrous fumarate with ascorbic acid Administered oral
Drug: ferrous fumarate with ascorbic acid
Administered iv
Oral administration
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
Plan to share: No
This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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Pharmacosmos A/S