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

Iron Deficiency Anemia of Pregnancy Clinical Trial

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

Status Completed

Clinical Trial Summary

Intravenous iron isomaltoside versus oral iron supplementation for treatment of iron deficiency in pregnancy

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Iron Deficiency Anemia of Pregnancy

• NCT number: NCT03188445
• Study type: Interventional
• Source: Pharmacosmos A/S
• Status: Completed
• Phase: Phase 4
• Start date: July 11, 2017
• Completion date: August 18, 2020