IV Iron Supplement - Phase III study to compare intravenous with oral iron to treat iron deficiency anaemia

Intravenous ferric carboxymaltose compared with oral iron in the treatment of iron deficiency anaemia at delivery in Tanzania

Anaemia is a major concern in Africa. Women with frequent pregnancies or multiple abortions are especially at high risk of iron deficiency anaemia. Intake of oral iron is often cumbersome (fasting, no tea, no coffee) and efficacy depends on good compliance. In contrast, intravenous iron infusions can easily be administered at the hospital during prenatal or postnatal pregnancy visits. Substitution per iron infusions has been demonstrated to have good efficacy and safety in northern countries.

In low resource countries, however, patients may have limited access to medication supply, different perception of medication needs and compliance as well as concomitant diseases like malaria, soil-transmitted helminths, schistosomiasis or HIV. All these factors may influence the efficacy of both the oral and the intravenous iron substitution modality. 

In northern countries, ferric carboxymaltose (Ferinject®) is already commonly used for intravenous substitution. This study will compare iron substitution with Ferinject® to oral iron substitution in pregnant women nearing delivery in Tanzania. They will be randomly assigned to receive either oral or intravenous iron substitution within 7 days post-delivery. The primary endpoint of the study will be the percentage of women with correction of haemoglobin or normal haemoglobin values at 6 weeks after treatment start.