A study of the induction and resolution of hypophosphatemia following intravenous iron (ferric carboxymaltose) treatment of anaemic Malawian pregnant women in their second trimester

Anaemia in pregnancy remains a critical global health problem, affecting 46% of pregnant women in Africa. Antenatal anaemia causes significant risks for both mother and child and can result in serious complications (including maternal mortality, low birth weight and premature delivery). In pregnancy, anaemia is commonly due to iron deficiency. Across Africa, few women receive or take the full recommended course of antenatal oral iron and may present for their initial visit far into the second trimester. This late presentation limits opportunities to treat antenatal anaemia, exposing women and their babies to its consequences. New intravenous iron products provide a chance to give high doses of iron in a single rapid infusion, thus eliminating the difficulties in monitoring oral iron compliance and allowing for a quick recovery to normal iron levels. Ferric Carboxymaltose is an intravenous iron formulation that is commonly used to treat anaemia. One noted side effect of Ferric Carboxymaltose infusion is a transient low phosphate in the blood (hypophosphatemia). Although the use of Ferric Carboxymaltose as a single treatment of anaemia in pregnancy has not been associated with significant clinical outcomes, there is limited data examining phosphate levels in pregnant women receiving this treatment in general, as well as within the African setting, where nutritional deficiencies may be more common. Our study is designed to accurately track the level and duration of any changes in serum phosphate following the use of Ferric Carboxymaltose to treat anaemia in pregnant Malawian women in their second trimester. Our study also aims to measure phosphate-related bone health markers and bone turnover markers in study participants following administration of Ferric Carboxymaltose. Our study will clarify the safety profile of Ferric Carboxymaltose when used to treat anaemia in pregnant women in Malawi and similar settings worldwide.