REVAMP-Phase

Kinetics of hypophosphatemia in Malawian pregnant women receiving intravenous iron administered during the second trimester in the management of anaemia

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The problem

Anaemia in pregnancy remains a critical global health problem, affecting nearly half of all pregnant women in Africa. In pregnancy, the primary cause of anaemia is iron deficiency. 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. Across Africa, few women receive or take the recommended course of oral iron supplementation and often present for their initial visit far into the second trimester of pregnancy. This late presentation limits opportunities to treat antenatal anaemia, exposing women and their babies to its consequences.

In low- and middle-income countries (LMICs), new intravenous iron products provide a novel opportunity to deliver high doses of iron in a single, rapid infusion, allowing for a quick recovery to normal iron levels, thereby reducing anaemia and improving maternal and neonatal outcomes.

Ferric carboxymaltose is an intravenous iron formulation widely available in high income settings that is commonly used to treat anaemia. One noted side effect of ferric carboxymaltose is transient low phosphate levels in the blood, or hypophosphatemia. Although the use of ferric carboxymaltose to treat anaemia in pregnancy has not been associated with significant clinical outcomes, there is limited data examining phosphate levels in pregnant women receiving this treatment, particularly in the African setting, where nutritional deficiencies may be more common.

The study

This research study aims to closely monitor the levels and changes in serum phosphate following the delivery of ferric carboxymaltose to treat anaemia in pregnant women in Malawi throughout 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 help clarify the safety profile of ferric carboxymaltose when used to treat anaemia in pregnant women in Malawi and other LMIC settings worldwide.