Project 08
REVAMP Phase
Kinetics of hypophosphatemia in Malawian pregnant women receiving intravenous iron administered during the second trimester in the management of anaemia – REVAMP Phase
A study of the induction and resolution of hypophosphatemia following intravenous (IV) iron (ferric carboxymaltose) treatment of anaemic Malawian pregnant women in their second trimester.
Broad Objective
To determine the impact of a single dose of IV ferric carboxymaltose on serum phosphate levels in anaemic pregnant women in their second trimester.
Rationale
Provision of IV iron to anaemic pregnant women quickly raises women’s haemoglobin levels and thus protects them from anaemia in the intrapartum period and facilitate the recovery postpartum. Furthermore, infants born from women who receive IV iron have more iron stores compared to those treated with oral iron. Administration of IV Ferric Carboxymaltose (FCM), however, may result in hypophosphatemia. Single dosing treatment of anaemia in pregnancy has not been associated with significant clinical outcomes. Recent studies have not linked the degree of hypophosphataemia with clinical symptoms. The severity and duration of hypophosphatemia in women in Africa, where nutritional deficiencies may be more common, may mean there are important variations in the effects of the drug on phosphate levels; it is imperative these be studied in detail prior to expansion of the use of FCM in clinical practice in Africa.
Methods
Single arm, open labelled Phase IV interventional trial.
Primary Outcomes
The nadir serum phosphate concentration following a single treatment dose of intravenous ferric carboxymaltose to treat anaemia in pregnancy. Safety outcomes include Proportion of women with at least one adverse effect (occurring immediately post-infusion, and within 7 days of commencement of treatment).
Funding
