EDIVA

Efficacy and Demonstration of IntraVenous Iron for Anaemia in Pregnancy

Anaemia in pregnancy is a major global health problem with significant health consequences for mothers and newborns. The primary cause of anaemia in pregnancy is iron deficiency.

In many low- and middle-income countries (LMICs), progress in reducing anaemia in pregnancy has been limited, despite routine antenatal oral iron supplementation. In high-income settings, modern intravenous iron products such as ferric carboxymaltose are widely available and deliver high doses of iron in a single, short infusion. In LMICs, intravenous iron formulations present a novel opportunity to rapidly cure moderate to severe anaemia in pregnancy, thereby improving maternal and neonatal outcomes.

This research project aims to assess the effectiveness and feasibility of intravenous iron to treat anaemia in pregnant women in Bangladesh.

A randomized controlled trial is being conducted to determine the effectiveness of treating moderate to severe anaemia during second and third trimester of pregnancy with an intravenous iron formulation (ferric carboxymaltose), compared to the standard of care of oral iron supplementation. The primary objective is to determine the effectiveness of intravenous iron in reducing maternal anaemia by 34 weeks’ gestation, compared to oral iron supplementation. Women and their infants will be followed up until 12 months postpartum, and key secondary outcomes of interest include birthweight and gestational age, maternal and child safety and wellbeing, and infant neurocognitive development and growth.

To determine the real-world feasibility of implementing the intervention in the Bangladesh health care setting we will be conducting a demonstration project alongside the randomized controlled trial. Intravenous iron will be delivered in government antenatal care services by government health workers. An independent implementation research team will collect information on implementation facilitators and barriers. This will inform the feasibility and acceptability of the intravenous iron treatment in low-income settings.

• Trials registry: ANZCTR registration
• Contact: pasricha.s@wehi.edu.au