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EDIVA-Phase

EDIVA-Phase

Evaluation of blood phosphate levels following intravenous iron treatment of anaemic pregnant women in their second trimester in Bangladesh.

The problem

In Bangladesh, anaemia is considered a major public health problem. Antenatal anaemia causes critical long-term risks for both mother and child. In most low- and middle-income countries (LMICs) in sub-Saharan Africa and South Asia, including Bangladesh, antenatal supplementation with iron and folic acid (IFA) is part of the standard antenatal care (ANC) package of services and is the primary intervention to prevent and treat anaemia during pregnancy. However, treatment with oral iron is poorly tolerated due to gastrointestinal adverse effects and requires extended contact with a well-functioning healthcare system.

In high-income settings, modern intravenous (IV) iron products (e.g., ferric carboxymaltose (FCM)) are delivered as a single infusion and are commonly used during pregnancy. FCM is known to cause a transient low blood phosphate level in various clinical settings. Although the use of FCM in pregnancy has not been associated with significant clinical problems, there is limited information examining phosphate levels in pregnant women receiving this treatment. Therefore, it is critical to confirm the safety and avoid risk of unexpected adverse events after IV iron administration as a key component in assessing the value and safety of parenteral iron formulation use in the South Asian context.

The trial

This single-arm, open-label intervention trial in women with moderate or severe anaemia during their second trimester, closely examines the kinetics of serum phosphate levels following FCM treatment. Participants will receive a single dose of iron (in the form of FCM) intravenously and be followed over the course of their pregnancy until delivery. The following figure demonstrates the recruitment and follow-up schedule.

The team

More information

Global maternal and child health trials in Africa and Asia
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