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REVAMP

Randomized controlled trial of the Effect of intraVenous iron on Anaemia in Malawian Pregnant women

The problem

Anaemia disproportionately affects pregnant women. In Africa, half of pregnant women become anaemic, with 40% of those having iron-deficiency. Antenatal iron supplementation has been shown to be critical to maternal and newborn health; however, in many low-income countries, access and adherence to oral iron is limited. Iron-deficiency and anaemia during pregnancy also play a role in the maternal and fetal outcomes of infection, particularly malaria.

There is a real need for the establishment of a parenteral iron formulation in women with moderate or severe IDA in pregnancy, whilst understanding how this affects their susceptibility to infection, thus guaranteeing optimal pregnancy outcomes.

Additionally, there is a pressing need to understand how these prenatal interventions affect a newborn’s hematological and iron parameters and importantly their development.

The trial

This is an open-label two arm parallel-group randomised controlled trial in anaemic pregnant women set in Blantyre and Zomba, Malawi. The trial randomised 892 women in the second trimester of pregnancy with a capillary haemoglobin concentration below 10.0g/dL.

The study comprises two arms:

  • (a) intravenous Ferric Carboxymaltose (20mg/kg up to 1000mg) given once at randomisation, and
  • (b) standard of care oral iron (65mg elemental iron twice daily) for the duration of pregnancy, whichever is shorter provided according to local health care practices.

We determined the efficacy and safety of delivering intravenous iron administration during the second trimester of pregnancy – given as Ferric Carboxymaltose compared with standard of care oral iron in improving maternal (especially anaemia) and infant (growth, birth weight) outcomes. Because anaemia in pregnancy may exert its influence in the postpartum period, we continued to follow the cohort of women and babies postpartum and investigate infant neurodevelopment outcomes using a portable MRI (Hyperfine), conducting EEGs and performing Bayley assessments. Additionally, other immune and clinical longer-term benefits and safety of this treatment are also being assessed.

Clinical trial diagram

The team

Resources

Global maternal and child health trials in Africa and Asia
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