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

The problem

Anaemia disproportionately affects pregnant women. In Africa, half of pregnant women become anaemic, with 40 per cent 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. Additionally, across Africa, women present for their initial visit far into the second trimester. This late presentation limits our opportunities to treat antenatal anaemia, in this population, exposing women and their babies to its consequences.

There is a real need for the establishment of a parenteral iron formulation in women with moderate or severe iron deficiency anaemia (IDA) in pregnancy, and perhaps in all women with IDA in the third trimester when fetal iron transfer is highest, and delivery (with the risk of blood loss) is imminent.

The trial

This research project aims to determine the effectiveness and safety of delivering intravenous iron administration during the third trimester of pregnancy – given as Ferric Carboxymaltose compared with standard of care oral iron in improving maternal (especially anaemia) and infant (growth, birth weight and development up to 12 months postpartum) outcomes.

This is an open-label two arm parallel-group randomised controlled trial in anaemic pregnant women set in eight primary health centres in Zomba district in Malawi.

The trial will randomise 590 women in the third 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

Because anaemia in pregnancy may exert its influence in the postpartum period, we will continue 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, as well as using x-rays to assess for the presence of radiological rickets.

Other immune and clinical longer-term benefits and safety of this treatment will also be assessed.

Schema of anaemia iron clinical study

The team

More information

Global maternal and child health trials in Africa and Asia
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