Global maternal and child health trials in Asia and Africa

• Our trials: Improving maternal and child health
• BRISC - Benefits and Risks of Iron InterventionS in Children: a randomized controlled trial in rural Bangladesh 
• EDIVA - Efficacy and Demonstration of IntraVenous Iron for Anaemia in pregnancy
• REVAMP-TT - Randomized controlled trial of the Effect of intraVenous iron on Anaemia in Malawian Pregnant women in the Third Trimester 

REVAMP-TT: 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.

The team

Professor Kamija Phiri, Principal Investigator, Training and Research Unit of Excellence, College of Medicine

Professor Sant-Rayn Pasricha, Principal Investigator, Population Health and Immunity Division, WEHI

Dr Martin Mwangi, Trial Manager, Training and Research Unit of Excellence, College of Medicine

Dr Ricardo Ataide, Trial Manager, Population Health and Immunity Division, WEHI

Ernest Moya, Team Coordinator, Training and Research Unit of Excellence, College of Medicine

Dr Zinani Truwah, Team Coordinator, Training and Research Unit of Excellence, College of Medicine

Dr Glory Mzembe, Team Coordinator, Training and Research Unit of Excellence, College of Medicine

Maclean Vokhiwa, Neuro Assessment Coordinator, Training and Research Unit of Excellence, College of Medicine

Dr Louise Randall, Neuro Study Coordinator, Population Health and Immunity Division, WEHI

Sabine Braat, Senior Biostatistician, Population Health and Immunity Division, WEHI

Dr Rebecca Harding, Trial Statistician, Population Health and Immunity Division, WEHI

Phoebe Fitzpatrick, Data Manager, Population Health and Immunity Division, WEHI

Mphatso Mwambinga, Data Officer, Training and Research Unit of Excellence, College of Medicine

William Nkhono, Data Officer, Training and Research Unit of Excellence, College of Medicine

Naomi Von Dinklage, Program Coordinator, Population Health and Immunity Division, WEHI

Dr Khic-Houy Prang, Implementation Science Researcher, The University of Melbourne​ 

Ebony Verbunt, Implementation Science Researcher, The University of Melbourne 

Dr Lucinda Manda-Taylor, Implementation Science Researcher, Kamuzu University of Health Sciences

Dr Effie Chipeta, Implementation Science Researcher, Kamuzu University of Health Sciences

Professor Gary Rance, Audiologist, the University of Melbourne

Dr Peter Carew, Audiologist, The University of Melbourne

Dr Sumie Leung, Cognitive Neuroscientist, The University of Melbourne

Associate Professor Stefan Bode, Cognitive Neuroscientist, The University of Melbourne

Associate Professor Katherine Johnson, Developmental Cognitive Neuroscientist, The University of Melbourne

Dr Peter Simm, Paediatric Endocrinologist and Honorary Fellow, Hormone Research, Murdoch Children's Research Insititute 

Associate Professor Marc Seal, Principal Research Fellow & Group Leader, Developmental Imaging, Murdoch Children's Research Institute

Partnerships/collaborators

• TRUE (Training and Research Unit of Excellence), Malawi
• The University of Melbourne, Melbourne, VIC, Australia
• The Royal Children’s Hospital, Melbourne, VIC, Australia
• The Murdoch Children’s Research Institute, Melbourne, VIC, Australia

Funders

• The Bill and Melinda Gates Foundation

More information

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