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
• REVAMP-TT - Randomized controlled trial of the Effect of intraVenous iron on Anaemia in Malawian Pregnant women in the Third Trimester 
• EDIVA - Efficacy and Demonstration of IntraVenous Iron for Anaemia in Pregnancy

EDIVA: Efficacy and Demonstration of IntraVenous Iron for Anaemia in Pregnancy

The problem

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.

The trial

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.

The team

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

Dr Jena Hamadani, Principal Investigator, Maternal and Child Health Division, International Centre for Diarrhoeal Disease Research, Bangladesh

Dr Imrul Mohammed Hasan, Trial Manager, Maternal and Child Health Division, International Centre for Diarrhoeal Disease Research, Bangladesh

Dr Eliza Davidson, Trial Manager, Population Health and Immunity Division, WEHI

Dr Alistair McLean, Trial Statistician, Population Health and Immunity Division, WEHI

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

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

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

Naomi VonDinklage, Program Coordinator, Population Health and Immunity Division, WEHI

Dr Louise Randall, Neuro Study 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 Bidhan Krishna Sarker, Implementation Science Researcher, International Centre for Diarrhoeal Disease Research, Bangladesh

Dr Shamim Ahmed, Trial Manager, International Centre for Diarrhoeal Disease Research, Bangladesh

Dr Quaiyum Rahman, Team Coordinator, International Centre for Diarrhoeal Disease Research, Bangladesh

Dr Saiful Alam Bhuiyan, Team Coordinator, International Centre for Diarrhoeal Disease Research, Bangladesh

Jahiduj Jaman, Data Team Coordinator, International Centre for Diarrhoeal Disease Research, Bangladesh

Shamima Shiraji, Developmental Assessment Team Coordinator, International Centre for Diarrhoeal Disease Research, Bangladesh

Partnerships/collaborators

• The International Centre for Diarrheal Disease Research, Dhaka (icddr,b), Bangladesh
• Melbourne School of Population and Global Health, The University of Melbourne, Australia
• Murdoch Children's Research Institute, Melbourne, Australia
• The Royal Children's Hospital, Melbourne, Australia

Funders

• The Bill and Melinda Gates Foundation

More information

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