The Centre for Clinical Trials, Research and Implementation Science (CCTRIS), University of Lagos (UNILAG), has concluded a five-year clinical trial comparing the effectiveness of intravenous iron and oral ferrous sulphate in treating moderate to severe postpartum anaemia among Nigerian women.
The study, led by Professor of Obstetrics and Gynaecology at UNILAG, Bosede Afolabi, was funded with a $2.5 million grant from the Bill and Melinda Gates Foundation.
Conducted across multiple sites in Lagos, Rivers, Kano, and Kwara States, the randomised controlled trial assessed the clinical effectiveness, tolerability, and safety of intravenous ferric carboxymaltose (intervention) versus oral ferrous sulphate (control). It also evaluated the acceptability and feasibility of introducing intravenous iron for postpartum anaemia treatment in Nigeria.
The overall goal, according to the researchers, is to generate evidence to guide policy integration of intravenous iron into treatment protocols for anaemia in pregnancy and the postpartum period, especially in resource-limited settings.
Anaemia in pregnancy, often caused by iron deficiency, remains a major public health challenge in Nigeria and other low- and middle-income countries (LMICs).
It contributes significantly to maternal morbidity and mortality and negatively affects newborn health. Statistics show that about three in five pregnant Nigerian women suffer from anaemia.
Speaking at the IVON-PP Trial Close-Out and Dissemination Meeting in Abuja, Afolabi said the trial found that intravenous ferric carboxymaltose was both effective and well-tolerated in treating postpartum anaemia.
“A single dose of the intravenous drug can treat anaemia and sustain women for up to six months more effectively than oral tablets,” she explained. “Just one dose administered immediately after delivery can achieve better outcomes than daily tablets taken for six weeks. We found it corrected anaemia faster and more effectively.”
Afolabi described the IVON-PP trial as one of the largest global studies comparing intravenous and oral iron in postpartum women, with 1,400 participants recruited across the four states.
She also noted that the trial was entirely led and implemented by Nigerian researchers, site coordinators, and doctors, demonstrating national capacity for large-scale clinical research. The study assessed both maternal outcomes, such as anaemia prevalence, postpartum haemorrhage, and blood transfusion needs and infant outcomes, including low birth weight, stillbirth, and neonatal mortality.
Trial Manager Chisom Chieme added that the study, conducted between December 2022 and June 2025, achieved a 98 per cent retention rate, tracking participants at two weeks, six weeks, 12 weeks, and six months postpartum. She emphasised that transparency during participant enrolment and robust monitoring systems were key lessons from the study.
In his remarks, Chief Medical Director of the Rivers State Hospitals Management Board, Dr Bright Ogbonda, noted that while research findings are often promising, implementation in hospitals can be hampered by the unavailability of products and consumables. He called for an effective logistics management system to ensure a consistent supply of essential drugs and clinical guidelines to support hospital adoption.
Also speaking, National Representative for the Essential Medicines List (EML), Talatu Fati, said integrating new research evidence into national treatment guidelines requires alignment with national healthcare policies.
“We have a structured process through the National Drug Formulary and Essential Drug List (NDF/EDL) Review Committee,” she explained. “With these findings now disseminated, the research team will present evidence for review, after which the committee will decide whether to include the intravenous iron in the National Essential Medicines List.”
