A team of researchers at the College of Medicine of University of Lagos (UNILAG), Nigeria led by Professor Bosede Afolabi, in collaboration with some researchers at Bayero University, Kano and the Karolinska Institutet, Sweden, amongst others, in a recently concluded clinical trial, called the IVON TRIAL, tested a medicine for treating anaemia (low blood level), called ferric
carboxymaltose, which is new Nigeria and most of sub-Saharan Africa.
They compared the effectiveness and safety of this medicine with that of a popular tablet, called ferrous sulphate, which is currently being used to treat anaemia in Nigeria.
They found that this new medicine given in drip (continuous fluid) through the vein works faster and better than iron tablet taken by mouth for treatment of anaemia; and it is as safe as the tablet.
This novel finding has just been published in a top-ranking journal, the Lancet Global Health, on Wednesday, September 18, 2024 (https:/bit.ly/VONTRIAL).
Why Are The Findings Of This Research Important?
Anaemia (low blood level) is a common cause of ill-health or death in mothers and their babies, especially in South-East Asia and sub-Saharan Africa where more than four out of ten pregnant women have the condition.
The study funded by Bill & Melinda Gates Foundation (Investment ID INV-017271) found that a sizeable proportion of pregnant women in Nigeria proceed to giving birth while still anaemic despite taking iron tablets for prevention during pregnancy.
Some reasons for this are that
some women do not tolerate the tablets because of side effects like diarrhoea, nausea, or
vomiting, or they forget to take the tablets.
Available iron preparation given through drip in Nigeria like iron dextran have been associated with high risk of severe side effect, while iron sucrose needs repeat dosing.
There is a need for an effective and safer alternative to overcome these problems.
How Was The Study Performed?
The IVON TRIAL enrolled 1,056 pregnant women, aged 15
– 49 years, who were between five and seven-and-half months pregnant and had anaemia with haemoglobin (red blood level) measurement less than 10 g/dl.
We used a web-based platform to assign them into groups; they were not allowed to switch afterwards. Half of the women were treated with one dose of iron given in drip through the vein while half took tablets three times a day till they gave birth. Their blood (haemoglobin level) and iron levels were checked, and they were screened for depression at specific time points.
They were followed-up until six weeks after delivery to collect more data from mother and baby.
Blood was collected from the baby’s cord at delivery to know if the medicine affected the baby’s
phosphate level.
What Did The Research Find?
Only one dose of iron (ferric
carboxymaltose) given by drip through a vein during pregnancy
causes a faster rise in blood level after four weeks compared to iron tablet taken by mouth three times every day.
The drip iron also corrects low body iron better than iron tablet.
The side effects of the drip iron are comparable to that with iron tablet, with no adverse effect on the babies.
These findings are reassuring because pregnant women often reject new medicines because of fear of harm to their babies.
We now have evidence that implementing the use of this new drip iron (ferric carboxymaltose) in regions where many pregnant women suffer anaemia like Africa, will be a valuable step towards reducing the proportion of pregnant women who suffer from this condition and its complications.
What Next Now That The IVON TRIAL İs OVer?
The IVON TRIAL had a clinical trial and an implementation research component. Cost-effectiveness analysis is currently ongoing.
At the beginning of the trial, we assessed the acceptability of using drip iron in our
environment and the results were encouraging.
The pregnant women were willing to accept the drip iron during pregnancy; supported by their families.
The healthcare workers were
ready to administer drip iron but identified a need to increase staff strength and possibly
medicine subsidy. Now that we know from the clinical trial that the drip iron is effective and
safe, we are already liaising with the Federal Ministry of Health, Nigeria to add it to the
essential drug list.
