Landmark Malawian clinical trial raises iron levels in pregnant women

Sub Levels

A world-first study exploring new ways to combat anemia in developing countries found that a single iron injection, compared to daily pills, could significantly reduce iron deficiency in pregnant women.

The World Health Organization (WHO) currently recommends twice-daily oral iron supplements as standard treatment in developing countries, but adherence to this treatment is poor.

The findings, driven by a collaboration of Australian and Malawian researchers, pave the way for more effective health policies to reduce the global health burden of anemia.

This research is published in The Lancet.

at a glance

  • First study of iron infusion of iron carboxymaltose (FCM) in pregnant women in developing countries. FCM is a common treatment for iron-deficient pregnant women in high-income countries like Australia.
  • This study showed that a single infusion of iron during the second trimester of pregnancy significantly reduced iron deficiency in pregnant women compared to the daily iron supplement currently recommended by the WHO.
  • The Malawi-based trial of 862 women may lead to urgently needed new treatment options for iron-deficient women in resource-poor communities.

Research nurses screen pregnant participants
Anemia by collecting a blood sample for hemoglobin.
Credit: Elisabeth Mamani-Mategula, Training and
Research Unit of Excellence (Malawi).

Iron deficiency is a major public health burden in resource-poor countries and an important precursor to anemia, a condition that affects nearly half of all pregnancies in Africa. Occurs when there is a shortage.

The WHO recommends that pregnant women in sub-Saharan Africa take oral iron twice daily, but less than 30% of the population consumes this recommended dose.

Iron carboxymaltose (FCM) is a 15-minute iron infusion treatment that is widely used for iron-deficient pregnant women in developed countries.

To find more effective ways to treat iron-deficient patients, WEHI researchers are collaborating with Malawian scientists from the Training Research Unit of Excellence and the Kamuzu University of Health Sciences to develop FCM and standard-of-care oral iron supplements. compared.
Half of the Malawian women (431) received FCM in the second trimester and the other half received standard of care oral iron supplements.

Professor Sant-Rayn Pasricha, a leading anemia expert and head of WEHI’s Department of Population Health and Immunity, said the trial was four times larger than the one conducted to bring FCM to market. I was.

“When we first embarked on this trial, people thought we were trying to achieve the impossible,” said Professor Pasricha, also a hematologist.

“We have not only demonstrated that FCM can be administered safely in resource-limited and complex settings such as Malawi, but it can also reduce the iron deficiency component of anemia by approximately 60%. is far superior to the oral iron supplements currently recommended in these populations.

“The results show that women who received FCM throughout the study had significantly reduced iron deficiency and iron deficiency anemia in the third trimester of pregnancy, at delivery and at 4 weeks postpartum.

“This opens up a whole new area of ​​research previously thought impossible and could help transform health policies in vulnerable communities.

“I am very excited that a drug that is widely used in high-income countries could be applied to help women in sub-Saharan Africa and other resource-poor settings. Our next task is to identify women who are most likely to benefit from IV treatment.”

A unique health challenge

Professor Sant-Rayn Pasricha (left) and Professor Kamija
Phiri (R) is exploring new ways to combat anemia in Malawi.

Pregnant women with anemia are at increased risk of complications such as postpartum hemorrhage, stillbirth, and low birth weight.

Despite the significant improvement in iron levels, this trial found that FCM was not superior to oral iron in reducing the overall burden of anemia in pregnant women, and that FCM was not superior to oral iron in reducing the overall burden of anemia in pregnant women. We found that it did not reduce birth weight or the incidence of anemia.

Researchers say that’s because anemia can be caused by factors other than iron deficiency in developing countries.
“Conditions like malaria and HIV, which are common in parts of sub-Saharan Africa, for example, can promote inflammation in the body and block access to iron stores,” says the leading epidemiologist. Physician and Director of Training and Research, Professor Kamija Fili. I said Unit of Excellence.

“In addition, hemoglobinopathies – a group of inherited blood disorders that primarily affect red blood cells – are common in the region and cause anemia.”

Professor Pasricha says the results highlight the urgent need for new mechanisms to address these unique health challenges.
“More than half of the participants had inflammation in their bodies even though they tested negative for malaria,” he said.

“Because there are parasites that can hide in the placenta during pregnancy, current tests may not be sensitive enough to understand the full health of the mother and the risks to the fetus.

“In developed countries, blood tests can be done to detect determinants of anemia such as ferritin, but in these parts of the world there are no such tools to measure iron status.

“Our study demonstrates the urgent need for field-friendly testing capabilities for iron status and causes of anemia, providing important insights into where and how medicines such as FCM should be used. will provide.”

As FCM remains an expensive treatment option, the researchers hope the promising results will encourage further research into this intervention and philanthropic efforts to make it more accessible to women in low-income settings. is.

The research team is currently following the mothers and their babies who participated in this study to assess whether the intervention affects the prevalence of anemia, postpartum depression, and neurodevelopment in children.

The study “Comparing Iron Carboxymaltose to Standard Oral Iron for the Treatment of Late Pregnancy Anemia in Pregnant Women in Malawi: A Randomized Controlled Trial” is published in The Lancet (DOI: 10.1016/ PIIS0140-6736(23)00278-7).

This research was funded by the Bill & Melinda Gates Foundation and a National Health and Medical Research Council (NHMRC) Investigator Grant awarded to Professor Pasricha.

WEHI authors: Sant-Rayn Pasricha, Ricardo Ataide, Rebecca Harding, Danielle Clucas, Sabine Braat.

/Release. This material from the original organization/author may be of a point-in-time nature and has been edited for clarity, style, and length. and do not take a stand. All views, positions and conclusions expressed herein are solely those of the author.

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