Journal article

Ferric carboxymaltose for anemia in late pregnancy: a randomized controlled trial

SR Pasricha, E Moya, R Ataíde, G Mzembe, R Harding, MN Mwangi, T Zinenani, KH Prang, J Kaunda, OPL Mtambo, M Vokhiwa, G Mhango, E Mamani-Mategula, K Fielding, A Demir, N Von Dinklage, H Verhoef, ARD McLean, L Manda-Taylor, S Braat Show all

Nature Medicine | NATURE PORTFOLIO | Published : 2025

Open access

Abstract

Over 46% of African pregnant women are anemic. Oral iron is recommended but often suboptimal, particularly late in pregnancy. Intravenous ferric carboxymaltose (FCM) could treat anemia in women in the third trimester in sub-Saharan Africa. In an open-label, individually randomized trial in antenatal clinics in southern Malawi, we randomized 590 women at 27–35 weeks of gestation with capillary hemoglobin <10.0 g dl−1 to FCM (20 mg kg−1 up to 1,000 mg, once at enrollment) or standard of care (60 mg elemental iron, twice daily for 90 days). Participants and their infants were followed to 4 weeks postpartum. Primary outcomes were maternal anemia at 36 weeks’ gestation or delivery (whichever occu..

View full abstract

Grants

Awarded by Bill and Melinda Gates Foundation


Funding Acknowledgements

The trial was funded by the Bill and Melinda Gates Foundation (INV-010612). S.-R.P. is funded by NHMRC Fellowship GNT2009047; the contents of this work are the responsibility of the authors and do not reflect the views of the NHMRC. This work was also supported by the Victoria State Government's Operational Infrastructure Support Program and the NHMRC Independent Research Institute Infrastructure Support Scheme (IRIISS). The funders had no role in the planning, conduct, analysis or decision to publish the paper. We thank the Data Safety Monitoring Committee for reviewing the safety data during the trial. We thank M. Starr of the Population Health and Immunity Division at the Walter and Eliza Hall Institute of Medical Research (Parkville VIC 3052 Australia) for assistance in data analysis. We thank local health workers, participants and their families for their involvement in the study.