Ferric carboxymaltose for anemia in late pregnancy: a randomized controlled trial
Details
Publication Year 2025-01,Volume 31,Issue #1,Page 197-206
Journal Title
Nature Medicine
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 occurred first) and neonatal birthweight. At the primary timepoint, 126 of 270 (46.7%) of women in the FCM group were anemic, compared to 170 of 271 (67.3%) women in the standard-of-care group (PR, 0.74 (95% CI 0.64, 0.87); P = 0.0002). There was no difference between groups in birthweight (mean difference 10.9 g (-65.7, 87.5 g); P = 0.78). No serious infusion-related reactions occurred, and there were no differences in adverse events between groups. In Malawian women in late pregnancy, FCM effectively and safely reduced anemia before childbirth. Australia New Zealand Clinical Trial registration: ANZCTR12621001239853.
Publisher
Springer Nature
Keywords
Humans; Female; Pregnancy; *Maltose/analogs & derivatives/therapeutic use/administration & dosage/adverse; effects; *Ferric Compounds/therapeutic use/administration & dosage/adverse effects; Adult; Anemia/drug therapy; Malawi; Pregnancy Trimester, Third; Pregnancy Complications, Hematologic/drug therapy; Infant, Newborn; Young Adult; Birth Weight; Hemoglobins/analysis/metabolism; Anemia, Iron-Deficiency/drug therapy
Research Division(s)
Infection and Global Health
PubMed ID
39762420
Open Access at Publisher's Site
https://doi.org/10.1038/s41591-024-03385-w
Terms of Use/Rights Notice
Refer to copyright notice on published article.


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