Trial reportThe Lancet. Global health2024
Postpartum maternal and infant haematological effects of second-trimester ferric carboxymaltose versus standard-of-care oral iron in Malawi: longitudinal follow-up of a randomised controlled trial.
Trial report in The Lancet. Global health, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
6 citing papers in PubMed, 1 synthesis or guideline pooled it.
- The effect of intravenous iron supplementation compared to oral iron supplementation during pregnancy on neonatal outcomes-a systematic review of randomized controlled trials.European journal of pediatrics · 2025Pooled it
- Prenatal Intravenous Iron and Child Growth: A Secondary Analysis of a Randomized Clinical Trial.JAMA network open · 2025Trial
- Postpartum anemia and maternal wellbeing: A cohort analysis of the WOMAN-2 trial.International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics · 2026Article
- Parenteral iron-Does it increase infection risk?Vox sanguinis · 2026Review
- Iron deficiency with and without anemia in pregnancy: A scoping review of prevalence and perinatal impact.International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics · 2026Article
- Getting back on track to meet global anaemia reduction targets: a Lancet Haematology Commission.The Lancet. Haematology · 2025Review
Corrections and comments
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Authors and funding
15 authors.
Funding
Abstract
backgroundAnaemia is common in mothers and infants in the first year postpartum, especially in sub-Saharan Africa. We evaluated whether treating anaemia in the second trimester of pregnancy with a single dose of intravenous iron, ferric carboxymaltose, compared with standard-of-care oral iron could alleviate anaemia in postpartum women and their infants.
methodsREVAMP (ACTRN12618001268235), an open-label, individually randomised, controlled trial done across nine urban and five rural health centres in Malawi, recruited women if they were in the second trimester of singleton pregnancy, had a capillary haemoglobin concentration of less than 10·0 g/dL, and had a negative malaria rapid diagnostic test. Once enrolled, women were randomly assigned (1:1) to receive intravenous ferric carboxymaltose (20 mg/kg up to 1000 mg) or standard of care (60 mg oral elemental iron twice daily for 90 days); all women received preventive malaria treatment. The primary endpoint of REVAMP was anaemia prevalence at 36 weeks of gestation, with follow-up of mothers and infants until 1 month postpartum. In REVAMP-EXTENDED, women from REVAMP who gave consent, and their infants, were followed up at 3, 6, 9, and 12 months postpartum, and venous blood was collected for haemoglobin, ferritin, and C-reactive protein measurement. Maternal postpartum outcomes comprised prevalence of anaemia (venous haemoglobin concentration <11 g/dL up to and including delivery and <12·0 g/dL postpartum) and haemoglobin concentration, as well as iron status (iron deficiency, defined as serum ferritin <15 μg/L, or <30 μg/L if C-reactive protein >5 mg/L, and iron deficiency anaemia [both iron deficiency and anaemia]). Infant outcomes comprised cord ferritin concentration, and haemoglobin and ferritin concentrations at 1, 3, 6, 9, and 12 months of age.
findingsBetween Nov 12, 2018, and March 2, 2021, 862 women were randomly assigned in REVAMP, of whom 793 (393 in the ferric carboxymaltose group [376 liveborn infants] and 400 [379 liveborn infants] in the standard-of-care group) provided consent for REVAMP-EXTENDED. At 12 months postpartum, ferritin concentrations were higher (geometric mean ratio 1·47 [95% CI 1·29-1·66], p<0·0001), and prevalence of iron deficiency was lower (prevalence ratio 0·65 [0·48-0·88], p=0·0050), in mothers receiving ferric carboxymaltose than in those receiving standard of care. Anaemia was less common in women who received ferric carboxymaltose than in those who received standard of care at 1 month (prevalence ratio 0·84 [95% CI 0·71-0·98], p=0·027), 3 months (0·75 [0·62-0·91], p=0·0029), and 6 months (0·78 [0·63-0·96], p=0·018) postpartum but not thereafter. There was no evidence of a difference between groups regarding cord ferritin, infant ferritin, or infant haemoglobin concentrations at any timepoint. Benefits on postpartum anaemia were restricted to mothers with baseline iron deficiency.
interpretationFerric carboxymaltose treatment in the second trimester protected women from postpartum anaemia and iron deficiency but did not affect infant haematological or iron status.
fundingBill & Melinda Gates Foundation. TRANSLATION: For the Chichewa translation of the abstract see Supplementary Materials section.
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