BACKGROUND Anaemia 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. METHODS REVAMP (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. FINDINGS Between 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. INTERPRETATION Ferric carboxymaltose treatment in the second trimester protected women from postpartum anaemia and iron deficiency but did not affect infant haematological or iron status. FUNDING Bill & Melinda Gates Foundation. TRANSLATION For the Chichewa translation of the abstract see Supplementary Materials section.

中文翻译：

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马拉维孕中期羧基麦芽糖铁与标准护理口服铁剂的产后母婴血液学影响：一项随机对照试验的纵向随访。


背景 贫血在产后第一年的母亲和婴儿中很常见，尤其是在撒哈拉以南非洲。我们评估了与标准护理口服铁剂相比，在妊娠中期用单剂量静脉注射铁剂羧基麦芽糖铁治疗贫血是否可以缓解产后妇女及其婴儿的贫血。方法 REVAMP （ACTRN12618001268235） 是一项在马拉维 9 个城市和 5 个农村卫生中心进行的开放标签、个体随机、对照试验，招募了处于单胎妊娠中期、毛细血管血红蛋白浓度低于 10·0 g/dL 且疟疾快速诊断试验阴性的妇女。入组后，女性被随机分配 （1：1） 接受静脉注射羧基麦芽糖铁（20 mg/kg 至 1000 mg）或标准护理（60 mg 口服元素铁，每天两次，持续 90 天）;所有妇女都接受了预防性疟疾治疗。REVAMP 的主要终点是妊娠 36 周时的贫血患病率，对母亲和婴儿进行随访直至产后 1 个月。在 REVAMP-EXTENDED 中，在产后 3 、 6 、 9 和 12 个月对同意的 REVAMP 妇女及其婴儿进行随访，并收集静脉血用于血红蛋白、铁蛋白和 C 反应蛋白测量。产妇产后结局包括贫血患病率（静脉血红蛋白浓度 <11 g/dL 直至分娩和产后 <12·0 g/dL）和血红蛋白浓度，以及铁状况（缺铁，定义为血清铁蛋白 <15 μg/L，如果 C 反应蛋白 >5 mg/L，则为 <30 μg/L，以及缺铁性贫血 [缺铁和贫血]）。 婴儿结局包括 1 、 3 、 6 、 9 和 12 个月大时的脊髓铁蛋白浓度以及血红蛋白和铁蛋白浓度。结果： 在 2018 年 11 月 12 日至 2021 年 3 月 2 日期间，862 名妇女被随机分配到 REVAMP 中，其中 793 名（羧基麦芽糖铁组 393 名 [376 名活产婴儿] 和 400 名 [标准护理组] [379 名活产婴儿] 同意 REVAMP-EXTENDED。产后 12 个月时，接受羧基麦芽糖铁的母亲的铁蛋白浓度较高（几何平均比值 1·47 [95% CI 1·29-1·66]，p<0·0001），缺铁患病率较低（患病率 0·65 [0·48-0·88]，p=0·0050），接受羧基麦芽糖铁的母亲比接受标准护理的母亲低。与接受标准护理的女性相比，接受羧基麦芽糖铁治疗的女性在产后 1 个月（患病率 0·84 [95% CI 0·71-0·98]，p=0·027）、3 个月（0·75 [0·62-0·91]，p=0·0·0029）和 6 个月（0·78 [0·63-0·96]，p=0·018）的贫血率低于接受标准护理的女性，但此后则不常见。没有证据表明组间在任何时间点的脐带铁蛋白、婴儿铁蛋白或婴儿血红蛋白浓度存在差异。对产后贫血的益处仅限于基线缺铁的母亲。解释 孕中期的羧基麦芽糖铁治疗可保护妇女免受产后贫血和铁缺乏症的影响，但不影响婴儿血液学或铁状况。资金 比尔和梅琳达·盖茨基金会。翻译 关于摘要的 Chichewa 翻译，参见 补充材料 部分。