Anaemia affects 46% of pregnancies in Africa; oral iron is recommended by WHO but uptake and adherence are suboptimal. We tested a single dose of a modern intravenous iron formulation, ferric carboxymaltose, for anaemia treatment in Malawian pregnant women. In this open-label, individually randomised controlled trial, we enrolled women with a singleton pregnancy of 13–26 weeks' gestation in primary care and outpatient settings across two regions in southern Malawi. Women were eligible if they had capillary haemoglobin of less than 10·0 g/dL and negative malaria rapid diagnostic test. Participants were randomised by sealed envelope 1:1. Assessors for efficacy outcomes (laboratory parameters and birthweight) were masked to intervention; participants and study nurses were not masked. Participants were given ferric carboxymaltose up to 1000 mg (given once at enrolment in an outpatient primary care setting), or standard of care (60 mg elemental iron twice daily for 90 days), along with intermittent preventive malaria treatment. The primary maternal outcome was anaemia at 36 weeks' gestation. The primary neonatal outcome was birthweight. Analyses were performed in the intention-to-treat population for mothers and liveborn neonates, according to their randomisation group. Safety outcomes included incidence of adverse events during infusion and all adverse events from randomisation to 4 weeks' post partum. The trial is registered with ANZCTR, ACTRN12618001268235. The trial has completed follow-up. Between Nov 12, 2018, and March 2, 2021, 21 258 women were screened, and 862 randomly assigned to ferric carboxymaltose (n=430) or standard of care (n=432). Ferric carboxymaltose did not reduce anaemia prevalence at 36 weeks' gestation compared with standard of care (179 [52%] of 341 in the ferric carboxymaltose group 189 [57%] of 333 in the standard of care group; prevalence ratio [PR] 0·92, 95% CI 0·81 to 1·06; p=0·27). Anaemia prevalence was numerically lower in mothers randomly assigned to ferric carboxymaltose compared with standard of care at all timepoints, although significance was only observed at 4 weeks' post-treatment (PR 0·91 [0·85 to 0·97]). Birthweight did not differ between groups (mean difference –3·1 g [–75·0 to 68·9, p=0·93). There were no infusion-related serious adverse events or differences in adverse events by any organ class (including malaria; ≥1 adverse event: ferric carboxymaltose 183 [43%] of 430 standard of care 170 [39%] of 432; risk ratio 1·08 [0·92 to 1·27]; p=0·34). In this malaria-endemic sub-Saharan African setting, treatment of anaemic pregnant women with ferric carboxymaltose was safe but did not reduce anaemia prevalence at 36 weeks' gestation or increase birthweight. Bill & Melinda Gates Foundation (INV-010612).

中文翻译：

---

羧基麦芽糖铁与标准护理口服铁治疗马拉维孕妇妊娠中期贫血的比较：一项随机对照试验

贫血症影响非洲 46% 的怀孕；世界卫生组织推荐口服铁剂，但吸收率和依从性均不理想。我们测试了单剂量的现代静脉注射铁制剂（羧基麦芽糖铁）对马拉维孕妇贫血的治疗效果。在这项开放标签、单独随机对照试验中，我们在马拉维南部两个地区的初级保健和门诊机构招募了妊娠 13-26 周的单胎妊娠妇女。如果女性的毛细血管血红蛋白低于 10·0 g/dL 并且疟疾快速诊断测试呈阴性，则符合资格。参与者按密封信封 1:1 随机分配。疗效结果（实验室参数和出生体重）的评估者不接受干预；参与者和研究护士没有戴口罩。参与者接受高达 1000 毫克的羧基麦芽糖铁（在门诊初级保健机构登记时给予一次），或标准护理（60 毫克元素铁，每天两次，持续 90 天），同时进行间歇性预防性疟疾治疗。主要产妇结局是妊娠 36 周时贫血。主要新生儿结局是出生体重。根据随机分组，对意向治疗人群中的母亲和活产新生儿进行了分析。安全性结果包括输注期间不良事件的发生率以及从随机分组到产后 4 周的所有不良事件。该试验已在 ANZCTR 注册，注册号为 ACTRN12618001268235。该试验已完成后续工作。2018 年 11 月 12 日至 2021 年 3 月 2 日期间，对 21 258 名女性进行了筛查，其中 862 名女性被随机分配至羧基麦芽糖铁 (n=430) 或标准护理组 (n=432)。与标准护理相比，羧基麦芽糖铁并未降低妊娠 36 周时的贫血患病率（羧基麦芽糖铁组中 341 人中的 179 人 [52%]；标准护理组中 333 人中的 189 人 [57%]；患病率 [PR] 0 ·92，95% CI 0·81 至 1·06；p=0·27)。与所有时间点的标准护理相比，随机分配至羧基麦芽糖铁的母亲的贫血患病率在数字上较低，尽管仅在治疗后 4 周观察到显着性（PR 0·91 [0·85 至 0·97]）。各组之间的出生体重没有差异（平均差 –3·1 g [–75·0 至 68·9，p=0·93）。没有输注相关的严重不良事件或任何器官类别的不良事件存在差异（包括疟疾；≥1 种不良事件：羧基麦芽糖铁 430 例中的​​ 183 [43%] 标准护理 432 例中的 170 例 [39%]；风险比 1 ·08 [0·92 至 1·27]；p=0·34)。在疟疾流行的撒哈拉以南非洲地区，用羧基麦芽糖铁治疗贫血孕妇是安全的，但并没有降低妊娠 36 周时的贫血患病率或增加出生体重。比尔及梅琳达·盖茨基金会 (INV-010612)。