BACKGROUND Oral iron for anaemia in pregnancy is often not well tolerated, with poor adherence. Iron administered intravenously might address these tolerance and adherence issues. We investigated the effectiveness and safety of intravenous ferric carboxymaltose versus oral ferrous sulphate on anaemia and iron deficiency among pregnant women in Nigeria. METHODS We did a multicentre, open-label, parallel, randomised controlled trial of pregnant women (aged 15-49 years) with haemoglobin (Hb) concentrations of less than 10 g/dL at 20-32 weeks' gestation from 11 primary, secondary, or tertiary health facilities in Nigeria (five in Lagos and six in Kano). Exclusion criteria included vaginal bleeding, blood transfusion or major surgery within the past 3 months, symptomatic anaemia, anaemia known to be unrelated to iron deficiency, clinically confirmed malabsorption syndrome, previous hypersensitivity to any form of iron, pre-existing maternal depression or other major psychiatric illness, immune-related diseases, such as systemic lupus erythematosus or rheumatoid arthritis, or severe allergic reactions. Participants were randomly assigned (1:1) by nurses and doctors using a web-based randomisation service to either receive a single dose of intravenous ferric carboxymaltose (20 mg/kg to a maximum of 1000 mg) or oral ferrous sulphate (200 mg; 65 mg elemental iron) three times daily until 6 weeks postpartum. The study was primarily unmasked. Primary outcomes were maternal anaemia (Hb <11 g/dL) at 36 weeks' gestation and preterm birth at before 37 weeks' gestation, with analysis by intention to treat in participants with available data. This study was registered at the ISRCTN registry on Dec 10, 2020 (ISRCTN63484804) and on ClinicalTrials.gov (NCT04976179) on April 7, 2021. FINDINGS Between Aug 10, 2021, and Dec 15, 2022, 13 724 pregnant women were screened for eligibility. 12 668 were excluded due to ineligibility for inclusion, and 1056 provided consent to participate and were randomly assigned to either the intravenous or oral administration groups. 527 were assigned to the intravenous ferric carboxymaltose group and 529 were assigned to the oral ferrous sulphate group. 518 in the intravenous group were assessed at 36 weeks' gestational age and after 518 deliveries, and 511 completed the 6 weeks postpartum visit. 513 in the oral ferrous sulphate group were assessed at 36 weeks' gestational age and after 512 deliveries, and 501 completed the 6 weeks postpartum visit. No significant difference was found in anaemia at 36 weeks (299 [58%] of 517 in the intravenous group vs 305 [61%] of 503 in the oral group; risk ratio 0·95, 95% CI 0·85-1·06; p=0·36), nor in preterm birth (73 [14%] of 518 vs 77 [15%] of 513; 0·94, 0·70-1·26; p=0·66). There were no significant differences in adverse events. The most common adverse events were diarrhoea (in six participants) and vomiting (in three participants) in the oral group and fatigue (in two participants) and headache (in two participants) in the intravenous group. INTERPRETATION Although the effect on overall anaemia did not differ, intravenous iron reduced the prevalence of iron deficiency to a greater extent than oral iron and was considered to be safe. We recommend that intravenous iron be considered for anaemic pregnant women in Nigeria and similar settings. FUNDING Bill & Melinda Gates Foundation.

中文翻译：

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尼日利亚孕妇贫血的静脉注射与口服铁剂比较（IVON）：一项开放标签、随机对照试验。


背景 口服铁剂治疗妊娠期贫血通常耐受性不佳，依从性较差。静脉注射铁剂可能会解决这些耐受性和依从性问题。我们研究了静脉注射羧基麦芽糖铁与口服硫酸亚铁对尼日利亚孕妇贫血和缺铁的有效性和安全性。方法 我们对妊娠 20-32 周时血红蛋白 (Hb) 浓度低于 10 g/dL 的孕妇（年龄 15-49 岁）进行了一项多中心、开放标签、平行、随机对照试验，研究对象为 11 名初级、二级患者。 ，或尼日利亚的三级医疗机构（拉各斯 5 个，卡诺 6 个）。排除标准包括过去 3 个月内阴道出血、输血或大手术、有症状的贫血、已知与缺铁无关的贫血、临床证实的吸收不良综合征、既往对任何形式的铁过敏、既往存在母亲抑郁症或其他严重疾病精神疾病、免疫相关疾病，如系统性红斑狼疮或类风湿性关节炎，或严重过敏反应。护士和医生使用基于网络的随机化服务将参与者随机分配（1:1），接受单剂量静脉注射羧基麦芽糖铁（20 毫克/公斤，最多 1000 毫克）或口服硫酸亚铁（200 毫克； 65 毫克元素铁）每天 3 次，直至产后 6 周。这项研究基本上是公开的。主要结局是妊娠 36 周时的母亲贫血 (Hb <11 g/dL) 和妊娠 37 周之前的早产，并根据现有数据对参与者进行意向治疗分析。该研究于2020年12月10日在ISRCTN注册中心（ISRCTN63484804）注册，并于2021年4月7日在ClinicalTrials.gov（NCT04976179）注册。 调查结果 2021 年 8 月 10 日至 2022 年 12 月 15 日期间，共有 13 724 名孕妇接受了资格筛查。 12 668 名患者因不符合纳入资格而被排除，1056 名患者同意参与并被随机分配到静脉注射组或口服给药组。 527 人被分配到静脉注射羧基麦芽糖铁组，529 人被分配到口服硫酸亚铁组。静脉注射组的 518 名患者在孕龄 36 周和 518 名分娩后接受评估，其中 511 名患者完成了 6 周的产后访视。口服硫酸亚铁组的 513 名患者在孕龄 36 周和 512 名分娩后接受了评估，其中 501 名患者完成了 6 周的产后访视。 36周时贫血没有发现显着差异（静脉注射组517例中有299例[58%]，口服组503例中有305例[61%]；风险比0·95，95％CI 0·85-1· 06；p=0·36），也没有发生在早产中（518 例中有 73 例 [14%] vs 513 例中有 77 例 [15%]；0·94、0·70-1·26；p=0·66）。不良事件没有显着差异。最常见的不良事件是口服组的腹泻（六名受试者）和呕吐（三名受试者）以及静脉注射组的疲劳（两名受试者）和头痛（两名受试者）。解释 尽管对总体贫血的影响没有差异，但静脉补铁比口服铁剂更大程度地降低了铁缺乏症的患病率，并且被认为是安全的。我们建议尼日利亚和类似地区的贫血孕妇考虑静脉注射铁剂。资助比尔及梅琳达·盖茨基金会。