Department of Obstetrics and Gynaecology, University of Lagos College of Medicine, Lagos, Nigeria
Department of Obstetrics and Gynaecology, Lagos University Teaching Hospital, Surulere, Nigeria.
BMJ Open. 2024 Aug 17;14(8):e086553. doi: 10.1136/bmjopen-2024-086553.
Postpartum anaemia is often caused by iron deficiency with onset during the antepartum period and can be exacerbated by excessive blood loss at birth. Its prevalence is estimated as 50-80% in low-income and middle-income countries. It poses adverse consequences on the mother and negatively impacts her ability to care for her newborn. Prompt treatment of postpartum anaemia is thus important. Adherence to oral iron is reportedly low in Nigeria due to its side effects and forgetfulness by the mothers. Intravenous iron such as ferric carboxymaltose, given as a single dose, might help overcome adherence issues, but investigation in a high-quality randomised control trial in Nigeria is first required while evaluation of challenges around its implementation is also warranted.
To determine the clinical effectiveness, tolerability and safety, of using intravenous ferric carboxymaltose (intervention) vs oral ferrous sulphate (control) for treating moderate to severe iron deficiency anaemia in postpartum women and to evaluate implementation of ferric carboxymaltose in treating postpartum anaemia in Nigeria.
This study is an open-label randomised controlled trial with a concurrent implementation study. It is a hybrid type 1 effectiveness-implementation design conducted in four states across Northern and Southern Nigeria. A total of 1400 eligible and consenting women with postpartum moderate to severe anaemia (haemoglobin concentration <100 g/L) will be randomised to intravenous ferric carboxymaltose; a single dose at 20 mg/kg to a maximum of 1000 mg infusion administered at enrolment (intervention) or oral ferrous sulphate; 200 mg (65 mg elemental iron) two times per day from enrolment until 6 weeks postpartum (control). The primary outcome, proportion of participants who are anaemic (Hb <110 g/L) at 6 weeks postpartum will be analysed by intention-to-treat. Haemoglobin concentration, full blood count, serum iron, serum ferritin, transferrin saturation and total iron binding capacity will be measured at specific intervals. Implementation outcomes such as acceptability and feasibility of using ferric carboxymaltose for postpartum anaemia treatment in Nigeria will be assessed.
This study is approved by the ethics committee of the teaching hospitals, Ministry of Health of the four states as required, National Health Research Ethics Committee and the drug regulatory agency, National Agency for Food and Drug Administration and Control (NAFDAC). Findings of this research will be presented at conferences and will be published in international peer-reviewed journals and shared with stakeholders within and outside Nigeria.
International standard randomised controlled trial number: ISRCTN51426226.
产后贫血通常是由缺铁引起的，在产前阶段发病，分娩时失血过多会加重病情。在低收入和中等收入国家，其患病率估计为 50-80%。它对母亲造成不良后果，并影响她照顾新生儿的能力。因此，及时治疗产后贫血非常重要。由于副作用和母亲健忘，尼日利亚口服铁的依从性据报道较低。静脉铁如羧基麦芽糖铁，单次给药，可能有助于克服依从性问题，但首先需要在尼日利亚进行高质量的随机对照试验研究，同时也需要评估其实施面临的挑战。
确定静脉注射羧基麦芽糖铁（干预）与口服硫酸亚铁（对照）治疗产后妇女中到重度缺铁性贫血的临床效果、耐受性和安全性，并评估在尼日利亚使用羧基麦芽糖铁治疗产后贫血的实施情况。
这是一项开放性标签随机对照试验，同时进行实施研究。这是在尼日利亚北部和南部四个州进行的 1 型有效性-实施设计的混合类型。共有 1400 名符合条件并同意参加的产后中重度贫血（血红蛋白浓度<100g/L）的妇女将被随机分配至静脉注射羧基麦芽糖铁；单次剂量 20mg/kg，最大剂量 1000mg 输注，在入组时（干预）或口服硫酸亚铁；从入组至产后 6 周，每天两次，每次 200mg（65mg 元素铁）（对照）。主要结局是产后 6 周时仍贫血（Hb<110g/L）的参与者比例，将按意向治疗进行分析。血红蛋白浓度、全血细胞计数、血清铁、血清铁蛋白、转铁蛋白饱和度和总铁结合能力将在特定时间间隔进行测量。将评估在尼日利亚使用羧基麦芽糖铁治疗产后贫血的可接受性和可行性等实施结果。
本研究已获得四个州教学医院、卫生部、国家卫生研究伦理委员会和药物监管机构国家食品和药物管理局和控制局（NAFDAC）的伦理委员会批准。该研究的结果将在会议上进行汇报，并将在国际同行评议期刊上发表，并与尼日利亚内外的利益相关者分享。
国际标准随机对照试验编号：ISRCTN51426226。
