Department of Obstetrics & Gynaecology, Faculty of Clinical Sciences, College of Medicine, University of Lagos, P.M.B. 12003, Idi-Araba, Lagos, Nigeria.
Department of Obstetrics and Gynaecology, Lagos University Teaching Hospital, Idi-Araba, Lagos, Nigeria.
Trials. 2022 Sep 8;23(1):763. doi: 10.1186/s13063-022-06690-2.
Anaemia in pregnancy is highly prevalent in African countries. High-dose oral iron is the current recommended treatment for pregnancy-related iron deficiency anaemia (IDA) in Nigeria and other African countries. This oral regimen is often poorly tolerated and has several side effects. Parenteral iron preparations are now available for the treatment of IDA in pregnancy but not widely used in Africa. The IVON trial is investigating the comparative effectiveness and safety of intravenous ferric carboxymaltose versus oral ferrous sulphate standard-of-care for pregnancy-related IDA in Nigeria. We will also measure the implementation outcomes of acceptability, feasibility, fidelity, and cost-effectiveness for intravenous ferric carboxymaltose.
This is an open-label randomised controlled trial with a hybrid type 1 effectiveness-implementation design, conducted at 10 health facilities in Kano (Northern) and Lagos (Southern) states in Nigeria. A total of 1056 pregnant women at 20-32 weeks' gestational age with moderate or severe anaemia (Hb < 10g/dl) will be randomised 1:1 into two groups. The interventional treatment is one 1000-mg dose of intravenous ferric carboxymaltose at enrolment; the control treatment is thrice daily oral ferrous sulphate (195 mg elemental iron daily), from enrolment till 6 weeks postpartum. Primary outcome measures are (1) the prevalence of maternal anaemia at 36 weeks and (2) infant preterm birth (<37 weeks' gestation) and will be analysed by intention-to-treat. Maternal full blood count and iron panel will be assayed at 4 weeks post-enrolment, 36 weeks' gestation, delivery, and 6 weeks postpartum. Implementation outcomes of acceptability, feasibility, fidelity, and cost will be assessed with structured questionnaires, key informant interviews, and focus group discussions.
The IVON trial could provide both effectiveness and implementation evidence to guide policy for integration and uptake of intravenous iron for treating anaemia in pregnancy in Nigeria and similar resource-limited, high-burden settings. If found effective, further studies exploring different intravenous iron doses are planned.
ISRCTN registry ISRCTN63484804 . Registered on 10 December 2020 Clinicaltrials.gov NCT04976179 . Registered on 26 July 2021 The current protocol version is version 2.1 (080/080/2021).
贫血在非洲国家的妊娠中非常普遍。高剂量口服铁剂是目前尼日利亚和其他非洲国家治疗妊娠相关缺铁性贫血（IDA）的推荐治疗方法。这种口服方案往往耐受性差，并有多种副作用。目前已有静脉铁制剂可用于治疗妊娠 IDA，但在非洲并未广泛使用。IVON 试验正在调查静脉给予羧基麦芽糖铁与口服硫酸亚铁标准治疗对尼日利亚妊娠相关 IDA 的比较效果和安全性。我们还将测量静脉给予羧基麦芽糖铁的可接受性、可行性、保真度和成本效益的实施结果。
这是一项在尼日利亚卡诺（北部）和拉各斯（南部）州的 10 个卫生设施进行的开放标签随机对照试验，采用混合 1 型有效性-实施设计。共有 1056 名妊娠 20-32 周、血红蛋白<10g/dl 的中度或重度贫血孕妇被随机分为两组，每组 528 人。干预治疗为入院时单次 1000mg 静脉给予羧基麦芽糖铁；对照组为入院时开始每日 3 次口服硫酸亚铁（每日 195mg 元素铁），直至产后 6 周。主要结局指标为（1）36 周时产妇贫血的患病率，（2）婴儿早产（<37 周妊娠），将通过意向治疗进行分析。在入院后 4 周、36 周妊娠、分娩和产后 6 周时，将检测产妇全血细胞计数和铁谱。通过结构问卷、关键知情人访谈和焦点小组讨论评估可接受性、可行性、保真度和成本的实施结果。
IVON 试验可以提供有效性和实施证据，以指导尼日利亚和类似资源有限、负担沉重的环境中整合和采用静脉铁治疗妊娠贫血的政策。如果发现有效，计划进一步研究不同的静脉铁剂量。
ISRCTN 注册处 ISRCTN63484804. 注册于 2020 年 12 月 10 日。Clinicaltrials.gov NCT04976179. 注册于 2021 年 7 月 26 日。当前协议版本为版本 2.1（080/080/2021）。
