铁母亲-每日与隔天富马酸亚铁治疗妊娠期缺铁性贫血的随机对照试验方案

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications Pub Date : 2025-02-03 DOI:10.1016/j.conctc.2025.101447

F.E. O'Toole , F.M. McAuliffe , J.M. Fitzgerald , G.A. Mealy , R. Petkute , L.A. Bolger , A. Murphy-Cruse , B. Soldati , M. Galligan , J.M. Walsh

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引用次数: 0

摘要

目的：缺铁性贫血（IDA）是妊娠期最常见的血液学问题，对母亲、胎儿和儿童的健康都有影响。尽管治疗价格低廉且容易获得，但在依从性、耐受性和有效性等问题上仍然具有挑战性。关于妊娠期口服补铁的最佳剂量缺乏共识。来自非怀孕人群的新证据表明隔天服药可能同样有效。方法：我们提出了一项IV期开放标签随机对照非劣效性试验，每天与隔天富马酸亚铁治疗妊娠期确证缺铁性贫血，为期4周。我们的研究人群包括妊娠14+0至34+0周的单胎妊娠，血红蛋白（Hb）为10.5g/dL，铁蛋白为30μg/L。干预是隔天富马酸亚铁305mg（元素铁100mg），比较者是每天富马酸亚铁305mg。主要终点，从随机化到第4周的Hb变化，将通过线性回归分析，调整基线Hb水平。分析将通过意向治疗分析和每个方案的敏感性分析进行。样本量的计算假设主要终点平均值之间没有差异，1型错误率为0.025，功率为90%，标准差为0.83 g/dL，非劣效边际为- 0.4 g/dL。在这些假设下，每个治疗组需要92名受试者进行非劣效性检验。结论我们假设妊娠期隔天补铁与每日补铁治疗缺铁性贫血同样有效。

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Iron mother- protocol for a randomised controlled trial of daily versus alternate day ferrous fumarate for the treatment of iron deficiency anaemia in pregnancy

Objective

Iron deficiency anaemia (IDA) is the commonest haematological problem in pregnancy and has implications for maternal, fetal, and childhood health. Treatment, despite being inexpensive and readily available, remains challenging with issues relating to compliance, tolerability, and effectiveness. There is a lack of consensus regarding the optimal dosing of oral iron replacement in pregnancy. Emerging evidence from non-pregnant populations suggest that alternate day dosing may be as effective.

Methods

We propose a phase IV open label randomised controlled non-inferiority trial of daily versus alternate day ferrous fumarate for a 4-week period for the treatment of confirmed iron deficiency anaemia in pregnancy. Our study population comprises singleton pregnancies between 14+0- and 34+0-weeks’ gestation with a haemoglobin (Hb) of <10.5g/dL and a ferritin of <30μg/L. The intervention is alternate day ferrous fumarate 305mg (100mg elemental iron) and the comparator is daily ferrous fumarate 305mg. The primary endpoint, change in Hb from randomisation to week 4, will be analysed by linear regression, adjusting for baseline Hb level. Analysis will be conducted by intention-to-treat analysis with per protocol sensitivity analysis. Sample size was calculated on the assumption of no difference between primary endpoint means, a Type 1 error rate of 0.025, a power of 90 %, a standard deviation of 0.83 g/dL and a non-inferiority margin of −0.4 g/dL. Under these assumptions, 92 subjects per treatment arm would be required to test for non-inferiority.

Conclusion

We hypothesise that alternate day iron in pregnancy will be as effective as daily iron for the treatment of iron deficiency anaemia.

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来源期刊

Contemporary Clinical Trials Communications Pharmacology, Toxicology and Pharmaceutics-Pharmacology

CiteScore

2.70

自引率

6.70%

发文量

146

审稿时长

20 weeks

期刊介绍： Contemporary Clinical Trials Communications is an international peer reviewed open access journal that publishes articles pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from a wide range of disciplines including medicine, life science, pharmaceutical science, biostatistics, epidemiology, computer science, management science, behavioral science, and bioethics. Contemporary Clinical Trials Communications is unique in that it is outside the confines of disease specifications, and it strives to increase the transparency of medical research and reduce publication bias by publishing scientifically valid original research findings irrespective of their perceived importance, significance or impact. Both randomized and non-randomized trials are within the scope of the Journal. Some common topics include trial design rationale and methods, operational methodologies and challenges, and positive and negative trial results. In addition to original research, the Journal also welcomes other types of communications including, but are not limited to, methodology reviews, perspectives and discussions. Through timely dissemination of advances in clinical trials, the goal of Contemporary Clinical Trials Communications is to serve as a platform to enhance the communication and collaboration within the global clinical trials community that ultimately advances this field of research for the benefit of patients.