Ferric carboxymaltose versus standard-of-care oral iron to treat second-trimester anaemia in Malawian pregnant women: a randomised controlled trial

医学 人口 儿科 怀孕 随机对照试验 疟疾 产科 不利影响 缺铁 入射(几何) 门诊部 妊娠期 内科学 贫血 遗传学 物理 环境卫生 光学 生物 免疫学
作者
Sant‐Rayn Pasricha,Martin N. Mwangi,Ernest Moya,Ricardo Ataíde,Glory Mzembe,Rebecca Harding,Zinenani Truwah,Leila M. Larson,Ayşe Y. Demir,William Nkhono,Jobiba Chinkhumba,J. A. Simpson,Danielle Clucas,William Stones,Sabine Braat,Kamija S. Phiri
出处
期刊:The Lancet [Elsevier]
卷期号:401 (10388): 1595-1609 被引量:26
标识
DOI:10.1016/s0140-6736(23)00278-7
摘要

BackgroundAnaemia 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.MethodsIn 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.FindingsBetween 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 vs 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 vs standard of care 170 [39%] of 432; risk ratio 1·08 [0·92 to 1·27]; p=0·34).InterpretationIn 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.FundingBill & Melinda Gates Foundation (INV-010612).
最长约 10秒,即可获得该文献文件

科研通智能强力驱动
Strongly Powered by AbleSci AI
更新
大幅提高文件上传限制,最高150M (2024-4-1)

科研通是完全免费的文献互助平台,具备全网最快的应助速度,最高的求助完成率。 对每一个文献求助,科研通都将尽心尽力,给求助人一个满意的交代。
实时播报
淼淼之锋完成签到 ,获得积分10
4秒前
史小刀完成签到 ,获得积分10
4秒前
Angenstern完成签到 ,获得积分10
14秒前
czj完成签到 ,获得积分10
15秒前
清爽绮彤完成签到 ,获得积分10
25秒前
Rainbow完成签到,获得积分10
26秒前
小巧的傲松完成签到 ,获得积分10
32秒前
42秒前
Lily完成签到,获得积分10
42秒前
学习完成签到 ,获得积分10
45秒前
Lily发布了新的文献求助10
46秒前
zjq完成签到 ,获得积分10
46秒前
CYL完成签到 ,获得积分10
50秒前
Tim完成签到 ,获得积分10
52秒前
青桔柠檬完成签到 ,获得积分10
55秒前
虚幻元风完成签到 ,获得积分10
1分钟前
TN完成签到 ,获得积分10
1分钟前
maclogos完成签到,获得积分10
1分钟前
舒心平蝶完成签到 ,获得积分10
1分钟前
whitepiece完成签到,获得积分10
1分钟前
woshiwuziq完成签到 ,获得积分10
1分钟前
1分钟前
Telomere完成签到 ,获得积分10
1分钟前
小二郎应助毛不二采纳,获得10
1分钟前
清新的冷松完成签到 ,获得积分10
1分钟前
zhangzhangzhang完成签到 ,获得积分10
1分钟前
小鸟芋圆露露完成签到 ,获得积分10
1分钟前
1分钟前
1分钟前
哭泣的缘郡完成签到 ,获得积分10
1分钟前
丁乙完成签到,获得积分20
1分钟前
xue完成签到 ,获得积分10
1分钟前
毛不二发布了新的文献求助10
1分钟前
丁乙发布了新的文献求助10
1分钟前
辜月十二完成签到 ,获得积分10
1分钟前
小鱼女侠完成签到 ,获得积分10
2分钟前
mark33442完成签到,获得积分10
2分钟前
Leo完成签到 ,获得积分10
2分钟前
小趴菜完成签到 ,获得积分10
2分钟前
空洛完成签到 ,获得积分10
2分钟前
高分求助中
The Young builders of New china : the visit of the delegation of the WFDY to the Chinese People's Republic 1000
юрские динозавры восточного забайкалья 800
English Wealden Fossils 700
Chen Hansheng: China’s Last Romantic Revolutionary 500
宽禁带半导体紫外光电探测器 388
Case Research: The Case Writing Process 300
Global Geological Record of Lake Basins 300
热门求助领域 (近24小时)
化学 医学 生物 材料科学 工程类 有机化学 生物化学 物理 内科学 纳米技术 计算机科学 化学工程 复合材料 基因 遗传学 催化作用 物理化学 免疫学 量子力学 细胞生物学
热门帖子
关注 科研通微信公众号,转发送积分 3142849
求助须知:如何正确求助?哪些是违规求助? 2793717
关于积分的说明 7807147
捐赠科研通 2450016
什么是DOI,文献DOI怎么找? 1303576
科研通“疑难数据库(出版商)”最低求助积分说明 627016
版权声明 601350