Harding Rebecca, Ataide Ricardo, Mwangi Martin N, Simpson Julie A, Mzembe Glory, Moya Ernest, Truwah Zinenani, Nkhwazi Brains Changaya, Mwabinga Mphatso, Nkhono William, Phiri Kamija S, Pasricha Sant-Rayn, Braat Sabine
Population Health and Immunity Division, The Walter and Eliza Hall Institute of Medical Research, 1G Royal Parade, Parkville, Melbourne, VIC, 3052, Australia.
Department of Infectious Diseases, Melbourne Medical School, The University of Melbourne, Melbourne, VIC, 3052, Australia.
Gates Open Res. 2022 Apr 14;5:174. doi: 10.12688/gatesopenres.13457.2. eCollection 2021.
Anaemia affects more than half of Africa's pregnancies. Standard care, with oral iron tablets, often fails to achieve results, with compliance and gastrointestinal side-effects being a significant issue. In recent years, intravenous iron formulations have become safe, effective, and quick to administer, allowing the complete iron requirements of pregnancy to be provided in one 15-minute infusion. The Randomized controlled trial of the Effect of intraVenous iron on Anaemia in Malawian Pregnant women (REVAMP) will evaluate whether a modern intravenous iron formulation, ferric carboxymaltose (FCM), given once during the second trimester is effective and safe in improving maternal and neonatal outcomes for treatment of moderate to severe anaemia in sub-Saharan Africa. The objective was to publish the detailed statistical analysis plan for the REVAMP trial prior to unblinding the allocated treatments and performing the analysis. REVAMP is a multicentre, two-arm, open-label, parallel-group randomized control trial (RCT) in 862 pregnant women in their second trimester. The trial statistician developed the statistical analysis plan in consultation with the trial management team based on the protocol, data collection forms, and study outcomes available in the blinded study database. The detailed statistical analysis plan will support the statistical analyses and reporting of the REVAMP trial after unblinding the treatment allocations. A statistical analysis plan allows for transparency as well as reproducibility of reporting and statistical analyses.
贫血影响了非洲一半以上的孕期女性。采用口服铁片的标准护理往往无法取得成效，依从性和胃肠道副作用是一个重大问题。近年来，静脉注射铁制剂已变得安全、有效且给药迅速，只需一次15分钟的输液就能满足孕期对铁的全部需求。马拉维孕妇静脉铁剂治疗贫血的随机对照试验（REVAMP）将评估在撒哈拉以南非洲，在孕中期给予一次现代静脉铁制剂——羧基麦芽糖铁（FCM），对于改善中重度贫血孕妇及其新生儿的治疗效果是否安全有效。其目的是在公开分配的治疗方法并进行分析之前，公布REVAMP试验的详细统计分析计划。REVAMP是一项针对862名孕中期孕妇的多中心、双臂、开放标签、平行组随机对照试验（RCT）。试验统计学家根据方案、数据收集表以及盲态研究数据库中的研究结果，与试验管理团队协商制定了统计分析计划。详细的统计分析计划将在公开治疗分配后支持REVAMP试验的统计分析和报告。统计分析计划有助于提高报告和统计分析的透明度及可重复性。
