A Randomized controlled trial of the Effect of intraVenous iron on Anaemia in Malawian Pregnant women (REVAMP): Statistical analysis plan

Gates Open Research

article

Rebecca Harding¹  Ricardo Ataíde¹  Martin N Mwangi³  Julie A Simpson⁵  Glory Mzembe³  Ernest Moya³  Zinenani Truwah³  Brains Changaya Nkhwazi³  Mphatso Mwabinga³  William Nkhono³  Kamija S Phiri³  Sant-Rayn Pasricha¹  Sabine Braat¹ 

[1] Population Health and Immunity Division, The Walter and Eliza Hall Institute of Medical Research, 1G Royal Parade;Department of Infectious Diseases, Melbourne Medical School, The University of Melbourne;Training and Research Unit of Excellence;School of Public Health and Family Medicine, Department of Public Health, College of Medicine, University of Malawi, Private Bag 360;Centre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, University of Melbourne;Diagnostic Haematology and Clinical Haematology, The Royal Melbourne Hospital and The Peter MacCallum Cancer Centre;Department of Medical Biology, Faculty of Medicine, Dentistry and Health Sciences, The University of Melbourne

关键词: anaemia;    iron deficiency;    intravenous iron;    ferric carboxymaltose (FCM);    pregnancy;    randomized controlled trial;    statistical analysis;    Malawi;   

DOI  :  10.12688/gatesopenres.13457.2

学科分类：电子与电气工程

来源: American Journal Of Pharmtech Research

【 摘 要 】

Background: 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.   Methods: 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.   Results: The detailed statistical analysis plan will support the statistical analyses and reporting of the REVAMP trial after unblinding the treatment allocations.   Conclusions: A statistical analysis plan allows for transparency as well as reproducibility of reporting and statistical analyses.

【 授权许可】

CC BY