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

Abstract

Background:Anaemia affectsmore than half ofAfrica'spregnancies.Standard care, with oral iron tablets,often fails to achieve results, with complianceandgastrointestinalside-effectsbeing a significant issue.In recent years,intravenousiron formulations havebecomesafe,effective,and quick to administer, allowingthecompleteiron requirementsofpregnancyto beprovidedin one15-minuteinfusion.The Randomized controlled trial of the Effect ofintraVenousiron on Anaemia in Malawian Pregnant women (REVAMP)will evaluate whethera modern intravenous ironformulation,ferriccarboxymaltose(FCM),given once during the second trimesteriseffective and safein improving maternal and neonatal outcomes for treatment of moderate to severe anaemiainsub-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 amulticentre, two-arm,open-label,parallel-grouprandomizedcontroltrial(RCT)in 862 pregnantwomen in their second trimester.The trial statistician developed the statistical analysis planin consultation with thetrial managementteambased 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 planallows for transparency as well as reproducibility of reporting and statistical analyses.