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.
Highlights
36.5% of pregnant women globally are anaemic (World Health Organization, 23 April 2021), and irondeficiency anaemia (IDA) is the cause of almost half of all anaemia during pregnancy[1]
The Randomized controlled trial of the Effect of intraVenous iron on Anaemia in Malawian Pregnant women (REVAMP) is an open-label randomized controlled trial conducted in the Blantyre and Zomba districts of Malawi designed to determine the efficacy and safety of delivering ferric carboxymaltose (FCM) in women with moderate or severe anaemia in the second trimester of pregnancy[13] (ACTRN12618001268235)
The study’s main objective is to determine the efficacy and safety of a single intravenous iron administration during the second trimester of pregnancy – given as ferric carboxymaltose compared with routinely delivered oral iron – given as ferrous sulphate – in improving maternal and neonatal outcomes
Summary
36.5% of pregnant women globally are anaemic (World Health Organization, 23 April 2021), and irondeficiency anaemia (IDA) is the cause of almost half of all anaemia during pregnancy[1]. Oral iron may be poorly tolerated due to gastrointestinal adverse events[8] and poorly adhered to over an entire course of treatment This may result in suboptimal adherence to prevention programs in low- and middle-income countries[9,10]. The safety and convenience of FCM make this drug an exciting opportunity to treat anaemia in pregnancy in low-income countries. The Randomized controlled trial of the Effect of intraVenous iron on Anaemia in Malawian Pregnant women (REVAMP) is an open-label randomized controlled trial conducted in the Blantyre and Zomba districts of Malawi designed to determine the efficacy and safety of delivering FCM (compared with standard-of-care oral iron) in women with moderate or severe anaemia in the second trimester of pregnancy[13] (ACTRN12618001268235). Finalization of the statistical analysis plan before study unblinding has been undertaken to ensure transparency in the methods used to analyze and report the data and create the evidence for the effects of intravenous iron supplementation on recovery from prenatal anaemia, haemoglobin, iron status, postpartum haemorrhage, and delivery outcomes
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