The impact of different doses of oral iron supplementation during pregnancy: a pilot randomized trial
Authors
Stanworth, Simon J.Churchill, David
Sweity, Samaher
Holmes, Tom
Hudson, Cara
Brown, Rosemary
Lax, Stephanie
Murray, Joanne
Spiby, Helen
Roy, Noemi
Farmer, Andrew
Gale, Chris
Crayton, Elise
Lorencatto, Fabiana
Griffiths, James
Mullings, Joanne
Last, Sara
Knight, Marian
Issue Date
2024-08-29
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Show full item recordAbstract
The burden of iron-deficiency anemia remains significant during pregnancy. Oral iron is first-line medication, but there is uncertainty about a range of factors including adherence and side-effects of different doses. We conducted a pilot randomized trial to investigate the impact of different doses of oral iron supplementation started early in pregnancy, in non-anemic women, for four main outcomes; recruitment and protocol compliance, adherence, maintenance of maternal hemoglobin and side-effects. Participants at antenatal clinic visits were allocated to one of three trial arms, in a 1:1:1 ratio, as 200mg ferrous sulphate daily, alternate days or three-times per week, with follow-up to delivery. Baseline characteristics of 300 recruited participants were well matched between trial arms. The mean proportion of tablets taken as expected per participant was 82.5% overall (72.3%, 89.6% and 84.5% for the daily, alternate days and three-times a week arm, respectively). There was a lower overall adherence rate in the daily arm (47%) compared with alternate days (62%) and three times per week (61%). Reduction in hemoglobin between randomization and 28 weeks appeared smaller for the daily arm. A range of side-effects were commonly reported at baseline before starting interventions, and by later antenatal visits. Many side effects of iron overlapped with normal pregnancy symptoms. A daily iron dosing schedule might give the best opportunity for delivering an adequate iron load during pregnancy in non-anemic women. Further randomized trials powered on clinical outcomes are needed to establish the clinical effectiveness of oral iron supplementation to prevent iron deficiency anemia. (ISRCTN12911644).Citation
Stanworth, S.J., Churchill, D., Sweity, S. et al. (2024) The impact of different doses of oral iron supplementation during pregnancy: a pilot randomized trial. Blood Advances. https://doi.org/10.1182/bloodadvances.2024013408Publisher
American Society of HematologyJournal
Blood AdvancesPubMed ID
39208353 (pubmed)Additional Links
http://dx.doi.org/10.1182/bloodadvances.2024013408Type
Journal articleLanguage
enDescription
© 2024 The Authors. Published by American Society of Hematology. This is an open access article available under a Creative Commons licence. The published version can be accessed at the following link on the publisher’s website: https://doi.org/10.1182/bloodadvances.2024013408ISSN
2473-9537EISSN
2473-9537Sponsors
The trial is funded by the NIHR Programme Grants for Applied Research programme (NIHR200869). AF is supported by the NIHR Oxford Biomedical Research Centre (NIHR203311).MKis an NIHR Senior Investigator (NIHR303806).ae974a485f413a2113503eed53cd6c53
10.1182/bloodadvances.2024013408
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Except where otherwise noted, this item's license is described as https://creativecommons.org/licenses/by-nc-nd/4.0/