Svanberg 1975.
Methods | RCT, 2 arms with individual randomisation. | |
Participants | 60 healthy primiparous women attending antenatal care clinic in Goteborg, Sweden with uncomplicated pregnancy and less than 14 weeks of gestation and with Hb concentrations above 120 g/L who had not received iron supplements in the previous 6 months or parenteral iron at any previous time. Women whose Hb concentration fell below 100 g/L during the study period were excluded and received immediate therapy. | |
Interventions | Participants were randomly allocated to receive 200 mg of elemental iron (as a sustained release preparation of ferrous sulphate) daily or placebo from 12 weeks of gestation until 9 weeks post delivery. Setting and health worker cadre: the intervention was performed by physicians at the University of Göthenburg in Sweden. |
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Outcomes | Maternal: iron absorption measurements; Hb concentration, HCT, bone marrow haemosiderin, MCHC, total iron binding capacity, transferrin saturation at baseline, and at weeks 16, 20, 24, 28, 32, and 35; and 8‐10 weeks after delivery. | |
Notes | Unsupervised.
Compliance measured by remaining pills count was 86 +/‐ 3%. Gestational age at start of supplementation: early gestational age (less than 20 weeks' gestation at the start of supplementation). Anaemic status at start of supplementation: non‐anaemic. Daily iron dose: higher dose (more than 60 mg elemental iron daily). Iron release formulation: sustained release preparation of ferrous sulphate. Iron compound: ferrous sulphate. Malaria setting: non‐malarial setting. As of 2011: Malaria: no risk. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not described. |
Allocation concealment (selection bias) | Unclear risk | Not described. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Participants, care provide, and outcome assessor blinded. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Participants, care provider, and outcome assessor blinded. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Less than 20% lost to follow‐up. |
Selective reporting (reporting bias) | Unclear risk | There is insufficient information to permit judgement. |
Other bias | Unclear risk | No other bias apparent. |