Taylor 1982.
| Methods | RCT, 2 arms with individual randomisation. | |
| Participants | 48 healthy pregnant women with no adverse medical or obstetric history attending antenatal care clinic in Newcastle, England, United Kingdom before 12 weeks of gestation. | |
| Interventions | Participants were randomly allocated to 1 of 2 groups: group 1 receive about 65 mg elemental iron (as 325 mg of ferrous sulphate) and 350 μg (0.35 mg) of folic acid daily from 12 weeks until delivery; group 2 received no supplements. Setting and health worker cadre: the intervention was performed by physicians at the Princess Mary Maternity Hospital in Newcastle upon Tyne, United Kingdom. |
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| Outcomes | Maternal: Hb concentration, serum ferritin, MCV at 12 weeks and every 4 weeks until delivery, and at 6 days, 6 weeks and 6 months after delivery; plasma volume at 12 and 36 weeks of gestation. Infant: birthweight, infant death, admission to special care unit. | |
| Notes | Unsupervised.
Compliance not reported. 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: mixed/unspecified anaemia status. Daily iron dose: higher daily dose (more than 60 mg elemental iron daily). Iron release formulation: normal release preparation/unspecified. 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 | "Randomly assigned". |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | No blinding. |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Low risk for laboratory outcomes. |
| 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. |