Paintin 1966.
Methods | RCT, 3 arms with individual randomisation. | |
Participants | 180 primigravidae women with less than 20 weeks' gestation and Hb > 100 g/L attending antenatal clinic in Aberdeen Maternity Hospital, United Kingdom. | |
Interventions | Participants were randomly assigned to 1 of 3 groups: group 1 received 3 tablets containing 4 mg elemental iron each (total 12 mg daily); group 2 received 3 tablets containing 35 mg elemental iron (total 105 mg elemental iron daily); group 3 received placebo. Intervention was from week 20 to week 36 of gestation. Setting and health worker cadre: the intervention was performed by clinic and laboratory staff of the Obstetric Medicine Research Unit of Aberdeen Maternity Hospital and Castle Terrace Antenatal Clinic in Aberdeen, United Kingdom. |
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Outcomes | Maternal: Hb, HCT at baseline, and at weeks 20, 30, 36 of gestation and 7‐13 days postpartum; plasma volume at 30 weeks, total red cell volume, serum iron and total iron binding capacity at 30 weeks, subjective health and side effects at 30 weeks. | |
Notes | Unsupervised.
Compliance estimated by measuring tablets returned. Authors report good compliance. Gestational age at start of supplementation: late gestational age (20 weeks' gestation at the start of supplementation). Anaemic status at start of supplementation: unspecified/mixed anaemia status at the start of supplementation. Daily iron dose: mixed doses (lower dose group ‐ 12 mg daily; higher dose group 105 mg daily). Iron release formulation: normal release preparation/not specified. Iron compound: not specified. 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) | Low risk | Placebo‐controlled with sequentially numbered packages. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | It was stated that women and staff were blind to treatment allocation. Placebo described as identical. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | It was stated that laboratory staff were blind to allocation until after the trial had been completed. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Less than 5%. |
Selective reporting (reporting bias) | Unclear risk | There is insufficient information to permit judgement. |
Other bias | Unclear risk | No other bias apparent. |