Kerr 1958.
Methods | RCT, 4 arms with individual randomisation. | |
Participants | 430 apparently healthy women with 24‐25 weeks of singleton pregnancy and Hb equal or above 104 g/L attending antenatal clinic at Simpson Memorial Maternity Pavillion, Edinburgh, United Kingdom. | |
Interventions | Participants were randomly allocated to 1 of 4 groups: group 1 received 35 mg of elemental iron (as ferrous sulphate) 3 times a day; group 2 received 35 mg of elemental iron (as ferrous gluconate) 3 times a day; group 3 received 35 mg of elemental iron (as ferrous gluconate) with 25 mg of ascorbic acid, 3 times a day; group 4 received placebo. Supplementation started at 24‐25th week of gestation until term. Setting and health worker cadre: the intervention was performed by physicians at the Simpson Memorial Maternity Pavilion in Edinburgh, United Kingdom. |
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Outcomes | Maternal: Hb, red cell count, HCT at baseline and at 37th week. | |
Notes | Unsupervised.
Groups 1 and 2 were merged for analysis. Group 3 was not used in this review.
Compliance not measured. Gestational age at start of supplementation: late gestational age (supplementation started after 20 weeks' gestation). Anaemic status at start of supplementation: unspecified/mixed anaemia status (no severe anaemia, all had Hb equal or above 104 g/L). Daily iron dose: higher iron dose (all treatment groups received more than 60 mg of elemental iron daily (105 mg)). Iron release formulation: normal release preparation/unspecified. Iron compound: ferrous gluconate. 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) | Low risk | By cards shuffle. |
Allocation concealment (selection bias) | Unclear risk | Not described. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Partial blinding. Placebo and all supplements described as identical. Women were blinded, but medical staff were aware of which was the control group. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Low risk for laboratory outcomes. Possible risk of bias for dietary survey and reporting of side effects. |
Incomplete outcome data (attrition bias) All outcomes | High risk | 23% of participants were 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. |