Holly 1955.
| Methods | RCT, 3 arms with individual randomisation. | |
| Participants | 207 pregnant women with less than 26 weeks of gestation and Hb > 100 g/L attending antenatal care clinic in Nebraska, USA. | |
| Interventions | Participants were randomly assigned to 1 of 3 groups: group 1 received 1 g of an iron salt daily; group 2 received 0.8‐1.2 g of ferrous sulphate and 60‐90 mg of cobalt chloride daily; group 3 received no treatment. Supplementation started at various times before 26th week of gestation for each of the participants until delivery. Setting and health worker cadre: the intervention was performed by obstetricians at the Department of Obstetrics and Gynecology of the Univeristy of Nebraska, College of Medicine in Omaha, Nebraska, United States of America. |
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| Outcomes | Maternal: Hb, HCT, serum iron, erythrocyte protoporphyrin at 3‐6 months and pre‐delivery. | |
| Notes | Unsupervised.
3 iron compounds (n = 94) were used: ferrous gluconate (n = 40), ferrous sulphate (n = 32) and Mol‐Iron® (n = 22). The iron‐treated groups with different iron salts were merged together by the author as iron‐treated group since the results were comparable. The iron and cobalt treatment group is not included in this review.
Compliance not reported. Gestational age at start of supplementation: mixed gestational age at the start of supplementation (before 26 weeks). Anaemic status at start of supplementation: mixed anaemia status (Hb > 100 g/L). Daily iron dose: higher daily dose (60 mg or more elemental iron). Iron release formulation: normal release preparation/not specified. Iron compound: mixed (groups merged in analysis). 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 | High risk | Neither participants nor provider blinded. |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Laboratory outcomes reported. |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Loss to follow‐up not described. |
| Selective reporting (reporting bias) | Unclear risk | There is insufficient information to permit judgement. |
| Other bias | Unclear risk | No other bias apparent. |