Hood 1960.
Methods | RCT, 3 arms, individual randomisation. | |
Participants | 75 consecutive apparently healthy pregnant women with 32‐34 weeks of gestation attending the maternity clinic at St Anthony's Hospital, Oklahoma City, Oklahoma, USA. | |
Interventions | Participants were randomly divided in 3 groups: group 1 served as control and received no treatment; group 2 received 220 mg elemental iron (as ferrous sulphate) daily; and group 3 received 55 mg elemental iron (as sustained release ferrous sulphate) daily.
Supplementation started at 32‐34 weeks of gestation until delivery. Setting and health worker cadre: the intervention was performed by obstetricians at the Department of Obstetrics and Gynecology of St. Anthony's Hospital in Oklahoma City, Oklahoma, United States of America. |
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Outcomes | Maternal: Hb, HCT, incidence and severity of side effects on a weekly basis until delivery. | |
Notes | Unsupervised.
For any iron vs no treatment comparison groups were merged.
Compliance not reported. Gestational age at start of supplementation: late gestational age (supplementation started after 20 weeks' gestation). Anaemic status at start of supplementation: unspecified/mixed anaemia. Daily iron dose: medium dose (55 mg elemental iron) and higher dose (220 mg elemental iron). Iron release formulation: sustained release preparation and normal release preparation/not specified. Iron compound: ferrous sulphate and sustained release 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 | High risk | Neither participant nor provider blinded. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Outcome assessor unclear. Low risk for laboratory outcomes but uncertain risk of bias for reported side effects. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Less than 20% losses to follow‐up. |
Selective reporting (reporting bias) | Unclear risk | There is insufficient information to permit judgement. |
Other bias | Unclear risk | No other bias apparent. |