Freire 1989.
Methods | RCT, 2 arms with individual randomisation. | |
Participants | 412 non‐black pregnant women with 26 ± 2 weeks of gestation, who had not received iron supplements in the previous 6 months, from low SES using the prenatal unit of public obstetric hospital in Quito, Ecuador. | |
Interventions | Participants were randomly assigned to receive 2 tablets containing 78 mg of elemental iron (as ferrous sulphate) daily or placebo during a period of 2 months. Setting and health worker cadre: the intervention was performed by physicians in the Prenatal Unit of Quito's public obstetric hospital in Quito, Ecuador. |
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Outcomes | Hb, PCV, red cell indices, serum ferritin, total iron binding capacity, serum folate, serum vitamin B12 at baseline and after 2 months. Prevalence of iron deficiency was estimated by response to therapy. | |
Notes | Apart from mean Hb levels at term no other prespecified outcomes from this review are presented in the paper. No data can be extracted from this trial. Gestational age at start of supplementation: late gestational age (supplementation started after 20 weeks' gestation). Anaemic status at start of supplementation: mixed/unspecified anaemia status. Daily iron dose: high daily dose (60 mg or more elemental iron). Iron release formulation: normal release preparation/unspecified. Iron compound: ferrous sulphate. Malaria setting: non‐malarial setting. The study was conducted in Quito where there is no risk of malaria. As of 2011: Malaria risk – P. vivax (87%), P. falciparum (13%) – exists throughout the year below 1500 m, with moderate transmission risk in coastal provinces. There is no risk in Guayaquil, Quito and other cities of the inter‐Andean region. P. falciparum resistance to chloroquine and sulphadoxine–pyrimethamine reported. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not described ("randomly assigned"). |
Allocation concealment (selection bias) | Unclear risk | Not described. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Described as "double‐blind", placebo tablets provided. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Laboratory outcomes. |
Incomplete outcome data (attrition bias) All outcomes | High risk | 412 women were recruited and 240 followed up. Loss to follow‐up was 41.7% and there were missing data for some outcomes. |
Selective reporting (reporting bias) | Unclear risk | There is insufficient information to permit judgement. |
Other bias | Unclear risk | No other bias apparent. |