Puolakka 1980.
| Methods | RCT, 2 arms with individual randomisation. | |
| Participants | 32 healthy non‐anaemic pregnant women attending antenatal care at maternity centres of Oulu University Central Hospital, Finland with uncomplicated pregnancy of less than 16 weeks, and no earlier haematological problems. | |
| Interventions | Participants were randomly assigned to 1 of 2 groups: group 1 received 200 mg of elemental iron (as ferrous sulphate) daily; group 2 received no treatment. Supplementation started at 16th week of gestation until 1 month postpartum. Setting and health worker cadre: the intervention was performed by obstetricians at maternity centres in Oulu, Finland. |
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| Outcomes | Maternal: Hb, HCT, RBC count, leucocyte count, reticulocytes, MCV, MCH, serum iron, total iron binding capacity, transferrin, vitamin B12, whole folate, and serum ferritin concentration at baseline, and at weeks, 16, 20, 24, 28, 32, 36, 40 and 5 days, 1, 2, and 6 months postpartum. Bone marrow aspirates at 16th and 32nd week and at 2 months postpartum. Infant: birthweight, Apgar scores at 5 minutes. | |
| Notes | Unsupervised.
Compliance not reported. Gestational age at start of supplementation: early gestational age (supplementation started before 20 weeks' gestation). Anaemic status at start of supplementation: non‐anaemic. Daily iron dose: higher daily dose (more than 60 mg elemental iron daily). Iron release formulation: normal release preparation/not specified. Iron compound: 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 | "randomly divided into two groups." |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | No blinding mentioned. |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Low risk for laboratory outcomes. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Less than 20% lost to follow‐up. It was stated that no women discontinued the study. |
| Selective reporting (reporting bias) | Unclear risk | There is insufficient information to permit judgement. |
| Other bias | Unclear risk | No other bias apparent. |