Ziaei 2008.
| Methods | RCT 2 arms with individual randomisation. | |
| Participants | 244 pregnant women 17‐35 years of age attending prenatal care in Tehran, Iran, with BMI between 19.8‐26 kg/m2, and 13‐18 weeks of gestation, with singleton pregnancy and non‐anaemic (Hb 132 g/L or higher) and normal serum ferritin (15 μg/L or higher). Women who smoked, had history of diseases such as polycythaemia, asthma, or chronic hypertension, or a history or threatened abortion in the present pregnancy were excluded. | |
| Interventions | Participants were randomly assigned to 1 of 2 groups: group 1 received 50 mg of elemental iron (as ferrous sulphate) daily; group 2 received placebo from 20th week of gestation until delivery. All women received 50 mg elemental iron (as ferrous sulphate) after delivery for 6 weeks. Setting and health worker cadre: the intervention was performed by midwives and physicians at a prenatal clinic in Tehran, Iran. |
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| Outcomes | Maternal: Hb, HCT, serum ferritin at baseline, at time of delivery, 1 week postpartum and 6 weeks postpartum, postpartum haemorrhage, caesarean sections. | |
| Notes | Unsupervised.
No compliance 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: medium dose (50 mg elemental iron). Iron release formulation: normal release preparation/unspecified. Iron compound: ferrous sulphate. Malaria setting: yes. As of 2011: Malaria risk due to P. vivax and P. falciparum exists from March to November inclusive in rural areas of the provinces of Hormozgan and Kerman (tropical part) and the southern part of Sistan‐Baluchestan. P. falciparum resistant to chloroquine and sulphadoxine–pyrimethamine reported. |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | By means of table of random numbers. |
| Allocation concealment (selection bias) | Low risk | Coded bottles. |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Participants and care provider blinded. |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Low risk for laboratory outcomes and other outcomes likely to have been recorded by blinded staff. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Less than 5% 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. |
BMI: body mass index Fe: iron GGT: gamma‐glutamyl transferase GSH‐Px: glutathione peroxidase Hb: haemoglobin HCT: hematocrit (same as PCV: packed cell volume) ICC: intraclass correlation co‐efficient ITT: intention‐to‐treat IV: intravenous LBW: low birthweight MCH: mean corpuscular (or cell) haemoglobin MCHC: mean corpuscular (or cell) haemoglobin concentration MCV: mean corpuscular (or cell) volume MDA: malondialdehyde OGIT: oral glucose intolerance test OGTT: oral glucose tolerance test PCV: packed cell volume (same as HCT: hematocrit) RBC: red blood cell RCT: randomised clinical trial SD: standard deviation SES: socioeconomic status SOD: superoxide dismutase vs: versus