Eskeland 1997.
Methods | RCT, 3‐arm trial with individual randomisation. | |
Participants | 90 healthy non‐anaemic pregnant women with singleton pregnancy of less than 13 weeks, attending an inner city maternity centre in Bergen, Norway and willing to participate. Exclusion criteria: uncertain gestational age according to menstrual history, Hb concentration < 110 g/L, chronic disease or pregnancy complications (hypertension, diabetes, bleeding), multiple pregnancy, liver enzymes out of normal range and logistic difficulties foreseen at baseline (moving out of area). | |
Interventions | Participants were randomly allocated to 1 of the following:
group 1: 3 tablets containing 1.2 mg heme iron from porcine blood and 9 mg of elemental iron (as ferrous fumarate) (Hemofer®) and 1 placebo tablet (total 27 mg elemental iron a day);
group 2: 1 tablet containing 27 mg elemental iron (as iron fumarate) with 100 mg vitamin C (Collet®) and 3 placebo tablets;
group 3: 4 placebo tablets.
Supplementation started at 20th week until 38‐40th week. Setting and health worker cadre: the intervention was performed by midwives and physicians at an inner city maternity centre in Bergen, Norway. |
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Outcomes | Maternal: Hb, RBC count, HCT, MCV, MCH, MCHC, reticulocytes, serum iron, total iron binding capacity, serum transferrin, erythrocyte protoporphyrin at baseline and at 20, 28, 38 weeks, 8 weeks postpartum, and 6 months postpartum; pregnancy complications: hypertension, pre‐eclampsia, forceps, postpartum haemorrhage, maternal well being and breastfeeding duration. Infant: birthweight and length. | |
Notes | Unsupervised.
Only groups 1 and 3 (placebo) were included in this review.
Compliance was 81% and 82% in groups 1 and 3 respectively. Gestational age at start of supplementation: late gestational age (supplementation started at or after 20 weeks' gestation). Anaemic status at start of supplementation: non‐anaemic. Daily iron dose: lower daily dose (less than 30 mg elemental iron daily). Iron release formulation: normal release preparation/not specified. Iron compound: iron fumarate. 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) | Low risk | Computer‐generated. |
Allocation concealment (selection bias) | Low risk | This was a placebo‐controlled trial. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Described as a double‐blind trial (placebo controlled). It was stated that staff providing care were not aware of treatment allocation and were only given information about Hb. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Double‐blind trial and laboratory outcomes. |
Incomplete outcome data (attrition bias) All outcomes | High risk | 23% and 21% in groups included. |
Selective reporting (reporting bias) | Unclear risk | There is insufficient information to permit judgement. |
Other bias | Unclear risk | No other bias apparent. |