Chisholm 1966.
Methods | Women attending the antenatal clinic at their first visit before the 28th week of pregnancy were asked to participate in a randomised clinical trial to investigate the best method of preventing anaemia during pregnancy in Oxford (UK). | |
Participants | Women who had haemoglobin level less than 11 g per 100 mL and serum iron of less than 60 µg per 100 mL were not included in the trial and were treated immediately (n = 542). | |
Interventions | Half of the patient treated with ferrous gluconate (300 mg) 3 times daily (n = 183) and half with placebo tablets (n = 177). These groups were again divided into 3 groups; 1 group was given 500 µg (n = 61), or a high dose of 5 mg folic acid (n = 62) or a placebo (n = 59). | |
Outcomes | Mean haemoglobin level (360), red cell folate level and folate levels (360). | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "Random allocation of women to one of the 6 treatment groups". |
Allocation concealment (selection bias) | Unclear risk | Quote: "Bottles containing the tablets were numbered by random selection". Comment: .insufficient information to permit judgement. |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Quote: "code was not known while the patients were still on trial". Comment: participants were blinded. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Insufficient information to permit judgement. |
Selective reporting (reporting bias) | Unclear risk | Insufficient information to permit judgement. |
Other bias | Unclear risk | No other bias identified but insufficient information available to fully assess this 'Risk of bias' domain. |