Balmelli 1974.
Methods | It was a RCT in which women were randomised into 2 groups and recruited from Clinic for Female Medicine at the University of Bern (Switzerland). Average age for iron group was 27.8 years while for Iron + folic acid group was 26.9 years. Measurement were taken over the period of 12 weeks. Blood samples were taken at monthly intervals. | |
Participants | Pregnant women between 20‐25 weeks of pregnancy (n = 42). | |
Interventions | Group 1: ferrous sulphate 125 mg + vitamin B12 100 µg (n = 21). Group 2: ferrous sulphate 125 mg + folic acid 100 µg + vitamin B12 100 µg (n = 21). |
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Outcomes | Pre‐delivery haemoglobin level (n = 42), serum folate level (n = 42). | |
Notes | All the women were the residents of Switzerland for longer than a year. Participants were restricted to patients with a haemoglobin level between 10‐12 g%, suspected abnormal pregnancies or patients suffering from intercurrent illness were excluded from study. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Adequate sequence generation was not described in the text. |
Allocation concealment (selection bias) | High risk | Quote " women were randomised into two groups". Comment: probably not done. |
Blinding (performance bias and detection bias) All outcomes | High risk | Treatment was not blinded. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Reasons for exclusion were described. Attrition (21%) with reasons were mentioned in the study. |
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. |