Roth 1980.
Methods | This is a RCT conducted during August 1976 ‐ September 1977. | |
Participants | 23 pregnant women were selected. | |
Interventions | Group A (11 patients): 1 x Tardyferon‐Fol tablet per day (80 mg iron sulphate, 80 mg mucoproteose, 350 µg folic acid) during pregnancy. Group B (12 patients): 1 x Tardyferon tablet per day (80 mg iron sulphate, 80 mg mucoproteose, no folic acid content) during pregnancy. Group A: 5 dropouts. Group B: 3 dropouts. Reasons for dropouts included irregular intake of the medication (3), change of residence (2), premature birth (2) and 1 unexplained failure to attend the final check‐up. |
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Outcomes | Haemoglobin level, red cell folate levels and serum folate levels (n = 23). | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "Randomised". Comment: insufficient information to make any judgement. |
Allocation concealment (selection bias) | Unclear risk | Quote: "The tablets used in treatment were identical in appearance". Comment: insufficient information to make any judgement. |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Quote: "Yes". Comment: insufficient information to make any judgement. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Insufficient information to make any judgement. |
Selective reporting (reporting bias) | Unclear risk | Insufficient information to make any judgement. |
Other bias | Unclear risk | No other bias identified but insufficient information available to fully assess this 'Risk of bias' domain. |