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. 2015 Nov 1;2015(11):CD004905. doi: 10.1002/14651858.CD004905.pub4
Methods Trial conducted in New Dehli and Tamil Nadu, India.
Participants Pregnant women with gestational age 22 ± 2 were eligible to participate in the trial. A total of 647 pregnant women participated in the trial. Women with chronic diseases like heart diseases, tuberculosis, leprosy, chronic diarrhoea and a Hb < 5 g/100 mL were excluded from the study.
Interventions There were total of 7 study groups. 2 in the control group and 5 in the intervention group. 1 of the control groups received placebo and other received vitamin B12 and folic acid alone. 4 intervention groups received vitamin B12, folic acid and iron in a range of 30 to 240 mg. The fifth intervention group received 120 mg of iron without vitamin B12 and folate. Supplementation was given for 10‐12 weeks.
Outcomes Outcomes were improvement in maternal Hb/haematocrit, iron absorption from maternal gut, fetal birthweight, maternal and fetal Hb 3 months postpartum, hookworm infestation in mother and side‐effects of supplementation.
Notes None of the outcomes were reported in a format that allowed inclusion of the data in this review.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "By reference to previously prepared random tables the women were allocated to one of the two streams A or B" and "within each stratum subjects were allotted to final treatment groups according to a set of random numbers".
Comment: probably done.
Allocation concealment (selection bias) High risk Quote: "By reference to previously prepared random tables the women were allocated to one of the two streams A or B" and "within each stratum subjects were allotted to final treatment groups according to a, set of random numbers".
Comment: probably not done.
Incomplete outcome data (attrition bias) All outcomes High risk Attrition was 30% and reasons for it were reported.
Selective reporting (reporting bias) Low risk Comment: all outcomes mentioned in the methods section were presented in the paper.
Other bias Low risk Comment: no other bias was identified.
Blinding of participants and personnel (performance bias) All outcomes Low risk Quote: "All the tablets had the same appearance and had the daily folic acid and iron dose divided into two tablets". Comment: participants, caregivers probably blinded to the treatment assignment.
Blinding of outcome assessment (detection bias) All outcomes Low risk Quote: "All the tablets had the same appearance and had the daily folic acid and iron dose divided into two tablets". Comment: outcome assessors probably blinded to the treatment assignment.