| Methods | This study was conducted in Guinea‐Bissau. | |
| Participants | Pregnant women with less than 37 weeks of gestation were eligible for enrolment. A total of 2100 women were randomised into 3 groups, MMN RDA group, MMN 2 RDA group and 60 mg iron 400 mcg folic acid group. | |
| Interventions | 15 micronutrients were included in the supplement at RDA level, except for folic acid that was included at 400 mcg level. Supplement consisted of vitamin A 800 mcg, D 200 IU, E 10 mg, C 70 mg, B1 1.4 mg, B2 1.4 mg, niacin 18 mg, B6 1.9 mg, B12 2.6 mg, folic acid 400 mcg, iron 30 mg, zinc 15 mg, copper 2 mg, selenium 65 mcg and iodine 150 mcg. Intervention group (n = 1392) received MMN supplements (supplement RDA n = 695, supplement 2 RDA n = 697) while the other group received folic acid 400 mcg and iron 60 mg n = 708. | |
| Outcomes | Size at birth, gestational age at birth, preterm birth (< 37 weeks of gestation), LBW (< 2500 g), miscarriage (fetal loss before 28 completed weeks of gestation), perinatal mortality (fetal loss between 28 weeks of gestation and first 7 days of life), neonatal mortality (deaths within the first 28 days of life), maternal Hb, anaemia (Hb < 100 g/L) and maternal death (death during pregnancy or within 42 days after termination of pregnancy), childhood mortality. It should be noted that the data for SGA was obtained from a separate report (Food and Nutrition Bulletin 2009) and not from the individual trial report. |
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| Notes | Malaria is endemic but HIV prevalence is relatively low. Iron folic acid given to all participants. There was no significant difference in baseline characteristics between randomisation groups. We used the 1 RDA and control groups in this review. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "Simple block randomisation with a block size of 150 was managed as follows: at entry, the project midwife randomly drew 1 piece of coloured paper corresponding to the colour code on the tablet containers from envelopes with initially 50 pieces of each of the three colours". Comment: probably done. |
| Allocation concealment (selection bias) | High risk | Quote: "at entry, the project midwife randomly drew one piece of coloured paper corresponding to the colour code on the tablet containers from envelopes with initially 50 pieces of each of the three colours". Comment: probably not done. |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Exclusion (3.1%) and attrition (20.4%) data was reported along with their reasons. |
| 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: "three identical‐looking micronutrient supplements", "code was kept secret from study participants, study personnel, and data analysts until data cleaning and preliminary data analysis had been carried out." and "the health workers who collected outcome data after delivery did not have any knowledge of intervention group of the women". Comment: participants and caregivers were probably blinded to the treatment assignment. |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "three identical‐looking micronutrient supplements", "code was kept secret from study participants, study personnel, and data analysts until data cleaning and preliminary data analysis had been carried out." and "the health workers who collected outcome data after delivery did not have any knowledge of intervention group of the women". Comment: outcome assessors were probably blinded to the treatment assignment. |