Ramakrishnan 2003.
| Methods | This RCT was carried out in Mexico Dates of study: 1997‐2000 |
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| Participants | Pregnant women who were < 13 weeks' pregnant, were not receiving MMN supplementation and who agreed to participate were included in the study. A total of 873 women were randomised into the MMN group (n = 435, mean age 23.09 ± 5.48) and the iron‐only group (n = 438, mean age 23.00 ± 5.08). | |
| Interventions |
All were given orally, from recruitment 6 days a week until delivery. |
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| Outcomes | Preterm births (< 37 weeks of gestation), SGA (below the 10th percentile for birthweight‐for‐gestational age), LBW (< 2500 g), perinatal mortality, mean Hb concentration, mean serum ferritin It should be noted that the data for SGA were obtained from a separate report (Food and Nutrition Bulletin 2009) and not from the individual trial report. |
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| Notes | Data on birth outcomes were only available for 656 pregnancies (MMN group n = 328 and control group, iron only n = 326). The 2 groups did not differ significantly in most of the characteristics at recruitment, except for marital status (more single mothers in MMN supplementation group) and mean BMI (significantly lower in the MMN supplementation group). Declarations of interest: the trial authors declared no conflict of interest. Funding sources: Thrasher Research Fund, United Nations Children's Fund (UNICEF) New York, Conacyt, and the Instituto Nacional de Salud Pública, Mexico |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "Randomization was carried out by using 4 color‐coded groups (2 per treatment) that were assigned a priori with the use of a computer‐generated list". Comment: probably done. |
| Allocation concealment (selection bias) | Low risk | Quote: "Four colors were used to ensure masking and were assigned at random before the study began to a list of serial numbers from 1 to 1000" and "pregnant women were allocated to the pre‐assigned color code as they were added to this list at the time of recruitment". Comment: probably done. |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "All study personnel and investigators were blinded to the group assignment, the details of which were kept at Emory University and the INSP in sealed envelopes that were opened only after preliminary data analysis was completed". Comment: participants and caregivers were probably blinded to the treatment assignment. |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "All study personnel and investigators were blinded to the group assignment, the details of which were kept at Emory University and the INSP in sealed envelopes that were opened only after preliminary data analysis was completed". Comment: outcome assessors were probably blinded to the treatment assignment. |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Exclusion was 5.2% but reasons for it were not reported. Attrition (26.2%) along with their reasons were reported. |
| Selective reporting (reporting bias) | Low risk | Comment: all outcomes mentioned in the methods section were presented in the various publications of this trial. |
| Other bias | Low risk | Comment: no other bias was identified. |