Random sequence generation (selection bias) |
Low risk |
Quote: “MINIMat was a randomised controlled field trial with a 2×3×2 factorial design” |
Comment: Adequately done |
Allocation concealment (selection bias) |
Unclear risk |
Comment: Insufficient information to permit judgement |
Blinding of participants and personnel (performance bias) |
Unclear risk |
Comment: Insufficient information to permit judgement |
Blinding of outcome assessment (detection bias) |
Unclear risk |
Comment: Insufficient information to permit judgement |
Incomplete outcome data (attrition bias) |
High risk |
Quote: “One hundred and thirteen women had temporarily moved to another location outside of Matlab for the pregnancy and birth; 11 had permanently moved; 20 were absent from their homes and no one reported where they had gone; two women refused to participate; two women had measles; and 111 had either miscarried, dropped out” |
Comment: 259/1300 × 100 = 19.9% lost to follow‐up |
Selective reporting (reporting bias) |
Low risk |
Comment: Outcomes mentioned in the protocol were reported (ISRCTN16581394) |
Other bias |
Low risk |
Comment: No other potential sources of bias reported |
Was the allocation sequence adequately generated? |
Unclear risk |
|
Was the allocation adequately concealed? |
Unclear risk |
|
Were baseline outcome measurements similar? |
Unclear risk |
|
Were baseline characteristics similar? |
Unclear risk |
|
Were incomplete outcome data adequately addressed? |
Unclear risk |
|
Was knowledge of the allocated intervention adequately prevented during the study? |
Unclear risk |
|
Was the study adequately protected against contamination? |
Unclear risk |
|
Was the study free from selective outcome reporting? |
Unclear risk |
|
Was the study free from other risk of bias? |
Unclear risk |
|