Greenwood 1989 GMB.
Methods | Trial design: Trial randomized by compound Data collected: 1984 to 1987 Length of follow‐up: from first prenatal visit until one week after delivery Frequency of follow‐up: unclear but administration was on weekly basis |
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Participants | Parity: all women Number: 1049 Inclusion criteria: all women in trial villages who became pregnant; some sub‐studies only followed up primigravidae Excluded: none stated |
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Interventions |
Given by village people employed by the project Other: no information Administration supervised: yes |
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Outcomes |
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Notes | Location: The Gambia Urban/rural: urban Malaria transmission: seasonal Drug resistance: none reported Funding: Unclear For the analysis we assumed that it is individually RCT |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "Once a woman had reported to a traditional birth attendant that she was pregnant, she was allocated to receive one tablet of Maloprim fortnightly or placebo and issued with a record card by an MRC field worker. Randomization was by compound." No details provided of a specific procedure used to generate allocation sequence. |
Allocation concealment (selection bias) | Unclear risk | "Treatment was indicated on the record card by a pictorial representation of a coloured tablet (white for Maloprim, pink for placebo)". Insufficient details provided. |
Blinding (performance bias and detection bias) All outcomes | Low risk | Placebo tablets used. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No details provided. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | "1208 pregnancies which progressed beyond the 28th week were recorded during the 3 years of the survey. During 1049 (87%) of these pregnancies women reported to the TBA resident and received one or more doses of Maloprim or placebo." Unclear risk. Assumption is that attrition rate was 13.2% (159/1208, where 159 = 1208‐1049). |
Selective reporting (reporting bias) | Low risk | No apparent risk. |
Other bias | Low risk | None identified. |