Morley 1964 NGA.
Methods | Trial design: Quasi‐RCT Data collected: 1957 Length of follow‐up: from first antenatal visit to delivery Frequency of follow‐up: insufficient detail (drugs given monthly) |
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Participants | All women Number: 429 Inclusion criteria: all pregnant women registered at dispensary Excluded: none stated |
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Interventions |
Other: fever treated with chloroquine sulphate in both groups Administration supervised: women were given drugs during antenatal visits |
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Outcomes |
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Notes | Location: Nigeria Urban/rural: rural (the village of Imesi) Malaria transmission: holoendemic area Drug resistance: none Funding: no information |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | "As the pregnant women were registered at the dispensary, they were given consecutive numbers and allotted to one or other of two groups. All women with even numbers were given 2 tablets (50 mg) of pyrimethamine once a month… The control group (the odd numbers) were given two tablets of placebo". Comment: not randomized. |
Allocation concealment (selection bias) | Unclear risk | Insufficient detail provided. |
Blinding (performance bias and detection bias) All outcomes | Low risk | Pyrimethamine and "similar tablets" placebo were used |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | "Blood films were examined in the hospital laboratory… The technicians did not know to which group a mother belonged." Assessors blinded. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Birthweight: data available for 93.7% (402/429 women). Incomplete data outcome for 6.3% (27/429) women: 17 stillbirths and 10 twin deliveries were excluded. |
Selective reporting (reporting bias) | Low risk | No selective reporting observed. |
Other bias | Low risk | None identified. |