Nahlen 1989 NGA.
Methods | Trial design: RCT Data collected: from January to June 1988 Length of follow‐up: 77 days (mean interval from day 7 post‐chloroquine treatment to documentation of parasitaemia was 74 days for pyrimethamine group) Frequency of follow‐up: weekly. Follow‐up examinations and blood smears were obtained on days 2, 7, 14, 21, 28, 35, 42, 49, 56, 63, 70, and 77 |
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Participants | Parity: all Number: 71 Inclusion criteria: antenatal and attending hospital and health centre; < 34 weeks gestation; no recent chloroquine taken; parasitaemic > 500 parasites/µL blood Excluded: history of antimalarial drug ingestion during the previous week |
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Interventions |
Other: treated with two doses of chloroquine at recruitment; folic acid and iron given to all women Administration supervised: yes |
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Outcomes |
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Notes | Location: Nigeria Urban/rural: urban (Ilorin, the capital of Kwara State) Malaria transmission: endemic area Drug resistance: possible pyrimethamine resistance present Funding: US Agency for International Development, Africa Child Survival‐Initiative‐Combatting Childhood Communicable Diseases Project, 698‐0421 |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "Women in group 2 were assigned randomly to a pyrimethamine treatment or a control group." The statement that women were randomly assigned is insufficient to be confident that the allocation sequence was genuinely randomized. |
Allocation concealment (selection bias) | High risk | "The treated group was observed to take 25 mg of pyrimethamine weekly and was instructed to take folic acid and iron supplements daily, while the control group took only folic acid and iron daily." Allocation not concealed. |
Blinding (performance bias and detection bias) All outcomes | High risk | Not blinded. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No details provided. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | "In vivo tests were completed successfully in all 71 women enrolled." Comment: There were no missing outcome data. |
Selective reporting (reporting bias) | Low risk | No apparent risk. |
Other bias | Low risk | None identified. |