Ndyomugyenyi 2011 UGA.
Methods | Trial design: individually RCT Data collected: 2004 to 2008 Length of follow‐up: from first antenatal visit to 28 days after delivery Frequency of follow‐up: regularly through ANC clinics, and every seven days postnatally |
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Participants | Parity: all parities Number: 5775 randomized; 4715 singleton births followed up Inclusion criteria: pregnant women < 27 weeks at first clinic visit Excluded: > 26 weeks pregnant, non‐residents and temporary residents |
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Interventions |
Drugs given under direct observation. Two doses of SP. |
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Outcomes | Prevalence of maternal anaemia (Hb < 11.0 g/L) mean Hb at 36 to 40 weeks Clinical malaria Peripheral and placental parasitaemia Abortions, preterm births, stillbirths, perinatal deaths, neonatal deaths Low birthweight Mean birthweight |
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Notes | Location: Kabale Highlands, Uganda Urban/rural: rural Malaria transmission: low/unstable area Drug resistance: SP thought to be effective HIV: low Funding: Gates Partnership |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "computer‐generated random number list". |
Allocation concealment (selection bias) | Low risk | "individual sealed envelopes". |
Blinding (performance bias and detection bias) All outcomes | Low risk | "Tablets of SP or placebo, identical in shape and colour". |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | "All study participants, health staff and researchers were blind to drug assignment (SP or placebo)". |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Delivery follow‐up: 92%, 92%, and 93% to one month. |
Selective reporting (reporting bias) | Low risk | No evidence of selective reporting. |
Other bias | Low risk | None identified. |