Nosten 1994 THA.
Methods | Trial design: RCT Data collected: 1987 to 1990 Length of follow‐up: from first antenatal visit at > 20 weeks of estimated gestation to 2 years after delivery Frequency of follow‐up: weekly |
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Participants | Parity: all Number: 339 Inclusion criteria: antenatal attendees > 20 weeks of gestation Excluded: none stated |
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Interventions |
Other: treated antenatally if parasitaemic; given folic acid and iron if anaemic Administration supervised: yes |
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Outcomes |
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Notes | Location: Thailand Urban/rural: rural (camps Wangka, Shoklo, Bonoko) Malaria transmission: unstable malarious area (mesoendemic) Drug resistance: multiple drug resistance present Funding: United Nations Development Programme/World Bank/WHO Special Programme for Research and Training in Tropical Diseases; Wellcome Trust of Great Britain; Prevention Foundation, The Hague |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Trial described as "a double‐blind, placebo‐controlled trial". No details provided of the sequence generation method used. |
Allocation concealment (selection bias) | Unclear risk | No details provided. |
Blinding (performance bias and detection bias) All outcomes | Low risk | Placebo tablets identical with treatments were used. "The investigators were unaware of the randomization". |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Blinding of outcome assessors not mentioned. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Attrition rate 8% (10/119) in Phase 1 and 8% (18/220) in Phase 2. Across groups: 7.1% (12/170) were excluded from the mefloquine group and 9.5% (16/169) were excluded from the placebo group. Explanation provided. |
Selective reporting (reporting bias) | Low risk | No apparent risk. |
Other bias | Low risk | None identified. |