Coulibaly 2006.
| Methods | Randomized controlled trial Generation of allocation sequence: computer‐generated, random‐number list Allocation concealment: no method reported Blinding: none Inclusion of all randomized participants: 83% (for treatment failure) |
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| Participants | Number: 147 randomized, 122 analysed Inclusion criteria: primigravidae or secundigravidae; gestation 12 to 36 weeks (fundal height < 30 cm); axillary temperature ≥ 37.5 °C; recent history of fever (within 48 hours preceding enrolment); or presence of clinical malaria‐related symptoms; mono‐infection with P. falciparum density ≥ 2000 parasites/mm3 blood; absence of clinical signs of severe malaria; absence of other patent infections; absence of previous severe reaction to chloroquine or sulfadoxine‐pyrimethamine; staying in neighbouring district/village; able to come for follow up; consent Exclusion criteria: other febrile disease than malaria; use of interfering treatment during follow‐up period; high‐risk pregnancy Age in years (median (range)): 20 (15 to 29) Parity: primigravidae and secundigravidae Early/late pregnancy: second and third trimester Symptomatic/asymptomatic malaria: all women symptomatic Anaemia on admission: 81% (21% severe malaria) |
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| Interventions | 1. Sulfadoxine‐pyrimethamine: 25 mg/kg sulfadoxine and 1.25 mg/kg pyrimethamine in 1 dose 2. Chloroquine: 10 mg/kg on days 0 and 1; 5 mg/kg on day 2 | |
| Outcomes | 1. Treatment failure at day 14
2. Treatment failure at day 28
3. Adverse reactions Not included in review: 4. Anaemia 5. Parasitaemia 6. Gametocytaemia 7. Early treatment failure 8. Late clinical failure 9. Late parasitological failure |
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| Notes | Location: Ouagadougou, Burkina Faso Local malaria endemicity/transmission: endemic but seasonal Local antimalarial drug resistance: increasing resistance to chloroquine; and some resistance to sulfadoxine‐pyrimethamine Supervision of treatment: all treatments were supervised Data awaiting: none Additional notes: trial for monitoring of therapeutic efficacy; women who failed study treatment were given quinine |
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