McGready 2001a.
Methods | Randomized controlled trial Generation of allocation sequence: no method reported Allocation concealment: no method reported Blinding: none Inclusion of all randomized participants: 71% (for treatment failure) and 83% (for low birthweight) |
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Participants | Number: 131 randomized, 129 analysed (93 and 109 for primary outcomes) Inclusion criteria: pregnant women; second or third trimester; seen at antenatal clinics of Shoklo and Maela camps; microscopy‐confirmed uncomplicated P. falciparum infection; consent Exclusion criteria: severe or complicated malaria; intercurrent infections requiring hospitalization; allergy to quinine, artesunate, clindamycin; major liver or kidney disease; gestation < 12 weeks Age in years (median (range)): artesunate group 25 (15 to 41); quinine plus clindamycin group 24 (15 to 41) Parity: artesunate group 26.2% primipara; quinine plus clindamycin group 26.6% primipara Early/late pregnancy: second and third trimester Symptomatic/asymptomatic malaria: many women are oligosymptomatic or asymptomatic Anaemia on admission: number not reported |
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Interventions | 1. Artesunate: 2 mg/kg on days 0 to 4; 1 mg/kg on days 5 and 6 2. Quinine plus clindamycin Quinine: 10 mg/kg every 8 hours for 7 days Clindamycin: 5 mg/kg every 8 hours for 7 days | |
Outcomes | 1. Treatment failure at day 42
2. Treatment failure (excludes new infections using PCR) at day 42
3. Congenital abnormalities
4. Stillbirth
5. Infant mortality
6. Low birthweight and mean birthweight
7. Anaemia
8. Haematocrit Not included in review: 9. Mean placental weight 10. Estimated gestational age at delivery |
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Notes | Location: Maela and Shoklo camps for displaced people of the Karen ethnic minority on the north‐west border of Thailand Local malaria endemicity/transmission: low and seasonal Local antimalarial drug resistance: multiple‐drug resistance Supervision of treatment: all treatments were supervised Data awaiting: authors contacted 2005, awaiting additional trial data Additional notes: Médecins Sans Frontières main provider of medicine; treatment given orally with a small amount of sugar and water; women asked to deliver at clinic (although usually deliver at home) |