McGready 2005.
Methods | Randomized controlled trial Generation of allocation sequence: computer generated in blocks of 10 Allocation concealment: envelopes Blinding: outcome assessor Inclusion of all randomized participants: 99% (for treatment failure) |
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Participants | Number: 81 randomized, 80 analysed Inclusion criteria: healthy; first episode of (uncomplicated) falciparum or mixed malaria detected by weekly screening; haematocrit level ≥ 20%; second (> 13 weeks) or early third (< 32 weeks) trimester of pregnancy Exclusion criteria: known chronic disease; inability to follow antenatal clinic consultation; history of alcohol abuse; imminent delivery; inability to tolerate oral treatment Age in years (mean (standard deviation)): 26 (7) vs 26 (6) Parity: just under 1/3 primigravida Early/late pregnancy: second and third trimester Symptomatic/asymptomatic malaria: detected by screening so likely to be asymptomatic Anaemia on admission: not severe anaemia |
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Interventions | 1. Quinine sulfate: 10 mg/kg every 8 hours for 7 days 2. Atovaquone‐proguanil plus artesunate Atovaquone‐proguanil: fixed‐dose tablet (atovaquone 20 mg/kg and primaquine 8 mg/kg) once a day for 3 days Artesunate: 4 mg/kg once a day for 3 days | |
Outcomes | 1. Treatment failure at day 63
2. Treatment failure at day 63 (excludes new infections using PCR)
3. Fever clearance time
4. Low birthweight and mean birthweight
5. Anaemia (and severe anaemia)
6. Prematurity and estimated gestational age at delivery
7. Intra‐uterine growth retardation
8. Congenital abnormality
9. Tinnitus Not included in review: 10. Stillbirth 11. Infant death in first 12 months (neonatal) 12. Total infant developmental score at 12 months 13. Vomiting drugs 14. Urticaria |
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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 (only artemisinin therapies known to be effective) Supervision of treatment: all treatments supervised Additional notes: treatment given orally with sugar and water (quinine) or chocolate milk (atovaquone proguanil plus artesunate); any women with reappearance of parasites after the primary treatment were retreated with artesunate and clindamycin for 7 days |