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. 2008 Oct 8;2008(4):CD004912. doi: 10.1002/14651858.CD004912.pub3

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)
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
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
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