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

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)
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
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
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)