Skip to main content
. 2008 Oct 8;2008(4):CD004912. doi: 10.1002/14651858.CD004912.pub3

McGready 2000.

Methods Randomized controlled trial
Generation of allocation sequence: block randomization
Allocation concealment: no method reported
Blinding: none
Inclusion of all randomized participants: 92% (for treatment failure) and 75% (for low birthweight)
Participants Number: 115 randomized, 108 analysed (86 and 108 for primary outcomes)
Inclusion criteria: pregnant women in their second or third trimester seen at antenatal clinics of Shoklo and Maela camps; microscopy‐confirmed uncomplicated P. falciparum infection; fully informed verbal consent
Exclusion criteria: severe complicated malaria; intercurrent infection requiring hospitalization; allergy to quinine or mefloquine; < 12 weeks gestation; history of mental disorder or mefloquine‐induced psychosis
Age in years (median (range)): artesunate plus mefloquine group 24 (15 to 37); quinine group 23 (16 to 36)
Parity: artesunate plus mefloquine group 18/66 primapara; quinine group 12/42 primapara
Early/late pregnancy: second and third trimester
Symptomatic/asymptomatic malaria: many women oligosymptomatic or asymptomatic
Anaemia on admission: artesunate plus mefloquine group 33/66 anaemic; quinine group 22/42 anaemic
Interventions 1. Artesunate plus mefloquine
 Artesunate: 4 mg/kg on days 0, 1, and 2
 Mefloquine: 15 mg/kg on day 1 and 10 mg/kg on day 2
2. Quinine sulfate: 10 mg/kg every 8 hours for 7 days
Outcomes 1. Treatment failure at day 28 (excludes new infections using PCR)
 2. Treatment failure at day 63 (excludes new infections using PCR)
 3. Abortion
 4. Stillbirth
 5. Congenital abnormalities
 6. Mean birthweight
 7. Anaemia and haematocrit
 8. Perinatal death
 9. Adverse events
Not included in review:
 10. Treatment failure at 48 hours
 11. Gametocyte positivity
 12. Person‐gametocyte‐weeks
 13. Placental weight
 14. Estimated gestational age
 15. Infant development
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 supervised
Data awaiting: authors contacted, awaiting additional trial data
Additional notes: Médecins Sans Frontières is the main provider of medicine; treatment failures (up to day 63) were given artesunate for a further 7 days; all mothers requested to deliver at clinic