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 |