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

Nosten 1993b.

Methods Quasi‐randomized controlled trial
Generation of allocation sequence: paired, restricted, sequential trial
Allocation concealment: no method reported
Blinding: none
Inclusion of all randomized participants: 74.4% (for treatment failure)
Participants Number: 43 randomized, 32 analysed
Inclusion criteria: uncomplicated P. falciparum malaria; second or third trimester; fully informed consent
Exclusion criteria: none reported
Average age in years (mean (standard devation)): quinine plus spiramycin group 26 (6.2); quinine plus placebo group 28 (6.8)
Parity (median): quinine plus spiramycin group 2; quinine plus placebo group 4
Early/late pregnancy in gestation weeks (median): second and third trimester
Symptomatic/asymptomatic malaria: many women oligosymptomatic or asymptomatic
Anaemia on admission: number not reported
Interventions 1. Quinine plus spiramycin
 Quinine sulfate salt: 30 mg/kg every day for 5 days
 Spiramycin: 2 "Miu" 3 times a day for 5 days
2. Quinine plus placebo
 Quinine sulfate salt: 30 mg/kg every day for 5 days
Outcomes 1. Treatment failure at day 28
 2. Parasite clearance time
 3. Abortion
 4. Adverse events
Notes Location: Shoklo camp, Thai‐Burmese border
Local malaria endemicity/transmission: not reported
Local antimalarial drug resistance: multiple‐drug resistance (unsupervised 7‐day quinine treatment has a failure rate of 50% in pregnant women with uncomplicated malaria)
Supervision of treatment: supervised
Data awaiting: authors contacted, awaiting additional trial data
Additional notes: despite high resistance, quinine is the only treatment available for pregnant women in the area; quinine was given as a supervised 5‐day course as this is the average actual intake when the standard 7‐day regimen is not supervised (usual practice)