Kalilani 2007.
Methods | Randomized controlled trial Generation of allocation sequence: random‐number list; block randomized Allocation concealment: sealed envelopes Blinding: outcome assessor Inclusion of all randomized participants: 84% (for treatment failure) |
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Participants | Number: 141 randomized, 118 analysed Inclusion criteria: peripheral parasitaemia; P. falciparum; aged 15 to 49 years; estimated fetal gestational age 14 to 26 weeks; mother had felt fetal movement; available for follow up until delivery Exclusion criteria: multiple gestations; history of chronic disease such as tuberculosis or diabetes; mental health disorder; known allergies to drugs containing sulfonamides; macrolides or pyrimethamine; pregnancy complications; taken antimalarial drugs within 28 days before enrolment Age in years (median (interquartile range)): 20 (17 to 24) Parity: mostly primigravidae, some secundigravidae Early/late pregnancy: mainly third trimester Symptomatic/asymptomatic malaria: not stated Anaemia on admission: not stated |
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Interventions | 1. Sulfadoxine‐pyrimethamine: 1500 mg sulfadoxine, 75 mg pyrimethamine in 1 dose
2. Sulfadoxine‐pyrimethamine and azithromycin: 1500 mg sulfadoxine, 75 mg pyrimethamine in 1 dose, and 1 g/day azithromycin for 2 days
3. Sulfadoxine‐pyrimethamine and artesunate: 1500 mg sulfadoxine, 75 mg pyrimethamine in 1 dose, and artesunate 200 mg/day for 3 days All treatment courses given twice, at least 4 weeks apart All participants also given 200 mg ferrous sulfate and 0.25 mg folic acid for daily administration, and insecticide‐treated bed nets |
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Outcomes | 1. Treatment failure at delivery or 40 days
2. Treatment failure at delivery or 40 days (excludes new infections using PCR)
3. Maternal anaemia
4. Low birthweight
5. Perinatal death
6. Neonatal death Not included in review: 7. Placental parasite clearance |
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Notes | Location: Mpemba and Madziabango health centres, Blantyre District, Malawi Local malaria endemicity/transmission: perennial, peaks in rainy season Local antimalarial drug resistance: not reported Supervision of treatment: directly observed Additional notes: pilot for larger study of intermittent preventive treatment, therefore two treatment courses given; trial authors report that statistically significantly more women who received sulfadoxine‐pyrimethamine or azithromycin plus sulfadoxine‐pyrimethamine were diagnosed as HIV positive than those who received artesunate plus sulfadoxine‐pyrimethamine (but many women refused the routine testing) |