• Pharmacokinetic parameters by measurement of whole blood levels of sulfadoxine and pyrimethamine and plasma levels of artesunate and its active metabolite dihydroartemisinin to determine Cmax, Tmax, AUC, half life, volume of distribution and clearance
  
• Correlation of treatment outcome with pharmacokinetic parameters and pregnancy status.
  

• Association of gametocyte carriage with pregnancy status
  
• Correlation of frequency of DHFR mutations at codons 108, 51, 59 (164) and DHPS mutations at codons 436, 437, 540 and 581 in maternal and placental samples with treatment outcome
  
• Birth outcomes in terms of congenital abnormalities, spontaneous abortions, still births and neonatal deaths, gestational age and birth weight, placental weight, newborn head circumference
  
• Risk of harm by describing adverse events and their causality assessments, neurodevelopmental assessment of infants and changes in full blood count (or haemoglobin), glucose, bilirubin, creatinine, urea and ALT
  
• Capacity building by describing the training and development of study teams and their subsequent skills attained.
  

The resistance of Plasmodium falciparum to anti-malarial drugs is a serious impediment to the control of malaria, and this poses a particular problem for the treatment of pregnant women, a group especially vulnerable to malaria; pregnancy increases the risk of disease progression and complications with up to a 10-fold increase in the malaria case fatality rate in areas of low transmission. As falciparum parasites can sequester in the placenta, pregnant women have been shown to develop recrudescence up to 85 days after quinine treatment, and are at increased risk of gametocyte carriage. Artemisinin-based combination therapies have been shown to improve cure rates and to delay antimalarial resistance. In humans the efficacy and safety of artesunate in the treatment of malaria in pregnancy has been studied in over 1000 women in which no evidence of foetal harm was demonstrated. Quinine is the only alternative currently available in Mozambique for treating malaria in pregnancy however there is relatively little data available on its efficacy or safety. There is no published information on the pharmacokinetics of SP in pregnancy, however data show a marked reduction in bioavailability of artesunate and its active metabolite, dihydroartemisinin. Thus, we cannot be confident that the standard dosage regimens of SP and of artesunate are optimal for the treatment of acute uncomplicated malaria in pregnancy or whether altered pharmacokinetics is contributing to the SP-treatment failures observed in pregnancy. This study creates the opportunity to study whether the pharmacokinetic properties of SP and artesunate are altered by physiological changes that occur during pregnancy.