Table 1 Outcomes

 To compare the effectiveness of IPTp-SP versus IPTp-SP+ for treating and preventing maternal P. falciparum infection

 To compare the safety and tolerability of IPTp-SP versus IPTp-SP+

• Relative hazard of P. falciparum infection diagnosed by PCR at day 42 after randomization (primary outcome)

• Relative hazard of P. falciparum infection diagnosed by PCR or microscopy at days 14, 28, 35, 42, 63, delivery, and 1-month post-partum in infants

• Proportion who experience at least one episode of P. falciparum infection by day 14, 28, 35, 42, or 63

• Proportion with treatment or prevention failure at day 42 stratified according to study drug (SP or DP)

• Median time to first episode of MIP

• Acute, chronic, and prior placental infection at delivery

• Medication-related adverse events and serious adverse events until 1-year post-partum (primary outcome)

 To compare the effectiveness of IPTp-SP versus IPTp-SP+ for reducing complications of MIP

• Mean birth weight and prevalence of low birth weight (within 72 hours post-partum), neonatal mortality (within 28 days post-partum), congenital malaria diagnosed by PCR, placental malaria diagnosed by histopathology using placental biopsies, maternal anemia (hemoglobin changes at days 14, 28, 42 and 63), congenital anemia, Incidences of pregnancy losses, congenital P. falciparum infection

 To compare selection for drug resistant parasites between infected individuals in the IPTp-SP and IPTp-SP+ treatment groups

• Relative allele frequencies of genotypic markers of drug resistance in malaria parasites

 To measure piperaquine exposure and duration

• Terminal elimination half-life of piperaquine determined by noncompartmental analysis of drug concentrations at 0, 14, 28, 35 and 42 days