Table 1.
Characteristics of Study Participants
| Study Period | Characteristic | Treatment Arm | ||
|---|---|---|---|---|
| Monthly SP | Monthly DP | |||
| Enrollment | Number of participants | 311 | 326 | |
| Age in years, mean (SD) | 24.0 (6.0) | 23.9 (5.7) | ||
| Gestational age, weeks, mean (SD) | 15.7 (2.4) | 15.4 (2.3) | ||
| Gravidity, n (%) | 1 | 81 (26.1) | 72 (22.1) | |
| 2 | 65 (20.9) | 85 (26.1) | ||
| ≥3 | 165 (53.1) | 169 (51.8) | ||
| Before administration of first dose of IPTp | Episodes of malaria, n (incidencea) | 15 (1.13) | 11 (0.81) | |
| Interval assessments,b n | 591 | 621 | ||
| Interval assessments with microscopic parasitemia, n (%) | 301 (50.9) | 338 (54.4) | ||
| Interval assessments with any parasitemia, n (%) | 494 (83.6) | 504 (81.1) | ||
| After administration of first dose of IPTp | Episodes of malaria, n (incidencea) | 70 (0.54) | 3 (0.02) | |
| Interval assessments, n | 1516 | 1616 | ||
| Interval assessments with microscopic parasitemia, n (%) | 45 (30.6) | 9 (0.5) | ||
| Interval assessments with any parasitemia, n (%) | 973 (64.2) | 326 (20.2) | ||
| Placental outcomes | Parasites detected in placental blood by microscopy, n/N (%) | 27/307 (8.8) | 1/326 (0.3) | |
| Parasites detected in placental blood by LAMP, n/N (%) | 67/301 (22.3) | 7/323 (2.2) | ||
| Parasites or pigment detected by histopathology, n/N (%) | 192/311 (61.7) | 92/326 (28.2) | ||
Abbreviations: DP, dihydroartemisinin-piperaquine; IPTp, intermittent preventative treatment in pregnancy; LAMP, loop-mediated isothermal amplification; SP, sulfadoxine-pyrimethamine.
aEpisodes per person-years.
bIncludes enrollment visit.