Table 1.
Characteristics of Study Participants
| Study Period | Characteristic | All | Randomized to Monthly SP | Randomized to Monthly DP | |
|---|---|---|---|---|---|
| At Enrollment | Number of participants | 637 | 311 | 326 | |
| Age in years, mean (SD) | 24.0 (5.8) | 24.0 (6.0) | 23.9 (5.7) | ||
| Gestational age in weeks, mean (SD) | 15.6 (2.3) | 15.7 (2.4) | 15.4 (2.3) | ||
| Gravidity, n (%) | 1 | 153 (24.0%) | 81 (26.1%) | 72 (22.1%) | |
| 2 | 150 (23.6%) | 65 (20.9%) | 85 (26.1%) | ||
| ≥3 | 334 (52.4%) | 165 (53.1%) | 169 (51.8%) | ||
| Parasite prevalence, n (%) | Microscopic | 330 (51.8%) | 156 (50.2%) | 174 (53.4%) | |
| Microscopic or submicroscopic | 524 (82.3%) | 260 (83.6%) | 264 (81.0%) | ||
| During Pregnancy | Parasite prevalencea, n/N (%) | Microscopic | 1114/4348 (25.6%) | 787/2110 (37.3%) | 347/2238 (15.5%) |
| Microscopic or submicroscopic | 2338/4348 (53.8%) | 1496/2110 (70.9%) | 842/2238 (37.6%) | ||
| Incidence of malaria, episodes per person years | 0.34 | 0.60 | 0.09 | ||
| At Delivery | Binary measures of malaria in pregnancy, n/N (%) | Maternal blood microscopy | 27/635 (4.3%) | 26/310 (8.4%) | 1/325 (0.3%) |
| Placental blood microscopy | 28/633 (4.4%) | 27/307 (8.8%) | 1/326 (0.3%) | ||
| Placental blood LAMPb | 74/624 (11.9%) | 67/301 (22.3%) | 7/323 (2.2%) | ||
| Histopathology | 284/637 (44.6%) | 192/311 (61.7%) | 92/326 (28.2%) | ||
| Adverse birth outcomes, n (%) | Low birth weight | 46 (7.2%) | 23 (7.4%) | 23 (7.1%) | |
| Small for gestational age | 70 (11.0%) | 33 (10.6%) | 37 (11.4%) | ||
| Preterm birth | 37 (5.8%) | 20 (6.4%) | 17 (5.2%) |
Abbreviations: DP, dihydroartemisinin-piperaquine; LAMP, loop-mediated isothermal amplification; SD, standard deviation; SP, sulfadoxine-pyrimethamine.
aDuring routine visits.
bLAMP of DNA.