Table 3.
Outcome | ITT analysis | PP analysis | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Control | Intervention | Risk ratio | P | Control | Intervention | Risk ratio | P | |||||
(SPCQ and placebo) | (SPAZ) | (95% CI) | (SPCQ and placebo) | (SPAZ) | (95% CI) | |||||||
Peripheral blood (light microscopy) | ||||||||||||
All infections | 40/1,022 | (3.9) | 23/1,023 | (2.3) | 0.57 (0.35–0.95) | 0.029 | 39/962 | (4.1) | 22/972 | (2.3) | 0.56 (0.33–0.93) | 0.024 |
P. falciparum | 29 | (2.8) | 18 | (1.8) | 0.62 (0.35–1.11) | 0.104 | 28 | (2.9) | 17 | (1.8) | 0.60 (0.33–1.09) | 0.090 |
P. vivax | 11 | (1.1) | 5 | (0.5) | 0.45 (0.16–1.30) | 0.142 | 11 | (1.1) | 5 | (0.5) | 0.45 (0.16–1.29) | 0.127 |
Placental blood (light microscopy) | ||||||||||||
All infections | 29/847 | (3.4) | 15/841 | (1.8) | 0.52 (0.28–0.97) | 0.035 | 28/800 | (3.5) | 14/803 | (1.7) | 0.50 (0.26–0.94) | 0.028 |
P. falciparum | 25 | (3.0) | 15 | (1.8) | 0.60 (0.32–1.14) | 0.115 | 24 | (3.0) | 14 | (1.7) | 0.58 (0.30–1.12) | 0.098 |
P. vivax | 1 | (0.1) | 0 | (0.0) | – | – | 1 | (0.1) | 0 | (0.0) | – | – |
Cord blood (light microscopy)a | 4/744 | (0.5) | 3/744 | (0.4) | 0.75 (0.17–3.34) | 1.000 | 4/695 | (0.6) | 3/716 | (0.4) | 0.73 (0.16–3.24) | 0.681 |
Placental malaria (histology) | ||||||||||||
Active and past infectionb | 150/736 | (20.4) | 128/736 | (17.4) | 0.85 (0.69–1.06) | 0.143 | 138/697 | (19.8) | 122/702 | (17.4) | 0.88 (0.71–1.10) | 0.245 |
Active infectionc | 65/736 | (8.8) | 44/736 | (6.0) | 0.68 (0.47–0.98) | 0.037 | 62/697 | (8.9) | 41/702 | (5.8) | 0.66 (0.45–0.96) | 0.029 |
Anaemia (Hb <11 g/dL) | 689/935 | (73.7) | 700/933 | (75.0) | 1.02 (0.97–1.07) | 0.508 | 647/883 | (73.3) | 663/889 | (74.6) | 1.02 (0.96–1.08) | 0.532 |
Severe anaemia (Hb <7 g/dL) | 44/935 | (4.7) | 37/933 | (4.0) | 0.84 (0.55–1.29) | 0.432 | 39/883 | (4.4) | 34/889 | (3.8) | 0.87 (0.55–1.36) | 0.531 |
Data are number (%). P <0.05 marked in bold.
aAll P. falciparum.
bDetection of parasites or malaria pigment.
cDetection of parasites.