Table 2.
LBW, preterm delivery, and mean birthweight, by treatment group
| Outcome | ITT analysis | PP analysis | ||||||
|---|---|---|---|---|---|---|---|---|
| Control (SPCQ and placebo) |
Intervention
(SPAZ) |
Risk ratio or ∆ mean (95% CI) | P | Control (SPCQ and placebo) |
Intervention
(SPAZ) |
Risk ratio or ∆ mean (95% CI) | P | |
| LBW (Birthweight < 2,500 g), unadjusted | 175/1,008 (17.4) | 130/1,013 (12.8) | 0.74 (0.60–0.91) | 0.005 | 159/952 (16.7) | 122/967 (12.6) | 0.76 (0.61–0.94) | 0.011 |
| LBW (Birthweight < 2,500 g), adjusteda | – | – | 0.72 (0.59–0.89) | 0.002 | – | – | 0.72 (0.58–0.89) | 0.003 |
| Birthweight (g) | 2,921.6 | 2,963.5 | 41.9 | 0.049 | 2,928.7 | 2,967.9 | 39.2 | 0.068 |
| unadjusted | [2,890.1–2,953.1] | [2,936.0–2,991.0] | (0.2–83.6) | [2,986.9–2,960.4] | [2,940.3–2,995.4] | (−2.8–81.2) | ||
| Birthweight (g) | 2,916.6 | 2,969.0 | 52.4 | 0.009 | 2922.9 | 2974.1 | 51.2 | 0.011 |
| adjustedb | [2,888.8–2944.3] | [2,941.4–2,996.6] | (13.2–91.6) | [2,895.0–2,950.9] | [2,946.4–3,001.8] | (11.7–90.6) | ||
| PTD (<37 GWs), n (%), unadjusted, best available dating ultrasound | 69/652 (10.6) | 44/668 (6.6) | 0.62 (0.43–0.89) | 0.010 | 63/622 (10.1) | 40/651 (6.1) | 0.61 (0.41–0.89) | 0.009 |
Data are number (%) or mean [95% CI], unless stated otherwise; ITT, Intention-to-treat; PP, Per-protocol; GW, Gestational weeks; CI, Confidence interval. P <0.05 marked in bold.
aAdjusted for infant gender, gravidity, no. of treatment courses (ITT only), clinic location, season of delivery, bed net use, mid-upper arm circumference, height, maternal highlander heritage.
bAdjusted for infant gender, gravidity, no. of treatment courses (ITT only), clinic location, mid-upper arm circumference, height, maternal highlander heritage.