Table 2 Results from the per-protocol and intention-to-treat analyses
Variable | Intention-to-treat population | Per-protocol population | ||||
|---|---|---|---|---|---|---|
Intervention Mean (SD) Median (range) (n = 438) | Controls Mean (SD) Median (range) (n = 871) | Adjusted p-valuea | Intervention Mean (SD) Median (range) (n = 116) | Controls Mean (SD) Median (range) (n = 845) | Adjusted p-valuea | |
Week of delivery | 39.1 (2.5) 40.0 (24–42) n = 429 | 39.8 (2.0) 40.0 (23–42) n = 866 | 0.001 | 39.6 (1.5) 40.0 (36–42) | 39.8 (2.0) 40.0 (23–42) | 0.142 |
Weight change: from first pregnancy visit to last pregnancy visit, kg | 10.3 (6.1) 10.0 (−6.0–41.0) | 11.2 (6.9) 11.0 (−15.0–46.0) | 0.695 | 8.9 (6.0) 9.00 (−6.0–28.0) | 11.2 (6.9) 11.0 (−15.0–46.0) | 0.031 |
Weight change: from first pregnancy visit to postpartum check-up, kg | 1.4 (6.4) 1.0 (−19.0–23.0) | 1.6 (6.5) 2.0 (−27.0–27.0) | 0.731 | −0.3 (6.0) −1.0 (− 17.0–18.0) | 1.6 (6.5) 2.00 (−27.0–27.0) | 0.019 |
Child weight at delivery, g | 3591 (594) 3605 (830–5430) n = 420 | 3695 (637) 3705 (418–5760) n = 866 | 0.037 | 3603 (505) 3515 (2480–5430) n = 113 | 3703 (627) 3705 (418–5760) | 0.300 |
n (%) | n (%) | n (%) | n (%) | |||
GWG < 7 kg | 120 (27.4) | 204 (23.4) | 0.882 | 43 (37.1) | 194 (23.0) | 0.036 |
Macrosomia | 22 (5.0) | 77 (8.8) | 0.017 | 5 (4.3) | 76 (9.0) | 0.172 |
SGAb | 34 (7.8) | 45 (5.2) | 0.196 | 10 (8.6) | 38 (4.5) | 0.199 |