Table 3.
Pre-specified infant birth outcomes at birth in intervention compared to control groups by intention-to-treat (ITT) analysis. Values for intervention and control are mean (SD) of raw data with missing values noted.
| Intervention n = 119 |
Control n = 122 |
Intervention Effect by ITT Mean Difference (95%CI) 1 |
p | |
|---|---|---|---|---|
| Birth weight (g) | 3553 (508) |
3476 (456) |
138.10 (−217.72, 493.93) |
0.432 |
| Missing | 12 | 11 | ||
| Gestational age (weeks) | 39.76 (1.30) |
39.72 (1.29) |
0.26 (−1.27, 1.80) |
0.718 |
| Missing | 13 | 10 | ||
| Birth weight category, n (%) 2 | ||||
| Small for gestational age < 10% | 8 (7.55) |
7 (6.31) |
2 | |
| Appropriate for gestational age 10–90% | 87 (82.08) |
97 (87.39) |
||
| Large for gestational age > 90% | 11 (10.38) |
7 (6.31) |
||
| Missing | 13 | 11 | ||
| Birth trauma, n (%) | 3 (2.91) |
0 | 2 | |
| Missing | 16 | 16 | ||
| 5-min Apgar score | 8.92 (0.05) |
8.93 (0.40) |
2 | |
| Missing | 17 | 16 |
1 OR = odds ratio; CI = confidence interval. 2 Due to a low number of events, adjusted regression analyses could not be performed on the categorical outcomes of SGA/AGA/LGA, birth trauma, and 5-min Apgar score. All analyses adjusted for site (Hamilton/Burlington, London) and pre-pregnancy BMI categories: underweight to normal weight (BMI ≤ 24.9), overweight (BMI = 25.0 – 29.9), obese (BMI = 30.0 – 39.9).