Table 4.
Gestational age, birth size, and postnatal growth in liveborn infants of women in the leflunomide-treated and comparison groups*
| Leflunomide group (56 live births) | Disease-matched comparison group (95 live births) | Healthy comparison group (72 live births) | P† | P, leflunomide group vs. disease- matched group‡ | |
|---|---|---|---|---|---|
| Gestational weeks | |||||
| Mean ± SD | 36.9 ± 3.2 | 38.2 ± 2.4 | 39.3 ± 1.5 | <0.01 | <0.01 |
| Range | 24.1–41.7 | 26.4–41.4 | 33.9–41.6 | ||
| Preterm delivery (<37 weeks)§ | 20 (35.7) | 23 (24.5) | 5 (6.9) | <0.01 | 0.19 |
| Full-term infants | |||||
| Weight, mean ± SD gm | 3,116 ± 457 | 3,310 ± 391 | 3,580 ± 420 | <0.01 | 0.02 |
| Length, mean ± SD cm | 50.0 ± 2.4 | 50.4 ± 2.6 | 51.2 ± 2.3 | 0.04 | 0.45 |
| Head circumference, mean ± SD cm | 34.1 ± 1.6 | 34.3 ± 1.6 | 34.6 ± 1.4 | 0.22 | – |
| Infants ≤10th centile at birth | |||||
| Weight | 9 (16.4) | 8 (8.5) | 1 (1.4) | <0.01 | 0.15 |
| Length | 2 (3.6) | 8 (8.5) | 0 | 0.02 | 0.27 |
| Head circumference | 5 (10.2) | 13 (15.3) | 5 (8.0) | 0.39 | – |
| Infants ≤10th centile postnatal | |||||
| Weight | 8 (16.0) | 13 (15.1) | 0 | <0.01 | 0.95 |
| Length | 7 (14.0) | 5 (6.0) | 2 (3.4) | 0.11 | – |
| Head circumference | 5 (10.2) | 9 (10.8) | 2 (3.4) | 0.24 | – |
Except where otherwise indicated, values are the number (%). In some cases, numbers do not sum to total, due to missing values (data on gestational age at delivery missing for 1 infant from the disease-matched group; data on head circumference at birth missing for 7 infants from the leflunomide-treated group, 10 infants from the disease-matched group, and 9 infants from the healthy comparison group).
Three-group comparisons, by Fisher’s exact test for categorical variables and analysis of variance for continuous variables.
Pairwise comparison of leflunomide-treated group and disease-matched comparison group, performed on variables for which the P value in the 3-group comparison was <0.05.
Of preterm infants, 4 were very preterm (<30 weeks gestation) (2 infants from the leflunomide-exposed group [3.6%] and 2 infants from the disease-matched comparison group [2.1%]).