Table 3. Post Hoc Per-Protocol Outcomes Analyses.
| Outcomes | Glyburide Group (n = 367) | Insulin Group (n = 442) | Difference, % (95% CI) | P Valuea |
|---|---|---|---|---|
| Composite Criterion Components | ||||
| Macrosomia, No. (%) | 59 (16.2) | 65 (14.8) | 1.4 (−3.9 to 6.6) | .59 |
| Hypoglycemia, No. (%) | 45 (12.2) | 32 (7.2) | 5.0 (0.5 to 9.5) | .02 |
| Hyperbilirubinemia, No. (%) | 14 (3.8) | 14 (3.1) | 0.6 (−2.0 to 3.3) | .61 |
| Neonatal Outcomes | ||||
| Birth weight, mean (SD), g | 3341 (513) | 3331 (476) | 10 (−58 to 78) | .77 |
| Birth weight >4000 g, No. (%) | 33 (9.3) | 28 (6.6) | 2.7 (−1.9 to 7.4) | .16 |
| Apgar score ≤7 at 5 min, No. (%) | 3 (0.8) | 11 (2.5) | −1.7 (−3.4 to 0.04) | .08 |
| Reason for admission to neonatal intensive care unit before 48 h of life, No. | ||||
| Severe respiratory distress syndrome | 8 | 11 | ||
| Otherb | 2 | 0 | ||
| Maternal Outcomes | ||||
| Insulin dosage received, mean (SD), units/dc | 19.6 (14.6) | |||
| Glyburide dosage received, mean (SD), mg/dc | 5.4 (3.4) | |||
| Maternal hypoglycemia, No. (%)d | 13 (3.8) | 4 (1.0) | 2.8 (0.2 to 5.5) | .02 |
a
P value of the test of the coefficient of the mixed-effects model used to account for multiple centers (logistic for qualitative variables, linear for quantitative ones).
b
One malformation and 1 maternal/fetal infection.
c
Mean dosages were calculated from diagnosis to delivery.
d
At least 1 fasting or postprandial blood glucose measurement <40 mg/dL during pregnancy.