Table 3.
Comparison of primary and powered secondary outcomes by randomized treatment group
| Treatment | Control | Comparisona (difference or risk ratio) with 95% CI |
Significancea | |
|---|---|---|---|---|
| Primary endpoint | ||||
| Fasting glucoseb | N Mean (SD) | N Mean (SD) | Difference (95% CI) | P = 0.xxx |
| Powered secondary endpoints (maternal) | ||||
| Fasting total cholesterol | N Mean (SD) | N Mean (SD) | Difference (95% CI) | P = 0.xxx |
| Fasting LDL cholesterol | N Mean (SD) | N Mean (SD) | Difference (95% CI) | P = 0.xxx |
| Powered secondary endpoint (fetal) | ||||
| Free fatty acids (cord blood) | N Mean (SD) | N Mean (SD) | Difference (95% CI) | P = 0.xxx |
| Triglycerides (cord blood) | N Geometric mean (SD) | N Geometric mean (SD) | Difference (95% CI) | P = 0.xxx |
a Significance tests for pre-planned primary and main secondary outcomes only
b Comparisons are adjusted for minimization variables (BMI Previous GDM and baseline fasting glucose), and baseline measurements where available