A planned randomized clinical trial of treatment for mild gestational diabetes mellitus

Objective: A planned study is described which will determine whether a benefit exists for the treatment of mild carbohydrate intolerance during pregnancy. Methods: A randomized clinical trial of women with mild gestational diabetes will compare perinatal outcomes in those receiving diet therapy and insulin as required versus those randomized to no specific treatment. Results: The primary outcome of this study will be a composite of neonatal morbidity in the treatment and control groups. Conclusions: A randomized treatment trial of mild gestational diabetes mellitus will clarify whether identification and treatment of mild gestational diabetes mellitus reduces perinatal morbidity. This information will aid in selecting appropriate thresholds for the treatment of gestational diabetes mellitus.