The National Institute of Child Health and Human Development Maternal-Fetal Medicine Unit Network Randomized Clinical Trial in Progress

Abstract

It is recognized that women with gestational diabetes mellitus (GDM) who have significantly elevated fasting blood glucose levels are at increased risk for fetal macrosomia and perinatal morbidity if treatment is not provided (1,2). The association of milder forms of GDM with perinatal morbidity and mortality remains unclear, primarily because the condition is often confounded with other risk factors such as maternal obesity, age, and parity. Screening for GDM is recommended for most pregnant women, yet it is unknown whether there is a benefit to the identification and treatment of mild carbohydrate intolerance during pregnancy (3,4). The present report is an update of our previous description of a current ongoing randomized treatment trial for mild GDM (5). A randomized clinical trial of women with mild GDM (fasting glucose <95 mg/dl) is being undertaken that compares perinatal outcomes in those receiving diet therapy and insulin as required versus those randomized to no specific treatment. This study aims to clarify whether there is utility in identifying and treating women with a normal fasting glucose level who meet standard criteria for GDM. We plan to compare perinatal outcomes in women who have been randomized to diet and/or insulin therapy with women who have been randomized to no specific treatment. A randomized treatment trial of mild GDM will clarify whether identification and treatment of mild GDM reduce perinatal morbidity. This information will assist in determining appropriate thresholds for the treatment of GDM. Overall, with broader identification and aggressive treatment, perinatal mortality rates associated with GDM appear to be similar to the nondiabetic population (1). Several analyses of 20 years ago did document an increased stillbirth rate for GDM pregnancies that would qualify as preexisting diabetes according to World Health Organization criteria (6–9). Below this threshold, the extent to …