A RANDOMIZED CLINICAL TRIAL OF TREATMENT FOR MILD GESTATIONAL DIABETES

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Will dietary treatment (and insulin therapy as required) for mild gestational diabetes reduce the frequency of neonatal morbidity associated with maternal carbohydrate intolerance? Mild gestational diabetes is defined as a normal fasting glucose level with two or more 3-hour oral glucose tolerance test values being abnormal. A composite endpoint has been chosen as the primary outcome. This consists of perinatal mortality and perinatal morbidities that have been shown to be associated with maternal carbohydrate intolerance, specifically stillbirth, neonatal hypoglycemia, neonatal hyperinsulinemia, neonatal hyperbilirubinemia and birth trauma. Individually the components of this composite outcome are rare. Many previous studies have focused on macrosomia or large for gestational age as the primary outcome, partly because the sample size required to demonstrate an effect on birth trauma, for example, would be prohibitive. By combining relevant morbidities, this problem can be overcome.