A RANDOMIZED CLINICAL TRIAL OF TREATMENT FOR GESTATIONAL DIABETES MELLITUS

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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. Gestational diabetes mellitus (GDM) is defined as carbohydrate intolerance of variable severity with onset or first recognition during pregnancy. The definition applies regardless of insulin use for treatment or the persistence of the condition after pregnancy and does not exclude the possibility that unrecognized glucose intolerance or overt diabetes may have preceded the pregnancy. It is known that pre-existing diabetes substantially contributes to perinatal morbidity and mortality. It is also generally agreed that patients with gestational diabetes who have significantly elevated fasting blood glucose levels appear to have an increased risk of intrauterine fetal death. However, this represents a small fraction of patients with gestational diabetes which complicates about two to three percent of all pregnancies. The association of milder forms of gestational diabetes with adverse pregnancy outcome including morbidities such as macrosomia, birth trauma and neonatal hypoglycemia, remains questionable because the condition is often confounded with other risk factors such as race, maternal obesity, age and parity. While it is likely that maternal carbohydrate intolerance reflects a continuum of risk for adverse outcomes, it is not known whether there is a benefit to identification and subsequent treatment of mild carbohydrate intolerance during pregnancy. This question has assumed greater importance with further lowering of the thresholds for diagnosis based on recommendations of the Fourth International Workshop Conference on GDM. Further, the trial will characterize the level of glucose abnormality where treatment results in decreased morbidity. To determine whether mild gestational diabetes is a risk factor for adverse perinatal outcome and whether there is utility in identifying and treating patients with mild disease, a randomized clinical trial is proposed for patients with a normal fasting glucose level. The study will compare patients with mild gestational diabetes who have been randomized to diet therapy (Group I) with patients who have been randomized to no treatment (Group IIA).