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. There is a consensus that during pregnancy, overt diabetes mellitus (DM), whether or not accompanied by symptoms or signs of metabolic decompensation, is associated with a significant risk of adverse outcome. However, the risk of adverse perinatal outcome associated with degrees of maternal glucose intolerance less severe than overt DM is controversial. We hypothesize that hyperglycemia, less severe than overt DM, is associated with increased risk of adverse maternal, fetal and neonatal outcome that is independently related to the degree of metabolic disturbance. To address this hypothesis, we propose participation in a large, multinational collaborative study, with the following specific aims: 1) to examine glucose tolerance in a large, heterogeneous, multinational, multicultural, ethnically diverse cohort of women in the third trimester of gestation with medical caregivers 'blinded' to status of glucose tolerance (except when predefined criteria are met) with collaborating investigators from sixteen centers around the world using a common protocol and data collection instruments, uniformly established training of personnel, and a central laboratory for analyses; and 2) to provide data on specific relationships between maternal glycemia and risk of specific adverse outcomes that can be used to derive internationally acceptable criteria for the diagnosis and classification of gestational diabetes mellitus (GDM). The primary outcomes of interest are those most strongly associated with the maternal metabolic disturbances of overt diabetes mellitus, specifically: fetal hyperinsulinism (cord blood c-peptide); fetal obesity (macrosomia as defined by excessive birth weight for length); cesarean delivery; shoulder dystocia; and neonatal hypoglycemia.
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