HYPERGLYCEMIA AND ADVERSE PREGNANCY OUTCOME STUDY (HAPO)

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。有一个共识是，在怀孕期间，明显的糖尿病（DM），无论是否伴有代谢失代偿的症状或体征，都与不良结局的显著风险相关。然而，与母体葡萄糖耐受不良程度低于显性糖尿病相关的不良围产期结局风险存在争议。我们假设，低血糖症的严重程度低于显性糖尿病，与母体、胎儿和新生儿不良结局的风险增加有关，而这与代谢紊乱的程度独立相关。为了解决这一假设，我们建议参与一项大型跨国合作研究，具体目标如下：1)与来自世界各地16个中心的合作研究者使用共同的方案和数据收集工具、统一建立的人员培训和中心实验室，在一个大型、异质、多国、多文化、多种族的妊娠晚期妇女队列中检查葡萄糖耐量，医疗护理人员对葡萄糖耐量状况“盲目”（除非满足预定义的标准）；2)提供孕产妇血糖与特定不良结局风险之间的特定关系的数据，可用于推导国际上可接受的妊娠糖尿病（GDM）诊断和分类标准。研究的主要结局是那些与母体显性糖尿病代谢紊乱最密切相关的结局，特别是：胎儿高胰岛素血症（脐带血c肽）；胎儿肥胖（以出生体重超过长度定义的巨大儿）；剖腹产;肩难产;还有新生儿低血糖。

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.