Hyperglycemia and Adverse Pregnancy Outcome (HAPO)

描述（由申请人提供）：有一个共识，即显性糖尿病（DM），无论是否伴有代谢失代偿的症状或体征，都与不良妊娠结局的显著风险相关。另一方面，葡萄糖耐受不良程度低于显性糖尿病的不良结局风险存在争议。高血压和不良妊娠结局（HAPO）研究是一项基础流行病学调查，旨在澄清妊娠晚期各种水平葡萄糖耐受不良与不良结局风险之间关系的未回答问题。其总体目标-通过涉及15个中心和大约25，000名孕妇的国际合作研究-是在妊娠期间葡萄糖水平的知识方面取得重大进展，使母亲，胎儿和新生儿处于更高的风险中。主要假设是妊娠期高血糖症，不像显性糖尿病那么严重，与母体、胎儿和新生儿不良结局风险增加相关，与代谢紊乱程度独立相关。HAPO的具体目标是：1。在一个大的、异质的、多国的、多文化的、种族多样的妊娠晚期妇女队列中检查葡萄糖耐量，其中医疗护理人员对葡萄糖耐量状态“不知情”（除了空腹和/或两小时OGTT血浆葡萄糖浓度超过预定截止值的那些情况）;和2.根据本研究建立的母体妊娠与特定不良结局风险之间的特定关系，推导出国际上可接受的妊娠期糖尿病（GDM）诊断和分类标准。HAPO正在通过对妊娠晚期（包括OGTT）和分娩时的妇女进行高质量标准化数据收集来完成，以评估不良结局，包括手术分娩（剖腹产）、胎儿尺寸增加（巨大儿/肥胖）、新生儿发病率（低血糖）和胎儿高胰岛素血症。HAPO包括临床协调中心（CCC）和数据协调中心，均位于芝加哥的西北大学范伯格医学院，以及位于英国贝尔法斯特的中心实验室。该申请要求为核心竞争力中心提供4年的额外资金，使HAPO能够实现其招募25 000名妇女的目标，完成所有登记妇女的所有数据收集，并完成所有数据分析。

DESCRIPTION (provided by applicant): There is a consensus that overt diabetes mellitus (DM), whether or not accompanied by symptoms or signs of metabolic decompensation, is associated with a significant risk of adverse pregnancy outcome. On the other hand, the risk of adverse outcome associated with degrees of glucose intolerance less severe than overt DM is controversial. The Hyperglycemia and Adverse Pregnancy Outcome (HAPO) Study is a basic epidemiologic investigation aiming to clarify unanswered questions on the association of various levels of glucose intolerance during the third trimester of pregnancy and risk of adverse outcomes. Its General Aim--by means of an international cooperative study involving 15 centers and approximately 25,000 pregnant women--is to achieve a major advance in knowledge on levels of glucose during pregnancy that place the mother, fetus, and neonate at increased risk. The primary hypothesis is that hyperglycemia during pregnancy, 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. Specific Aims of HAPO are: 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 in those instances where fasting and/or two hour OGTT plasma glucose concentration exceeds a predefined cutoff value); and 2. to derive internationally acceptable criteria for the diagnosis and classification of gestational diabetes mellitus (GDM) based on the specific relationships between maternal glycemia and the risk of specific adverse outcomes that are established through this study. HAPO is being accomplished with high quality standardized data collection on the women during the third trimester of gestation (including the OGTT) and at time of delivery for assessment of adverse outcomes, including operative delivery (caesarean section), increased fetal size (macrosomia/obesity), neonatal morbidity (hypoglycemia), and fetal hyperinsulinism. HAPO includes a Clinical Coordinating Center (CCC) and Data Coordinating Center, both located at the Northwestern University Feinberg School of Medicine in Chicago, as well as a Central Laboratory located in Belfast, UK. This application requests 4 years of additional funding for the CCC, to allow HAPO to achieve its recruitment goal of 25,000 women, complete all data collection on all enrolled women, and complete all data analyses.