Hyperglycemia and Adverse Pregnancy Outcome (HAPO)

描述（由申请人提供）：有一个共识，显性糖尿病（DM），无论是否伴有代谢失代偿的症状或体征，与不良妊娠结局的显著风险相关。另一方面，与显性糖尿病相比，葡萄糖耐受不良程度较轻的不良结局风险存在争议。高血糖和不良妊娠结局（HAPO）研究是一项基础流行病学调查，旨在澄清妊娠晚期不同水平的葡萄糖耐受不良与不良结局风险之间的关系。它的总体目标是通过一项涉及15个中心和大约2.5万名孕妇的国际合作研究，在孕期血糖水平方面取得重大进展，从而使母亲、胎儿和新生儿面临更高的风险。主要假设是妊娠期间的高血糖（不像显性糖尿病那么严重）与母体、胎儿和新生儿不良结局的风险增加相关，且与代谢紊乱程度独立相关。HAPO的具体目标是：1。在大量、异质、跨国、多文化、多种族的妊娠晚期妇女队列中，在医疗护理人员对葡萄糖耐量状况“盲法”的情况下（除了空腹和/或两小时OGTT血浆葡萄糖浓度超过预定临界值的情况）检查葡萄糖耐量；和2。基于本研究建立的孕妇血糖与特定不良结局风险之间的特定关系，得出国际上可接受的妊娠期糖尿病（GDM）的诊断和分类标准。HAPO是通过在妊娠晚期（包括OGTT）和分娩时收集高质量的标准化数据来完成的，以评估不良后果，包括手术分娩（剖腹产）、胎儿大小增加（巨大儿/肥胖）、新生儿发病率（低血糖）和胎儿高胰岛素血症。HAPO包括位于芝加哥西北大学范伯格医学院的临床协调中心（CCC）和数据协调中心，以及位于英国贝尔法斯特的中央实验室。该申请要求为CCC提供4年的额外资金，以使HAPO能够实现招募25,000名妇女的目标，完成所有注册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.