HAPO: DATA COORDINATING CENTER

HAPO：数据协调中心

• 批准号: 7053366
• 负责人: Alan R Dyer
• 金额: $ 41.84万
• 依托单位: NORTHWESTERN UNIVERSITY AT CHICAGO
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-05-04 至 2008-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7053366
• 关键词: blood chemistry; clinical research; cooperative study; data management; disease /disorder classification; disease /disorder proneness /risk; embryo /fetus disorder; epidemiology; female; gestational diabetes mellitus; glucose tolerance; glucose tolerance test; human pregnant subject; human subject; hyperglycemia; hyperinsulinism; hypoglycemia; infant mortality; labor complications; metabolism disorder diagnosis; newborn human (0-6 weeks); pregnancy; prenatal growth disorder; statistics /biometry; women' s health

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 and Data Coordinating Center (DCC), 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 DCC, 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.

描述（由申请人提供）：有一个共识，即明显的糖尿病（DM），无论是伴随着症状还是代谢代谢的迹象，都与出现不良怀孕的严重风险有关。另一方面，与明显的DM相比，与葡萄糖不耐症的严重程度相关的不良预后风险是有争议的。高血糖和不良妊娠结局（HAPO）研究是一项基本的流行病学研究，旨在阐明有关妊娠三个月的各种葡萄糖不耐症的关联和不良后果的风险。它的一般目标 - 一项涉及15个中心和约25,000名孕妇的国际合作研究手段，即在怀孕期间对葡萄糖水平的知识取得了重大进步，使母亲，胎儿和新生儿的风险增加。主要的假设是，怀孕期间高血糖（不如公开DM）与不良母体，胎儿和新生儿结局的风险增加有关，与代谢性疾病的程度独立相关。 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);和2。基于母体血糖与通过这项研究确定的特定不良结果的特定关系，得出妊娠糖尿病（GDM）诊断和分类的国际可接受标准。在妊娠三个月（包括OGTT）和交付时，HAPO通过高质量的标准化数据收集，以评估不良后果（包括手术递送（剖腹产），胎儿大小（Macrososomia/obesity），新生儿疾病（Neonatal Worbisity），Neonatal Wormbysia和fetal hyperalimismimismimismiminslimismiminslimismismimiss。 HAPO包括位于芝加哥西北大学Feinberg医学院的临床协调中心和数据协调中心（DCC），以及位于英国贝尔法斯特的中央实验室。该申请要求为DCC提供4年的额外资金，以允许Hapo实现其招聘目标的25,000名妇女完成所有数据收集的所有数据收集，并完成所有数据分析。