Hyperglycemia and Adverse Pregnancy Outcome (HAPO)

高血糖和不良妊娠结局 (HAPO)

• 批准号: 7052820
• 负责人: BOYD E METZGER
• 金额: $ 235.47万
• 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/7052820
• 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 (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.

描述（由申请人提供）：人们一致认为，明显的糖尿病（DM），无论是否伴有代谢失代偿的症状或体征，都与不良妊娠结局的显着风险相关。另一方面，与明显糖尿病相比不太严重的葡萄糖耐受不良程度相关的不良结果风险存在争议。高血糖和不良妊娠结局 (HAPO) 研究是一项基本的流行病学调查，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联的尚未解答的问题。其总体目标是通过一项涉及 15 个中心和大约 25,000 名孕妇的国际合作研究，在妊娠期间血糖水平方面取得重大进展，因为妊娠期间血糖水平会使母亲、胎儿和新生儿面临更高的风险。主要假设是，妊娠期高血糖的严重程度低于明显的糖尿病，但与孕产妇、胎儿和新生儿不良结局的风险增加相关，而不良结局与代谢紊乱的程度独立相关。 HAPO 的具体目标是： 1. 在妊娠晚期的大型、异质、跨国、多文化、种族不同的妇女群体中检查葡萄糖耐量，医疗护理人员对葡萄糖耐量状态“不知情”（除非空腹和/或两小时 OGTT 血浆葡萄糖浓度超过预定临界值）； 2. 根据本研究确定的母亲血糖与特定不良后果风险之间的具体关系，得出国际上可接受的妊娠期糖尿病 (GDM) 诊断和分类标准。 HAPO 正在通过收集妇女在妊娠晚期（包括 OGTT）和分娩时的高质量标准化数据来完成，以评估不良后果，包括手术分娩（剖腹产）、胎儿体积增大（巨大儿/肥胖）、新生儿发病率（低血糖）和胎儿胰岛素过多症。 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心实验室。该申请要求为 CCC 提供 4 年的额外资金，以使 HAPO 实现招募 25,000 名女性的目标，完成所有登记女性的所有数据收集，并完成所有数据分析。