HYPERGLYCEMIA AND ADVERSE PREGNANCY OUTCOME

高血糖和不良妊娠结局

• 批准号: 2745557
• 负责人: BOYD E METZGER
• 金额: $ 86.64万
• 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 2004-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2745557
• 关键词: clinical research; cooperative study; disease /disorder proneness /risk; epidemiology; female; gestational diabetes mellitus; glucose tolerance; human birth weight; human pregnant subject; human subject; hyperglycemia; hyperinsulinism; hypoglycemia; labor complications; newborn human (0-6 weeks); pregnancy; women's health

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 16 field 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, 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 provide data that can be used to derive internationally acceptable criteria for the diagnosis and classification of gestational diabetes mellitus (GDM) based on the identification of pregnancies at risk for specific adverse outcomes. The study is to be 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 fetal hyperinsulinism, fetal obesity (macrosomia), operative delivery (caesarian section), and neonatal morbidity (hypoglycemia). HAPO is to include field centers and regional centers where the participants will be studied, a Clinical Coordinating Center and Data Coordinating Center, both located at the Northwestern University Medical School in Chicago, as well as a Central Laboratory located in Belfast, Northern Ireland. This application requests support for the Clinical Coordinating Center, the field and regional centers and Central Laboratory. Cost effectiveness for the HAPO study is enhanced through cost sharing by colleagues in non-U.S. centers.

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，与不良妊娠结局的显着风险相关。 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。 其总体目标是通过一项涉及16个现场中心和约25，000名孕妇的国际合作研究，在妊娠期间葡萄糖水平方面取得重大进展，使母亲，胎儿和新生儿处于更高的风险中。 主要假设是，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的风险增加相关，这与代谢紊乱的程度独立相关。 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.提供可用于基于识别具有特定不良结局风险的妊娠得出妊娠期糖尿病（GDM）诊断和分类的国际可接受标准的数据。 本研究将在妊娠晚期（包括OGTT）和分娩时收集高质量的标准化数据，以评估不良结局，包括胎儿高胰岛素血症、胎儿肥胖（巨大儿）、手术分娩（剖腹产）和新生儿发病率（低血糖）。 HAPO将包括将对参与者进行研究的现场中心和区域中心、位于芝加哥西北大学医学院的临床协调中心和数据协调中心，以及位于北方爱尔兰贝尔法斯特的中心实验室。 本申请要求为临床协调中心、现场和区域中心以及中心实验室提供支持。HAPO研究的成本效益通过非美国中心的同事分担成本而得到提高。