Comparing Glycemic Profiles in Pregnancy and Maternal and Child Health Outcomes

比较妊娠期血糖状况和母婴健康结果

• 批准号: 10021663
• 负责人: ERIKA F WERNER
• 金额: $ 73.21万
• 依托单位: WOMEN AND INFANTS HOSPITAL-RHODE ISLAND
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-20 至 2025-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10021663
• 关键词: 2 year old; Address; Admission activity; American College of Obstetricians and Gynecologists; Birth trauma; Body mass index; Caring; Cesarean section; Child; Childhood; Clinic; Clinical Research; Cohort Studies; Consensus; Cost Analysis; Data; Decision Modeling; Diabetes Mellitus; Diagnosis; Enrollment; Ensure; Fasting; Female; First Pregnancy Trimester; Functional disorder; Future Generations; Gestational Age; Gestational Diabetes; Glucose; Glucose tolerance test; Glycosylated Hemoglobin; Health; Healthcare; Hospitals; Hyperbilirubinemia; Infant; Intensive Care Units; Knowledge; Lead; Life; Maternal and Child Health; Measurement; Measures; Metabolic; Modality; Morbidity - disease rate; Neonatal; Neonatal Hypoglycemia; Obesity; Outcome; Pathologic; Physiological; Population; Postpartum Period; Pre-Eclampsia; Pregnancy; Pregnancy Complications; Pregnancy in Diabetics; Pregnant Women; Premature Birth; Prenatal care; Professional Organizations; Prospective cohort; Prospective cohort study; Research Infrastructure; Risk; Risk Factors; Savings; Second Pregnancy Trimester; Societies; Techniques; Testing; Third Pregnancy Trimester; Time; United States; United States National Institutes of Health; Universities; Variant; Woman; adult obesity; biobank; clinically significant; cost; cost effective; design; early childhood; ethnic diversity; follow-up; glucose monitor; high risk; improved; maternal serum; monitoring device; neonate; next generation; obesity in children; offspring; population health; pregnant; premature; screening; screening guidelines; societal costs; success; tool

Four million women undergo a 50 gram glucose tolerance test at 24-28 weeks gestation annually in the United States. This universal screen for gestational diabetes mellitus (GDM) is intended to improve health and reduce costs by allowing for treatments that will reduce the known complications associated with GDM. However, as currently screened for, diagnosed, and treated, offspring born to women with GDM are still at much higher risk for childhood obesity compared to the offspring of women without GDM. These female children born to women with GDM are more likely to become obese adults and because GDM risk is dependent on maternal body mass index, these women will be more likely to have GDM themselves when they become pregnant. This cycle of GDM leading to increasingly obese future generations can only be broken with a better understanding of the maternal glycemic profile during gestation so that the timing and types of dysglycemia most associated with pregnancy complications, including childhood obesity, can be identified. The overall objective of this application is to leverage Brown University/Women & Infants Hospital's considerable pregnancy research infrastructure, high rates of early prenatal care, large delivery volume, and track record of successful clinical research in diabetes in pregnancy to ensure this collaborative cohort study investigating maternal glycemia in pregnancy is a success. Brown University/Women & Infants Hospital will enroll at least 400 women (of the 2000 total enrollment) in the first trimester of pregnancy and follow them and their offspring until the children are two years of age. While the final aims will be determined by a steering committee of all participating centers, the following specific aims are proposed: 1) Utilize continuous glucose monitoring (CGM) at 5 time points during gestation (first trimester, early second trimester, 24-28 weeks, third trimester, and post-partum) to better understand critical values and time periods when dysglycemia is associated with pregnancy, and neonatal or early childhood complications, including adiposity and body mass index z-score >85th percentile at 2 years of life; 2) create a biobank of maternal serum at the 5 time points that will be used to compare traditional glucose tests (fasting, glycosylated hemoglobin, and glucose challenge) to CGM results to determine optimal screen-positive cut-offs; 3) use decision modeling to assess the costs and effects to US health care of any changes to the timing or modality of GDM testing in pregnancy. If successful, this project will result in a more complete understanding of glycemic changes over gestation, identify critical measures and gestational age windows most associated with morbidity, and determine the optimal screening test to identify clinically significant dysglycemia. This will allow glucose testing in pregnancy to be re-designed to achieve both a healthier next generation and fiscal savings.

在美国，每年有400万妇女在怀孕24-28周时接受50克葡萄糖耐量试验。 States.妊娠期糖尿病（GDM）的普遍筛查旨在改善健康状况， 通过允许治疗，将减少与GDM相关的已知并发症的成本。但随着 目前筛查，诊断和治疗，后代出生的妇女与GDM仍然在高得多的风险 与没有GDM的女性的后代相比，儿童肥胖症。这些女性的孩子 GDM患者更有可能成为肥胖的成年人，因为GDM的风险取决于母体 这些妇女在怀孕时更有可能患GDM。这 GDM导致后代越来越肥胖的循环只能用更好的方法来打破。 了解妊娠期母体血糖谱，以便确定 与妊娠并发症（包括儿童肥胖）最相关的精神障碍， 鉴定此应用程序的总体目标是利用布朗大学/妇女和婴儿医院的 相当多的妊娠研究基础设施，早期产前护理率高，分娩量大， 成功的妊娠期糖尿病临床研究的跟踪记录，以确保这项合作性队列研究 调查孕妇怀孕期间的行为是成功的。布朗大学/妇女和婴儿医院将 在怀孕的前三个月招募至少400名妇女（2000名总招募人数）并对其进行随访， 他们的孩子直到两岁。虽然最终的目标将由一个方向盘决定， 所有参与中心的委员会，提出了以下具体目标：1）使用连续葡萄糖 在妊娠期间的5个时间点（妊娠早期、妊娠中期早期、24-28 周，妊娠晚期和产后），以更好地了解临界值和时间段， 胎儿发育不良与妊娠、新生儿或幼儿期并发症有关，包括 2岁时肥胖和体重指数z评分>第85百分位数; 2）创建一个生物库， 在5个时间点的母体血清用于比较传统的葡萄糖测试（空腹， 糖化血红蛋白和葡萄糖激发）对CGM结果的影响，以确定最佳筛查阳性 3）使用决策模型来评估任何变化对美国医疗保健的成本和影响， 妊娠期GDM检测的时间或方式。如果成功的话，这个项目将带来更多的 全面了解妊娠期血糖变化，确定关键指标和胎龄 与发病率最相关的窗口，并确定最佳筛选试验，以确定临床 严重精神障碍这将使怀孕期间的葡萄糖测试能够重新设计，以实现 更健康的下一代和财政储蓄。