The Hoosier Moms Cohort
赞助:
Indiana University
合作者:
信息的提供 (责任方):
，
| 追踪信息 | |||
|---|---|---|---|
| 首次提交日期 ICMJE | October 3, 2018 | ||
| 首次发布日期e ICMJE | October 4, 2018 | ||
| 最后更新发布日期 | October 4, 2018 | ||
| 预计研究开始日期 ICMJE | November 2018 | ||
| 预计主要完成日期 | November 2021 (主要结果测量的最终数据收集日期) | ||
| 目前主要观察指标 ICMJE |
GDM Diagnosis[ Time Frame: 42 weeks or less gestational age ] Number of subjects diagnosed with GDM |
||
| 原始主要观察测量 ICMJE | 与当前相同 | ||
| 目前的二级观察 ICMJE |
|
||
| 描述性信息 | |||
| 简略标题 ICMJE | The Hoosier Moms Cohort | ||
| 正式标题 ICMJE | Understanding Diverse Contributors to Gestational Diabetes Mellitus and Its Near-to-Long Term Consequences: An Indiana University Grand Challenges Precision Health Initiative Cohort Study (The Hoosier Moms Cohort) | ||
| 简要概况 | The Hoosier Moms Cohort (HMC) study's goal is to better understand the pathophysiology underlying the development of gestational diabetes mellitus (GDM) in pregnant women and its transition to Type 2 diabetes mellitus in mothers and their exposed children. The HMC study wants to determine what biomarkers (genetic, blood based and behavioral/interventional) can be identified in pregnant women affected with GDM and how those biomarkers can be used to impact preventative care. |
||
| 详细说明 | Predictive GDM genetic risk models will be tested and refined in the Hoosier Moms Cohort. In addition to prospectively using genetic information to predict GDM risk, the Hoosier Moms Cohort will incorporate the use of wearable/digital devices for collection of detailed behavioral information, support development of novel dietary capture methods, and enable the collection of specimens specifically aimed at multiple 'omics' techniques to engage in a detailed, multidimensional assessment of pathophysiologic pathways and biomarkers. | ||
| 研究类型 ICMJE | Observational | ||
| 研究阶段 | |||
| 研究设计 ICMJE | 分配: 干预模型: 干预模型描述: 盲法: Observational 盲法描述: 主要目的: |
||
| 适用条件 ICMJE | |||
| 干预项目 ICMJE |
|
||
| 研究工具 |
|
||
| 招募信息 | |||
| 招募状态 ICMJE | Not yet recruiting | ||
| 预计入组 ICMJE |
500 | ||
| 原始预计入组 ICMJE | 与当前相同 | ||
| 预计研究完成日期 | November 2025 | ||
| 预计主要完成日期 | November 2021 (主要结果测量的最终数据收集日期) | ||
| 合格标准 ICMJE | Inclusion Criteria: - Singleton gestation - Gestational age ≤ 20+0 confirmed via American Congress of Obstetrics and Gynecology (ACOG) ultrasound dating guidelines - 18 years old or greater at time of consent Exclusion Criteria: - Pre pregnancy diagnosis of Type 1 Diabetes or Type 2 Diabetes or Screening Hemoglobin A1C that is greater than or equal to 6.5% or two abnormal values on a 3 hours Oral Glucose Tolerance Test (100g load) before 20 weeks gestation - Pre pregnancy chronic usage of systemic steroids (inhaled and short term usage acceptable) - Planned pregnancy termination - Unable to provide informed consent in English or Spanish - Major fetal anomalies as listed below that are known prior to enrollment. If these are discovered after enrollment, the participant may be allowed to participate, unless the discovered fetal anomaly is a lethal anomaly. Major Fetal Anomalies to be Excluded: - Congenital diaphragmatic hernia - Congenital cystic adenomatoid malformation - Pleural effusions - Chylothorax - Bronchogenic cyst - Bronchopulmonary sequestration - Anomalous pulmonary venous return - Tricuspid atresia - Mitral atresia - Double right ventricle - Ebstein's malformation - Pulmonary atresia - Hypoplastic left heart syndrome - Aortic coarctation - Fetal arrhythmias (tachycardia or bradycardia) - Transposition of the great vessels - Tetrology of Fallot - Double outlet right ventricle - Aortic stenosis - Holoprosencephaly - Anencephaly - Dandy-Walker malformation or variant - Septo-optic dysplasia - Neural tube defect - Vein of Galen aneurysm - Bilateral renal agenesis - Cystic renal disease (polycystic or multicystic) - Any genitourinary lesion accompanied by oligohydramnios at <24 weeks - Obstructive uropathy - Horseshoe kidney - Megacystis microcolon - Achondrogenesis - Thanatophoric dysplasia - Thoracic dysplasia - Osteogenesis imperfect - Short rib polydactyly - Any skeletal defect associated with small thorax - Hypophosphatemia - Any karyotypic abnormality - Any suspected genetic syndrome - Cleft lip/palate - Micrognathia - Hydrops - Fetal anemia (<35% on cordocentesis) - Neck mass - Gastroschisis - Omphalocele | ||
| 性别 |
|
||
| 年龄 | 最小年龄：18 Years ，最大年龄：N/A | ||
| 接受健康的志愿者 | 没有 | ||
| 可入组国家 ICMJE | United States | ||
| 管理信息 | 数据检测委员会 | No | |
| 研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: No 研究涉及美国FDA监管的设备产品: No |
||
| IPD 共享声明 |
|
||
| 责任方 | ， | ||
| 研究赞助商 ICMJE | Indiana University | ||
| 合作者 ICMJE | |||
| 研究员 ICMJE |
|
||
| PRS 账户 | |||
| 验证日期 | October 2018 | ||
|
ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |
|||
请使用微信扫码报名
京公网安备 11010102003638号