Predictability of Gestational Diabetes Mellitus in First and Second Trimester, Using Novel Biomarkers, and the Development of New Biomarkers by Quantitative Proteomic Analysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 820
- 试验地点
- 1
- 主要终点
- Development of Gestational Diabetes in second/third trimester
研究概览
简要总结
The objective of the study is, if an early oral glucose tolerance test combined with maternal history, condition and multiple biomarker analysis can be used to detect gestational diabetes mellitus in the first trimester (12-14 weeks of gestation).
详细描述
It is the investigators' aim to prospectively examine an extended form of the current 1st trimester screening test for the detection of foetal aneuploidy, in order to ascertain whether this can also be used for the detection of patients at-risk for gestational diabetes mellitus. For this purpose the investigators will include a combination of new markers in a multiplex bio-array manner in conjunction with an early oral glucose tolerance test. A nested case-control proteomic analysis will be performed in a retrospective manner at the completion of this study in order to develop more specific biomarker panels.
The primary outcome will be development of gestational diabetes mellitus in the second or third trimester.
The secondary endpoints are the delivery outcome, neonatal morbidity, neonatal mortality, maternal morbidity and costs.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy singleton pregnancies
- •Women at least 18 years old and not under guardianship
排除标准
- •Maternal diseases like hypertension, diabetes mellitus and chronic disease, known infection like hepatitis or human immunodeficiency virus
- •Maternal history of hypertensive diseases in previous pregnancy and now under prophylactic acetylsalicylate treatment
- •Foetal genetic, chromosomal or intervention-requiring morphologic abnormalities
结局指标
主要结局
Development of Gestational Diabetes in second/third trimester
时间窗: 24-28 weeks of gestation
Development of gestational diabetes in 24-28 weeks of gestation by pathological values in oral glucose tolerance test 75g
次要结局
未报告次要终点