Subject Enrollment and Specimen Collection Protocol to Validate the Performance of the Mellitus GCD59 ELISA for Gestational Diabetes Screening
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 19
- 主要终点
- Negative predictive value (NPV) and positive predictive value (PPV) of the Mellitus GCD59 ELISA for gestational diabetes mellitus screening
研究概览
简要总结
Demonstrate effective performance of the Mellitus GCD59 Test (an ELISA) in screening for gestational diabetes mellitus (GDM)
详细描述
Validate the performance of the Mellitus GCD59 ELISA as a screening test for GDM by evaluating its negative predictive value (NPV) and positive predictive value (PPV) to identify pregnant women at risk for GDM. Sensitivity and specificity of the Mellitus GCD59 ELISA will also be evaluated.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women 18 years of age or older at enrollment
- •Has an established viable singleton pregnancy
- •Is recommended for routine GDM screening between 24-28 weeks gestation
- •Has confirmed gestational age of 24-28 weeks at the Screening Visit
- •Is willing and able to provide documentation of informed consent
排除标准
- •Has diabetes before pregnancy or has already been diagnosed with GDM
- •Has contraindications for drinking oral glucose solution up to 100 g of sugar
- •Is taking metformin for any reason
- •Has any concomitant illness, disease or condition that, in the clinical judgment of the investigator, is likely to prevent the subject from complying with any aspect of the protocol, or that may put the subject at unacceptable risk
结局指标
主要结局
Negative predictive value (NPV) and positive predictive value (PPV) of the Mellitus GCD59 ELISA for gestational diabetes mellitus screening
时间窗: The 24-28th gestational week of singleton pregnancy
NPV and PPV will be based on two or more abnormal oral glucose tolerance test (OGTT) results (abnormal for OGTT as defined by Carpenter and Coustan diagnostic criteria)
次要结局
- NPV, PPV, sensitivity and specificity of the GCD59 ELISA for the risk of GDM using one or more abnormal OGTT results(The 24-28th gestational week of singleton pregnancy)
- Sensitivity and specificity of the GCD59 ELISA to that of glucose load test (GLT) using two or more abnormal oral glucose tolerance test (OGTT) results(The 24-28th gestational week of singleton pregnancy)
- Sensitivity and specificity of the Mellitus GCD59 ELISA for gestational diabetes mellitus screening, using two or more abnormal OGTT results (abnormal for OGTT as defined by Carpenter and Coustan diagnostic criteria)(The 24-28th gestational week of singleton pregnancy)