Development of a Bio marker based test for Prediction of Gestational Diabetes Mellitus(GDM) and Preterm birth (PTB)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- Determine ability and predictive value of biomarkers or combination of biomarkers to predict GDM and PTB early in first/second trimester vs GTT based diagnosis.
研究概览
简要总结
We plan to recruit ~300 pregnant women in early pregnancy and 50 healthy control women. Clinically confirmed pregnant women (by urine pregnancy test and/or by ultrasound scan) in 1st trimester of pregnancy (women maximum up to 3rd pregnancy), HIV negative, attending OPD of Cloudnine Care hospitals, Bangalore. Investigation methods, study protocols and patient consent forms have been approved by hospital ethics committee/IRB prior to beginning of study and enrolling the patients.
Urine and blood samples will be collected at monthly intervals along with their complete medical check up and follow-ups throughout the pregnancy. GTT will be done at 24-28 week of pregnancy. The clinical samples will be tested for presence of biomarkers in validated tests/kit mentioned above. A correlation of biomarker data with GTT, BMI, obesity, GDM, clinical outcomes, preterm births (PTB), and post natal consequences will be analysed by using appropriate statistical tools. The predictive value of the proposed biomarkers/combinations to predict GDM and propensity to preterm birth will be determined.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •Recruit women >18-40 years with clinically confirmed pregnancy, status healthy, no chronic disorder, HIV negative, no diabetes at enrollment and number of pregnancy <
- •Recruitment up to max of 12 weeks of pregnancy.
- •Recruit only those who commit to stay till delivery (stable population).
排除标准
- •Women <18 years or >40 years, HIV positives & Preexisting history of diabetes.
- •Those deliver outside will be excluded.
结局指标
主要结局
Determine ability and predictive value of biomarkers or combination of biomarkers to predict GDM and PTB early in first/second trimester vs GTT based diagnosis.
时间窗: Outcome name: Biomarker signatures Time points : 9 months/ at the end of pregnancy
次要结局
- Develop a diagnostic kit of biomarkers suitable for hospitals & point of care (POC) testing for field settings.(Outcome name : correlation of biomarkers with GTM Time points : 12 months.)