Comparing the efficacy of First Trimester Fasting Blood Glucose versus IADPSG Criteria at 24 to 28 weeks in Diagnosis of Gestational Diabetes Mellitus- A One year Prospective Observational study at KAHERs Dr. Prabhakar Kore Hospital and Medical Research Centre, Belagavi.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 175
- 试验地点
- 1
- 主要终点
- To know the efficacy of Fasting blood glucose in First trimester and IADPSG Criteria in 24 to 28 weeks in diagnosis of Gestational Diabetes mellitus.
研究概览
简要总结
NEED FOR THE STUDY :
| International Association of Diabetes and Pregnancy Study Groups (IADPSG) criteria that is most widely used for diagnosing GDM recommends that GDM can be diagnosed in 24 to 28 weeks period of gestation if any of the values of fasting plasma glucose(FPG), 1-hour and 2-hour Plasma Glucose is equal to or above 92 mg/dl, 180 mg/dl or 153 mg/dl respectively. Fasting blood sugar measurement at the time of first booking will be useful to screen for previously undiagnosed pre-existing diabetes and also help to predict the development of Gestational diabetes mellitus earlier. |
The main need for study is to compare the first trimester Fasting blood glucose against IADPSG criteria in 24 to 28 weeks period of gestation for diagnosis of GDM and to determine the diagnostic accuracy of these methods.
STUDY PROTOCOL :
Subjects will be recruited according to the inclusion and exclusion criteria.
A detailed history with physical examination will be taken.
Participants in the study visiting antenatal OPD in their first trimester will be tested for Fasting blood glucose with overnight fast of atleast 8 hours.
If the Fasting blood glucose is < 92 mg/dl then they will be diagnosed as Non GDM.
If the Fasting blood glucose value is in between 92 to 125 mg/dl then they will be diagnosed as GDM.
If the Fasting Blood glucose value is >/= 126 mg/dl then they will be diagnosed with Overt Diabetes.
Participants who were diagnosed as Non GDM through the fasting blood glucose value < 92mg/dl during their first visit will be advised to follow up during 24 to 28 weeks period of gestation and will be repeated with 75g Oral glucose tolerance test( OGTT) according to IADPSG criteria after an overnight fast of atleast 8 hours. Venous blood sample was drawn at fasting, 1 hour and 2 hours after load with 75g of glucose.
According to IADPSG criteria GDM can be diagnosed if any one of the values of Fasting plasma glucose, 1- hour and 2- hour plasma glucose is equal to or above 92 mg/dl, 180 mg/dl and 153 mg/dl respectively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)(—)
- 性别
- Female
入选标准
- •Pregnant women above 18 years of age
- •Pregnant women till their 28 weeks period of Gestation.
排除标准
- •Pregnant women diagnosed with Pre Gestational Diabetes
- •Pregnant women on Corticosteroids.
结局指标
主要结局
To know the efficacy of Fasting blood glucose in First trimester and IADPSG Criteria in 24 to 28 weeks in diagnosis of Gestational Diabetes mellitus.
时间窗: till 28 weeks period of Gestation.
次要结局
- Feto Maternal Outcomes in Gestational Diabetes Mellitus(40 weeks)
研究者
Dr Chilukuri Anila Reddy
Jawaharlal Nehru Medical College, KLE University
