Serum Ferritin Concentration in early Pregnancy and risk of subsequent development of Gestational Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- If a strong association is proven between Serum Ferritin Assay in first trimester and risk of development of Gestational Diabetes Mellitus , then it can be used as a predictive marker for GDM
研究概览
简要总结
The study will be conducted in KH, Manipal. Ethical clearance will be obtained from IEC.
Eligible Pregnant women between 11-14weeks of gestation are recruited for OBG OPD during their routine antenatal check up or during their patient stay.
RBS> 200mg/dl or HbA1c > 6.5% was described as overt diabetic and patients with Pre-existing Type 1 or Type 2 and patients with increased Pre-conceptional BMI>26 are not eligible for the study.
Detailed description of the study procedure will be explained to them and the willing and eligible participants will be recruited after informed written consent.
In all pregnant women participating in the study the following will be done-
A) Thorough History Taking
B) BMI Calculation
C) Gestational Age determined on the last menstrual period confirmed by an early First Trimester Ultrasound Scan
Special Investigations-
A) First Trimester Ferritin Assay between 12-16weeks
B) Oral Glucose Tolerance Test between 24-28weeks of gestation after an overnight fast of greater than 8hours
All these patients will be followed up during second trimester and will undergo 75g OGTT between 24-28weeks of period of gestation.
The test will be done following an overnight fast of greater than 8hours with sampling at 1hour and 2hour post load.
Diagnostic criteria of GDM (IADPSG):
Fasting glucose > 92mg/dl
Post prandial 1hr > 180mg/dl
Post prandial 2 hr> 153mg/dl
One or more abnormal values from the 75g OGTT are diagnosed as GDM. Positively diagnosed GDM and negatively diagnosed GDM patient will be differentiated.
After the investigations we will determine the correlation between Serum Ferritin and Glucose Tolerance Test. According to the test, the pregnant women will lie in two different categories-
-
Normal Glucose Tolerance
-
Gestational Diabetes Mellitus
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)(—)
- 性别
- Female
入选标准
- •Singleton Pregnancy First Trimester Pregnant Women.
排除标准
- •Multiple Pregnancies Overt Diabetics Iron Deficiency on treatment Presence of any Hemoglobinopathies Acute/Chronic Inflammatory Conditions.
结局指标
主要结局
If a strong association is proven between Serum Ferritin Assay in first trimester and risk of development of Gestational Diabetes Mellitus , then it can be used as a predictive marker for GDM
时间窗: 24weeks of Gestation
次要结局
未报告次要终点
研究者
Dr Aditi Bharuka
Kasturba Medical College, Manipal
