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临床试验/CTRI/2024/06/069153
CTRI/2024/06/069153尚未招募不适用

Serum Ferritin Concentration in early Pregnancy and risk of subsequent development of Gestational Diabetes Mellitus

Kasturba Medical College Manipal1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2024年6月29日最近更新:

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-

  1. Normal Glucose Tolerance

  2. 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

申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Aditi Bharuka

Kasturba Medical College, Manipal

研究点 (1)

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