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临床试验/CTRI/2018/05/013946
CTRI/2018/05/013946已完成不适用

Markers For Early Risk-Stratification Of Gestational Diabetes (MERGD)â€: A Prospective Cohort Study

Lata Medical Research Foundation1 个研究点 分布在 1 个国家目标入组 1,500 人开始时间: 2018年5月23日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
1,500
试验地点
1
主要终点
Quantify the burden of GD in central India

研究概览

简要总结

The pandemic of diabetes is increasing at an alarming rate worldwide. During pregnancy, there is heightened insulin resistance which leads to gestational diabetes (GD) which can revert to a normal state after delivery or continue as type 2 diabetes later in life. The prevalence of GD in Indian pregnant women has been reported to be very high (16%). GD is associated with several adverse outcomes for both the mother and the fetus. Early detection of GD forms a cornerstone of GD control. To that end, detection of serum or plasma biomarkers early during pregnancy is considered an important first step. However, given the wide array of biomarkers available that have varied accuracy of prediction, a cogent collection of the early markers of GD is still awaited, especially in India. The proposed work aims to bridge this knowledge gap and also provide an estimate of the prevalence of GD in central India. The proposed work will piggyback on the PRIME study, which is currently in the second year and will enroll a total of 3,000 pregnant women this year. Of these, we will enroll 1200-1500 pregnant women who will satisfy the inclusion and exclusion criteria. This study will exploit the enrolment opportunity provided by the PRIME study as well as the infrastructural capacity of the Lata Medical Research Foundation. It is expected that the proposed work will not only provide the research information but will also yield a rational approach to early detection and risk-stratification of pregnant women with regards to GD. The proposed work will also provide later opportunities for exciting genetic, epigenetic and other biomarker studies that are likely to provide interesting and novel insights into the pathogenesis of GD.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 50.00 Year(s)(—)
性别
Female

入选标准

  • 1.If the candidate woman has come to antenatal care before 20 weeks of gestation
  • Those who have consented.

排除标准

  • 1.If the candidate woman has come to antenatal care after 20 weeks of gestation
  • Those who have not consented.

结局指标

主要结局

Quantify the burden of GD in central India

时间窗: At the time of delivery

次要结局

  • biomarker-based incremental prediction of maternal and fetal outcomes over and beyond that based on clinical risk factors.(After 1 year)

研究者

申办方类型
Research institution

研究点 (1)

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