World Health Organisation (WHO) Versus International Association of Diabetes and Pregnancy Study Group (IADPSG) Diagnostic Criteria of Gestational Diabetes Mellitus and Their Associated Maternal and Neonatal Outcomes
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 506
- 试验地点
- 2
- 主要终点
- To measure the prevalence of GDM diagnosed using WHO versus IADPSG criteria
研究概览
简要总结
Aim for this study is to measure the prevalence of Gestational Diabetes Mellitus (GDM) using World Health Organisation (WHO) versus International Association of Diabetes in Pregnancy Study Group (IADPSG) criteria among pregnant mother in Universiti Kebangsaan Malaysia Medical Centre (UKMMC)
详细描述
It will then be used to measure the incidence of adverse maternal and neonatal outcomes in women diagnosed with GDM using either of the criteria.
Patients with risk factors for GDM will be recruited and randomised to either group once fulfilled the inclusion and exclusion criteria and agreed to join this study. Subjects will then undergo 75g oral glucose tolerance test and diagnosis will be established based on the group assigned.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Malaysian citizen and able to speak and understand Malay or English
- •Pregnant women with one or more risk factors for GDM between 14-37 gestational weeks
- •Singleton pregnancy
排除标准
- •Inability to complete OGTT
- •Women previously diagnosed with Type 2 and Type 1 DM
- •Pregnant women who refuse to participate
结局指标
主要结局
To measure the prevalence of GDM diagnosed using WHO versus IADPSG criteria
时间窗: 14-37weeks
Prevalence of GDM will be reported in percentage for both groups- WHO and IADPSG
次要结局
- To measure the incidence of adverse maternal outcomes in women diagnosed with GDM using either of the criteria (WHO or IADPSG)(14-37 weeks)
- To measure the incidence of adverse neonatal outcomes in women diagnosed with GDM using either of the criteria (WHO or IADPSG)(14-37 weeks)