CTRI/2025/12/099631尚未招募不适用
Impact of intensified lifestyle modification during first trimester for women at risk in preventing Gestational diabetes mellitus - A randomized control trial
Dr Rajshree Ramlal Somani1 个研究点 分布在 1 个国家目标入组 616 人开始时间: 2026年1月1日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 616
- 试验地点
- 1
研究概览
简要总结
This study evaluates the impact of intensified lifestyle modification (individualized diet and exercise) started in the first trimester on the prevention of GDM among high-risk Indian pregnant women in a randomized controlled trial. Key outcomes are incidence of GDM, maternal and neonatal health metrics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •Pregnant women less than or equal to 12 weeks gestation, age 18 to 40 years, singleton pregnancy, at least one risk factor: maternal age more than 35, BMI more than or equal to 30, previous GDM, family history of diabetes, macrosomic baby.
排除标准
- •Pre-existing diabetes (Type 1 or 2), multifetal pregnancy, severe medical illness (cardiac, renal, liver), on steroids or metformin, substance abuse, physical disability, psychiatric disorder, unable to comply, language barrier, or history of mid trimester loss, PV bleed.
研究者
Dr Rajshree Ramlal Somani
Fernandez Hospital
研究点 (1)
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