Effect of Early Lifestyle Intervention on Perinatal Outcomes in High-risk Women for Gestational Hyperglycemia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 604
- 试验地点
- 1
- 主要终点
- The incidence of gestational diabetes(GDM)
研究概览
简要总结
This study aims to explore whether early intervention for high-risk groups of gestational hyperglycemia can improve insulin resistance and effectively prevent the occurrence of GDM, and evaluate which pathophysiological subtypes of GDM have the best effect on improving maternal and fetal adverse prognosis, so as to provide evidence for stratified management and individualized clinical intervention of high glucose groups in pregnancy
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •18-55 years old
- •6-14 weeks of pregnancy
- •at least one risk factor for GDM
- •signed a written informed consent
排除标准
- •Individuals diagnosed with diabetes or prediabetes prior to pregnancy
- •currently taking medications affecting blood glucose levels such as metformin
- •women at risk of miscarriage
- •individuals with chronic conditions (such as uncontrolled hypertension, severe heart disease)
- •those with movement disorders or contraindicated conditions for physical activity
- •patients undergoing gastrointestinal surgeries that alter glucose absorption
- •those unable to maintain regular prenatal care (such as non-compliance with medical instructions or mental health issues).
结局指标
主要结局
The incidence of gestational diabetes(GDM)
时间窗: 24-28 weeks pregnant
The 75g 2h oral glucose tolerance test is performed at 24-28 weeks of gestation, and the cut-off points of venous blood glucose values are 5.1mmol/L (fasting), 10.0mmol/L (1h after glucose load), 8.5mmol/L (2h after glucose load). If any one of the three blood glucose measures is above the cut-off points, then GDM is diagnosed..
次要结局
未报告次要终点
研究者
Chen Xu
Professor
Tianjin Central Hospital of Gynecology Obstetrics