Diagnostic Efficiency Analysis of Oral Glucose Tolerance Test and Prediction Model Establishment in the First Trimester for Gestational Diabetes Mellitus: a Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 入组人数
- 781
- 试验地点
- 1
- 主要终点
- gestational diabetes mellitus
研究概览
简要总结
The aim of this study is to explore the diagnostic efficacy of oral glucose tolerance test in early pregnancy and establish the prediction model for gestational diabetes mellitus, so as to provide the optimal screening of gestational diabetes mellitus in the first trimester. The treatment started when the pregnancy was confirmed by transvaginal ultrasound (around 6 weeks of gestation) and continued until 42 days postpartum. The study is a single center, prospective cohort study. A total of 781 participants within 14 weeks of gestation were recruited.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Intrauterine pregnancy within 7-14 weeks of gestation
- •20-45 years of age
- •Singleton pregnancy
- •Giving informed consent and willing to participate in this study
- •Planning to give birth in Women's Hospital School of Medicine Zhejiang University
排除标准
- •Pre-existing diabetes
- •Taking medications that may affect blood glucose levels within one month
- •Participating in other intervention studies
- •Recurrent abortion, threatened abortion, cervical incompetence or fetal malformation
结局指标
主要结局
gestational diabetes mellitus
时间窗: 24-28 weeks of gestation
any of the fasting, 1-hour and 2-hour blood glucose ≥ 5.1, 10.0, 8.5 mmol/L, respectively, in the 75g oral glucose tolerance test during 24-28 weeks of gestation
次要结局
- gestational age at delivery(through study completion, an average of 39 gestational weeks)
- neonatal weight, height and head circumference(42 days after birth)
- gestational weight gain(before delivery)
- birthweight(within 24 hours after birth)