Establishment of Gestational Weight Gain Criteria for Pregnant Women With Gestational Diabetes Mellitus in China: a Multicenter Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10,000
- 试验地点
- 1
- 主要终点
- Maternal outcomes
研究概览
简要总结
Appropriate gestational weight gain (GWG) is a key factor in balancing maternal and neonatal needs of nourishment and health, which is especially important in women with gestational diabetes mellitus (GDM). However, there are no specific guidelines for GWG in Chinese pregnant women and even for GDM pregnant women.This project intends to fill in the gaps of this field through multi-center large sample prospective cohort study.
详细描述
Inappropriate gestational weight gain (GWG) is an important risk factor affecting adverse pregnancy outcomes. However, the current guidelines for GWG are based on American population and may not apply to pregnant women in China, especially for those with gestational diabetes mellitus (GDM) who have high risk factors. The big gaps in academic-related fields need to be filled.
Our research group has previously found the heterogeneous relationships between GWG and adverse outcomes in GDM women with different abnormal glucose metabolism. Therefore, based on the principles of precision medicine, this project intends to establish for the first time the GWG standard for Chinese pregnant women to optimize the GWG management through a multicenter prospective cohort study. At the same time, specific GWG guidelines applicable to GDM women with different glucose metabolism abnormalities were innovatively constructed. Our study will provide strong evidence for stratified management and precise intervention of GDM pregnant women, which is of great significance to ensure health of both mothers and their offspring.
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 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Maternal age: 20-49 years;
- •Natural conception;
- •Single pregnancy;
- •Plan to have routine prenatal examinations and give birth in the research center;
- •No plan to move within two years;
- •No second pregnancy within two years;
- •Willing to cooperate with the hospital to follow up after childbirth.
排除标准
- •Have diseases that affect metabolic function or even threaten the life of the mother and fetus before pregnancy, such as diabetes, hypertension, heart disease, liver and kidney diseases, thyroid diseases, autoimmune diseases, malignant tumors, AIDS, etc.;
- •Assisted reproduction;
- •Multiple pregnancy;
- •Fetus has a known deformity or genetic defects;
- •Incomplete clinical data.
结局指标
主要结局
Maternal outcomes
时间窗: Through delivery completion, up to 40 weeks
Including pregnancy-induced hypertension, preterm delivery, abortion, delivery way and so on. They are diagnosed by clinicians and the data is gathered from medical records.
Neonatal outcomes
时间窗: Through delivery completion, up to 40 weeks
Birth weight（in gram), birth height (in centimetre), gestational week (in week) and so on. They are diagnosed by clinicians and the data is gathered from medical records.
次要结局
- glucose metabolism index(postpartum 42 days)
- offspring(postpartum 42 days)
- annual follow-up results(1 or 2 years after delivery)