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临床试验/NCT05212519
NCT05212519Unknown不适用

Correlation of Vitamin D Levels in Early Pregnancy With Gestational Diabetes and Pregnancy Outcomes

Min Shang1 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2022年1月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
2,000
试验地点
1
主要终点
Whether suffering from gestational diabetes

研究概览

简要总结

Explore the specific correlation between different concentration levels of vitamin D in early pregnancy and blood glucose levels at each time node of OGTT, the correlation between different concentrations of vitamin D levels and A1 and A2 diabetes in pregnancy, and the impact on maternal and infant outcomes , And provide a basis for the prevention and treatment of GDM.

详细描述

  1. According to the diagnostic criteria of GDM proposed by the International Association for the Study of Diabetes and Pregnancy (IADPSG), the 18-45-year-old pregnant women who were filed and delivered by the Obstetrics Department of Beijing Friendship Hospital from September 2022 to September 2024 were selected to collect their early pregnancy (pregnancy 1- 3 months) Vitamin d level, divided into three groups: A (<20 ng/ml), B (20~<30 ng/ml), and C (≥30 ng/ml), compare the early pregnancy (1-3 months of pregnancy) Differences in vitamin D levels.
  2. Follow-up patients with gestational diabetes mellitus are divided into type A1 gestational diabetes patients (GDM 1 group) and type A2 gestational diabetes patients (GDM 2 group) according to whether participant are treated with insulin, and study vitamins through multiple linear and logistic regression models The relationship between D level and GDM and follow-up pregnancy outcome
  3. Analyze the relationship between the level of vitamin D in early pregnancy and pregnancy complications, such as whether it is combined with premature rupture of membranes, hypertension during pregnancy, whether it is a cesarean section, whether it is a giant baby, whether there is asphyxia in newborns, etc.

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
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Pregnant women aged 18 to 45 years who have received regular antenatal examinations and delivered in the department of obstetrics in Beijing Friendship Hospital, Capital Medical University.

排除标准

  • (1) chronic or acute disease history (diabetes mellitus, hypertension,or thyroid disease); (2) any mental disorder; (3) abortion (fetal loss before 28 gestational weeks); (4)multiple fetuses; (5) planning to give birth in other hospitals.

结局指标

主要结局

Whether suffering from gestational diabetes

时间窗: 2022-1-1to2024-1-1

Low vitamin D levels are more likely to develop diabetes

次要结局

未报告次要终点

研究者

发起方
Min Shang
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Min Shang

Chief Physician, Department of Obstetrics and Gynecology, Beijing Friendship Hospital

Beijing Friendship Hospital

研究点 (1)

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