Maternal TSH Level and TPOAb Status in Early Pregnancy and Their Relationship to the Risk of Gestational Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7,729
- 主要终点
- 75g oral glucose tolerance test (OGTT) positive or not
研究概览
简要总结
This study was conducted to analyze the role of TSH level and TPOAb status in early pregnancy and use this information in assessment of the risk of gestational diabetes mellitus at different weeks of gestation when the FT4 level is normal.
详细描述
A total of 7,729 women with singleton pregnancies who were receiving antenatal care at Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine between December 2012 and March 2014 were included in the study. All these women underwent screening for thyroid function (TSH,FT4 and TPOAb) at the first antenatal visit and a 75 g oral glucose tolerance test at 24-28 weeks of gestation. The correlation between a combination of TSH level and TPOAb status and the risk of gestational diabetes mellitus was analyzed.
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 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •≤19+6 weeks of gestation at the first antenatal visit;
- •singleton pregnancy;
- •FT4 level is within the normal range;
- •TSH level is normal or beyond the normal range.
排除标准
- •age <18 years or >40 years;
- •thyroid disease history before pregnancy, e.g. hyperthyroidism, clinical hypothyroidism and malignant tumors of the thyroid, regardless of medication treatment is needed or not;
- •twin or multiple gestations;
- •diagnosed with diabetes mellitus before pregnancy, or fasting blood-glucose level ≥ 7.0 mmol/L or HbA1C≥6.5% at the first antenatal visit;
- •diseases causing abnormal glycometabolism or severe co-morbidities or diseases causing abnormal glycometabolism.
结局指标
主要结局
75g oral glucose tolerance test (OGTT) positive or not
时间窗: 24-28 weeks
次要结局
未报告次要终点
研究者
Hao Ying
Director,Clinical research
Shanghai First Maternity and Infant Hospital