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临床试验/NCT04936698
NCT04936698Unknown不适用

The Prevalence and Risk Factors for Thyroid Dysfunction in Pregnant Women in Taiwan

Chang Gung Memorial Hospital1 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2021年7月16日最近更新:
适应症
干预措施
相关药物

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
The prevalence thyroid dysfunction

研究概览

简要总结

The investigators' aim is to enroll around 2000 patients from Taipei, Keelung, Linkou, Chiayi and Kaohsiung CGMH. All participants will receive universal thyroid function screening at 1st trimester, and those who was found to have hyperthyroidism or hypothyroidism will be referred to Endocrine department for further treatment. All participants will be followed at outpatient clinic, and their obstetric visit finding will be recorded. The maternal and neonatal outcomes will be 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 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Pregnant women at first trimester (< 14 weeks of gestational age)

排除标准

  • 未提供

研究组 & 干预措施

Hyperthyroidism

Elevated fT4, low TSH

干预措施: PTU 50 MG Oral Tablet (Drug)

Hypothyroidism

Elevated TSH, low fT4

干预措施: Levothyroxin (Drug)

结局指标

主要结局

The prevalence thyroid dysfunction

时间窗: 40 weeks

Hypothyroidism: defined as serum TSH \> 2.5U/mL and decreased fT4\*; Hyperthyroidism: defined as fT4 \> normal range\* and TSH undetectable \* Serum free T4 range varies according to trimesters.

次要结局

未报告次要终点

研究者

发起方
Chang Gung Memorial Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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