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临床试验/NCT02966405
NCT02966405Unknown不适用

The Establish of Trimester-specific Reference Ranges for Thyroid Tests in Pregnant Women and the Influence of Thyroid Disorders on Pregnancy and Its Outcomes.

Xiaomei Zhang1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2016年12月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
1,000
试验地点
1
主要终点
Detection the FT3,FT4,TSH,TPOAb of the pregnant women in trimester of pregnancy.

研究概览

简要总结

A descriptive analysis involving 300 healthy pregnant women to the establish of trimester-specific reference ranges for thyroid tests in pregnant women. 700 cases were selected as the normal pregnant population to establish a self-sequential longitudinal reference range.

详细描述

A descriptive analysis involving 300 healthy pregnant women according NACB to the establish of trimester-specific reference ranges for thyroid tests in pregnant women. According to the selection criteria, 700 cases were selected as the normal pregnant population to establish a self-sequential longitudinal reference range. The aim of this study to monitor the change of thyroid function and antibody during the course of pregnancy in those who suffer from various thyroid disorders and normal control.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
19 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • The people who lived in the city more than five years, aged between 19 and 45, or the single pregnancy women who registered or checked in Peking University international hospital would be enrolled.
  • The pregnancy confirmed by the ultrasound or blood HCG test.
  • In order to build a pregnancy reference range of normal pregnant women who must meet the NACB standard.

排除标准

  • The history of thyroid disorders.
  • Oral contraceptives or any drugs affected the function of thyroid.
  • With other chronic autoimmune disease, malignant tumor, blood disease, etc
  • Twin pregnancies and multiple pregnancies

结局指标

主要结局

Detection the FT3,FT4,TSH,TPOAb of the pregnant women in trimester of pregnancy.

时间窗: up to 2 years

Detection the FT3,FT4,TSH,TPOAb of the pregnant women in trimester of pregnancy.

次要结局

  • The influence of thyroid disorders its outcomes.(up to 2 years)
  • The influence of thyroid disorders on pregnancy.(up to 2 years)

研究者

发起方
Xiaomei Zhang
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Xiaomei Zhang

Director

Peking University International Hospital

研究点 (1)

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