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临床试验/NCT03761602
NCT03761602Unknown不适用

The Correlation Between Iodine and Selenium Status in Pregnancy and Risk of Thyroid Disease: a Prospective Registry Study

Rongrong Li0 个研究点目标入组 290 人开始时间: 2018年12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
290
主要终点
pregnancy outcomes

研究概览

简要总结

Two hundred and ninety pregnant women with gestational age less than 20 weeks will be recruited in this study. Selenium and iodine conditions, and risk of thyroid disease will be monitored until termination of pregnancy, with pregnancy outcomes recorded.

详细描述

The study will recruit 290 pregnant women with gestational age less than 20 weeks. Iodine and selenium condition will be evaluated through dietary recall (on base of Chinese food ingredient information) and biochemical examinations (serum iodine concentrations, urinary iodine concentrations, serum selenium concentrations, etc). The nutritional status of iodine and selenium will be monitored and followed up for all the included subjects throughout the pregnancy. The information of thyroid function and level of anti-TPO and anti-TG will be collected. And all the complications (especially thyroid disease) in pregnancy will also be recorded. All pregnant women will be followed up until the termination of pregnancy, with pregnancy outcomes recorded.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
Female
接受健康志愿者

入选标准

  • Clinical confirmation of being pregnant.
  • Being within less than 20 weeks of gestationa.

排除标准

  • Being pregnant but over 20 weeks of gestationa.
  • Mentally or psychologically unstable.

结局指标

主要结局

pregnancy outcomes

时间窗: From date of participant inclusion until the date of termination of pregnancy, assessed up to 8 months

prevalence of premature birth, stillbirth and abortion

risk of thyroid disease

时间窗: From date of participant inclusion until the date of termination of pregnancy, assessed up to 8 months

prevalence of thyroid disease (abnormal thyroid function; development of thyroid antibodies)

次要结局

  • prevalence of other pregnant complications(From date of participant inclusion until the date of termination of pregnancy, assessed up to 8 months)
  • prevalence of thyroid disease in neonates(From date of birth to 4 weeks after birth)

研究者

发起方
Rongrong Li
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Rongrong Li

Nutrition physician

Peking Union Medical College Hospital

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