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临床试验/NCT05677581
NCT05677581招募中不适用

Longitudinal Study on the Influence of Iodine Nutrition Status on Thyroid Function of Childbearing Age Women During Pregnancy and 6 Weeks Postpartum

Beijing Friendship Hospital1 个研究点 分布在 1 个国家目标入组 2,100 人开始时间: 2023年11月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
2,100
试验地点
1
主要终点
Data of pregnant women in the third trimester of pregnancy

研究概览

简要总结

The goal of this observational study is to provide a reference for formulating individual appropriate iodine intake programs for women during pregnancy and postpartum and improving the monitoring and evaluation system of maternal iodine nutrition status. The main questions it aims to answer are:

  • To analyse the longitudinal changes of urinary iodine, urinary iodine/creatinine ratio, thyroid function and related factors in different periods of early, middle, late pregnancy and 6 weeks postpartum in Beijing area.
  • To explore the relationship between iodine nutrition status and the changes of thyroid function and to further clarify the effect of iodine nutrition status on thyroid function of women of childbearing age during pregnancy and postpartum in combination with dietary intake of iodine questionnaire.

Participants will be detected there thyroid function, the level of median urinary iodine and urinary iodine/creatinine.

Researchers will compare healthy women of childbearing age served as the control group in the same period.

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
是

入选标准

  • •primigravida
  • •no chronic hypertension, thromboembolic disease, severe gastrointestinal, cardiopulmonary and liver diseases before pregnancy
  • •no systemic lupus erythematosus, rheumatic diseases and other connective tissue diseases or immune diseases before pregnancy
  • •no adrenocortical hyperplasia, pituitary endocrine diseases and other diseases before pregnancy

排除标准

  • •multiple pregnancies and multigravida
  • •a history of type I or type II diabetes before pregnancy
  • •a clear history of thyroid diseases before pregnancy
  • •taking drugs that affect thyroid function and/or blood sugar before or during early pregnancy
  • •Healthy women of childbearing age:
  • •Inclusion Criteria:
  • •20-40 years old
  • •no chronic hypertension, thromboembolic disease, severe gastrointestinal, cardiopulmonary and liver diseases
  • •no systemic lupus erythematosus, rheumatic diseases and other connective tissue diseases or immune diseases
  • •no adrenocortical hyperplasia, pituitary endocrine diseases and other diseases
  • •Exclusion Criteria:
  • •a history of type I or type II diabetes
  • •a clear history of thyroid diseases
  • •taking drugs that affect thyroid function and/or blood sugar

结局指标

主要结局

Data of pregnant women in the third trimester of pregnancy

时间窗: Any day between weeks 36 of gestation to the day before parturition

detect the level of serum TSH, FT4, TPOAb, TGAb and the level of median urinary

Data of postpartum women

时间窗: 6 weeks after parturition

detect the level of serum TSH, FT4, TPOAb, TGAb and the level of median urinary

Data of pregnant women in the middle trimester of pregnancy

时间窗: Any day between weeks 24 and 28 of gestation

detect the level of serum TSH, FT4, TPOAb, TGAb and the level of median urinary

Data of pregnant women in the early trimester of pregnancy

时间窗: Any day between weeks 8 and 12 of gestation

detect the level of serum TSH, FT4, TPOAb, TGAb and the level of median urinary iodine and urinary iodine/creatinine

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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