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临床试验/NCT03120221
NCT03120221Unknown不适用

Iodine Status in Pregnant Women in Israel

Clalit Health Services2 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2017年7月4日最近更新:
适应症

试验速览

阶段
不适用
入组人数
160
试验地点
2
主要终点
Evaluation of average iodine consumption in food

研究概览

简要总结

Worldwide Data suggest that Iodine deficiency is a concern among healthy pregnant women. Thus, screening first trimester healthy pregnant women for iodine status is of clinical value for mother and child as iodine deficiency might have implications on thyroid function as well as pregnancy outcomes

详细描述

New emerging data suggest pregnant women in Israel are iodine deficient in the first trimester of pregnancy. This is of major concern as first trimester iodine sufficiency is critical for the development of the fetal brain. Our aim is to evaluate iodine consumption in first trimester pregnant women in Israel through dietary questioners, Urinary iodine samples and thyroid functions test assessed through blood samples. All data will be analyzed in a central lab.

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
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • First trimester pregnant women with a singleton pregnancy

排除标准

  • Women with a known thyroid disease treated or untreated
  • Women who received contrast material in the year previous to the study
  • women with any chronic disease
  • Women who receive chronic medication not including vitamins

结局指标

主要结局

Evaluation of average iodine consumption in food

时间窗: 1 year

Iodine consumption will be evaluated trough detailed food questionnaires. Data will be quantified and reported in micrograms per day

Evaluation of urinary iodine concentration

时间窗: 1 year

Women will give a spot urine sample for urinary iodine concentration measurement. All data will be analyzed and reported in micrograms/L. Data obtained will be compared to World Health Organization requirements

Thyroid function test measurement

时间窗: 1 year

Thyroid function will be evaluated through blood tests in the first trimester of pregnancy. Data will be analyzed in accordance with local guidelines.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Viviana Ostrovsky

Principal Investigator, Senior Physician, Endocrinology Department

Clalit Health Services

研究点 (2)

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