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临床试验/NCT04167423
NCT04167423已完成不适用

Thyroid Disease in Pregnancy and Its Impact on the Quality of Life

Value Outcomes Ltd.7 个研究点 分布在 1 个国家目标入组 253 人开始时间: 2020年1月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
253
试验地点
7
主要终点
Utility by five-dimensional five-level generic EuroQoL questionnaire (EQ5D 5L)

研究概览

简要总结

Natural thyroid function changes during pregnancy. In up to tens of percent of pregnant women, these changes can lead to pathological fluctuations in hormone and antibody production. Although the effects on pregnancy and child development are well described, none has determined their influence on mother's emotional well-being and the quality of life.

At present, universal thyroid screening in pregnancy in the Czech Republic is not covered by health insurance. The aim of the project is to change this situation by providing quality of life estimate for the cost-effectiveness model.

This is a project of three specialized institutions aimed at mapping various aspects of the quality of life of pregnant women and describing the impact of thyroid disease on their lives. The project is a parallel study to a larger project Early screening for thyreopathy in pregnancy (CZ.03.2.63/0.0/0.0/15_039/0009643) supported by the European Fund Operational Programme Employment through the National screening centre. The data will be collected through online questionnaire from women enrolled in the Early screening for thyreopathy in pregnancy (CZ.03.2.63/0.0/0.0/15_039/0009643) who were screened for TSH, TPOAb and FT4.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

性别
Female
接受健康志愿者

入选标准

  • pregnant women
  • screened for laboratory signs of thyreopathy anytime during pregnancy
  • willing/able to participate in online survey

排除标准

  • women whose laboratory results were not available or inconclusive
  • already participated in this survey by filling the online questionnaire
  • not able to complete the entire questionnaire

结局指标

主要结局

Utility by five-dimensional five-level generic EuroQoL questionnaire (EQ5D 5L)

时间窗: Immediately after the reception of laboratory results

Health-related quality of life measured as EQ5D 5L questionnaire, score 1 is the best and -0,594 the worst

次要结局

  • Thyroid-Related Quality-of-Life Patient-Reported Outcome questionnaire short form (ThyPRO-39)(Immediately after the reception of laboratory results)

研究者

发起方
Value Outcomes Ltd.
申办方类型
Other
责任方
Sponsor

研究点 (7)

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