Mapping Health-related Quality of Life in Pregnant Women With Thyroid Disease.

Study Overview
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Brief Summary
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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.

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

Conditions
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Thyroid Diseases, Pregnancy Related, Quality of Life

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: pregnant women screened for laboratory signs of thyreopathy anytime during pregnancy willing/able to participate in online survey Exclusion Criteria: 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
Sexes Eligible for Study
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Female

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy<br>No thyroid disease in pregnancy defined as plasma TSH (thyrotropin), TPOAb (thyroperoxidase auto antibodies) or FT4 (free thyroxin) out of the ranges proposed by 2014 European Thyroid Association Guideline. | |
| hyperthyroidism<br>Thyroid disease in pregnancy defined as plasma TSH, or FT4 out of the ranges proposed by 2014 European Thyroid Association Guideline. | |
| hypothyroidism<br>Thyroid disease in pregnancy defined as plasma TSH, or FT4 out of the ranges proposed by 2014 European Thyroid Association Guideline. | |
| thyroid autoimmunity<br>Thyroid disease in pregnancy defined as plasma TPOAb out of the ranges proposed by 2014 European Thyroid Association Guideline. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Utility by five-dimensional five-level generic EuroQoL questionnaire (EQ5D 5L) | Health-related quality of life measured as EQ5D 5L questionnaire, score 1 is the best and -0,594 the worst | Immediately after the reception of laboratory results | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thyroid-Related Quality-of-Life Patient-Reported Outcome questionnaire short form (ThyPRO-39) | Health-related quality of life measured as ThyPRO-39 questionnaire, each domain scores between 0 and 100. The higher the score the worse the symptoms. | Immediately after the reception of laboratory results | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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quality of life, EQ5D, ThyPRO-39, pregnancy, thyroid disease, thyrotropin, thyroxine, thyroid autoantibodies