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| Name | Class |
|---|---|
| Charles University, Czech Republic | OTHER |
| Institute of Health Information and Statistics of the Czech Republic | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy | 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 | Thyroid disease in pregnancy defined as plasma TSH, or FT4 out of the ranges proposed by 2014 European Thyroid Association Guideline. | ||
| hypothyroidism | Thyroid disease in pregnancy defined as plasma TSH, or FT4 out of the ranges proposed by 2014 European Thyroid Association Guideline. | ||
| thyroid autoimmunity | Thyroid disease in pregnancy defined as plasma TPOAb out of the ranges proposed by 2014 European Thyroid Association Guideline. |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Pregnant women who were screened for laboratory signs of thyreopathy during pregnancy.
All screened women attending the study center will be proposed to participate.
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| Name | Affiliation | Role |
|---|---|---|
| Jan Tužil, MSc et Eng | Value Outcomes Ltd. et First Medical Faculty at Charles University, Prague | Study Director |
| Tomáš Doležal, MD et PhD | Value Outcomes Ltd. | Study Chair |
| Jana Bartáková, Ing et PhD | Value Outcomes Ltd. et First Medical Faculty at Charles University, Prague | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MUDr. Milan Kučera. s.r.o. | Kladno | Czech Republic | 27201 | Czechia | ||
| MUDr. Eva Novotná - FEMCARE s.r.o. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36878311 | Derived | Tuzil J, Pilnackova BF, Watt T, Jiskra J, Koudelkova M, Novotna E, Tuzilova K, Dolezal T, Bartakova J. The Impact of Subclinical Hypothyroidism on the Quality of Life During Pregnancy: Mapping 5-Level Version of EQ-5D and ThyPRO-39. Value Health. 2023 Jul;26(7):1085-1097. doi: 10.1016/j.jval.2023.02.015. Epub 2023 Mar 5. |
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| ID | Term |
|---|---|
| D013959 | Thyroid Diseases |
| ID | Term |
|---|---|
| D004700 | Endocrine System Diseases |
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| Odolena Voda |
| Czech Republic |
| 25070 |
| Czechia |
| Mediva s.r.o. | Prague | Czech Republic | 15500 | Czechia |
| MUDr.Tereza Šmrhová-Kovács | Tábor | Czech Republic | 39003 | Czechia |
| Nemocnice Havlíčkův Brod | Havlíčkův Brod | Czechia |
| Všeobecná Fakultní Nemocnice | Prague | Czechia |
| Oblastní nemocnice Příbram, a.s. | Příbram | 26101 | Czechia |