Mapping Health-related Quality of Life in Pregnant Women With Thyroid Disease.
NCT ID: NCT04167423
Last Updated: 2022-05-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
253 participants
OBSERVATIONAL
2020-01-14
2022-04-04
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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OTHER
CROSS_SECTIONAL
Study Groups
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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.
No interventions assigned to this group
hyperthyroidism
Thyroid disease in pregnancy defined as plasma TSH, or FT4 out of the ranges proposed by 2014 European Thyroid Association Guideline.
No interventions assigned to this group
hypothyroidism
Thyroid disease in pregnancy defined as plasma TSH, or FT4 out of the ranges proposed by 2014 European Thyroid Association Guideline.
No interventions assigned to this group
thyroid autoimmunity
Thyroid disease in pregnancy defined as plasma TPOAb out of the ranges proposed by 2014 European Thyroid Association Guideline.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* screened for laboratory signs of thyreopathy anytime during pregnancy
* willing/able to participate in online survey
Exclusion Criteria
* already participated in this survey by filling the online questionnaire
* not able to complete the entire questionnaire
FEMALE
No
Sponsors
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Charles University, Czech Republic
OTHER
Institute of Health Information and Statistics of the Czech Republic
OTHER_GOV
Value Outcomes Ltd.
OTHER
Responsible Party
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Principal Investigators
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Jan Tužil, MSc et Eng
Role: STUDY_DIRECTOR
Value Outcomes Ltd. et First Medical Faculty at Charles University, Prague
Tomáš Doležal, MD et PhD
Role: STUDY_CHAIR
Value Outcomes Ltd.
Jana Bartáková, Ing et PhD
Role: STUDY_CHAIR
Value Outcomes Ltd. et First Medical Faculty at Charles University, Prague
Locations
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MUDr. Milan Kučera. s.r.o.
Kladno, Czech Republic, Czechia
MUDr. Eva Novotná - FEMCARE s.r.o.
Odolena Voda, Czech Republic, Czechia
Mediva s.r.o.
Prague, Czech Republic, Czechia
MUDr.Tereza Šmrhová-Kovács
Tábor, Czech Republic, Czechia
Nemocnice Havlíčkův Brod
Havlíčkův Brod, , Czechia
Všeobecná Fakultní Nemocnice
Prague, , Czechia
Oblastní nemocnice Příbram, a.s.
Příbram, , Czechia
Countries
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References
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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.
Other Identifiers
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ThyPreQol2020
Identifier Type: -
Identifier Source: org_study_id
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