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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04167423
Acronym
ThyPreQol2020
Enrollment
253
Registered
2019-11-18
Start date
2020-01-14
Completion date
2022-04-04
Last updated
2022-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy Related, Quality of Life, Thyroid Diseases

Keywords

quality of life, EQ5D, ThyPRO-39, pregnancy, thyroid disease, thyrotropin, thyroxine, thyroid autoantibodies

Brief summary

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.

Interventions

None listed

Sponsors

Charles University, Czech Republic
CollaboratorOTHER
Institute of Health Information and Statistics of the Czech Republic
CollaboratorOTHER_GOV
Value Outcomes Ltd.
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE

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

Design outcomes

Primary

MeasureTime frameDescription
Utility by five-dimensional five-level generic EuroQoL questionnaire (EQ5D 5L)Immediately after the reception of laboratory resultsHealth-related quality of life measured as EQ5D 5L questionnaire, score 1 is the best and -0,594 the worst

Secondary

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

Countries

Czechia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026