ThyPreQol2020: Mapping Health-related Quality of Life in Pregnant Women With Thyroid Disease.

Sponsor
Value Outcomes Ltd. (Other)
Overall Status
Completed
CT.gov ID
NCT04167423
Collaborator
Charles University, Czech Republic (Other), Institute of Health Information and Statistics of the Czech Republic (Other)
245
Enrollment
7
Locations
26.6
Actual Duration (Months)
35
Patients Per Site
1.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    245 participants
    Observational Model:
    Other
    Time Perspective:
    Cross-Sectional
    Official Title:
    Thyroid Disease in Pregnancy and Its Impact on the Quality of Life
    Actual Study Start Date :
    Jan 14, 2020
    Actual Primary Completion Date :
    Apr 4, 2022
    Actual Study Completion Date :
    Apr 4, 2022

    Arms and Interventions

    ArmIntervention/Treatment
    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 2017 American Thyroid Association Guideline.

    hyperthyroidism

    Thyroid disease in pregnancy defined as plasma TSH, or FT4 out of the ranges proposed by 2017 American Thyroid Association Guideline.

    hypothyroidism

    Thyroid disease in pregnancy defined as plasma TSH, or FT4 out of the ranges proposed by 2017 American Thyroid Association Guideline.

    thyroid autoimmunity

    Thyroid disease in pregnancy defined as plasma TPOAb out of the ranges proposed by 2017 American Thyroid Association Guideline.

    Outcome Measures

    Primary Outcome Measures

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

    Secondary Outcome Measures

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

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    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

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1MUDr. Milan Kučera. s.r.o.KladnoCzech RepublicCzechia27201
    2MUDr. Eva Novotná - FEMCARE s.r.o.Odolena VodaCzech RepublicCzechia25070
    3Mediva s.r.o.PragueCzech RepublicCzechia15500
    4MUDr.Tereza Šmrhová-KovácsTáborCzech RepublicCzechia39003
    5Nemocnice Havlíčkův BrodHavlíčkův BrodCzechia
    6Všeobecná Fakultní NemocnicePrahaCzechia
    7Oblastní nemocnice Příbram, a.s.PříbramCzechia26101

    Sponsors and Collaborators

    • Value Outcomes Ltd.
    • Charles University, Czech Republic
    • Institute of Health Information and Statistics of the Czech Republic

    Investigators

    • Study Director: Jan Tužil, MSc et Eng, Value Outcomes Ltd. et First Medical Faculty at Charles University, Prague
    • Study Chair: 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 Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Value Outcomes Ltd.
    ClinicalTrials.gov Identifier:
    NCT04167423
    Other Study ID Numbers:
    • ThyPreQol2020
    First Posted:
    Nov 18, 2019
    Last Update Posted:
    Apr 6, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Value Outcomes Ltd.
    quality of life
    EQ5D
    ThyPRO-39
    pregnancy
    thyroid disease
    thyrotropin
    thyroxine
    thyroid autoantibodies
    Additional relevant MeSH terms:
    Thyroid Diseases

    Study Results

    No Results Posted as of Apr 6, 2022