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Completed

NCT Number: NCT04167423

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

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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Key information

Sex eligibility

Female

Study type

Observational

Primary location

MUDr. Milan Kučera. s.r.o., Kladno, Czech Republic, Czechia

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Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: 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 outcomes

  1. Thyroid-Related Quality-of-Life Patient-Reported Outcome questionnaire short form (ThyPRO-39)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Value Outcomes Ltd.

Other

Collaborators

  • Charles University, Czech Republic
  • Institute of Health Information and Statistics of the Czech Republic

Registry information

Official study title

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

Acronym: ThyPreQol2020

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Nov 18, 2019
Registry last updated
May 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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