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

Quality of Life Clinical Trial

— ThyPreQol2020  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04167423
• Other study ID #: ThyPreQol2020
• Status: Completed
• Start date: January 14, 2020
• Est. completion date: April 4, 2022

Study information

• Verified date: April 2022
• Source: Value Outcomes Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 253
• Est. completion date: April 4, 2022
• Est. primary completion date: April 4, 2022
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Pregnancy Related
• Quality of Life
• Thyroid Diseases

Locations

Country	Name	City	State
Czechia	Nemocnice Havlíckuv Brod	Havlíckuv Brod
Czechia	MUDr. Milan Kucera. 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	Všeobecná Fakultní Nemocnice	Praha
Czechia	Oblastní nemocnice Príbram, a.s.	Príbram
Czechia	MUDr.Tereza Šmrhová-Kovács	Tábor	Czech Republic

Sponsors (3)

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

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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