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

Completed

• Conditions: Thyroid Diseases; Quality of Life; Pregnancy Related

• Registration Number: NCT04167423
• Lead Sponsor: Value Outcomes Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-11-11
• Study First Submitted QC: 2019-11-15
• Study First Posted: 2019-11-18
• Study Start: 2020-01-14
• Status Verified: 2022-04
• Primary Completion: 2022-04-04
• Study Completion: 2022-04-04
• Last Update Submitted: 2022-05-06
• Last Update Posted: 2022-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 253

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (7)

Všeobecná Fakultní Nemocnice; 🇨🇿 Praha, Czechia

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

MUDr. Eva Novotná - FEMCARE s.r.o.; 🇨🇿 Odolena Voda, Czech Republic, Czechia

Nemocnice Havlíčkův Brod; 🇨🇿 Havlíčkův Brod, Czechia

MUDr.Tereza Šmrhová-Kovács; 🇨🇿 Tábor, Czech Republic, Czechia

Mediva s.r.o.; 🇨🇿 Prague, Czech Republic, Czechia

Oblastní nemocnice Příbram, a.s.; 🇨🇿 Příbram, Czechia