Clinical trial NCT04167423: Mapping Health-related Quality of Life in Pregnant Women With Thyroid Disease.
Official title: Thyroid Disease in Pregnancy and Its Impact on the Quality of Life
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thyroid Diseases
Pregnancy Related
Quality of Life
Keywords: quality of life
EQ5D
ThyPRO-39
pregnancy
thyroid disease
thyrotropin
thyroxine
thyroid autoantibodies
Lead sponsor: Value Outcomes Ltd.
Sponsor class: OTHER
Collaborators: name: Charles University, Czech Republic
name: Institute of Health Information and Statistics of the Czech Republic
First posted: 2019-11-18
Enrollment: 253
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women who were screened for laboratory signs of thyreopathy during pregnancy.

All screened women attending the study center will be proposed to participate.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Utility by five-dimensional five-level generic EuroQoL questionnaire (EQ5D 5L)
timeFrame: Immediately after the reception of laboratory results
Secondary outcomes:
measure: Thyroid-Related Quality-of-Life Patient-Reported Outcome questionnaire short form (ThyPRO-39)
timeFrame: Immediately after the reception of laboratory results
Other outcomes:
Locations:
city: Kladno
country: Czechia
facility: MUDr. Milan Kučera. s.r.o.
state: Czech Republic
city: Odolena Voda
country: Czechia
facility: MUDr. Eva Novotná - FEMCARE s.r.o.
state: Czech Republic
city: Prague
country: Czechia
facility: Mediva s.r.o.
state: Czech Republic
city: Tábor
country: Czechia
facility: MUDr.Tereza Šmrhová-Kovács
state: Czech Republic
city: Havlíčkův Brod
country: Czechia
facility: Nemocnice Havlíčkův Brod
city: Praha
country: Czechia
facility: Všeobecná Fakultní Nemocnice
city: Příbram
country: Czechia
facility: Oblastní nemocnice Příbram, a.s.
Study officials:
affiliation: Value Outcomes Ltd. et First Medical Faculty at Charles University, Prague
name: Jan Tužil, MSc et Eng
role: STUDY_DIRECTOR
affiliation: Value Outcomes Ltd.
name: Tomáš Doležal, MD et PhD
role: STUDY_CHAIR
affiliation: Value Outcomes Ltd. et First Medical Faculty at Charles University, Prague
name: Jana Bartáková, Ing et PhD
role: STUDY_CHAIR
References: