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

NCT ID: NCT04167423

Last Updated: 2022-05-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

253 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-14

Study Completion Date

2022-04-04

Brief Summary

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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

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Conditions

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Thyroid Diseases Pregnancy Related Quality of Life

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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 2014 European Thyroid Association Guideline.

No interventions assigned to this group

hyperthyroidism

Thyroid disease in pregnancy defined as plasma TSH, or FT4 out of the ranges proposed by 2014 European Thyroid Association Guideline.

No interventions assigned to this group

hypothyroidism

Thyroid disease in pregnancy defined as plasma TSH, or FT4 out of the ranges proposed by 2014 European Thyroid Association Guideline.

No interventions assigned to this group

thyroid autoimmunity

Thyroid disease in pregnancy defined as plasma TPOAb out of the ranges proposed by 2014 European Thyroid Association Guideline.

No interventions assigned to this group

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Charles University, Czech Republic

OTHER

Sponsor Role collaborator

Institute of Health Information and Statistics of the Czech Republic

OTHER_GOV

Sponsor Role collaborator

Value Outcomes Ltd.

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jan Tužil, MSc et Eng

Role: STUDY_DIRECTOR

Value Outcomes Ltd. et First Medical Faculty at Charles University, Prague

Tomáš Doležal, MD et PhD

Role: STUDY_CHAIR

Value Outcomes Ltd.

Jana Bartáková, Ing et PhD

Role: STUDY_CHAIR

Value Outcomes Ltd. et First Medical Faculty at Charles University, Prague

Locations

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MUDr. Milan Kučera. s.r.o.

Kladno, Czech Republic, Czechia

Site Status

MUDr. Eva Novotná - FEMCARE s.r.o.

Odolena Voda, Czech Republic, Czechia

Site Status

Mediva s.r.o.

Prague, Czech Republic, Czechia

Site Status

MUDr.Tereza Šmrhová-Kovács

Tábor, Czech Republic, Czechia

Site Status

Nemocnice Havlíčkův Brod

Havlíčkův Brod, , Czechia

Site Status

Všeobecná Fakultní Nemocnice

Prague, , Czechia

Site Status

Oblastní nemocnice Příbram, a.s.

Příbram, , Czechia

Site Status

Countries

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Czechia

References

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Tuzil J, Pilnackova BF, Watt T, Jiskra J, Koudelkova M, Novotna E, Tuzilova K, Dolezal T, Bartakova J. The Impact of Subclinical Hypothyroidism on the Quality of Life During Pregnancy: Mapping 5-Level Version of EQ-5D and ThyPRO-39. Value Health. 2023 Jul;26(7):1085-1097. doi: 10.1016/j.jval.2023.02.015. Epub 2023 Mar 5.

Reference Type DERIVED
PMID: 36878311 (View on PubMed)

Other Identifiers

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ThyPreQol2020

Identifier Type: -

Identifier Source: org_study_id

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