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

NCT04167423 | Completed

• 1 other identifier: ThyPreQol2020
• Study Type: observational
• Target: 253
• Locations: 1 country
• Sites: 7

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.

Conditions

Thyroid Diseases; Pregnancy Related; Quality of Life

Keywords

quality of life; EQ5D; ThyPRO-39; pregnancy; thyroid disease; thyrotropin; thyroxine; thyroid autoantibodies

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  Immediately after the reception of laboratory results

Study Arms (4)

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.

hyperthyroidism

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

hypothyroidism

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

thyroid autoimmunity

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

Eligibility Criteria

• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• pregnant women
• screened for laboratory signs of thyreopathy anytime during pregnancy
• willing/able to participate in online survey

You may not qualify if:

• 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

Sponsors & Collaborators

• Value Outcomes Ltd.: lead
• Charles University, Czech Republic: collaborator
• Institute of Health Information and Statistics of the Czech Republic: collaborator

Study Sites (7)

MUDr. Milan Kučera. s.r.o.

Kladno, Czech Republic, 27201, Czechia

Location

MUDr. Eva Novotná - FEMCARE s.r.o.

Odolena Voda, Czech Republic, 25070, Czechia

Location

Mediva s.r.o.

Prague, Czech Republic, 15500, Czechia

Location

MUDr.Tereza Šmrhová-Kovács

Tábor, Czech Republic, 39003, Czechia

Location

Nemocnice Havlíčkův Brod

Havlíčkův Brod, Czechia

Location

Všeobecná Fakultní Nemocnice

Prague, Czechia

Location

Oblastní nemocnice Příbram, a.s.

Příbram, 26101, Czechia

Location

Related Publications (1)

• 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.

  PMID: 36878311 DERIVED

MeSH Terms

Conditions

Thyroid Diseases

Condition Hierarchy (Ancestors)

Endocrine System Diseases

Study Officials

• Jan Tužil, MSc et Eng

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

  STUDY DIRECTOR

• Tomáš Doležal, MD et PhD

  Value Outcomes Ltd.

  STUDY CHAIR

• Jana Bartáková, Ing et PhD

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

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2019
• First Posted: November 18, 2019
• Study Start: January 14, 2020
• Primary Completion: April 4, 2022
• Study Completion: April 4, 2022
• Last Updated: May 12, 2022

Record last verified: 2022-04

Locations

CZ (7)