ThyPreQol2020: Mapping Health-related Quality of Life in Pregnant Women With Thyroid Disease.

• Sponsor: Value Outcomes Ltd. (Other)
• Overall Status: Completed
• CT.gov ID: NCT04167423
• Collaborator: Charles University, Czech Republic (Other), Institute of Health Information and Statistics of the Czech Republic (Other)
• Enrollment: 253
• Locations: 7
• Actual Duration (Months): 26.6
• Patients Per Site: 36.1
• Patients Per Site Per Month: 1.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Thyroid Diseases; Pregnancy Related; Quality of Life

Study Design

• Study Type: Observational
• Actual Enrollment: 253 participants
• Observational Model: Other
• Time Perspective: Cross-Sectional
• Official Title: Thyroid Disease in Pregnancy and Its Impact on the Quality of Life
• Actual Study Start Date: Jan 14, 2020
• Actual Primary Completion Date: Apr 4, 2022
• Actual Study Completion Date: Apr 4, 2022

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: Female

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	MUDr. Milan Kučera. s.r.o.	Kladno	Czech Republic	Czechia	27201
2	MUDr. Eva Novotná - FEMCARE s.r.o.	Odolena Voda	Czech Republic	Czechia	25070
3	Mediva s.r.o.	Prague	Czech Republic	Czechia	15500
4	MUDr.Tereza Šmrhová-Kovács	Tábor	Czech Republic	Czechia	39003
5	Nemocnice Havlíčkův Brod	Havlíčkův Brod		Czechia
6	Všeobecná Fakultní Nemocnice	Praha		Czechia
7	Oblastní nemocnice Příbram, a.s.	Příbram		Czechia	26101

Sponsors and Collaborators

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

Investigators

• Study Director: Jan Tužil, MSc et Eng, Value Outcomes Ltd. et First Medical Faculty at Charles University, Prague
• Study Chair: 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Value Outcomes Ltd.
• ClinicalTrials.gov Identifier: NCT04167423
• Other Study ID Numbers: ThyPreQol2020
• First Posted: Nov 18, 2019
• Last Update Posted: May 12, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Value Outcomes Ltd.: quality of life; EQ5D; ThyPRO-39; pregnancy; thyroid disease; thyrotropin; thyroxine; thyroid autoantibodies
• Additional relevant MeSH terms: Thyroid Diseases

Study Results

No Results Posted as of May 12, 2022