Thyroid DiseasesThyPreQol2020NCT04167423
Mapping Health-related Quality of Life in Pregnant Women With Thyroid Disease.
An observational study of Thyroid Diseases and Pregnancy Related, run by Value Outcomes Ltd. at 7 sites in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Thyroid Diseases, Pregnancy Related, Quality of Life
- How many people
- 253 participants
- Where
- 7 sitesCzechia
- Study dates
- 14 Jan 2020to 4 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Child, Adult, Older adult
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.
Who may be able to join
- pregnant women
- screened for laboratory signs of thyreopathy anytime during pregnancy
- willing/able to participate in online survey
Who cannot join
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Czechia7 sites
Nemocnice Havlíčkův Brod
Havlíčkův Brod
MUDr. Milan Kučera. s.r.o.
Kladno, Czech Republic, 27201
MUDr. Eva Novotná - FEMCARE s.r.o.
Odolena Voda, Czech Republic, 25070
Mediva s.r.o.
Prague, Czech Republic, 15500
Všeobecná Fakultní Nemocnice
Prague
Oblastní nemocnice Příbram, a.s.
Příbram, 26101
MUDr.Tereza Šmrhová-Kovács
Tábor, Czech Republic, 39003
About this study
Official title: Thyroid Disease in Pregnancy and Its Impact on the Quality of Life
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
- Medical subject headings
- Thyroid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Immediately after the reception of laboratory results
Secondary outcomes (1)
Thyroid-Related Quality-of-Life Patient-Reported Outcome questionnaire short form (ThyPRO-39)
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.
Measured: Immediately after the reception of laboratory results
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2019
- Study start14 Jan 2020
- Primary completion4 Apr 2022
- Study completion4 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Thyroid DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 253 participants (actual)
Sponsor and investigators
- Lead sponsor
- Value Outcomes Ltd.
- Sponsor type
- University, hospital or other
- Collaborators
- Charles University, Czech Republic, Institute of Health Information and Statistics of the Czech Republic
- Responsible party
- Sponsor
- Investigators
- Jan Tužil, MSc et Eng, Study director, Value Outcomes Ltd. et First Medical Faculty at Charles University, PragueTomáš Doležal, MD et PhD, Study chair, Value Outcomes Ltd.Jana Bartáková, Ing et PhD, Study chair, Value Outcomes Ltd. et First Medical Faculty at Charles University, Prague
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04167423
- Sponsor's protocol ID
- ThyPreQol2020
- Acronym
- ThyPreQol2020
- Status last verified
- Apr 2022
- First submitted
- 11 Nov 2019
- Last updated
- 12 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 36878311
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thyroid Disease in Pregnancy and Its Impact on the Quality of Life
- ClinicalTrials.gov ID
- NCT04167423
- Acronym / sponsor ID
- ThyPreQol2020 / ThyPreQol2020
- Conditions
- Thyroid Diseases, Pregnancy Related, Quality of Life
- Keywords
- quality of life, EQ5D, ThyPRO-39, pregnancy, thyroid disease, thyrotropin, thyroxine, thyroid autoantibodies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 253 participants (actual)
- Lead sponsor
- Value Outcomes Ltd.University, hospital or other
- Collaborators
- Charles University, Czech Republic, Institute of Health Information and Statistics of the Czech Republic
- Study start
- 14 Jan 2020 (actual)
- Primary completion
- 4 Apr 2022 (actual)
- Study completion
- 4 Apr 2022 (actual)
- First posted
- 18 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- Female only
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- pregnant women
- screened for laboratory signs of thyreopathy anytime during pregnancy
- willing/able to participate in online survey
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Utility by five-dimensional five-level generic EuroQoL questionnaire (EQ5D 5L)
Time frame: 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
1 secondary outcome
Thyroid-Related Quality-of-Life Patient-Reported Outcome questionnaire short form (ThyPRO-39)
Time frame: Immediately after the reception of laboratory results
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2022.
- Derived from this study: PubMed 36878311Tuzil 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Tužil, MSc et Eng study director
Value Outcomes Ltd. et First Medical Faculty at Charles University, Prague
Tomáš Doležal, MD et PhD study chair
Value Outcomes Ltd.
Jana Bartáková, Ing et PhD study chair
Value Outcomes Ltd. et First Medical Faculty at Charles University, Prague
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroid Diseases and Pregnancy Related, run by Value Outcomes Ltd. at 7 sites in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Utility by five-dimensional five-level generic EuroQoL questionnaire (EQ5D 5L) (time frame: Immediately after the reception of laboratory results). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04167423, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2022.