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

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.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Thyroid Diseases; Pregnancy Related

• Study Type: Observational
• Enrollment (Actual): 253

Contacts and Locations

Study Locations

• Czechia
  • Havlíčkův Brod, Czechia
    • Nemocnice Havlíčkův Brod
  • Praha, Czechia
    • Vseobecna Fakultni Nemocnice
  • Příbram, Czechia, 26101
    • Oblastní nemocnice Příbram, a.s.
  • Czech Republic
    • Kladno, Czech Republic, Czechia, 27201
      • MUDr. Milan Kučera. s.r.o.
    • Odolena Voda, Czech Republic, Czechia, 25070
      • MUDr. Eva Novotná - FEMCARE s.r.o.
    • Prague, Czech Republic, Czechia, 15500
      • Mediva s.r.o.
    • Tábor, Czech Republic, Czechia, 39003
      • MUDr.Tereza Šmrhová-Kovács

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Immediately after the reception of laboratory results

Collaborators and Investigators

• Sponsor: Value Outcomes Ltd.
• Collaborators: 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 record dates

Study Major Dates

• Study Start (ACTUAL): January 14, 2020
• Primary Completion (ACTUAL): April 4, 2022
• Study Completion (ACTUAL): April 4, 2022

Study Registration Dates

• First Submitted: November 11, 2019
• First Submitted That Met QC Criteria: November 15, 2019
• First Posted (ACTUAL): November 18, 2019

Study Record Updates

• Last Update Posted (ACTUAL): May 12, 2022
• Last Update Submitted That Met QC Criteria: May 6, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: quality of life; pregnancy; thyroxine; EQ5D; thyroid disease; ThyPRO-39; thyrotropin; thyroid autoantibodies
• Additional Relevant MeSH Terms: Endocrine System Diseases; Thyroid Diseases
• Other Study ID Numbers: ThyPreQol2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No