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

Value Outcomes

Status: Completed

Conditions: Thyroid Diseases; Quality of Life; Pregnancy Related

Study type: Observational

Funder types: Other

Identifiers

NCT04167423

ThyPreQol2020

Details and patient eligibility

About

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.

Enrollment: 253 patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

253 participants in 4 patient groups

Healthy

Description:

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

Description:

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

hypothyroidism

Description:

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

thyroid autoimmunity

Description:

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