Gestational Age Specific Thyroid Function Reference Range

It has been well accepted that maternal thyroid dysfunction has adverse affects on both mothers and fetuses. However, the dramatical changes during pregnancy make the interpretation of thyroid function test (TFT, i.e. free triiodothyronine [FT3], free thyroxine [FT4] and thyrotropin [TSH]) very difficult. Previous studies have shown that the level of thyroid hormones differs from non-pregnant population and varies from gestational ages. Moreover, studies have shown the agreement among different instrument platforms was quite low. This study is aimed to determine gestational age specific TFT reference ranges of the local pregnant population for all available platforms currently used under Hospital Authority and Department of Health.

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Key information

Conditions

Thyroid Endocrine System Diseases Pregnancy Reference Values Thyroid Diseases

Age range

16 year–50 year

Sex eligibility

Female

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Pregnant women receiving pregnancy and postnatal care in the Department of Obstetrics & Gynaecology, Prince of Wales Hospital, Hong Kong

Exclusion criteria

1. Previous history of thyroid dysfunction (hypothyroidism or hyperthyroidism);
2. Autoimmune disease, particularly those receiving corticosteroid or immunosuppressant: e.g. systemic lupus erythematosus;
3. Disease associated with thyroid dysfunction: e.g. molar pregnancy

Treatment and study plan

Primary outcomes

Change of free triiodothyronine (FT3) during pregnancy

Time frame: At the time of booking for antenatal visit (1st trimester), oral glucose tolerance test (24-32 weeks), admission for delivery (3rd trimester) and a gestational age assigned randomly.

gestational FT3 level
Change of free thyroxine (FT4) during pregnancy

Time frame: At the time of booking for antenatal visit (1st trimester), oral glucose tolerance test (24-32 weeks), admission for delivery (3rd trimester) and a gestational age assigned randomly.

gestational FT4 level
Change of thyrotropin (TSH) during pregnancy

Time frame: At the time of booking for antenatal visit (1st trimester), oral glucose tolerance test (24-32 weeks), admission for delivery (3rd trimester) and a gestational age assigned randomly.

gestational TSH level

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

Gestational Age Specific Thyroid Function Reference Range in Hong Kong

Important dates

Study start: 2014
Primary completion: 2016
Study completion: 2016
First posted: Sep 10, 2018
Registry last updated: Sep 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed