Gestational Age Specific Thyroid Function Reference Range

Completed

• Conditions: Reference Values; Thyroid; Pregnancy

• Registration Number: NCT03663517
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07-02
• Primary Completion: 2016-04-30
• Study Completion: 2016-04-30
• Study First Submitted: 2018-08-21
• Status Verified: 2018-09
• Study First Submitted QC: 2018-09-06
• Last Update Submitted: 2018-09-06
• Study First Posted: 2018-09-10
• Last Update Posted: 2018-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 599

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change of free triiodothyronine (FT3) during pregnancy	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	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	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