Gestational Age Specific Thyroid Function Reference Range

NCT03663517 | Completed

• 1 other identifier: CUHK_TMP00159
• Study Type: observational
• Target: 599
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Thyroid; Reference Values; Pregnancy

Keywords

Thyroid; Reference values; Pregnancy

Outcome Measures

Primary Outcomes (3)

• Change of free triiodothyronine (FT3) during pregnancy

  gestational FT3 level

  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.

• Change of free thyroxine (FT4) during pregnancy

  gestational FT4 level

  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.

• Change of thyrotropin (TSH) during pregnancy

  gestational TSH level

  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.

Study Arms (1)

pregnant women

pregnant women in Hong Kong

Eligibility Criteria

• Age: 16 Years - 50 Years
• Gender Eligibility Details: Gestational age-specific thyroid function reference range
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Hong Kong women

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

Cord blood

MeSH Terms

Conditions

Thyroid Diseases

Condition Hierarchy (Ancestors)

Endocrine System Diseases

Study Officials

• Wing Hung Tam, MD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 21, 2018
• First Posted: September 10, 2018
• Study Start: July 2, 2014
• Primary Completion: April 30, 2016
• Study Completion: April 30, 2016
• Last Updated: September 10, 2018

Record last verified: 2018-09