Gestational Age Specific Thyroid Function Reference Range

Pregnancy Clinical Trial

Official title:

Gestational Age Specific Thyroid Function Reference Range in Hong Kong

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03663517
• Other study ID #: CUHK_TMP00159
• Status: Completed
• Start date: July 2, 2014
• Est. completion date: April 30, 2016

Study information

• Verified date: September 2018
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 599
• Est. completion date: April 30, 2016
• Est. primary completion date: April 30, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Pregnancy
• Reference Values
• Thyroid
• Thyroid Diseases

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.