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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03663517
Other study ID # CUHK_TMP00159
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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.
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