Pregnancy Clinical Trial
Official title:
Gestational Age Specific Thyroid Function Reference Range in Hong Kong
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 |
Verified date | September 2018 |
Source | Chinese University of Hong Kong |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Chinese University of Hong Kong |
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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