Gestational Age Specific Thyroid Function Reference Range

NCT ID: NCT03663517

Last Updated: 2018-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

599 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-07-02

Study Completion Date

2016-04-30

Brief Summary

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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

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Conditions

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Thyroid Reference Values Pregnancy

Study Design

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Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

PROSPECTIVE

Study Groups

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pregnant women

pregnant women in Hong Kong

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Chinese University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Wing Hung Tam

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wing Hung Tam, MD

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Other Identifiers

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CUHK_TMP00159

Identifier Type: -

Identifier Source: org_study_id

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