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Gestational Age Specific Thyroid Function Reference Range

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03663517
Recruitment Status : Completed
First Posted : September 10, 2018
Last Update Posted : September 10, 2018
Sponsor:
Information provided by (Responsible Party):
Wing Hung Tam, Chinese University of Hong Kong

Study Description
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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.

Condition or disease
Thyroid Reference Values Pregnancy

Study Design
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Study Type : Observational
Actual Enrollment : 599 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Gestational Age Specific Thyroid Function Reference Range in Hong Kong
Actual Study Start Date : July 2, 2014
Actual Primary Completion Date : April 30, 2016
Actual Study Completion Date : April 30, 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Thyroid

Groups and Cohorts
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Group/Cohort
pregnant women
pregnant women in Hong Kong


Outcome Measures
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Primary Outcome Measures :
  1. Change of free triiodothyronine (FT3) during pregnancy [ Time Frame: 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. ]
    gestational FT3 level

  2. Change of free thyroxine (FT4) during pregnancy [ Time Frame: 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. ]
    gestational FT4 level

  3. Change of thyrotropin (TSH) during pregnancy [ Time Frame: 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. ]
    gestational TSH level


Biospecimen Retention:   Samples Without DNA
Cord blood

Eligibility Criteria
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Ages Eligible for Study:   16 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Gestational age-specific thyroid function reference range
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Hong Kong women
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03663517


Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
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Principal Investigator: Wing Hung Tam, MD Chinese University of Hong Kong
More Information
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Responsible Party: Wing Hung Tam, Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT03663517    
Other Study ID Numbers: CUHK_TMP00159
First Posted: September 10, 2018    Key Record Dates
Last Update Posted: September 10, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: To be confirmed.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wing Hung Tam, Chinese University of Hong Kong:
Thyroid
Reference values
Pregnancy
Additional relevant MeSH terms:
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Thyroid Diseases
Endocrine System Diseases