Upper Limit for TSH of First and Second Trimester Pregnancy in Turkey
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|ClinicalTrials.gov Identifier: NCT03754621|
Recruitment Status : Recruiting
First Posted : November 27, 2018
Last Update Posted : April 23, 2019
Physiological changes necessitate the use of pregnancy-specific reference ranges for TSH and FT4 to diagnose thyroid dysfunction during pregnancy. Although many centers use fixed upper limits for TSH of 2.5 or 3.0 mU/L, this may lead to overdiagnosis or even overtreatment.
The new guidelines of the American Thyroid Association have considerably changed recommendations regarding thyroid function reference ranges in pregnancy accordingly. Any hospital or physician that is still using the 2.5 or 3.0 mU/l cut-off for TSH during pregnancy should evaluate their own lab-specific cut-offs.
The investigator's objective is to establish a rational reference range of serum TSH for diagnosis of subclinical hypothyroidism in the first and second trimester of pregnant women in west Black Sea region in Turkey.
|Condition or disease||Intervention/treatment|
|Thyroid Thyroid Dysfunction Hypothyroidism Pregnancy Early||Diagnostic Test: Serum thyroid functions tests|
|Study Type :||Observational|
|Estimated Enrollment :||400 participants|
|Official Title:||What is the Rational Upper Limit for TSH and T4 During First and Second Trimester Pregnancy in West Black Sea Region of Turkey|
|Actual Study Start Date :||October 15, 2018|
|Estimated Primary Completion Date :||July 2, 2019|
|Estimated Study Completion Date :||July 15, 2019|
400 pregnant women with a singleton pregnancy, free of pre-existing thyroid disease, that do not use thyroid interfering medication, that did not undergo IVF treatment and are TPOAb negative. Serum thyroid functions tests will be obtained on the first visit.
Diagnostic Test: Serum thyroid functions tests
Serum TSH, fT3, fT4 and anti-TPO
- TSH [ Time Frame: Day 1 ]Serum TSH (mU/I)
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03754621
|Contact: Murat Yassa, MDemail@example.com|
|Bartin State Hospital||Recruiting|
|Contact: Murat Yassa, MD|
|Principal Investigator:||Murat Yassa, MD||Bartin State Hospital|