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Upper Limit for TSH of First and Second Trimester Pregnancy in Turkey

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03754621
Recruitment Status : Recruiting
First Posted : November 27, 2018
Last Update Posted : April 23, 2019
Information provided by (Responsible Party):
Murat Yassa, Bartin State Hospital

Brief Summary:

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

Detailed Description:
Serum thyroid function tests (including T3, T4, TSH, Anti-TPO) will be obtained from the singleton pregnancies in first and second trimester to determine the local specific normal ranges.

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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Case-Control
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Thyroid Diseases
Drug Information available for: Thyroid

Group/Cohort Intervention/treatment
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

Primary Outcome Measures :
  1. TSH [ Time Frame: Day 1 ]
    Serum TSH (mU/I)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Turkish pregnant women living in Bartin Region of Turkey

Inclusion Criteria:

  • Singleton pregnancy
  • Free of pre-existing thyroid disease
  • That do not use thyroid interfering medication
  • That did not undergo IVF treatment
  • TPOAb negative

Exclusion Criteria:

  • Adolescent pregnancy

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 identifier (NCT number): NCT03754621

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Contact: Murat Yassa, MD +905335106312

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Bartin State Hospital Recruiting
Bartin, Turkey
Contact: Murat Yassa, MD         
Sponsors and Collaborators
Bartin State Hospital
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Principal Investigator: Murat Yassa, MD Bartin State Hospital
Publications of Results:
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Responsible Party: Murat Yassa, Principal Investigator, Bartin State Hospital Identifier: NCT03754621    
Other Study ID Numbers: IlSaglik2018-2
First Posted: November 27, 2018    Key Record Dates
Last Update Posted: April 23, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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 Murat Yassa, Bartin State Hospital:
Additional relevant MeSH terms:
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Thyroid Diseases
Endocrine System Diseases