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

Last updated: April 21, 2019
Sponsor: Bartin State Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Female Hormonal Deficiencies/abnormalities

Hormone Deficiencies

Thyroid Disorders

Treatment

N/A

Clinical Study ID

NCT03754621
IlSaglik2018-2
  • Ages > 18
  • Female
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Adolescent pregnancy

Study Design

Total Participants: 400
Study Start date:
October 15, 2018
Estimated Completion Date:
July 15, 2019

Study 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.

Connect with a study center

  • Bartin State Hospital

    Bartin,
    Turkey

    Active - Recruiting

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