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

What is the Rational Upper Limit for TSH and T4 During First and Second Trimester Pregnancy in West Black Sea Region of Turkey

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03754621
Enrollment
400
Registered
2018-11-27
Start date
2018-10-15
Completion date
2019-07-15
Last updated
2019-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypothyroidism, Pregnancy Early, Thyroid, Thyroid Dysfunction

Keywords

TSH

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.

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.

Interventions

DIAGNOSTIC_TESTSerum thyroid functions tests

Serum TSH, fT3, fT4 and anti-TPO

Sponsors

Bartin State Hospital
Lead SponsorOTHER_GOV

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
TSHDay 1Serum TSH (mU/I)

Countries

Turkey (Türkiye)

Contacts

Primary ContactMurat Yassa, MD
murat.yassa@gmail.com+905335106312

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026