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

Bartin State Hospital

Status: Unknown

Conditions: Hypothyroidism; Thyroid Dysfunction; Thyroid; Pregnancy Early

Treatments: Diagnostic Test: Serum thyroid functions tests

Study type: Observational

Funder types: Other

Identifiers

NCT03754621

IlSaglik2018-2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

400 participants in 1 patient group

Pregnants

Description:

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.

Treatment:

Diagnostic Test: Serum thyroid functions tests