Normal Range of TSH and FT4 in Pregnancy (NRTSHTURKEY)

Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital

Status: Completed

Conditions: Dysfunction; Hypothyroidism; Iodine Deficiency; Thyroid; Pregnancy Related

Treatments: Diagnostic Test: Serum thyroid function tests

Study type: Observational

Funder types: Other

Identifiers

NCT04860622

NR TSH TURKEY

Details and patient eligibility

About

Physiological changes necessitate the use of pregnancy-specific reference ranges for thyrotrophin (TSH) and free T4 (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 the diagnosis of subclinical hypothyroidism in the first, second, and third trimester of pregnant women in the Sancaktepe region in Turkey.

Full description

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

Enrollment: 528 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No 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
• Patient with pre-existing thyroid disease
• TPOAb positive
• Patient using thyroid interfering medication
• That had IVF treatment

Trial design

528 participants in 1 patient group

Pregnant women

Description:

500 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 function tests will be obtained on the first visit.

Treatment:

Diagnostic Test: Serum thyroid function tests