NCT04860622

Normal Range of TSH and FT4 in Pregnancy

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 528 (actual)
• Sponsor: Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: —

Summary

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.

Detailed 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.

Conditions

• Hypothyroidism
• Pregnancy Related
• Thyroid
• Dysfunction
• Iodine Deficiency

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Serum thyroid function tests	At the first hospital visit, the blood tests will be made for TSH, FT4, FT3, and beta HCG concentration measurement

Timeline

• Start date: 2021-04-01
• Primary completion: 2021-08-15
• Completion: 2021-09-01
• First posted: 2021-04-27
• Last updated: 2021-09-29

Locations

1 site across 1 country: Turkey (Türkiye)