Normal Range of TSH and FT4 in Pregnancy

Pregnancy Related Clinical Trial

— NRTSHTURKEY  

Official title:

Normal Range of TSH and FT4 in Pregnancy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04860622
• Other study ID #: NR TSH TURKEY
• Status: Completed
• Start date: April 1, 2021
• Est. completion date: September 1, 2021

Study information

• Verified date: September 2021
• Source: Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 528
• Est. completion date: September 1, 2021
• Est. primary completion date: August 15, 2021
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Turkey	Sehit Prof Dr Ilhan Varank Sancaktepe Training and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Alexander EK, Pearce EN, Brent GA, Brown RS, Chen H, Dosiou C, Grobman WA, Laurberg P, Lazarus JH, Mandel SJ, Peeters RP, Sullivan S. 2017 Guidelines of the American Thyroid Association for the Diagnosis and Management of Thyroid Disease During Pregnancy and the Postpartum. Thyroid. 2017 Mar;27(3):315-389. doi: 10.1089/thy.2016.0457. Erratum in: Thyroid. 2017 Sep;27(9):1212. — View Citation

Donovan LE, Metcalfe A, Chin A, Yamamoto JM, Virtanen H, Johnson JA, Krause R. A Practical Approach for the Verification and Determination of Site- and Trimester-Specific Reference Intervals for Thyroid Function Tests in Pregnancy. Thyroid. 2019 Mar;29(3):412-420. doi: 10.1089/thy.2018.0439. Epub 2019 Feb 4. — View Citation

Panesar NS, Li CY, Rogers MS. Reference intervals for thyroid hormones in pregnant Chinese women. Ann Clin Biochem. 2001 Jul;38(Pt 4):329-32. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TSH	Trimester specific TSH level	On day 1
Secondary	free T4	Trimester specific free T4 level	On day 1