Normal Range of TSH and FT4 in Pregnancy

NCT04860622 | Completed

• 1 other identifier: NR TSH TURKEY
• Study Type: observational
• Target: 528
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypothyroidism; Pregnancy Related; Thyroid; Dysfunction; Iodine Deficiency

Keywords

Hypothyroidism; Pregnancy; trimester; thyroid dysfunction; iodine level

Outcome Measures

Primary Outcomes (1)

• TSH

  Trimester specific TSH level

  On day 1

Secondary Outcomes (1)

• free T4

  On day 1

Study Arms (1)

Pregnant women

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.

Diagnostic Test: Serum thyroid function tests

Interventions

Serum thyroid function tests DIAGNOSTIC_TEST

At the first hospital visit, the blood tests will be made for TSH, FT4, FT3, and beta HCG concentration measurement

Also known as: Beta HCG and thyroid peroxidase antibody, Thyroid ultrasonography

Pregnant women

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Turkish pregnant women living in Sancaktepe Region of Turkey

You may qualify if:

• Singleton pregnancy
• Free of pre-existing thyroid disease
• That do not use thyroid interfering medication
• That did not undergo IVF treatment
• TPOAb negative

You may not qualify if:

• Adolescent pregnancy
• Patient with pre-existing thyroid disease
• TPOAb positive
• Patient using thyroid interfering medication
• That had IVF treatment

Sponsors & Collaborators

• Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital: lead

Study Sites (1)

Sehit Prof Dr Ilhan Varank Sancaktepe Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

Related 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.

  PMID: 28056690 BACKGROUND

• 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. doi: 10.1258/0004563011900830.

  PMID: 11471873 BACKGROUND

• 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.

  PMID: 30595114 BACKGROUND

MeSH Terms

Conditions

Hypothyroidism; Thyroid Diseases

Interventions

Pregnancy Tests

Condition Hierarchy (Ancestors)

Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Obstetrical and Gynecological; Investigative Techniques

Study Officials

• Murat Yassa, MD

  Specialist

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist M.D.

Study Record Dates

• First Submitted: April 22, 2021
• First Posted: April 27, 2021
• Study Start: April 1, 2021
• Primary Completion: August 15, 2021
• Study Completion: September 1, 2021
• Last Updated: September 29, 2021

Record last verified: 2021-09

Locations

TU (1)