NRTSHTURKEY: Normal Range of TSH and FT4 in Pregnancy
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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
At the first hospital visit, the blood tests will be made for TSH, FT4, FT3, and beta HCG concentration measurement
Other Names:
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Outcome Measures
Primary Outcome Measures
- TSH [On day 1]
Trimester specific TSH level
Secondary Outcome Measures
- free T4 [On day 1]
Trimester specific free T4 level
Eligibility Criteria
Criteria
Inclusion Criteria:
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Singleton pregnancy
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Free of pre-existing thyroid disease
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That do not use thyroid interfering medication
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That did not undergo IVF treatment
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TPOAb negative
Exclusion Criteria:
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Adolescent pregnancy
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Patient with pre-existing thyroid disease
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TPOAb positive
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Patient using thyroid interfering medication
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That had IVF treatment
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sehit Prof Dr Ilhan Varank Sancaktepe Training and Research Hospital | Istanbul | Turkey |
Sponsors and Collaborators
- Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
Investigators
- Principal Investigator: Murat Yassa, MD, Specialist
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- NR TSH TURKEY