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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| TSH | Trimester specific TSH level | On day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| free T4 | Trimester specific free T4 level | On day 1 |
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Inclusion Criteria:
Exclusion Criteria:
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Turkish pregnant women living in Sancaktepe Region of Turkey
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| Name | Affiliation | Role |
|---|---|---|
| Murat Yassa, MD | Specialist | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sehit Prof Dr Ilhan Varank Sancaktepe Training and Research Hospital | Istanbul | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28056690 | Background | 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. | |
| 11471873 |
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| ID | Term |
|---|---|
| D007037 | Hypothyroidism |
| D013959 | Thyroid Diseases |
| ID | Term |
|---|---|
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D011258 | Pregnancy Tests |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003944 | Diagnostic Techniques, Obstetrical and Gynecological |
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|
| 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. |
| 30595114 | 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. |
| D008919 | Investigative Techniques |