Upper Limit for TSH of First and Second Trimester Pregnancy in Turkey

Hypothyroidism Clinical Trial

Official title:

What is the Rational Upper Limit for TSH and T4 During First and Second Trimester Pregnancy in West Black Sea Region of Turkey

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03754621
• Other study ID #: IlSaglik2018-2
• Status: Recruiting
• Start date: October 15, 2018
• Est. completion date: July 15, 2019

Study information

• Verified date: April 2019
• Source: Bartin State Hospital
• Contact: Murat Yassa, MD
• Phone: +905335106312
• Email: murat.yassa[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Physiological changes necessitate the use of pregnancy-specific reference ranges for TSH and 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 diagnosis of subclinical hypothyroidism in the first and second trimester of pregnant women in west Black Sea region in Turkey.

Description:

Serum thyroid function tests (including T3, T4, TSH, Anti-TPO) will be obtained from the singleton pregnancies in first and second trimester to determine the local specific normal ranges.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: July 15, 2019
• Est. primary completion date: July 2, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Hypothyroidism
• Pregnancy Early
• Thyroid
• Thyroid Diseases
• Thyroid Dysfunction

Intervention

Diagnostic Test:
• Serum thyroid functions tests
Serum TSH, fT3, fT4 and anti-TPO

Locations

Country	Name	City	State
Turkey	Bartin State Hospital	Bartin

Sponsors (1)

Lead Sponsor	Collaborator
Bartin State Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Korevaar TIM. The upper limit for TSH during pregnancy: why we should stop using fixed limits of 2.5 or 3.0 mU/l. Thyroid Res. 2018 May 21;11:5. doi: 10.1186/s13044-018-0048-7. eCollection 2018. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TSH	Serum TSH (mU/I)	Day 1