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

• Conditions: Pregnancy Early; Thyroid; Thyroid Dysfunction; Hypothyroidism
• Interventions: Diagnostic Test: Serum thyroid functions tests

• Registration Number: NCT03754621
• Lead Sponsor: Bartin State Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2018-10-15
• Study First Submitted: 2018-11-23
• Study First Submitted QC: 2018-11-23
• Study First Posted: 2018-11-27
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-21
• Last Update Posted: 2019-04-23
• Primary Completion: 2019-07-02
• Study Completion: 2019-07-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 400

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pregnants	Serum thyroid functions tests	400 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 functions tests will be obtained on the first visit.

Primary Outcome Measures

Name	Time	Method
TSH	Day 1	Serum TSH (mU/I)

Trial Locations

Locations (1)

Bartin State Hospital; 🇹🇷 Bartin, Turkey