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Normal Range of TSH and FT4 in Pregnancy

NCT04860622 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 528

Last updated 2021-09-29

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

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

    lead OTHER

Principal Investigators

  • Murat Yassa, MD · Specialist

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-01
Primary Completion
2021-08-15
Completion
2021-09-01

Countries

  • Turkey (Türkiye)

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04860622 on ClinicalTrials.gov