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Completed

NCT Number: NCT04860622

Normal Range of TSH and FT4 in Pregnancy

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.

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Key information

Conditions

Hypothyroidism Dysfunction Endocrine System Diseases Iodine Deficiency Pregnancy Related Thyroid Thyroid Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Sehit Prof Dr Ilhan Varank Sancaktepe Training and Research Hospital

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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
  • Patient with pre-existing thyroid disease
  • TPOAb positive
  • Patient using thyroid interfering medication
  • That had IVF treatment

Treatment and study plan

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

Other names: Beta HCG and thyroid peroxidase antibody, Thyroid ultrasonography

Primary outcomes

  1. TSH

    Time frame: On day 1

    Trimester specific TSH level

Secondary outcomes

  1. free T4

    Time frame: On day 1

    Trimester specific free T4 level

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Acronym: NRTSHTURKEY

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Apr 27, 2021
Registry last updated
Sep 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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