Normal Range of TSH and FT4 in Pregnancy (NRTSHTURKEY)

September 23, 2021 updated by: Arzu Bilge Tekin, Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

528

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Sehit Prof Dr Ilhan Varank Sancaktepe Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Turkish pregnant women living in Sancaktepe Region of Turkey

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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
Other Names:
  • Beta HCG and thyroid peroxidase antibody
  • Thyroid ultrasonography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
TSH
Time Frame: On day 1
Trimester specific TSH level
On day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
free T4
Time Frame: On day 1
Trimester specific free T4 level
On day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 1, 2021

Primary Completion (ACTUAL)

August 15, 2021

Study Completion (ACTUAL)

September 1, 2021

Study Registration Dates

First Submitted

April 22, 2021

First Submitted That Met QC Criteria

April 22, 2021

First Posted (ACTUAL)

April 27, 2021

Study Record Updates

Last Update Posted (ACTUAL)

September 29, 2021

Last Update Submitted That Met QC Criteria

September 23, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NR TSH TURKEY

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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