<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03754621</url>
  </required_header>
  <id_info>
    <org_study_id>IlSaglik2018-2</org_study_id>
    <nct_id>NCT03754621</nct_id>
  </id_info>
  <brief_title>Upper Limit for TSH of First and Second Trimester Pregnancy in Turkey</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bartin State Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bartin State Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Physiological changes necessitate the use of pregnancy-specific reference ranges for TSH and&#xD;
      FT4 to diagnose thyroid dysfunction during pregnancy. Although many centers use fixed upper&#xD;
      limits for TSH of 2.5 or 3.0 mU/L, this may lead to overdiagnosis or even overtreatment.&#xD;
&#xD;
      The new guidelines of the American Thyroid Association have considerably changed&#xD;
      recommendations regarding thyroid function reference ranges in pregnancy accordingly. Any&#xD;
      hospital or physician that is still using the 2.5 or 3.0 mU/l cut-off for TSH during&#xD;
      pregnancy should evaluate their own lab-specific cut-offs.&#xD;
&#xD;
      The investigator's objective is to establish a rational reference range of serum TSH for&#xD;
      diagnosis of subclinical hypothyroidism in the first and second trimester of pregnant women&#xD;
      in west Black Sea region in Turkey.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Serum thyroid function tests (including T3, T4, TSH, Anti-TPO) will be obtained from the&#xD;
      singleton pregnancies in first and second trimester to determine the local specific normal&#xD;
      ranges.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">October 15, 2018</start_date>
  <completion_date type="Anticipated">July 15, 2019</completion_date>
  <primary_completion_date type="Anticipated">July 2, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>TSH</measure>
    <time_frame>Day 1</time_frame>
    <description>Serum TSH (mU/I)</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">400</enrollment>
  <condition>Thyroid</condition>
  <condition>Thyroid Dysfunction</condition>
  <condition>Hypothyroidism</condition>
  <condition>Pregnancy Early</condition>
  <arm_group>
    <arm_group_label>Pregnants</arm_group_label>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Serum thyroid functions tests</intervention_name>
    <description>Serum TSH, fT3, fT4 and anti-TPO</description>
    <arm_group_label>Pregnants</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Turkish pregnant women living in Bartin Region of Turkey&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Singleton pregnancy&#xD;
&#xD;
          -  Free of pre-existing thyroid disease&#xD;
&#xD;
          -  That do not use thyroid interfering medication&#xD;
&#xD;
          -  That did not undergo IVF treatment&#xD;
&#xD;
          -  TPOAb negative&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Adolescent pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Murat Yassa, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Bartin State Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Murat Yassa, MD</last_name>
    <phone>+905335106312</phone>
    <email>murat.yassa@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Bartin State Hospital</name>
      <address>
        <city>Bartin</city>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Murat Yassa, MD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <results_reference>
    <citation>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.</citation>
    <PMID>29942352</PMID>
  </results_reference>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>November 23, 2018</study_first_submitted>
  <study_first_submitted_qc>November 23, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 27, 2018</study_first_posted>
  <last_update_submitted>April 21, 2019</last_update_submitted>
  <last_update_submitted_qc>April 21, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 23, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Bartin State Hospital</investigator_affiliation>
    <investigator_full_name>Murat Yassa</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>TSH</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thyroid Diseases</mesh_term>
    <mesh_term>Hypothyroidism</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03754621
org study id: IlSaglik2018-2
nct id: NCT03754621
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Case-Control
time perspective: Prospective
measure: TSH
time frame: Day 1
description: Serum TSH (mU/I)
arm group label: Pregnants
description: 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.
intervention type: Diagnostic Test
intervention name: Serum thyroid functions tests
description: Serum TSH, fT3, fT4 and anti-TPO
arm group label: Pregnants
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Murat Yassa, MD
role: Principal Investigator
affiliation: Bartin State Hospital
last name: Murat Yassa, MD
phone: +905335106312
email: murat.yassa@gmail.com
facility: 
status: Recruiting
contact: 
country: Turkey
citation: 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.
PMID: 29942352
responsible party type: Principal Investigator
investigator affiliation: Bartin State Hospital
investigator full name: Murat Yassa
investigator title: Principal Investigator
mesh term: Thyroid Diseases
mesh term: Hypothyroidism
sharing ipd: Undecided