<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/NCT03036956</url>
  </required_header>
  <id_info>
    <org_study_id>EPIDI051</org_study_id>
    <nct_id>NCT03036956</nct_id>
  </id_info>
  <brief_title>The Prevalence of Sub Clinical Hypothyroidism During Early Pregnancy in Pakistan</brief_title>
  <acronym>PRECIOUS</acronym>
  <official_title>The Prevalence of Sub Clinical Hypothyroidism During Early Pregnancy in Pakistan</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Abbott</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Dimension Research</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Abbott</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The Precious study is likely to help determine the frequency (percentage) of subclinical&#xD;
      hypothyroidism among pregnant women in Pakistan It will also help to determine the risk&#xD;
      factors for developing subclinical hypothyroidism during pregnancy&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">January 2018</completion_date>
  <primary_completion_date type="Actual">January 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Frequency of subclinical hypothyroidism in pregnant females</measure>
    <time_frame>12 months</time_frame>
    <description>Continuous variables with normal and non-normal distributions would be reported as mean (SD) and median [inter-quartile range (IQR)], respectively. Prevalence of subclinical hypothyroidism with 95% confidence Interval (CI) will be calculated. Continuous variables between group will compared by using Independent sample t test, and categorical variables will compare by using the chi-square test.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The risk factors that might be associated with subclinical hypothyroidism in all enrolled pregnant patients.</measure>
    <time_frame>12 months</time_frame>
    <description>Odds Ratios (OR) and their 95% Confidence Intervals (CI) will be estimated using Logistic Regression. The likelihood ratio test used to assess the association between the explanatory variables and the risk of the subclinical hypothyroidism. Univariable analyses will perform to examine the effect of each variable on the risk of subclinical hypothyroidism. In multivariate analysis all insignificant variables (p &gt;0.05) will check for their confounding and interaction effects before their removal from the final model.</description>
  </secondary_outcome>
  <enrollment type="Actual">500</enrollment>
  <condition>Subclinical Hypothyroidism</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Primary Care Clinic/Private Clinic&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects must meet all of the following criteria to be enrolled into the study&#xD;
&#xD;
          -  Patient between 18-45 years of age; is pregnant and in First Trimester&#xD;
&#xD;
          -  Patient willing to give blood sample for laboratory testing&#xD;
&#xD;
          -  Patient willing to provide written authorization to obtain data for the study&#xD;
&#xD;
          -  Exclusion Criteria:&#xD;
&#xD;
          -  Patients suffering from any&#xD;
&#xD;
               -  Chronic Cardiac Disease - Chronic Cardiac Failure, Cardiac Arrhythmia&#xD;
&#xD;
               -  Hepatic Disorder : Cirrhosis&#xD;
&#xD;
               -  Renal Disease : Patients on dialysis and Transplant Therapy&#xD;
&#xD;
               -  Respiratory Disorder&#xD;
&#xD;
          -  Subjects with history of non-thyroid malignancy&#xD;
&#xD;
          -  Patient currently taking medication for hyperthyroidism&#xD;
&#xD;
          -  Active systemic infection&#xD;
&#xD;
          -  Patient with physical or mental impairment&#xD;
&#xD;
          -  Patients on systemic steroid therapy or lithium therapy&#xD;
&#xD;
          -  Patients in second or third trimester of pregnancy&#xD;
&#xD;
          -  Patient not willing to give blood sample for laboratory testing&#xD;
&#xD;
          -  Patient not willing to provide written authorization to obtain data for the study&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Raeefuddin Ahmed, MD</last_name>
    <role>Study Director</role>
    <affiliation>Abbott</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Isra University hospital</name>
      <address>
        <city>Hyderabad</city>
        <zip>71800</zip>
        <country>Pakistan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pakistam Insititute of Medical science</name>
      <address>
        <city>Islamabad</city>
        <zip>144001</zip>
        <country>Pakistan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Atia Hospital Hospital</name>
      <address>
        <city>Karachi</city>
        <zip>75100</zip>
        <country>Pakistan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Boluvard Hospital</name>
      <address>
        <city>Karachi</city>
        <zip>75500</zip>
        <country>Pakistan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MediCell Hospital</name>
      <address>
        <city>Karachi</city>
        <zip>75500</zip>
        <country>Pakistan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Services Hospital</name>
      <address>
        <city>Lahore</city>
        <zip>54000</zip>
        <country>Pakistan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sir Ganga Ram hospital</name>
      <address>
        <city>Lahore</city>
        <zip>54000</zip>
        <country>Pakistan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Welcare Medical Centre</name>
      <address>
        <city>Muzafferabad, Azad Kashmir</city>
        <zip>13100</zip>
        <country>Pakistan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lady Reading hospital</name>
      <address>
        <city>Peshawar</city>
        <zip>25000</zip>
        <country>Pakistan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Pakistan</country>
  </location_countries>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>January 26, 2017</study_first_submitted>
  <study_first_submitted_qc>January 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 31, 2017</study_first_posted>
  <last_update_submitted>March 13, 2018</last_update_submitted>
  <last_update_submitted_qc>March 13, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 14, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>subclinical hypothyroidism in pregnancy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypothyroidism</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03036956
org study id: EPIDI051
nct id: NCT03036956
lead sponsor: 
collaborator: 
has dmc: No
The Precious study is likely to help determine the frequency (percentage) of subclinical
      hypothyroidism among pregnant women in Pakistan It will also help to determine the risk
      factors for developing subclinical hypothyroidism during pregnancy
observational model: Cohort
time perspective: Prospective
measure: Frequency of subclinical hypothyroidism in pregnant females
time frame: 12 months
description: Continuous variables with normal and non-normal distributions would be reported as mean (SD) and median [inter-quartile range (IQR)], respectively. Prevalence of subclinical hypothyroidism with 95% confidence Interval (CI) will be calculated. Continuous variables between group will compared by using Independent sample t test, and categorical variables will compare by using the chi-square test.
measure: The risk factors that might be associated with subclinical hypothyroidism in all enrolled pregnant patients.
time frame: 12 months
description: Odds Ratios (OR) and their 95% Confidence Intervals (CI) will be estimated using Logistic Regression. The likelihood ratio test used to assess the association between the explanatory variables and the risk of the subclinical hypothyroidism. Univariable analyses will perform to examine the effect of each variable on the risk of subclinical hypothyroidism. In multivariate analysis all insignificant variables (p >0.05) will check for their confounding and interaction effects before their removal from the final model.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: Raeefuddin Ahmed, MD
role: Study Director
affiliation: Abbott
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Pakistan
responsible party type: Sponsor
mesh term: Hypothyroidism
sharing ipd: No