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PRECIOUS: The Prevalence of Sub Clinical Hypothyroidism During Early Pregnancy in Pakistan

Sponsor
Abbott (Industry)
Overall Status
Completed
CT.gov ID
NCT03036956
Collaborator
Dimension Research (Industry)
500
Enrollment
9
Locations
12
Actual Duration (Months)
55.6
Patients Per Site
4.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    500 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    The Prevalence of Sub Clinical Hypothyroidism During Early Pregnancy in Pakistan
    Actual Study Start Date :
    Jan 1, 2017
    Actual Primary Completion Date :
    Jan 1, 2018
    Actual Study Completion Date :
    Jan 1, 2018

    Outcome Measures

    Primary Outcome Measures

    1. Frequency of subclinical hypothyroidism in pregnant females [12 months]

      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.

    Secondary Outcome Measures

    1. The risk factors that might be associated with subclinical hypothyroidism in all enrolled pregnant patients. [12 months]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Subjects must meet all of the following criteria to be enrolled into the study

    • Patient between 18-45 years of age; is pregnant and in First Trimester

    • Patient willing to give blood sample for laboratory testing

    • Patient willing to provide written authorization to obtain data for the study

    • Exclusion Criteria:

    • Patients suffering from any

    • Chronic Cardiac Disease - Chronic Cardiac Failure, Cardiac Arrhythmia

    • Hepatic Disorder : Cirrhosis

    • Renal Disease : Patients on dialysis and Transplant Therapy

    • Respiratory Disorder

    • Subjects with history of non-thyroid malignancy

    • Patient currently taking medication for hyperthyroidism

    • Active systemic infection

    • Patient with physical or mental impairment

    • Patients on systemic steroid therapy or lithium therapy

    • Patients in second or third trimester of pregnancy

    • Patient not willing to give blood sample for laboratory testing

    • Patient not willing to provide written authorization to obtain data for the study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Isra University hospital Hyderabad Pakistan 71800
    2 Pakistam Insititute of Medical science Islamabad Pakistan 144001
    3 Atia Hospital Hospital Karachi Pakistan 75100
    4 Boluvard Hospital Karachi Pakistan 75500
    5 MediCell Hospital Karachi Pakistan 75500
    6 Services Hospital Lahore Pakistan 54000
    7 Sir Ganga Ram hospital Lahore Pakistan 54000
    8 Welcare Medical Centre Muzafferabad, Azad Kashmir Pakistan 13100
    9 Lady Reading hospital Peshawar Pakistan 25000

    Sponsors and Collaborators

    • Abbott
    • Dimension Research

    Investigators

    • Study Director: Raeefuddin Ahmed, MD, Abbott

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Abbott
    ClinicalTrials.gov Identifier:
    NCT03036956
    Other Study ID Numbers:
    • EPIDI051
    First Posted:
    Jan 31, 2017
    Last Update Posted:
    Mar 14, 2018
    Last Verified:
    Mar 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Abbott
    subclinical hypothyroidism in pregnancy
    Additional relevant MeSH terms:
    Hypothyroidism

    Study Results

    No Results Posted as of Mar 14, 2018