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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03036956
Recruitment Status : Completed
First Posted : January 31, 2017
Last Update Posted : March 14, 2018
Sponsor:
Collaborator:
Dimension Research
Information provided by (Responsible Party):
Abbott

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
Subclinical Hypothyroidism

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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 : January 2017
Actual Primary Completion Date : January 2018
Actual Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypothyroidism




Primary Outcome Measures :
  1. Frequency of subclinical hypothyroidism in pregnant females [ Time Frame: 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. [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Primary Care Clinic/Private Clinic
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03036956


Locations
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Pakistan
Isra University hospital
Hyderabad, Pakistan, 71800
Pakistam Insititute of Medical science
Islamabad, Pakistan, 144001
Atia Hospital Hospital
Karachi, Pakistan, 75100
Boluvard Hospital
Karachi, Pakistan, 75500
MediCell Hospital
Karachi, Pakistan, 75500
Services Hospital
Lahore, Pakistan, 54000
Sir Ganga Ram hospital
Lahore, Pakistan, 54000
Welcare Medical Centre
Muzafferabad, Azad Kashmir, Pakistan, 13100
Lady Reading hospital
Peshawar, Pakistan, 25000
Sponsors and Collaborators
Abbott
Dimension Research
Investigators
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Study Director: Raeefuddin Ahmed, MD Abbott

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Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT03036956     History of Changes
Other Study ID Numbers: EPIDI051
First Posted: January 31, 2017    Key Record Dates
Last Update Posted: March 14, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Abbott:
subclinical hypothyroidism in pregnancy

Additional relevant MeSH terms:
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Hypothyroidism
Thyroid Diseases
Endocrine System Diseases