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

March 13, 2018 updated by: Abbott
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

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

500

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

  • Pakistan
      • Hyderabad, Pakistan, 71800
        • Isra University hospital
      • Islamabad, Pakistan, 144001
        • Pakistam Insititute of Medical science
      • Karachi, Pakistan, 75100
        • Atia Hospital Hospital
      • Karachi, Pakistan, 75500
        • Boluvard Hospital
      • Karachi, Pakistan, 75500
        • MediCell Hospital
      • Lahore, Pakistan, 54000
        • Services Hospital
      • Lahore, Pakistan, 54000
        • Sir Ganga Ram Hospital
      • Muzafferabad, Azad Kashmir, Pakistan, 13100
        • Welcare Medical Centre
      • Peshawar, Pakistan, 25000
        • Lady Reading 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 45 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Primary Care Clinic/Private Clinic

Description

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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months

Collaborators and Investigators

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

Sponsor

Abbott

Collaborators

Dimension Research

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)

January 1, 2017

Primary Completion (ACTUAL)

January 1, 2018

Study Completion (ACTUAL)

January 1, 2018

Study Registration Dates

First Submitted

January 26, 2017

First Submitted That Met QC Criteria

January 26, 2017

First Posted (ESTIMATE)

January 31, 2017

Study Record Updates

Last Update Posted (ACTUAL)

March 14, 2018

Last Update Submitted That Met QC Criteria

March 13, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EPIDI051

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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