The Prevalence of Sub Clinical Hypothyroidism During Early Pregnancy in Pakistan

Subclinical Hypothyroidism Clinical Trial

— PRECIOUS  

Official title:

The Prevalence of Sub Clinical Hypothyroidism During Early Pregnancy in Pakistan

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03036956
• Other study ID #: EPIDI051
• Status: Completed
• Phase: N/A
• First received: January 26, 2017
• Last updated: March 13, 2018
• Start date: January 2017
• Est. completion date: January 2018

Study information

• Verified date: March 2018
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypothyroidism
• Subclinical Hypothyroidism

Locations

Country	Name	City	State
Pakistan	Isra University hospital	Hyderabad
Pakistan	Pakistam Insititute of Medical science	Islamabad
Pakistan	Atia Hospital Hospital	Karachi
Pakistan	Boluvard Hospital	Karachi
Pakistan	MediCell Hospital	Karachi
Pakistan	Services Hospital	Lahore
Pakistan	Sir Ganga Ram hospital	Lahore
Pakistan	Welcare Medical Centre	Muzafferabad, Azad Kashmir
Pakistan	Lady Reading hospital	Peshawar

Sponsors (2)

Lead Sponsor	Collaborator
Abbott	Dimension Research

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of subclinical hypothyroidism in pregnant females	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	The risk factors that might be associated with subclinical hypothyroidism in all enrolled pregnant patients.	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