The Prevalence of Sub Clinical Hypothyroidism During Early Pregnancy in Pakistan

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

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Key information

Conditions

Subclinical Hypothyroidism

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Isra University hospital, Hyderābād, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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 outcomes

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.

Sponsors and collaborators

Lead sponsor

Abbott

Industry

Collaborators

Dimension Research

Registry information

Acronym: PRECIOUS

Important dates

Study start: 2017
Primary completion: 2018
Study completion: 2018
First posted: Jan 31, 2017
Registry last updated: Mar 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed