The Prevalence of Sub Clinical Hypothyroidism During Early Pregnancy in Pakistan

NCT03036956 | Completed

• 1 other identifier: EPIDI051
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 9

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

Conditions

Subclinical Hypothyroidism

Keywords

subclinical hypothyroidism in pregnancy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The risk factors that might be associated with subclinical hypothyroidism in all enrolled pregnant patients.

  12 months

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Primary Care Clinic/Private Clinic

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott: lead
• Dimension Research: collaborator

Study Sites (9)

Isra University hospital

Hyderābād, 71800, Pakistan

Location

Pakistam Insititute of Medical science

Islamabad, 144001, Pakistan

Location

Atia Hospital Hospital

Karachi, 75100, Pakistan

Location

Boluvard Hospital

Karachi, 75500, Pakistan

Location

MediCell Hospital

Karachi, 75500, Pakistan

Location

Services Hospital

Lahore, 54000, Pakistan

Location

Sir Ganga Ram hospital

Lahore, 54000, Pakistan

Location

Welcare Medical Centre

Muzafferabad, Azad Kashmir, 13100, Pakistan

Location

Lady Reading hospital

Peshawar, 25000, Pakistan

Location

Study Officials

• Raeefuddin Ahmed, MD

  Abbott

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2017
• First Posted: January 31, 2017
• Study Start: January 1, 2017
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: March 14, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (9)