Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03036956
Other study ID # EPIDI051
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Not yet recruiting NCT05019118 - Dietary Intervention With Únicla Dairy Products (DANTIAN) N/A
Completed NCT01838031 - Thyroid Screening Protocol During Pregnancy: a Multi-center Prospective Controlled Study N/A
Completed NCT01335802 - Relation Between Subclinical Hypothyroidism and Outcome of Pregnancy
Terminated NCT00962221 - Lipids Profile in Subclinical Hypothyroidism N/A
Completed NCT00388297 - Thyroid Therapy for Mild Thyroid Deficiency in Pregnancy Phase 3
Completed NCT03898622 - Supplementation of Thyroid Hormone for TSH Control in Patients With Chronic Kidney Disease Without TRR. Phase 3
Completed NCT01985204 - Iodine Supplementation in Obesity N/A
Recruiting NCT06041204 - Best Treatment for Women With Both (Polycystic Ovary Syndrome) PCOS and Subclinical Hypothyroidism N/A
Completed NCT01660126 - Thyroid Hormone Replacement for Subclinical Hypothyroidism Phase 4
Completed NCT04354896 - The Effect of Thyroid Hormone Therapy on Muscle Mass and Function in Older Adults With Subclinical Hypothyroidism Phase 4
Completed NCT02090907 - Effects of Levothyroxine on Endothelial Function of Patients With Subclinical Hypothyroidism Phase 2/Phase 3
Completed NCT04288115 - Discontinuation of Levothyroxine Therapy for Patients With Subclinical Hypothyroidism Phase 4
Completed NCT01853579 - The TRUST Study - Depression Substudy Phase 4
Completed NCT00921050 - Subclinical Hypothyroidism and Mind in the Elderly Phase 2/Phase 3
Completed NCT00535561 - Iron Deficiency Anemia Can be an Indication for Treatment of Subclinical Hypothyroidism Phase 1
Completed NCT00498238 - The Effect of Levothyroxine on Arterial Stiffness and Lipid Profile in Patients With Subclinical Hypothyroidism N/A
Completed NCT02061111 - NeoThyr - the Role of Mitochondria-dysfunction in Newborns of Mothers With Autoimmune Thyroid Disease
Completed NCT01832753 - Treatment Trial of Subclinical Hypothyroidism in Down Syndrome N/A
Completed NCT02399475 - Mechanistic Study of Subclinical Hypothyroidism In the Elderly N/A
Completed NCT00437931 - Color Flow Doppler Ultrasound in Subclinical Thyroid Dysfunction N/A