Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2026-04-23 @ 8:36 AM
Study NCT ID:
NCT03036956
Status:
COMPLETED
Last Update Posted:
2018-03-14
First Post:
2017-01-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Prevalence of Sub Clinical Hypothyroidism During Early Pregnancy in Pakistan
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2018-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-13', 'studyFirstSubmitDate': '2017-01-26', 'studyFirstSubmitQcDate': '2017-01-26', 'lastUpdatePostDateStruct': {'date': '2018-03-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of subclinical hypothyroidism in pregnant females', 'timeFrame': '12 months', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'The risk factors that might be associated with subclinical hypothyroidism in all enrolled pregnant patients.', 'timeFrame': '12 months', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['subclinical hypothyroidism in pregnancy'], 'conditions': ['Subclinical Hypothyroidism']}, 'descriptionModule': {'briefSummary': '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'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Primary Care Clinic/Private Clinic', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects must meet all of the following criteria to be enrolled into the study\n* Patient between 18-45 years of age; is pregnant and in First Trimester\n* Patient willing to give blood sample for laboratory testing\n* Patient willing to provide written authorization to obtain data for the study\n* Exclusion Criteria:\n* Patients suffering from any\n\n * Chronic Cardiac Disease - Chronic Cardiac Failure, Cardiac Arrhythmia\n * Hepatic Disorder : Cirrhosis\n * Renal Disease : Patients on dialysis and Transplant Therapy\n * Respiratory Disorder\n* Subjects with history of non-thyroid malignancy\n* Patient currently taking medication for hyperthyroidism\n* Active systemic infection\n* Patient with physical or mental impairment\n* Patients on systemic steroid therapy or lithium therapy\n* Patients in second or third trimester of pregnancy\n* Patient not willing to give blood sample for laboratory testing\n* Patient not willing to provide written authorization to obtain data for the study'}, 'identificationModule': {'nctId': 'NCT03036956', 'acronym': 'PRECIOUS', 'briefTitle': 'The Prevalence of Sub Clinical Hypothyroidism During Early Pregnancy in Pakistan', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott'}, 'officialTitle': 'The Prevalence of Sub Clinical Hypothyroidism During Early Pregnancy in Pakistan', 'orgStudyIdInfo': {'id': 'EPIDI051'}}, 'contactsLocationsModule': {'locations': [{'zip': '71800', 'city': 'Hyderābād', 'country': 'Pakistan', 'facility': 'Isra University hospital', 'geoPoint': {'lat': 25.39689, 'lon': 68.37718}}, {'zip': '144001', 'city': 'Islamabad', 'country': 'Pakistan', 'facility': 'Pakistam Insititute of Medical science', 'geoPoint': {'lat': 33.72148, 'lon': 73.04329}}, {'zip': '75100', 'city': 'Karachi', 'country': 'Pakistan', 'facility': 'Atia Hospital Hospital', 'geoPoint': {'lat': 24.8608, 'lon': 67.0104}}, {'zip': '75500', 'city': 'Karachi', 'country': 'Pakistan', 'facility': 'Boluvard Hospital', 'geoPoint': {'lat': 24.8608, 'lon': 67.0104}}, {'zip': '75500', 'city': 'Karachi', 'country': 'Pakistan', 'facility': 'MediCell Hospital', 'geoPoint': {'lat': 24.8608, 'lon': 67.0104}}, {'zip': '54000', 'city': 'Lahore', 'country': 'Pakistan', 'facility': 'Services Hospital', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}, {'zip': '54000', 'city': 'Lahore', 'country': 'Pakistan', 'facility': 'Sir Ganga Ram hospital', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}, {'zip': '13100', 'city': 'Muzafferabad, Azad Kashmir', 'country': 'Pakistan', 'facility': 'Welcare Medical Centre'}, {'zip': '25000', 'city': 'Peshawar', 'country': 'Pakistan', 'facility': 'Lady Reading hospital', 'geoPoint': {'lat': 34.008, 'lon': 71.57849}}], 'overallOfficials': [{'name': 'Raeefuddin Ahmed, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Abbott'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Dimension Research', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}