Subclinical HypothyroidismPRECIOUSNCT03036956
The Prevalence of Sub Clinical Hypothyroidism During Early Pregnancy in Pakistan
An observational study of Subclinical Hypothyroidism, run by Abbott at 9 sites in Pakistan.
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 Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Subclinical Hypothyroidism
- How many people
- 500 participants
- Where
- 9 sitesPakistan
- Study dates
- Jan 2017to Jan 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Primary Care Clinic/Private Clinic
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Pakistan9 sites
Isra University hospital
Hyderābād, 71800
Pakistam Insititute of Medical science
Islamabad, 144001
Atia Hospital Hospital
Karachi, 75100
Boluvard Hospital
Karachi, 75500
MediCell Hospital
Karachi, 75500
Services Hospital
Lahore, 54000
Sir Ganga Ram hospital
Lahore, 54000
Welcare Medical Centre
Muzafferabad, Azad Kashmir, 13100
Lady Reading hospital
Peshawar, 25000
About this study
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (1)
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionJan 2018
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subclinical HypothyroidismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Dimension Research
- Responsible party
- Sponsor
- Investigators
- Raeefuddin Ahmed, MD, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03036956
- Sponsor's protocol ID
- EPIDI051
- Acronym
- PRECIOUS
- Status last verified
- Mar 2018
- First submitted
- 26 Jan 2017
- Last updated
- 14 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prevalence of Sub Clinical Hypothyroidism During Early Pregnancy in Pakistan
- ClinicalTrials.gov ID
- NCT03036956
- Acronym / sponsor ID
- PRECIOUS / EPIDI051
- Conditions
- Subclinical Hypothyroidism
- Keywords
- subclinical hypothyroidism in pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Collaborators
- Dimension Research
- Study start
- Jan 2017 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 31 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Primary Care Clinic/Private Clinic
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (13 listed)
- Patients suffering from any
- Subjects with history of non-thyroid malignancy
- Patient currently taking medication for hyperthyroidism
- Active systemic infection
- Patient with physical or mental impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
The risk factors that might be associated with subclinical hypothyroidism in all enrolled pregnant patients.
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raeefuddin Ahmed, MD study director
Abbott
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Subclinical Hypothyroidism, run by Abbott at 9 sites in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of subclinical hypothyroidism in pregnant females (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2018.