Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
528 participants
OBSERVATIONAL
2021-04-01
2021-09-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The new guidelines of the American Thyroid Association have considerably changed recommendations regarding thyroid function reference ranges in pregnancy accordingly. Any hospital or physician that is still using the 2.5 or 3.0 mU/l cut-off for TSH during pregnancy should evaluate their own lab-specific cut-offs.
The investigator's objective is to establish a rational reference range of serum TSH for the diagnosis of subclinical hypothyroidism in the first, second, and third trimester of pregnant women in the Sancaktepe region in Turkey.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Upper Limit for TSH of First and Second Trimester Pregnancy in Turkey
NCT03754621
Gestational Age Specific Thyroid Function Reference Range
NCT03663517
The Establish of Specific Reference Ranges for Thyroid Tests in Pregnant Women
NCT02966405
Thyroid Stimulating Hormone (TSH) Level Variations in Early Pregnancy
NCT04565873
Maternal Thyroid Function in Early Pregnancy and Their Relationship With Gestational Diabetes Mellitus
NCT02555332
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Pregnant women
500 pregnant women with a singleton pregnancy, free of pre-existing thyroid disease, that do not use thyroid interfering medication, that did not undergo IVF treatment, and are TPOAb negative. Serum thyroid function tests will be obtained on the first visit.
Serum thyroid function tests
At the first hospital visit, the blood tests will be made for TSH, FT4, FT3, and beta HCG concentration measurement
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Serum thyroid function tests
At the first hospital visit, the blood tests will be made for TSH, FT4, FT3, and beta HCG concentration measurement
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Free of pre-existing thyroid disease
* That do not use thyroid interfering medication
* That did not undergo IVF treatment
* TPOAb negative
Exclusion Criteria
* Patient with pre-existing thyroid disease
* TPOAb positive
* Patient using thyroid interfering medication
* That had IVF treatment
18 Years
50 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Arzu Bilge Tekin
Specialist M.D.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Murat Yassa, MD
Role: PRINCIPAL_INVESTIGATOR
Specialist
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Sehit Prof Dr Ilhan Varank Sancaktepe Training and Research Hospital
Istanbul, , Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Alexander EK, Pearce EN, Brent GA, Brown RS, Chen H, Dosiou C, Grobman WA, Laurberg P, Lazarus JH, Mandel SJ, Peeters RP, Sullivan S. 2017 Guidelines of the American Thyroid Association for the Diagnosis and Management of Thyroid Disease During Pregnancy and the Postpartum. Thyroid. 2017 Mar;27(3):315-389. doi: 10.1089/thy.2016.0457.
Panesar NS, Li CY, Rogers MS. Reference intervals for thyroid hormones in pregnant Chinese women. Ann Clin Biochem. 2001 Jul;38(Pt 4):329-32. doi: 10.1258/0004563011900830.
Donovan LE, Metcalfe A, Chin A, Yamamoto JM, Virtanen H, Johnson JA, Krause R. A Practical Approach for the Verification and Determination of Site- and Trimester-Specific Reference Intervals for Thyroid Function Tests in Pregnancy. Thyroid. 2019 Mar;29(3):412-420. doi: 10.1089/thy.2018.0439. Epub 2019 Feb 4.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NR TSH TURKEY
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.