ThyroidNCT03754621
Upper Limit for TSH of First and Second Trimester Pregnancy in Turkey
An observational study of Thyroid and Thyroid Dysfunction, run by Bartin State Hospital at 1 site in Turkey (Türkiye).
Trial summary
Physiological changes necessitate the use of pregnancy-specific reference ranges for TSH and FT4 to diagnose thyroid dysfunction during pregnancy. Although many centers use fixed upper limits for TSH of 2.5 or 3.0 mU/L, this may lead to overdiagnosis or even overtreatment. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Thyroid, Thyroid Dysfunction, Hypothyroidism
- What is being tested?
- Serum thyroid functions tests
- How many people
- 400 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Oct 2018to 15 Jul 2019
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Turkish pregnant women living in Bartin Region of Turkey
Who may be able to join
- Singleton pregnancy
- Free of pre-existing thyroid disease
- That do not use thyroid interfering medication
- That did not undergo IVF treatment
- TPOAb negative
Who cannot join
- Adolescent pregnancy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Bartin State Hospital
Bartın
Murat Yassa, MD
About this study
Official title: What is the Rational Upper Limit for TSH and T4 During First and Second Trimester Pregnancy in West Black Sea Region of Turkey
Physiological changes necessitate the use of pregnancy-specific reference ranges for TSH and FT4 to diagnose thyroid dysfunction during pregnancy. Although many centers use fixed upper limits for TSH of 2.5 or 3.0 mU/L, this may lead to overdiagnosis or even overtreatment.
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 diagnosis of subclinical hypothyroidism in the first and second trimester of pregnant women in west Black Sea region in Turkey.
Read the detailed description
Serum thyroid function tests (including T3, T4, TSH, Anti-TPO) will be obtained from the singleton pregnancies in first and second trimester to determine the local specific normal ranges.
- Conditions
- Thyroid, Thyroid Dysfunction, Hypothyroidism, Pregnancy Early
- Being tested
- Serum thyroid functions tests
- Keywords
- TSH
- Medical subject headings
- Thyroid Diseases, Hypothyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum thyroid functions testsDiagnostic test
Serum TSH, fT3, fT4 and anti-TPO
| Study group | Role | What they receive |
|---|---|---|
| Pregnants | 400 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 functions tests will be obtained on the first visit. Receives: Diagnostic Test: Serum thyroid functions tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
TSH
Serum TSH (mU/I)
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2018
- Study start15 Oct 2018
- Primary completion2 Jul 2019 (estimated)
- Study completion15 Jul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ThyroidStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bartin State Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Murat Yassa, Bartin State Hospital
- Investigators
- Murat Yassa, MD, Principal investigator, Bartin State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03754621
- Sponsor's protocol ID
- IlSaglik2018-2
- Status last verified
- Apr 2019
- First submitted
- 23 Nov 2018
- Last updated
- 23 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Korevaar TIM. The upper limit for TSH during pregnancy: why we should stop using fixed limits of 2.5 or 3.0 mU/l. Thyroid Res. 2018 May 21;11:5. doi: 10.1186/s13044-018-0048-7. eCollection 2018.
PubMed 29942352
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What is the Rational Upper Limit for TSH and T4 During First and Second Trimester Pregnancy in West Black Sea Region of Turkey
- ClinicalTrials.gov ID
- NCT03754621
- Acronym / sponsor ID
- IlSaglik2018-2
- Conditions
- Thyroid, Thyroid Dysfunction, Hypothyroidism, Pregnancy Early
- Keywords
- TSH
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Bartin State HospitalOther government
- Study start
- 15 Oct 2018 (actual)
- Primary completion
- 2 Jul 2019 (estimated)
- Study completion
- 15 Jul 2019 (estimated)
- First posted
- 27 Nov 2018 (actual)
- 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.
Physiological changes necessitate the use of pregnancy-specific reference ranges for TSH and FT4 to diagnose thyroid dysfunction during pregnancy. Although many centers use fixed upper limits for TSH of 2.5 or 3.0 mU/L, this may lead to overdiagnosis or even overtreatment.
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 diagnosis of subclinical hypothyroidism in the first and second trimester of pregnant women in west Black Sea region in Turkey.
Detailed description
Serum thyroid function tests (including T3, T4, TSH, Anti-TPO) will be obtained from the singleton pregnancies in first and second trimester to determine the local specific normal ranges.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnants | – | Diagnostic Test: Serum thyroid functions tests400 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 functions tests will be obtained on the first visit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Turkish pregnant women living in Bartin Region of Turkey
Key inclusion criteria (5 listed)
- Singleton pregnancy
- Free of pre-existing thyroid disease
- That do not use thyroid interfering medication
- That did not undergo IVF treatment
- TPOAb negative
Key exclusion criteria (1 listed)
- Adolescent pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Serum thyroid functions testsSerum TSH, fT3, fT4 and anti-TPO | Diagnostic test | Pregnants |
Primary outcome
TSH
Time frame: Day 1
Serum TSH (mU/I)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2019.
- Results publication: PubMed 29942352Korevaar TIM. The upper limit for TSH during pregnancy: why we should stop using fixed limits of 2.5 or 3.0 mU/l. Thyroid Res. 2018 May 21;11:5. doi: 10.1186/s13044-018-0048-7. eCollection 2018.
- Individual participant dataSharing planned: Undecided
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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.
Murat Yassa, MD principal investigator
Bartin State Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroid and Thyroid Dysfunction, run by Bartin State Hospital at 1 site in Turkey (Türkiye).
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 5 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 23 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Murat Yassa, MD (+905335106312, murat.yassa@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TSH (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03754621, which also lists 1 linked publication.
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 23 Apr 2019.