HypothyroidismNRTSHTURKEYNCT04860622
Normal Range of TSH and FT4 in Pregnancy
An observational study of Hypothyroidism and Pregnancy Related, run by Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Physiological changes necessitate the use of pregnancy-specific reference ranges for thyrotrophin (TSH) and free T4 (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 to 50 years, women only
- Conditions the study is for
- Hypothyroidism, Pregnancy Related, Thyroid
- What is being tested?
- Serum thyroid function tests
- How many people
- 528 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2021to 1 Sep 2021
- How long will I take part?
- 3 Months
- 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 50 years
- Women only
- Adult
Study population: Turkish pregnant women living in Sancaktepe 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
- Patient with pre-existing thyroid disease
- TPOAb positive
- Patient using thyroid interfering medication
- That had IVF treatment
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sehit Prof Dr Ilhan Varank Sancaktepe Training and Research Hospital
Istanbul
About this study
Physiological changes necessitate the use of pregnancy-specific reference ranges for thyrotrophin (TSH) and free T4 (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 the diagnosis of subclinical hypothyroidism in the first, second, and third trimester of pregnant women in the Sancaktepe 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 the first, second, and third trimester to determine the local specific normal ranges.
- Conditions
- Hypothyroidism, Pregnancy Related, Thyroid, Dysfunction, Iodine Deficiency
- Being tested
- Serum thyroid function tests
- Keywords
- Hypothyroidism, Pregnancy, trimester, thyroid dysfunction, iodine level
- Medical subject headings
- Hypothyroidism, Thyroid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum thyroid function testsDiagnostic test
Also called Beta HCG and thyroid peroxidase antibody, Thyroid ultrasonography
At the first hospital visit, the blood tests will be made for TSH, FT4, FT3, and beta HCG concentration measurement
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Serum thyroid function tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
TSH
Trimester specific TSH level
Measured: On day 1
Secondary outcomes (1)
free T4
Trimester specific free T4 level
Measured: On 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 Apr 2021
- Study start1 Apr 2021
- Primary completion15 Aug 2021
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for 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
- 528 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arzu Bilge Tekin, Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
- Investigators
- Murat Yassa, MD, Principal investigator, Specialist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04860622
- Sponsor's protocol ID
- NR TSH TURKEY
- Acronym
- NRTSHTURKEY
- Status last verified
- Sep 2021
- First submitted
- 22 Apr 2021
- Last updated
- 29 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 28056690Panesar 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.
PubMed 11471873Donovan 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.
PubMed 30595114
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Normal Range of TSH and FT4 in Pregnancy
- ClinicalTrials.gov ID
- NCT04860622
- Acronym / sponsor ID
- NRTSHTURKEY / NR TSH TURKEY
- Conditions
- Hypothyroidism, Pregnancy Related, Thyroid, Dysfunction, Iodine Deficiency
- Keywords
- Hypothyroidism, Pregnancy, trimester, thyroid dysfunction, iodine level
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 528 participants (actual)
- Lead sponsor
- Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 15 Aug 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 27 Apr 2021 (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 thyrotrophin (TSH) and free T4 (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 the diagnosis of subclinical hypothyroidism in the first, second, and third trimester of pregnant women in the Sancaktepe region in Turkey.
Detailed description
Serum thyroid function tests (including T3, T4, TSH, Anti-TPO) will be obtained from the singleton pregnancies in the first, second, and third trimester to determine the local specific normal ranges.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant women | – | Diagnostic Test: Serum thyroid function tests500 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Turkish pregnant women living in Sancaktepe 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 (5 listed)
- Adolescent pregnancy
- Patient with pre-existing thyroid disease
- TPOAb positive
- Patient using thyroid interfering medication
- That had IVF treatment
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 function testsAlso: Beta HCG and thyroid peroxidase antibody, Thyroid ultrasonographyAt the first hospital visit, the blood tests will be made for TSH, FT4, FT3, and beta HCG concentration measurement | Diagnostic test | Pregnant women |
Primary outcome
TSH
Time frame: On day 1
Trimester specific TSH level
1 secondary outcome
free T4
Time frame: On day 1
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 29 Sep 2021.
- Background: PubMed 28056690Alexander 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.
- Background: PubMed 11471873Panesar 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.
- Background: PubMed 30595114Donovan 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.
- 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
Specialist
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 Hypothyroidism and Pregnancy Related, run by Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research 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 5 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 29 Sep 2021. 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?
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?
TSH (time frame: On 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 NCT04860622, which also lists 3 linked publications.
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 29 Sep 2021.