Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04860622
Other study ID # NR TSH TURKEY
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 1, 2021
Est. completion date September 1, 2021

Study information

Verified date September 2021
Source Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 528
Est. completion date September 1, 2021
Est. primary completion date August 15, 2021
Accepts healthy volunteers
Gender Female
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria: - Singleton pregnancy - Free of pre-existing thyroid disease - That do not use thyroid interfering medication - That did not undergo IVF treatment - TPOAb negative Exclusion Criteria: - Adolescent pregnancy - Patient with pre-existing thyroid disease - TPOAb positive - Patient using thyroid interfering medication - That had IVF treatment

Study Design


Intervention

Diagnostic Test:
Serum thyroid function tests
At the first hospital visit, the blood tests will be made for TSH, FT4, FT3, and beta HCG concentration measurement

Locations

Country Name City State
Turkey Sehit Prof Dr Ilhan Varank Sancaktepe Training and Research Hospital Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. Erratum in: Thyroid. 2017 Sep;27(9):1212. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary TSH Trimester specific TSH level On day 1
Secondary free T4 Trimester specific free T4 level On day 1
See also
  Status Clinical Trial Phase
Completed NCT05017974 - Research on Improving Sleep During Pregnancy N/A
Completed NCT03284515 - Vaccination In Pregnancy Gene Signature: VIP Signature Study
Recruiting NCT05969795 - Comparison of Live Birth Rate in Natural Cycle Single Euploid FET Versus Without Luteal Phase Support Phase 1
Recruiting NCT06051201 - Innovation for Small-scale Experiments: ReceptIVFity Test N/A
Recruiting NCT04828382 - Prospective Study of Pregnancy in Women With Cystic Fibrosis
Enrolling by invitation NCT04527926 - STEPuP: Prenatal Provider Education and Training to Improve Medication-assisted Treatment Use During Pregnancy N/A
Recruiting NCT04278651 - Early Antenatal Support for Iron Deficiency Anemia Phase 4
Recruiting NCT04405700 - Measuring Adverse Pregnancy and Newborn Congenital Outcomes
Recruiting NCT06258902 - Odevixibat Pregnancy and Lactation Surveillance Program: A Study to Evaluate the Safety of Odevixibat During Pregnancy and/or Lactation
Completed NCT05487196 - Effectiveness of Clonidine, Dexmedetomidine, and Fentanyl Adjuncts for Labor Epidural Analgesia Phase 2
Completed NCT03750968 - Lutein & Zeaxanthin in Pregnancy - Carotenoid Supplementation During Pregnancy: Ocular and Systemic Effects Phase 2
Enrolling by invitation NCT06127277 - Next4You: A Fully Mobile Relationships Based Program for Youth in Foster Care N/A
Completed NCT05897697 - Assessing Women's Preferences for Postpartum Thromboprophylaxis: the Prefer-Postpartum Study
Recruiting NCT05899101 - The Impact of Opioid and Cannabis Exposure on Fetal Growth
Completed NCT05502510 - Assessing the Effectiveness and Efficacy of the MyHealthyPregnancy Application
Completed NCT04296396 - Opioid Prescription After Cesarean Trial Phase 3
Not yet recruiting NCT06069856 - Multiple Micronutrient Supplementation (MMS) IFA- Iron Dose Acceptability Crossover Trial Phase 3
Not yet recruiting NCT06069869 - Multiple Micronutrient Supplementation (MMS) Iron Dose Acceptability Crossover Trial Phase 3
Not yet recruiting NCT06079918 - Multiple Micronutrient Supplementation for Maternal Anemia Prevention in Tanzania Phase 3
Not yet recruiting NCT06163651 - Evaluating a One-Year Version of the Parent-Child Assistance Program N/A