Upper Limit for TSH of First and Second Trimester Pregnancy in Turkey
What is the Rational Upper Limit for TSH and T4 During First and Second Trimester Pregnancy in West Black Sea Region of Turkey
1 other identifier
observational
400
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2018
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 15, 2018
CompletedFirst Submitted
Initial submission to the registry
November 23, 2018
CompletedFirst Posted
Study publicly available on registry
November 27, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 2, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 15, 2019
CompletedApril 23, 2019
April 1, 2019
9 months
November 23, 2018
April 21, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
TSH
Serum TSH (mU/I)
Day 1
Study Arms (1)
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.
Interventions
Eligibility Criteria
Turkish pregnant women living in Bartin Region of Turkey
You may qualify if:
- Singleton pregnancy
- Free of pre-existing thyroid disease
- That do not use thyroid interfering medication
- That did not undergo IVF treatment
- TPOAb negative
You may not qualify if:
- Adolescent pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bartin State Hospital
Bartın, Turkey (Türkiye)
Related Publications (1)
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.
PMID: 29942352RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Murat Yassa, MD
Bartin State Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 23, 2018
First Posted
November 27, 2018
Study Start
October 15, 2018
Primary Completion
July 2, 2019
Study Completion
July 15, 2019
Last Updated
April 23, 2019
Record last verified: 2019-04