Upper Limit for TSH of First and Second Trimester Pregnan... | NCT03754621

Studies
Upper Limit for TSH of First and Second Trimester Pregnancy in Turkey

NCT03754621

Sponsor

Bartin State Hospital

Status

Unknown status

Last Update Posted

Apr 23, 2019Actual

Enrollment

400Estimated

Phase

Not provided

Conditions

Thyroid
Thyroid Dysfunction
Hypothyroidism
Pregnancy Early

Interventions

Serum thyroid functions tests

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 15, 2018Actual

Primary Completion Date

Jul 2, 2019Estimated

Completion Date

Jul 15, 2019Estimated

First Submitted Date

Nov 23, 2018

First Submission Date that Met QC Criteria

Nov 23, 2018

First Posted Date

Nov 27, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 21, 2019

Last Update Posted Date

Apr 23, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

400Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.	Diagnostic Test: Serum thyroid functions tests

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Serum thyroid functions tests	Diagnostic Test	Serum TSH, fT3, fT4 and anti-TPO	Pregnants

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
TSH	Serum TSH (mU/I)	Day 1

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Turkish pregnant women living in Bartin Region of Turkey

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Murat Yassa, MD	Contact	+905335106312		murat.yassa@gmail.com

Overall Officials

Name	Affiliation	Role
Murat Yassa, MD	Bartin State Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bartin State Hospital	Recruiting	Bartın			Turkey (Türkiye)

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29942352	Result	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.

ID	Term
D013959	Thyroid Diseases
D007037	Hypothyroidism