The Prevalence and Risk Factors for Thyroid Dysfunction i... | NCT04936698

Studies
The Prevalence and Risk Factors for Thyroid Dysfunction in Pregnant Women in Taiwan

NCT04936698

Sponsor

Chang Gung Memorial Hospital

Status

Unknown status

Last Update Posted

Aug 16, 2021Actual

Enrollment

2,000Estimated

Phase

Not provided

Conditions

Thyroid Disease Pregnancy

Interventions

PTU 50 MG Oral Tablet
Levothyroxin

Countries

Taiwan

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

Jun 2021

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

Jul 16, 2021Actual

Primary Completion Date

Mar 2022Estimated

Completion Date

Mar 2022Estimated

First Submitted Date

Jun 17, 2021

First Submission Date that Met QC Criteria

Jun 21, 2021

First Posted Date

Jun 23, 2021Actual

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

Aug 12, 2021

Last Update Posted Date

Aug 16, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

The investigators' aim is to enroll around 2000 patients from Taipei, Keelung, Linkou, Chiayi and Kaohsiung CGMH. All participants will receive universal thyroid function screening at 1st trimester, and those who was found to have hyperthyroidism or hypothyroidism will be referred to Endocrine department for further treatment. All participants will be followed at outpatient clinic, and their obstetric visit finding will be recorded. The maternal and neonatal outcomes will be analyzed.

Detailed Description

Not provided

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

2,000Estimated

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
Hyperthyroidism	Elevated fT4, low TSH	Drug: PTU 50 MG Oral Tablet
Hypothyroidism	Elevated TSH, low fT4	Drug: Levothyroxin
Euthyroid	Normal TSH/fT4 level

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PTU 50 MG Oral Tablet	Drug	to treat if the patient has hyperthyroidism	Hyperthyroidism

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The prevalence thyroid dysfunction	Hypothyroidism: defined as serum TSH > 2.5U/mL and decreased fT4; Hyperthyroidism: defined as fT4 > normal range and TSH undetectable * Serum free T4 range varies according to trimesters.	40 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Pregnant women at first trimester (< 14 weeks of gestational age)

Exclusion Criteria:

None

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Pregnant women at their first trimester of pregnancy may be enrolled.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Tai-ho Hung, PhD	Contact	886-2-27135211	3179	thh20@cgmh.org.tw
Chen-ai Sung, MD	Contact	886-2-27135211	3410	pgy1105@cgmh.org.tw

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chang Gung Memorial hospital	Recruiting	Taipei		105	Taiwan

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

The decision will be made once the study is completed.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013607	Tablets
D013974	Thyroxine

Ancestor Terms

ID	Term
D004304	Dosage Forms
D004364	Pharmaceutical Preparations
D013963	Thyroid Hormones
D006728	Hormones

Browse Leaves

Not provided

Browse Branches

Not provided