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

NCT ID: NCT04936698

Last Updated: 2021-08-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-07-16

Study Completion Date

2022-03-31

Brief Summary

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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

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Conditions

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Thyroid Disease Pregnancy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Hyperthyroidism

Elevated fT4, low TSH

PTU 50 MG Oral Tablet

Intervention Type DRUG

to treat if the patient has hyperthyroidism

Hypothyroidism

Elevated TSH, low fT4

Levothyroxin

Intervention Type DRUG

to treat if the patient has hypothyroidism

Euthyroid

Normal TSH/fT4 level

No interventions assigned to this group

Interventions

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PTU 50 MG Oral Tablet

to treat if the patient has hyperthyroidism

Intervention Type DRUG

Levothyroxin

to treat if the patient has hypothyroidism

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* None
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chang Gung Memorial hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Tai-ho Hung, PhD

Role: CONTACT

886-2-27135211 ext. 3179

Chen-ai Sung, MD

Role: CONTACT

886-2-27135211 ext. 3410

Facility Contacts

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Chen Ai Sung, M.D.

Role: primary

886-9-78835376

Other Identifiers

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202100365B0

Identifier Type: -

Identifier Source: org_study_id

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