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

August 12, 2021 updated by: Chang Gung Memorial Hospital
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Taiwan
      • Taipei City, Taiwan, 105
        • Recruiting
        • Chang Gung Memorial Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Hyperthyroidism
Elevated fT4, low TSH
Drug: PTU 50 MG Oral Tablet
to treat if the patient has hyperthyroidism
Hypothyroidism
Elevated TSH, low fT4
Drug: Levothyroxin
to treat if the patient has hypothyroidism
Euthyroid
Normal TSH/fT4 level

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The prevalence thyroid dysfunction
Time Frame: 40 weeks

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 16, 2021

Primary Completion (Anticipated)

March 1, 2022

Study Completion (Anticipated)

March 1, 2022

Study Registration Dates

First Submitted

June 17, 2021

First Submitted That Met QC Criteria

June 21, 2021

First Posted (Actual)

June 23, 2021

Study Record Updates

Last Update Posted (Actual)

August 16, 2021

Last Update Submitted That Met QC Criteria

August 12, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202100365B0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The decision will be made once the study is completed.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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