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

• Conditions: Thyroid Disease Pregnancy
• Interventions: Drug: PTU 50 MG Oral Tablet; Drug: Levothyroxin

• Registration Number: NCT04936698
• Lead Sponsor: Chang Gung Memorial Hospital

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 available

Study Timeline

• Status Verified: 2021-06
• Study First Submitted: 2021-06-17
• Study First Submitted QC: 2021-06-21
• Study First Posted: 2021-06-23
• Study Start: 2021-07-16
• Last Update Submitted: 2021-08-12
• Last Update Posted: 2021-08-16
• Primary Completion: 2022-03
• Study Completion: 2022-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 2000

Inclusion Criteria

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

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Exclusion Criteria

• None

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hyperthyroidism	PTU 50 MG Oral Tablet	Elevated fT4, low TSH
Hypothyroidism	Levothyroxin	Elevated TSH, low fT4

Primary Outcome Measures

Name	Time	Method
The prevalence thyroid dysfunction	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.

Trial Locations

Locations (1)

Chang Gung Memorial hospital; 🇨🇳 Taipei City, Taiwan