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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04936698
Other study ID # 202100365B0
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 16, 2021
Est. completion date March 2022

Study information

Verified date June 2021
Source Chang Gung Memorial Hospital
Contact Tai-ho Hung, PhD
Phone 886-2-27135211
Email thh20@cgmh.org.tw
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 2000
Est. completion date March 2022
Est. primary completion date March 2022
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria: - Pregnant women at first trimester (< 14 weeks of gestational age) Exclusion Criteria: - None

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
PTU 50 MG Oral Tablet
to treat if the patient has hyperthyroidism
Levothyroxin
to treat if the patient has hypothyroidism

Locations

Country Name City State
Taiwan Chang Gung Memorial hospital Taipei City

Sponsors (1)

Lead Sponsor Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
See also
  Status Clinical Trial Phase
Completed NCT03922087 - No-worry Baby Project