NCT04936698

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 17, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 23, 2021

Completed
23 days until next milestone

Study Start

First participant enrolled

July 16, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

August 16, 2021

Status Verified

June 1, 2021

Enrollment Period

8 months

First QC Date

June 17, 2021

Last Update Submit

August 12, 2021

Conditions

Thyroid Disease Pregnancy

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

Hyperthyroidism

Elevated fT4, low TSH

Drug: PTU 50 MG Oral Tablet

Hypothyroidism

Elevated TSH, low fT4

Drug: Levothyroxin

Euthyroid

Normal TSH/fT4 level

Interventions

PTU 50 MG Oral TabletDRUG

to treat if the patient has hyperthyroidism

Hyperthyroidism
LevothyroxinDRUG

to treat if the patient has hypothyroidism

Hypothyroidism

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung Memorial hospital

Taipei, 105, Taiwan

RECRUITING

MeSH Terms

Interventions

TabletsThyroxine

Intervention Hierarchy (Ancestors)

Dosage FormsPharmaceutical PreparationsThyroid HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsAmino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and Proteins

Central Study Contacts

Tai-ho Hung, PhD

CONTACT

886-2-27135211thh20@cgmh.org.tw

Chen-ai Sung, MD

CONTACT

886-2-27135211pgy1105@cgmh.org.tw

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2021

First Posted

June 23, 2021

Study Start

July 16, 2021

Primary Completion

March 1, 2022

Study Completion

March 1, 2022

Last Updated

August 16, 2021

Record last verified: 2021-06

Locations

TW(1)