Thyroid Disease PregnancyNCT04936698
The Prevalence and Risk Factors for Thyroid Dysfunction in Pregnant Women in Taiwan
An observational study of Thyroid Disease Pregnancy, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Thyroid Disease Pregnancy
- What is being tested?
- PTU 50 MG Oral Tablet and Levothyroxin
- Type of treatment
- Pill or oral medicine
- How many people
- 2,000 participants
- Where
- 1 siteTaiwan
- Study dates
- 16 Jul 2021to Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Study population: Pregnant women at their first trimester of pregnancy may be enrolled.
Who may be able to join
- Pregnant women at first trimester (< 14 weeks of gestational age)
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung Memorial hospital
Taipei, 105
Chen Ai Sung, M.D., 886-9-78835376, faithdafatty@gmail.com
About this study
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.
- Conditions
- Thyroid Disease Pregnancy
- Being tested
- PTU 50 MG Oral Tablet, Levothyroxin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PTU 50 MG Oral TabletDrug
to treat if the patient has hyperthyroidism
LevothyroxinDrug
to treat if the patient has hypothyroidism
| Study group | Role | What they receive |
|---|---|---|
| Hyperthyroidism | Elevated fT4, low TSH Receives: Drug: PTU 50 MG Oral Tablet | |
| Hypothyroidism | Elevated TSH, low fT4 Receives: Drug: Levothyroxin | |
| Euthyroid | Normal TSH/fT4 level |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 40 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2021
- Study start16 Jul 2021
- Primary completionMar 2022 (estimated)
- Study completionMar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid Disease PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04936698
- Sponsor's protocol ID
- 202100365B0
- Status last verified
- Jun 2021
- First submitted
- 17 Jun 2021
- Last updated
- 16 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The decision will be made once the study is completed.
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prevalence and Risk Factors for Thyroid Dysfunction in Pregnant Women in Taiwan
- ClinicalTrials.gov ID
- NCT04936698
- Acronym / sponsor ID
- 202100365B0
- Conditions
- Thyroid Disease Pregnancy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 16 Jul 2021 (actual)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- Mar 2022 (estimated)
- First posted
- 23 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hyperthyroidism | – | Drug: PTU 50 MG Oral TabletElevated fT4, low TSH |
| Hypothyroidism | – | Drug: LevothyroxinElevated TSH, low fT4 |
| Euthyroid | – | –Normal TSH/fT4 level |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Pregnant women at their first trimester of pregnancy may be enrolled.
Key inclusion criteria (1 listed)
- Pregnant women at first trimester (< 14 weeks of gestational age)
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PTU 50 MG Oral Tabletto treat if the patient has hyperthyroidism | Drug | Hyperthyroidism |
| Levothyroxinto treat if the patient has hypothyroidism | Drug | Hypothyroidism |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2021.
- Individual participant dataSharing planned: Undecided. The decision will be made once the study is completed.
Related trials for Thyroid Disease Pregnancy
Not yet recruiting
MYTP01 for Immune-Mediated Diseases
IgA Nephropathy, Kidney Transplant Recipients
Enrolling by invitationPhase 3
Long-Term Extension Study for Participants Previously Enrolled in an Exelixis-Sponsored Study
Cancer, Renal Cell Carcinoma (RCC)
Not yet recruitingPhase 1
Study of ACC-1898 in Adult Participants With Advanced Solid Tumors
Hepatocellular Carcinoma, Renal Cell Carcinoma
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Active, not recruitingPhase 2
Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroid Disease Pregnancy, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tai-ho Hung, PhD (886-2-27135211 ext. 3179, thh20@cgmh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The prevalence thyroid dysfunction (time frame: 40 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2021.