UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027191 |
|---|---|
| Receipt number | R000024532 |
| Scientific Title | A Retrospective Observational Study for Subclinical Thyroid Disease Diagnosed during Pregnancy (Tottori, Japan) |
| Date of disclosure of the study information | 2017/05/01 |
| Last modified on | 2023/03/21 14:47:10 |
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Basic information
Public title
A Retrospective Observational Study for Subclinical Thyroid Disease Diagnosed during Pregnancy (Tottori, Japan)
Acronym
SCHP-T
Scientific Title
A Retrospective Observational Study for Subclinical Thyroid Disease Diagnosed during Pregnancy (Tottori, Japan)
Scientific Title:Acronym
SCHP-T
Region
| Japan |
Condition
Condition
Subclinical thyroid disease during pregnancy
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Understanding pathogenesis and clinical significance of serum TSH abnormality diagnosed in early pregnancy.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
1. Understanding the pathogenesis of subclinical thyroid diseases in early pregnancy.
2. Clinical outcome of pregnancy and complications associated with subclinical thyroid diseases.
Key secondary outcomes
1) Incidence and clinical significance of subclinical thyroid disease in early pregnancy.
2) Levothyroxine treatment for subclinical hypothyroidism.
3) Reproducibility of serum TSH level in repeated pregnancy.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 45 | years-old | >= |
Gender
Female
Key inclusion criteria
Pregnant women who examined serum TSH level in first trimester and observed by the childbirth.
Key exclusion criteria
1) Past medical history of thyroid disease
2) Abortion except for medical reasons
3) Others
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shoichiro Izawa |
Organization
Tottori University Hospital
Division name
Endocrinology and Metabolism
Zip code
Address
36-1, Nishi-cho, Yonago, JAPAN
TEL
0859-38-6517
s-izawa@med.tottori-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shoichiro Izawa |
Organization
Tottori University Hospital
Division name
Endocrinology and Metabolism
Zip code
Address
36-1, Nishi-cho, Yonago, JAPAN
TEL
0859-38-6517
Homepage URL
s-izawa@med.tottori-u.ac.jp
Sponsor or person
Institute
Tottori University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 05 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 04 | Month | 12 | Day |
Anticipated trial start date
| 2017 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2018 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2022 | Year | 03 | Month | 31 | Day |
Other
Other related information
None
Management information
Registered date
| 2017 | Year | 04 | Month | 29 | Day |
Last modified on
| 2023 | Year | 03 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024532
| Research Plan | |
|---|---|
| Registered date | File name |
| 2017/10/29 | （妊娠初期甲状腺検査）研究計画書第2版.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
