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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000027191
Receipt No. 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 2018/10/30

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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 Obsterics 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
Email 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
Email s-izawa@med.tottori-u.ac.jp

Sponsor
Institute Tottori University Hospital
Institute
Department

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
Email

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 No longer recruiting
Date of protocol fixation
2016 Year 03 Month 01 Day
Date of IRB
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
2019 Year 09 Month 30 Day

Other
Other related information None

Management information
Registered date
2017 Year 04 Month 29 Day
Last modified on
2018 Year 10 Month 30 Day


Link to view the page
URL(English) https://upload.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


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