UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039377 |
|---|---|
| Receipt number | R000044902 |
| Scientific Title | A retrospective observational study of the development of retinopathy associated with pregnancy with impaired glucose tolerance in Japan using a medical fee claim database |
| Date of disclosure of the study information | 2020/02/03 |
| Last modified on | 2020/02/03 15:58:14 |
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Basic information
Public title
A retrospective observational study of the development of retinopathy associated with pregnancy with impaired glucose tolerance in Japan using a medical fee claim database
Acronym
A retrospective observational study of the development of retinopathy associated with pregnancy with impaired glucose tolerance in Japan
Scientific Title
A retrospective observational study of the development of retinopathy associated with pregnancy with impaired glucose tolerance in Japan using a medical fee claim database
Scientific Title:Acronym
A retrospective observational study of the development of retinopathy associated with pregnancy with impaired glucose tolerance in Japan
Region
| Japan |
Condition
Condition
carbohydrate metabolic disorders duri ng pregnancy
Classification by specialty
| Obstetrics and Gynecology | Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To Understand the actual situation of t he progression of retinopathy in carbo hydrate metabolic disorders during pregnancyusing a medical fee claim database.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Progression of diabetic retinopathy
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| 50 | years-old | > |
Gender
Female
Key inclusion criteria
Pregnant female with carbohydrate metabolic disorders during pregnancy who received examination in gynecology and ophthalmology during 1/1/2013 to 31/12/2017
Key exclusion criteria
*) Patient with ocular disease except diabetic retinopathy, unstable general condition
*)PI decide the patients as inappropriate.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Masahiko |
| Middle name | |
| Last name | Sugimoto |
Organization
Mie University Graduate School of Medicine
Division name
Department of Ophthalmology
Zip code
514-8507
Address
2-174, Edobashi, Tsu, Mie, Japan
TEL
0592315027
sugmochi@clin.medic.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | Masahiko |
| Middle name | |
| Last name | Sugimoto |
Organization
Mie University Graduate School of Medicine
Division name
Department of Ophthalmology
Zip code
514-8507
Address
2-174, Edobashi, Tsu, Mie, Japan
TEL
0592315027
Homepage URL
sugmochi@clin.medic.mie-u.ac.jp
Sponsor or person
Institute
Department of Ophthalmology, Mie University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Ophthalmology, Mie University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Mie University Graduate School of Medicine
Address
2-174, Edobashi, Tsu, Mie, Japan
Tel
0592315027
sugmochi@clin.medic.mie-u.ac.jp
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
| 2020 | Year | 02 | Month | 03 | 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
Preinitiation
Date of protocol fixation
| 2020 | Year | 02 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 02 | Month | 03 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2020 | Year | 02 | Month | 03 | Day |
Last modified on
| 2020 | Year | 02 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044902
