UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037670 |
|---|---|
| Receipt number | R000042961 |
| Scientific Title | A nationwide survey on the progression of retinopathy in carbohydrate metabolic disorders during pregnancy |
| Date of disclosure of the study information | 2019/08/13 |
| Last modified on | 2019/08/13 08:05:20 |
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Basic information
Public title
A nationwide survey on the progression of retinopathy in carbohydrate metabolic disorders during pregnancy
Acronym
The progression of retinopathy in carbohydrate metabolic disorders during pregnancy
Scientific Title
A nationwide survey on the progression of retinopathy in carbohydrate metabolic disorders during pregnancy
Scientific Title:Acronym
The progression of retinopathy in carbohydrate metabolic disorders during pregnancy
Region
| Japan |
Condition
Condition
carbohydrate metabolic disorders during pregnancy
Classification by specialty
| Obstetrics and Gynecology | Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To Understand the actual situation of the progression of retinopathy in carbohydrate metabolic disorders during pregnancy with a nationwide survey.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
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
Male
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
Mie University.
Institute
Department
Personal name
Funding Source
Organization
Other.
Organization
Division
Category of Funding Organization
Self funding
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
| 2019 | Year | 08 | Month | 13 | 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
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 08 | Month | 09 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 09 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 09 | Day |
Last follow-up date
| 2022 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2019 | Year | 08 | Month | 13 | Day |
Last modified on
| 2019 | Year | 08 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042961
