UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030231 |
|---|---|
| Receipt number | R000034519 |
| Scientific Title | Phase2 study on the validity of initiating treatment during midtrimester for GDM patients |
| Date of disclosure of the study information | 2017/12/05 |
| Last modified on | 2021/12/07 10:54:00 |
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Basic information
Public title
Phase2 study on the validity of initiating treatment during midtrimester for GDM patients
Acronym
GDM intervention trial
Scientific Title
Phase2 study on the validity of initiating treatment during midtrimester for GDM patients
Scientific Title:Acronym
GDM intervention trial
Region
| Japan |
Condition
Condition
GDM
Classification by specialty
| Obstetrics and Gynecology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To validiate timing of treatment for GDM patients
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
large for gestational age(%)
Key secondary outcomes
Incidence of macrosomia
SGA
shoulder dystocia
GDM associated neonatal complications
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Treatment timing for GDM patients
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
early onset mild GDM
Key exclusion criteria
overt DM
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Shigeru |
| Middle name | |
| Last name | Aoki |
Organization
Yokohama City University Medical Center
Division name
Perinatal Center for Maternity and Neonate
Zip code
2320024
Address
4-57 Urafunecho, Minami-ku, Yokahama City
TEL
045-261-5656
smyyaoki@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Shigeru |
| Middle name | |
| Last name | Aoki |
Organization
Yokohama City University Medical Center
Division name
Perinatal Center for Maternity and Neonate
Zip code
2320024
Address
4-57 Urafunecho, Minami-ku, Yokahama City
TEL
045-261-5656
Homepage URL
smyyaoki@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Medical Center
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
Yokohama City University
Address
3-9 fukuura kanazawa-ku, Yokahama City Kanagawa 232-0024, Japan
Tel
045-370-7627
rinri@yokohama-cu.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
| 2017 | Year | 12 | Month | 05 | 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
| 2017 | Year | 12 | Month | 10 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 28 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 09 | Month | 28 | Day |
Date trial data considered complete
| 2020 | Year | 09 | Month | 28 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 12 | Month | 03 | Day |
Last modified on
| 2021 | Year | 12 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034519
