UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024373 |
|---|---|
| Receipt number | R000028061 |
| Scientific Title | A study to evaluate pregnancy outcome and to establish a registration database of pregnant women with preexisting diabetes and Overt diabetes in pregnancy:a multicenter, prospective study -Diabetes and Pregnancy Outcome for Mother and Baby Study,DM and Overt DM-Pregnant Outcome study[DREAMBee study,DM/OvertDM-PO] |
| Date of disclosure of the study information | 2016/10/12 |
| Last modified on | 2016/10/12 15:49:01 |
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Basic information
Public title
A study to evaluate pregnancy outcome and to establish a registration database of pregnant women with preexisting diabetes and Overt diabetes in pregnancy:a multicenter, prospective study
-Diabetes and Pregnancy Outcome for Mother and Baby Study,DM and Overt DM-Pregnant Outcome study[DREAMBee study,DM/OvertDM-PO]
Acronym
DREAMBee study[DM/OvertDM-PO]
Scientific Title
A study to evaluate pregnancy outcome and to establish a registration database of pregnant women with preexisting diabetes and Overt diabetes in pregnancy:a multicenter, prospective study
-Diabetes and Pregnancy Outcome for Mother and Baby Study,DM and Overt DM-Pregnant Outcome study[DREAMBee study,DM/OvertDM-PO]
Scientific Title:Acronym
DREAMBee study[DM/OvertDM-PO]
Region
| Japan |
Condition
Condition
preexisting diabetes
Overt diabetes in pregnancy
Classification by specialty
| Endocrinology and Metabolism | Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the actual condition of pregnancy with preexisting diabetes and Overt diabetes in pregnancy in Japan
To clarify if it is possible to improve pregnancy outcome by screening, management and treatment of diabetes
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The rate of preterm birth, low birth weight,congenital anomaly
The rate of emergency cesarean section
The rate of neonatal hypoglycemia
Maternal glycemic control of 1 year postpartum
Growth of infant until first birthday
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Women who meet the following 1)and 2) or 1)and 3)
1)Pregnant women with preexisting diabetes
2)Pregnant women were diagnosed Overt diabetes in pregnancy
3)Woman who can respond to the questionnaire in Japanese
Key exclusion criteria
Not applicable
Target sample size
135
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuji Hiramatsu |
Organization
Okayama University Graduate School of Medicine,Dentistry and Pharmaceutical Sciences
Division name
department of obstetrics and gynecology
Zip code
Address
5-1,Shikada cho,2 chome,Kita,Okayama,Tokyo,700-8558,JAPAN
TEL
086-235-7320
dreambee@ncchd.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoko Arata,Takeshi Sugiyama,Tastumi Moriya |
Organization
National Center for Child Health and Development, Tokyo, Japan
Division name
secretariat of DREAMBee study
Zip code
Address
10-1,Okura,2 chome,Setagaya,Tokyo,157-8538,JAPAN
TEL
03-3416-0181
Homepage URL
http://www.dm-net.co.jp/jsdp/information/025441.php
dreambee@ncchd.go.jp
Sponsor or person
Institute
The Japanese Society of Dianetes and Pregnancy
Institute
Department
Personal name
Funding Source
Organization
The Japanese Society of Dianetes and Pregnancy
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
| 2016 | Year | 10 | Month | 12 | 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
Date of protocol fixation
| 2016 | Year | 04 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2031 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Registration period is eight years
Conduct a review of the protocol every two years.
Follow up period of mothers is 1 year postpartum.
Follow up period of infants is until first birthday.
In the case of maternal mortality, follow up of infant stop at that point in time
Management information
Registered date
| 2016 | Year | 10 | Month | 12 | Day |
Last modified on
| 2016 | Year | 10 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028061
