UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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]
Title of the study (Brief title)	DREAMBee study[DM/OvertDM-PO]
Region	Japan

Condition
Condition	preexisting diabetes Overt diabetes in pregnancy
Classification by specialty	Endocrinology and Metabolism Obsterics 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	Yuji Hiramatsu
Organization	Okayama University Graduate School of Medicine,Dentistry and Pharmaceutical Sciences
Division name	department of obstetrics and gynecology
Address	5-1,Shikada cho,2 chome,Kita,Okayama,Tokyo,700-8558,JAPAN
TEL	086-235-7320
Email	dreambee@ncchd.go.jp

Public contact
Name of contact person	Naoko Arata,Takeshi Sugiyama,Tastumi Moriya
Organization	National Center for Child Health and Development, Tokyo, Japan
Division name	secretariat of DREAMBee study
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
Email	dreambee@ncchd.go.jp

Sponsor
Institute	The Japanese Society of Dianetes and Pregnancy
Institute
Department

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)

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

Progress
Recruitment status	Recruiting
Date of protocol fixation	2016 Year 04 Month 18 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028061