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 gestational diabetes mellitus(GDM) :a multicenter, prospective study -Diabetes and Pregnancy Outcome for Mother and Baby Study,GDM-Pregnant Outcome study[DREAMBee study,GDM-PO]
Title of the study (Brief title)	DREAMBee study[GDM-PO]
Region	Japan

Condition
Condition	Gestational diabetes mellitus(GDM)
Classification by specialty	Endocrinology and Metabolism Obsterics and gynecology Pediatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the actual condition of pregnancy with GDM in Japan To clarify if it is possible to improve pregnancy outcome by screening, management and treatment of GDM
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The rate of macrosomia heavy for date(HFD) low birth weight first caesarean section preterm birth shoulder dystocia rate neonatal hypoglycemia
Key secondary outcomes	The rate of light for date(LFD) admission to NICU perinatal mortality gestational hypertension breastfeeding rate within 3 months after childbirth exclusive breastfeeding rate within 3 months after childbirth 75g OGTT implementation rate of less within 3 months after childbirth

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	Pregnant women who meet the following 1) or 2) 1)Pregnant women who diagnosed GDM in early pregnancy(earlier than 20weeks of gestation )by 75g OGTT,or Pregnant women who diagnosed GDM in mid pregnancy(24 to 32 weeks of gestation is desirable)by 75g OGTT 2)pregnant women were diagnosed normal glucose tolerance in mid or late pregnancy(24 to 32 weeks of gestation is desirable)by 75g OGTT
Key exclusion criteria	Not applicable
Target sample size	1800

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	secretariatof DREAMBee study
Address	10-1,Okura,2 chome,Setagaya,Tokyo,157-8538,JAPAN
TEL	03-3416-0181
Homepage URL
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 08 Month 01 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2015 Year 02 Month 05 Day
Anticipated trial start date	2015 Year 10 Month 01 Day
Last follow-up date
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. With regard to pregnancy outcome study,follow up period is three months postpartum(required). Some facility where conduct the long term follow up,investigate medical information including blood glucose up to five years postpartum(+-6 months).

Management information
Registered date	2016 Year 08 Month 01 Day
Last modified on	2016 Year 08 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026797