UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000023420
Receipt number R000026797
Scientific Title 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]
Date of disclosure of the study information 2016/08/01
Last modified on 2016/08/01 12:00:38

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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 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]

Acronym

DREAMBee study[GDM-PO]

Scientific Title

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]

Scientific Title:Acronym

DREAMBee study[GDM-PO]

Region

Japan


Condition

Condition

Gestational diabetes mellitus(GDM)

Classification by specialty

Endocrinology and Metabolism Obstetrics 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

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

Email

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

secretariatof DREAMBee study

Zip code


Address

10-1,Okura,2 chome,Setagaya,Tokyo,157-8538,JAPAN

TEL

03-3416-0181

Homepage URL


Email

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


Email



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


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

2015 Year 02 Month 05 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026797


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name