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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040938
Receipt No. R000046730
Scientific Title Study of perinatal ketone bodies
Date of disclosure of the study information 2020/06/30
Last modified on 2020/06/29

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Basic information
Public title
Study of perinatal ketone bodies
Acronym
perinatal ketone bodies
Scientific Title
Study of perinatal ketone bodies
Scientific Title:Acronym perinatal ketone bodies
Region
Japan

Condition
Condition Gestational diabetes
Classification by specialty
Obsterics and gynecology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Perinatal ketone body safety and efficacy
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes
Ketone levels in the fetus, placenta, and newborn
Key secondary outcomes Blood sugar level, hydroxybutyric acid level

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
18 years-old <=
Age-upper limit
43 years-old >=
Gender Female
Key inclusion criteria Pregnant women who can understand and cooperate with research protocols
Key exclusion criteria Targets who have difficulty understanding and cooperating with research protocols
Target sample size 150

Research contact person
Name of lead principal investigator
1st name Tetsuo
Middle name
Last name Muneta
Organization Muneta Maternity Clinic
Division name Medical office
Zip code 290-0024
Address Neda 320-7 ,Ichihara,Chiba,Japan
TEL 090-3086-8585
Email czf06641@nifty.com

Public contact
Name of contact person
1st name Tetsuo
Middle name
Last name Muneta
Organization Muneta Maternity Clinic
Division name Medical office
Zip code 290-0024
Address Neda 320-7 ,Ichihara,Chiba,Japan
TEL 09030868585
Homepage URL
Email czf06641@nifty.com

Sponsor
Institute Medical office
Institute
Department

Funding Source
Organization Muneta Maternity Clinic
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 Muneta Maternity Clinic
Address Neda 320-7 ,Ichihara,Chiba,Japan
Tel 09030868585
Email czf06641@nifty.com

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
2020 Year 06 Month 30 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 Preinitiation
Date of protocol fixation
2015 Year 07 Month 15 Day
Date of IRB
2015 Year 08 Month 05 Day
Anticipated trial start date
2015 Year 08 Month 20 Day
Last follow-up date
2020 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Measurement of blood glucose and ketone body levels in placenta, newborn and pregnant women

Measurement of fetal villous ketone bodies

Correlation with diet during pregnancy

Management information
Registered date
2020 Year 06 Month 29 Day
Last modified on
2020 Year 06 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046730

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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