UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040938 |
|---|---|
| Receipt number | R000046730 |
| Scientific Title | Study of perinatal ketone bodies |
| Date of disclosure of the study information | 2020/06/30 |
| Last modified on | 2020/06/29 01:03:28 |
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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
| Obstetrics 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
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
czf06641@nifty.com
Sponsor or person
Institute
Medical office
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046730
