UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039543 |
|---|---|
| Receipt number | R000045093 |
| Scientific Title | Placental function evaluation focusing on placental blood flow and oxygenation by imaging, mainly non-contrasted placental MRI in pregnant women |
| Date of disclosure of the study information | 2020/02/20 |
| Last modified on | 2020/02/20 13:22:17 |
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Basic information
Public title
Placental function evaluation focusing on placental blood flow and oxygenation by imaging, mainly non-contrasted placental MRI in pregnant women
Acronym
Evaluation of placental function by non-contrast enhanced MRI in pregnant women
Scientific Title
Placental function evaluation focusing on placental blood flow and oxygenation by imaging, mainly non-contrasted placental MRI in pregnant women
Scientific Title:Acronym
Evaluation of placental function by non-contrast enhanced MRI in pregnant women
Region
| Japan |
Condition
Condition
Fetal Growth Restriction
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify placental functions that cause fetal growth failure using non-contrast enhanced MRI.
Basic objectives2
Others
Basic objectives -Others
Clarify BOLD value.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Maximum BOLD value during shooting period
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Non-contrast-enhanced MRI is performed in the second trimester (20 to 28 weeks) and late (29 to 37 weeks).
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
| 20 | years-old | <= |
Age-upper limit
| 45 | years-old | >= |
Gender
Female
Key inclusion criteria
(1)Pregnant women who do not judge that the doctor is incompatible
1.The umbilical cord attachment is lateral
2.The umbilical cord attachment is marginal
3.The mother has pregnancy-induced hypertension syndrome
4.The mother has gestational diabetes
5.Unknown cause of fetal growth restriction
(2) Pregnancy 20 weeks or more and less than 37 weeks
(3) For pregnant women, the expected delivery date is determined according to the Gynecology and Obstetrics Practice Guidelines-Obstetrics Edition 2014.
(4) Informed consent has been obtained from the person (maternal) regarding participation in the test
Key exclusion criteria
Patients who are judged inappropriate by the Principal Investigator or Research Investigator as study subjects.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Tomoaki |
| Middle name | |
| Last name | Ikeda |
Organization
Mie University Hospital
Division name
Obstetrics and gynecology
Zip code
5148507
Address
2-174 Edobashi, Tsu City, Mie
TEL
059-232-1111
t-ikeda@clin.medic.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | masafumi |
| Middle name | |
| Last name | nii |
Organization
Mie University Hospital
Division name
Obstetrics and gynecology
Zip code
5148507
Address
2-174 Edobashi, Tsu City, Mie
TEL
059-232-1111
Homepage URL
tadafer.study@gmail.com
Sponsor or person
Institute
Mie University Hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
Mie University Hospital
Address
2-174 Edobashi, Tsu City, Mie
Tel
059-232-1111
tadafer.study@gmail.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 | 02 | Month | 20 | 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
| 2017 | Year | 06 | Month | 19 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 15 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 17 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 02 | Month | 20 | Day |
Last modified on
| 2020 | Year | 02 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045093
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
