UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039551 |
|---|---|
| Receipt number | R000045102 |
| Scientific Title | Observational study on changes in uterine artery blood flow and placental oxygen concentration during maternal medication using MRI |
| Date of disclosure of the study information | 2020/02/20 |
| Last modified on | 2020/02/20 18:07:21 |
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Basic information
Public title
Observational study on changes in uterine artery blood flow and placental oxygen concentration during maternal medication using MRI
Acronym
Observational study on changes in uterine artery blood flow and placental oxygen concentration using MRI
Scientific Title
Observational study on changes in uterine artery blood flow and placental oxygen concentration during maternal medication using MRI
Scientific Title:Acronym
Observational study on changes in uterine artery blood flow and placental oxygen concentration using MRI
Region
| Japan |
Condition
Condition
Pregnant women with conditions mainly due to placental abnormalities such as preeclampsia or fetal growth restriction
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to measure the blood flow of the uterine artery before and after drug administration, evaluate the effect of the drug on the placenta, and clarify the effect on the fetus.
Basic objectives2
Others
Basic objectives -Others
Correlation between birth weight, delivery weeks and changes in BOLD signal and uterine artery blood flow
Correlation between placental histopathology (pathological image, evaluation of oxygenation by immunostaining) and changes in BOLD signal and uterine artery blood flow
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes and trends in BOLD signal before and after administration of drugs that may affect hemodynamics. Changes and trends in uterine artery blood flow.
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
After obtaining consent for singleton pregnancy after 20 weeks of gestation, when a drug that may affect the hemodynamics is newly administered, a uteroplacental MRI will be taken immediately before drug administration.
Uterine placenta MRI is performed on the same subject as the first imaging after administration of the drug within 7 days after the first imaging.
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. Singleton pregnancy between the ages of 20 and 45
2. Pregnant women who receive new drugs that may affect hemodynamics
3. 20 weeks or more of pregnancy
4. Informed consent has been obtained from the person (maternal) regarding the participation in the research
Key exclusion criteria
If consent cannot be obtained after sufficient informed consent.
When the mother has signs of premature birth.
Target sample size
20
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
514-8507
Address
2-174 Edobashi, Tsu City, Mie
TEL
0592321111
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
514-8507
Address
2-174 Edobashi, Tsu City, Mie
TEL
0592321111
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
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Mie University Hospital
Address
Mie University Hospital
Tel
0592321111
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
| 2018 | Year | 12 | Month | 06 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 18 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2021 | 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=R000045102
| Research Plan | |
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| 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 |
