UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013360 |
|---|---|
| Receipt number | R000015554 |
| Scientific Title | Evaluation of the usefulness of Contrast-enhanced US using Sonazoid for Postpartum hemorrhage (PPH) |
| Date of disclosure of the study information | 2014/06/01 |
| Last modified on | 2020/03/10 10:05:53 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Evaluation of the usefulness of Contrast-enhanced US using Sonazoid for Postpartum hemorrhage (PPH)
Acronym
Diagnosis of PPH using Sonazoid
Scientific Title
Evaluation of the usefulness of Contrast-enhanced US using Sonazoid for Postpartum hemorrhage (PPH)
Scientific Title:Acronym
Diagnosis of PPH using Sonazoid
Region
| Japan |
Condition
Condition
Postpartum hemorrhage
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
For the quick diagnosis and treatment, we will evaluate the usefulness of Contrast-enhanced US using Sonazoid for Postpartum hemorrhage (PPH).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We will use Contrast-enhanced US using Sonazoid for Postpartum hemorrhage (PPH), and time to start of treatment followed by the exact diagnosis will be evaluated. The data will be reviewed with the technique of Inflow-Time Mapping later on.
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
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Sonazoid
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
Postpartum hemorrhage without any other complication
Key exclusion criteria
In the case with no benefit of the present technique for PPH
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Shintaro |
| Middle name | |
| Last name | Makino |
Organization
Juntendo University
Division name
Obstetrics and Gynecology
Zip code
113-8421
Address
2-1-1 Hongo Bunkyoku Tokyo, 113-8421, Japan
TEL
03-3813-3111
shintaro@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Shintaro |
| Middle name | |
| Last name | Makino |
Organization
Juntendo University
Division name
Obstetrics and Gynecology
Zip code
113-8421
Address
2-1-1 Hongo Bunkyoku Tokyo, 113-8421, Japan
TEL
03-3813-3111
Homepage URL
shintaro@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Juntendo University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Juntendo Clinical Research and Trial Center
Address
2-1-1 Hongo Bunkyoku Tokyo, 113-8421, Japan
Tel
03-3813-3111
chiken@juntendo.ac.jp
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
| 2014 | Year | 06 | 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
Main results already published
Date of protocol fixation
| 2014 | Year | 02 | Month | 24 | Day |
Date of IRB
| 2014 | Year | 02 | Month | 14 | Day |
Anticipated trial start date
| 2014 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | 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
| 2014 | Year | 03 | Month | 06 | Day |
Last modified on
| 2020 | Year | 03 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015554
