UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000013360
Receipt No. 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

* 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
Obsterics 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
Email 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
Email shintaro@juntendo.ac.jp

Sponsor
Institute Juntendo University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015554

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.