UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000015554