UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057236 |
|---|---|
| Receipt number | R000065423 |
| Scientific Title | Japanese Study Using Real world date of Vascular InterVEntional radiology for Primary Postpartum Hemorrhage (SURVIVE-PPH study) |
| Date of disclosure of the study information | 2025/04/01 |
| Last modified on | 2025/03/07 15:42:48 |
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Basic information
Public title
Japanese Study Using Real world date of Vascular InterVEntional radiology for Primary Postpartum Hemorrhage (SURVIVE-PPH study)
Acronym
SURVIVE-PPH study
Scientific Title
Japanese Study Using Real world date of Vascular InterVEntional radiology for Primary Postpartum Hemorrhage (SURVIVE-PPH study)
Scientific Title:Acronym
SURVIVE-PPH study
Region
| Japan |
Condition
Condition
Postpartum Hemorrhage
Classification by specialty
| Obstetrics and Gynecology | Radiology | Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The main purpose of this study is to clarify the extent to which IVR treatment for postpartum hemorrhage contributes to saving the lives of pregnant women and preserving the uterus.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Survival rate
Key secondary outcomes
Procedural success rate
Clinical success rate
Uterine preservation rate
Identification of related factors in fatal cases
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
Patients who were diagnosed with primary postpartum hemorrhage (PPH) occurring within 24 hours after delivery between January 1, 2015 and December 31, 2024, were transported to an IVR training facility, and underwent transcatheter arterial embolization.
Key exclusion criteria
Patients who are deemed inappropriate by a doctor
Patients who have requested to refuse the use of their information by opting out
Target sample size
4000
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Kawada |
Organization
Gifu university
Division name
Department of Radiology
Zip code
501-1194
Address
1-1, Yanaito, Gifu city
TEL
058-230-6437
kawada.hiroshi.p2@f.gifu-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Kawada |
Organization
Gifu university
Division name
Department of Radiology
Zip code
501-1194
Address
1-1, Yanagito, Gifu city
TEL
058-230-6437
Homepage URL
kawada.hiroshi.p2@f.gifu-u.ac.jp
Sponsor or person
Institute
Gifu university
Institute
Department
Personal name
Funding Source
Organization
Japanese society of Interventional radiology
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
Research Support Section, Gifu University Graduate School of Medicine and Faculty of Medicine
Address
1-1, Yanagito, Gifu city
Tel
058-230-6059
rinri@t.gifu-u.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
| 2025 | Year | 04 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 01 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2025 | Year | 03 | Month | 07 | Day |
Last modified on
| 2025 | Year | 03 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065423
