UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059799 |
|---|---|
| Receipt number | R000068374 |
| Scientific Title | A Study on the Efficacy of Emergency Uterine Artery Embolisation (UAE) for Obstetric Haemorrhage |
| Date of disclosure of the study information | 2025/11/17 |
| Last modified on | 2025/11/17 11:10:47 |
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Basic information
Public title
Shock Index-Guided Selection of Embolic Material for Emergency Uterine Artery Embolization in Postpartum Hemorrhage
Acronym
Shock Index-Guided Selection of Embolic Material for Emergency Uterine Artery Embolization in Postpartum Hemorrhage
Scientific Title
A Study on the Efficacy of Emergency Uterine Artery Embolisation (UAE) for Obstetric Haemorrhage
Scientific Title:Acronym
A Study on the Efficacy of Emergency Uterine Artery Embolisation (UAE) for Obstetric Haemorrhage
Region
| Japan |
Condition
Condition
Obstetric hemorrhage
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Uterine artery embolization (UAE) is an effective hemostatic intervention for managing obstetric hemorrhage. Temporary embolic agents are generally preferred to preserve fertility; however, achieving hemostasis can be challenging in patients with disseminated intravascular coagulation (DIC). This study aimed to determine the optimal selection of embolic agents based on the shock index (SI), a simple indicator of bleeding severity, to help minimize bleeding.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
This study aimed to clarify the optimal selection of embolic material based on SI values.
Furthermore, it aimed to examine the association with prior uterine surgery history and the use of assisted reproductive technology (ART), as well as the relationship between embolic material and fertility.
Key secondary outcomes
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Patients requiring uterine artery embolisation at our hospital due to uncontrollable haemorrhage from the following conditions:
1. Postpartum haemorrhage
2. Placenta praevia, placenta accreta haemorrhage
3. Haemorrhage due to retained placenta accreta
4. Uterine inversion
5. Perineal laceration
6. Post-hysterectomy haemorrhage
Key exclusion criteria
Patients under 18 years of age at the time of implementation in the UAE
Patients who declined to participate in the study
Target sample size
48
Research contact person
Name of lead principal investigator
| 1st name | Hiroe |
| Middle name | |
| Last name | Ito |
Organization
Tokyo Medical University
Division name
Department of Obstetrics and gynecology
Zip code
160-0023
Address
6-7-1, Nishishinjuku, Shinjuku-ku, Tokyo, Japan
TEL
03-3342-6111
hiroe@tokyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Hiroe |
| Middle name | |
| Last name | Ito |
Organization
Tokyo Medical University
Division name
Department of Obstetrics and gynecology
Zip code
160-0023
Address
6-7-1, Nishishinjuku, Shinjuku-ku, Tokyo, Japan
TEL
0333426111
Homepage URL
hiroe@tokyo-med.ac.jp
Sponsor or person
Institute
Tokyo Medical University
Institute
Department
Personal name
Funding Source
Organization
none
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
Tokyo Medical University
Address
6-7-1, Nishishinjuku, Shinjuku-ku, Tokyo, Japan
Tel
0333426111
hiroe@tokyo-med.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 | 11 | Month | 17 | 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 | 02 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 11 | Month | 18 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We retrospectively analyzed 48 cases of emergency UAE performed for postpartum hemorrhage (PPH) between January 2012 and December 2024. Patients were categorized into three groups according to SI at the time of UAE:group A (n = 19) with SI is less than 1.0, group B (n = 18) with SI greater than or equal to 1.0 but less than 1.5, and group C (n = 11) withSI of 1.5 or above. Patient characteristics, embolic materials used, perioperative outcomes, and subsequent pregnancy results were evaluated.
Management information
Registered date
| 2025 | Year | 11 | Month | 17 | Day |
Last modified on
| 2025 | Year | 11 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068374
