UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054122 |
|---|---|
| Receipt number | R000061802 |
| Scientific Title | Evaluation of hemastasis effect by chitosan gauze in obstetrics and gynecology field |
| Date of disclosure of the study information | 2024/04/15 |
| Last modified on | 2024/04/11 15:00:26 |
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Basic information
Public title
Evaluation of hemastasis effect by chitosan gauze in obstetrics and gynecology field
Acronym
Clinical trial of chitosan gauze in obstetrics and gynecology field
Scientific Title
Evaluation of hemastasis effect by chitosan gauze in obstetrics and gynecology field
Scientific Title:Acronym
Clinical trial of chitosan gauze in obstetrics and gynecology field
Region
| Japan |
Condition
Condition
birth canal injury
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Clinical trial of chitosan gauze against birth canal hemorrhage. Evaluation of hemostasis effect of chitosan gauze.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
hemostasis effect after 30-minute vaginal use of chitosan gauze
Key secondary outcomes
hemorrhage from vaginal injury
use of blood transfusion
presence of postpartum anemia
presence of inflammation after gauze use
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Chitosan gauze is used for hemostasis in birth canal injury that is difficult to stop bleeding by surgical suture. The gauze is removed after 30 minutes to evaluate the hemostasis effect.
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
| 55 | years-old | >= |
Gender
Female
Key inclusion criteria
Expectant mothers who are plannning to labour in our hospital from April 2024, obtained written informed consent.
Key exclusion criteria
minor
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Kiguna[ |
| Middle name | Okawa |
| Last name | Sei |
Organization
Seirei Hamamatsu General Hospital
Division name
Department of Obstetrics and Gynecology
Zip code
410-8558
Address
2-12-12, Sumiyoshi, Tyuuou-ku, Hamamatsu-shi, Sizuoka-ken
TEL
053-474-2222
k.sei@sis.seirei.or.jp
Public contact
Name of contact person
| 1st name | Kiguna |
| Middle name | Okawa |
| Last name | Sei |
Organization
Seirei Hamamatsu General Hospital
Division name
Department of Obstetrics and Gynecology
Zip code
430-8558
Address
2-12-12, Sumiyoshi, Tyuuou-ku, Hamamatsu-shi, Sizuoka-ken
TEL
0534742222
Homepage URL
k.sei@sis.seirei.or.jp
Sponsor or person
Institute
Seirei Hamamatsu General Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Seirei Hamamatsu General Hospital
Address
2-12-12, Sumiyoshi, Tyuuou-ku, Hamamatsu-shi, Sizuoka-ken
Tel
053-474-2222
k.sei@sis.seirei.or,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
聖隷浜松病院（静岡県）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 04 | Month | 15 | 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
| 2024 | Year | 03 | Month | 19 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 21 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 15 | Day |
Last follow-up date
| 2025 | 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
| 2024 | Year | 04 | Month | 11 | Day |
Last modified on
| 2024 | Year | 04 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061802
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
