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 |
Evaluation of hemastasis effect by chitosan gauze in obstetrics and gynecology field
Clinical trial of chitosan gauze in obstetrics and gynecology field
Evaluation of hemastasis effect by chitosan gauze in obstetrics and gynecology field
Clinical trial of chitosan gauze in obstetrics and gynecology field
Japan |
birth canal injury
Obstetrics and Gynecology |
Others
NO
Clinical trial of chitosan gauze against birth canal hemorrhage. Evaluation of hemostasis effect of chitosan gauze.
Safety
Confirmatory
Pragmatic
Not applicable
hemostasis effect after 30-minute vaginal use of chitosan gauze
hemorrhage from vaginal injury
use of blood transfusion
presence of postpartum anemia
presence of inflammation after gauze use
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
NO
NO
Institution is not considered as adjustment factor.
NO
No need to know
1
Treatment
Device,equipment |
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.
18 | years-old | <= |
55 | years-old | >= |
Female
Expectant mothers who are plannning to labour in our hospital from April 2024, obtained written informed consent.
minor
50
1st name | Kiguna[ |
Middle name | Okawa |
Last name | Sei |
Seirei Hamamatsu General Hospital
Department of Obstetrics and Gynecology
410-8558
2-12-12, Sumiyoshi, Tyuuou-ku, Hamamatsu-shi, Sizuoka-ken
053-474-2222
k.sei@sis.seirei.or.jp
1st name | Kiguna |
Middle name | Okawa |
Last name | Sei |
Seirei Hamamatsu General Hospital
Department of Obstetrics and Gynecology
430-8558
2-12-12, Sumiyoshi, Tyuuou-ku, Hamamatsu-shi, Sizuoka-ken
0534742222
k.sei@sis.seirei.or.jp
Seirei Hamamatsu General Hospital
None
Non profit foundation
Seirei Hamamatsu General Hospital
2-12-12, Sumiyoshi, Tyuuou-ku, Hamamatsu-shi, Sizuoka-ken
053-474-2222
k.sei@sis.seirei.or,jp
NO
聖隷浜松病院(静岡県)
2024 | Year | 04 | Month | 15 | Day |
Unpublished
Preinitiation
2024 | Year | 03 | Month | 19 | Day |
2024 | Year | 03 | Month | 21 | Day |
2024 | Year | 04 | Month | 15 | Day |
2025 | Year | 03 | Month | 31 | Day |
2024 | Year | 04 | Month | 11 | Day |
2024 | Year | 04 | Month | 11 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061802