UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032011 |
|---|---|
| Receipt number | R000036456 |
| Scientific Title | Reduction of complications and changes of amniotic fluid embolism marker by using retractor in cesarean section |
| Date of disclosure of the study information | 2018/05/15 |
| Last modified on | 2022/10/03 12:53:39 |
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Basic information
Public title
Reduction of complications and changes of amniotic fluid embolism marker by using retractor in cesarean section
Acronym
Reduction of complications and changes of amniotic fluid embolism marker by using retractor in cesarean section
Scientific Title
Reduction of complications and changes of amniotic fluid embolism marker by using retractor in cesarean section
Scientific Title:Acronym
Reduction of complications and changes of amniotic fluid embolism marker by using retractor in cesarean section
Region
| Japan |
Condition
Condition
Scheduled cesarean section patient over 20 years old and scheduled after 37 weeks
Classification by specialty
| Obstetrics and Gynecology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
As an abdominal wall retention at the time of cesarean section, it is classified into two group using a metal retractor and using a wound retractor. We evaluate wound infection, postoperative pain, and serum marker of amniotic fluid embolism, and compare and consider the difference between the two groups.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
marker of amniotic fluid embolism
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Use Alexis for abdominal wall grasping fixation during cesarean section.
Interventions/Control_2
Use conventional metal retractor for abdominal wall grasping fixation during cesarean section.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Scheduled cesarean section patient over 20 years old, after 37 weeks
Key exclusion criteria
twin pregnancy,and serious maternal complication becomes the reason for cesarean section.
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Kouitirou |
| Middle name | |
| Last name | Shimoya |
Organization
Kawasaki Medical University
Division name
Department of Obstetrics and gynecology1
Zip code
7010192
Address
Okayama Prefecture Kurashiki city Matsushima 577
TEL
086-462-1111
shimoya@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | Mika |
| Middle name | |
| Last name | Sugihara |
Organization
Kawasaki Medical University
Division name
Department of Obstetrics and gynecology1
Zip code
7010192
Address
Okayama Prefecture Kurashiki city Matsushima 577
TEL
086-462-1111
Homepage URL
msugihara@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki Medical University
Institute
Department
Personal name
Funding Source
Organization
Kawasaki Medical University
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
Kawasaki Medical University
Address
Okayama Prefecture Kurashiki city Matsushima 577
Tel
0864621111
msugihara@med.kawasaki-m.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
| 2018 | Year | 05 | 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
Completed
Date of protocol fixation
| 2018 | Year | 05 | Month | 15 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 12 | Day |
Anticipated trial start date
| 2018 | Year | 11 | Month | 15 | Day |
Last follow-up date
| 2023 | Year | 11 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 03 | Month | 30 | Day |
Last modified on
| 2022 | Year | 10 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036456
