UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016981 |
|---|---|
| Receipt number | R000019706 |
| Scientific Title | Retrospective investigation of perioperative management for obstetric surgery |
| Date of disclosure of the study information | 2015/03/31 |
| Last modified on | 2015/03/31 09:31:01 |
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Basic information
Public title
Retrospective investigation of perioperative management for obstetric surgery
Acronym
Retrospective investigation for obstetric anesthesia
Scientific Title
Retrospective investigation of perioperative management for obstetric surgery
Scientific Title:Acronym
Retrospective investigation for obstetric anesthesia
Region
| Japan |
Condition
Condition
Patients who received obstetric surgery
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigating exacerbation risks of peri- and postoperative courses in obstetric surgical patients
Basic objectives2
Others
Basic objectives -Others
Investigating optimal anesthetic management which contributes not only the prognosis but the quality of postoperative course
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Incidence of massive hemorrhage, postoperative complications (pneumonia, cardiovascular complications, cerebral vascular damage, disseminated intervascular coagulation, amniotic embolism), ICU stay and length of stay, intensity of postoperative pain, postoperative ambulation, length of hospital stay, mortality rate within 30 days after surgery
Key secondary outcomes
Yearly transition of the statistical factors for primary 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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Patients who received obstetric surgery between 2002 April and 2014 March in Jichi Medical University Hospital
Key exclusion criteria
Parturients received cervical cerclage
Target sample size
6000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Soichiro Inoue |
Organization
Jichi Medical University
Division name
Department of Anesthesiology and Critical Care Medicine
Zip code
Address
Yakushiji 3311-1, Shimotsuke Tochigi, Japan
TEL
0285-58-7383
inoues@jichi.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Soichiro Inoue |
Organization
Jichi Medical University
Division name
Department of Anesthesiology and Critical Care Medicine
Zip code
Address
Yakushiji 3311-1, Shimotsuke, Tochigi, Japan
TEL
0285-58-7383
Homepage URL
inoues@jichi.ac.jp
Sponsor or person
Institute
Jichi Medical University
Institute
Department
Personal name
Funding Source
Organization
Department of Anesthesiology and Critical Care Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2015 | Year | 03 | Month | 31 | 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
| 2014 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 11 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Data for statistical analysis is collecting from our electrical medical record system
Management information
Registered date
| 2015 | Year | 03 | Month | 31 | Day |
Last modified on
| 2015 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019706
