UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034406 |
|---|---|
| Receipt number | R000039235 |
| Scientific Title | retrospective study of anesthetic management in cesarean section cases |
| Date of disclosure of the study information | 2018/10/09 |
| Last modified on | 2024/04/16 17:51:07 |
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Basic information
Public title
retrospective study of anesthetic management in cesarean section cases
Acronym
retrospective study of anesthetic management in cesarean section cases
Scientific Title
retrospective study of anesthetic management in cesarean section cases
Scientific Title:Acronym
retrospective study of anesthetic management in cesarean section cases
Region
| Japan |
Condition
Condition
parturients
Classification by specialty
| Obstetrics and Gynecology | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To review anesthetic management of cesarean section in Tokyo Women's Medical University Hospital and to investigate perioperative or perinatal outcome
Basic objectives2
Others
Basic objectives -Others
To improve our anesthetic management in the future
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
perioperative or postoperative status of the patient
Key secondary outcomes
maternal blood sampling, the course of anesthesia administration, the hemodynamic state during the operation, the state of the patient during the operation, the state of the patient after the operation, the state of the newborn
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
parturients who had a cesarean operation application at Tokyo Women's Medical University Hospital between January 2014 and August 2019
Key exclusion criteria
parturients who were younger than 20 years of age, parturient who delivered by vaginal delivery or instrument delivery after application of cesarean section, parturients who are judged inappropriate as research subjects
Target sample size
1400
Research contact person
Name of lead principal investigator
| 1st name | Yasuko |
| Middle name | |
| Last name | Nagasaka |
Organization
Tokyo Women's Medical University
Division name
Department of Anesthesiology
Zip code
1628666
Address
8-1 Kawada-cho, Shinjuku-ku, Tokyo, Japan
TEL
03-3353-8111
moz@twmu.ac.jp
Public contact
Name of contact person
| 1st name | Risa |
| Middle name | |
| Last name | Fukushima |
Organization
Tokyo Women's Medical University
Division name
Department of Anesthesiology
Zip code
1628666
Address
8-1 Kawada-cho, Shinjuku-ku, Tokyo, Japan
TEL
0333538111
Homepage URL
rfukushima-twmu@umin.ac.jp
Sponsor or person
Institute
Department of Anesthesiology, Tokyo Women's Medical University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Women's Medical University
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
Tokyo Women's Medical University
Address
8-1 Kawada-cho, Shinjuku-ku, Tokyo, Japan
Tel
0333538111
ohta.megumi@twmu.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 | 10 | Month | 09 | 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 | 10 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 30 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
maternal blood sampling, the course of anesthesia administration, the hemodynamic state during the operation, the state of the patient during the operation, the state of the patient after the operation, the state of the newborn
Management information
Registered date
| 2018 | Year | 10 | Month | 08 | Day |
Last modified on
| 2024 | Year | 04 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039235
