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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034406
Receipt No. 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 2018/10/08

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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
Obsterics 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 December 2017
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 1500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Makoto Ozaki
Organization Tokyo Women's Medical University
Division name Department of Anesthesiology
Zip code
Address 8-1 Kawada-cho, Shinjuku-ku, Tokyo, Japan
TEL 03-3353-8111
Email moz@twmu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Risa Fukushima
Organization Tokyo Women's Medical University
Division name Department of Anesthesiology
Zip code
Address 8-1 Kawada-cho, Shinjuku-ku, Tokyo, Japan
TEL 0333538111
Homepage URL
Email rfukushima-twmu@umin.ac.jp

Sponsor
Institute Department of Anesthesiology, Tokyo Women's Medical University
Institute
Department

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
Address
Tel
Email

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 Open public recruiting
Date of protocol fixation
2018 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 10 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 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
2018 Year 10 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039235

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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