UMIN-CTR Clinical Trial

Basic information
Public title	Investigation of airway method for extremely emergent cesarean section
Acronym	Investigation of airway method for extremely emergent cesarean section
Scientific Title	Investigation of airway method for extremely emergent cesarean section
Scientific Title:Acronym	Investigation of airway method for extremely emergent cesarean section
Region	Japan

Condition
Condition	extremely emergent cesarean section
Classification by specialty	Obsterics and gynecology Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Investigation of airway method for extremely emergent cesarean section
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Airway method
Key secondary outcomes	postoperative pneumonia

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	extremely emergent cesarean section
Key exclusion criteria	none
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Hironobu Middle name Last name Ueshima
Organization	Showa University Hospital
Division name	Anesthesiology
Zip code	142-8666
Address	1-5-8 Hatanodai, Shinagawa-ku, Tokyo, Japan
TEL	03-3784-8575
Email	ueshimhi@yahoo.co.jp

Public contact
Name of contact person	1st name Hironobu Middle name Last name Ueshima
Organization	Showa University Hospitalhowa
Division name	Anesthesiology
Zip code	142-8666
Address	1-5-8 Hatanodai, Shinagawa-ku, Tokyo, Japan
TEL	03-3784-8575
Homepage URL
Email	ueshimhi@yahoo.co.jp

Sponsor
Institute	Showa University Hospital
Institute
Department

Funding Source
Organization	Showa University Hospital
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	Showa university hospital
Address	1-5-8, hatanodai, shinagawa-ku, tokyo
Tel	03-3784-8575
Email	ueshimhi@med.showa-u.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	2016 Year 06 Month 19 Day

Related information
URL releasing protocol	file:///Users/UESHIMAHIRONOBU/Desktop.htm
Publication of results	Published

Result
URL related to results and publications	file:///Users/UESHIMAHIRONOBU/Desktop.htm
Number of participants that the trial has enrolled	200
Results	Safety
Results date posted	2019 Year 06 Month 22 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	pregnancy
Participant flow	general anesthesia
Adverse events	none
Outcome measures	safety
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 06 Month 19 Day
Date of IRB	2016 Year 06 Month 19 Day
Anticipated trial start date	2016 Year 06 Month 19 Day
Last follow-up date	2016 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Survey time is from January 2014 to December 2015. Investigation items are airway method and postoperative pneumonia.

Management information
Registered date	2016 Year 06 Month 19 Day
Last modified on	2019 Year 06 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000026266