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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000039981
Receipt No. R000045584
Scientific Title Delivery outcomes of emergent cesarean section candidates: a prospective data collection
Date of disclosure of the study information 2020/03/31
Last modified on 2020/11/02

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Basic information
Public title Delivery outcomes of emergent cesarean section candidates
Acronym Delivery outcomes of emergent cesarean section candidates
Scientific Title Delivery outcomes of emergent cesarean section candidates: a prospective data collection
Scientific Title:Acronym Delivery outcomes of emergent cesarean section candidates
Region
Japan

Condition
Condition Pregnancy and delivery
Classification by specialty
Obsterics and gynecology Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the risk of developing emergent cesarean section among parturients considered candidates for emergent cesarean section.
Basic objectives2 Others
Basic objectives -Others Epidemiological research
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The risk of developing emergent cesarean section in parturients considered candidates for emergent cesarean section.
Key secondary 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 Parturients hospitalized in Teine Keijinkai Hospital, who were considered candidates for emergent cesarean section.
Key exclusion criteria Patients who refused to participate in the study.
Target sample size 85

Research contact person
Name of lead principal investigator
1st name Satoshi
Middle name
Last name Ishihara
Organization Teine Keijinkai Hospital
Division name Department of anesthesiology
Zip code 006-8555
Address Maeda 1-12-1-40, Teine-ku, Sapporo, Hokkaido
TEL 011-681-8111
Email ishihara-sat@keijinkai.or.jp

Public contact
Name of contact person
1st name Satoshi
Middle name
Last name Ishihara
Organization Teine Keijinkai Hospital
Division name Departmedn of anesthesiology
Zip code 006-8555
Address Maeda 1-12-1-40, Teine-ku, Sapporo, Hokkaido
TEL 011-681-8111
Homepage URL
Email ishihara-sat@keijinkai.or.jp

Sponsor
Institute Teine Keijinkai Hospital
Institute
Department

Funding Source
Organization Self funding
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 Teine Keijinkai Hospital
Address Maeda 1-12-1-40, Teine-ku, Sapporo, Hokkaido
Tel 011-681-8111
Email tkh-rinriml@keijinkai.or.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 手稲渓仁会病院(北海道)

Other administrative information
Date of disclosure of the study information
2020 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 Open public recruiting
Date of protocol fixation
2020 Year 03 Month 06 Day
Date of IRB
2020 Year 03 Month 12 Day
Anticipated trial start date
2020 Year 04 Month 01 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Parturients who were hospitalized in Teine Keijinkai Hospital and considered candidates of emergent cesarean section are enrolled. Their delivery outcome data (i.e. emergent cesarean section or other modalities of delivery) are prospectively collected, to clarify the risk of developing emergent cesarean section.

Management information
Registered date
2020 Year 03 Month 30 Day
Last modified on
2020 Year 11 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045584

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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