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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000024430
Receipt No. R000027947
Scientific Title Dose spinal anesthesia for caesarean section in pregnant women cause the supine hypotensive syndrome ?
Date of disclosure of the study information 2016/10/16
Last modified on 2016/10/16

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Basic information
Public title Dose spinal anesthesia for caesarean section in pregnant women cause the supine hypotensive syndrome ?
Acronym Hypotension after spinal anesthesia in pregnant women
Scientific Title Dose spinal anesthesia for caesarean section in pregnant women cause the supine hypotensive syndrome ?
Scientific Title:Acronym Hypotension after spinal anesthesia in pregnant women
Region
Japan

Condition
Condition the supine hypotensive syndrome
Classification by specialty
Obsterics and gynecology Anesthesiology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate if spinal anesthesia for caesarian section in pregnant women cause the spine hypotensive syndrome
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes hemodynamics
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
20 years-old <=
Age-upper limit
40 years-old >=
Gender Female
Key inclusion criteria elective caesarean section
spinal anesthesia for caesarean section
Key exclusion criteria emergency caesarean section
twin pregnancy
obesity
coaglation disorder
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kanosue Ikuyo
Organization Saiseikai Shimonoseki general hospital
Division name anesthesiology
Zip code
Address 8-5-1 Yasuoka , Shimonoseki city , Yamaguchi 759-6603, Japan
TEL 08362622300
Email another-door-of-happiness-118@hotmail.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kanosue Ikuyo
Organization Saiseikai Shimonoseki general hospital
Division name anesthesiology
Zip code
Address 8-5-1 Yasuoka , Shimonoseki city , Yamaguchi 759-6603, Japan
TEL 08362622300
Homepage URL
Email another-door-of-happiness-118@hotmail.co.jp

Sponsor
Institute Saiseikai Shimonoseki general hospital
Institute
Department

Funding Source
Organization none
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
2016 Year 10 Month 16 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 Enrolling by invitation
Date of protocol fixation
2016 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 10 Month 14 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Observational

Management information
Registered date
2016 Year 10 Month 16 Day
Last modified on
2016 Year 10 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027947

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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