UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010223 |
|---|---|
| Receipt number | R000011859 |
| Scientific Title | Prediction of hypotension during spinal anesthesia for caesarean section: a observational study. |
| Date of disclosure of the study information | 2013/03/15 |
| Last modified on | 2015/03/19 18:20:51 |
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Basic information
Public title
Prediction of hypotension during spinal anesthesia for caesarean section: a observational study.
Acronym
Prediction of hypotension during spinal anesthesia for caesarean section: a observational study.
Scientific Title
Prediction of hypotension during spinal anesthesia for caesarean section: a observational study.
Scientific Title:Acronym
Prediction of hypotension during spinal anesthesia for caesarean section: a observational study.
Region
| Japan |
Condition
Condition
Women who were to undergo elective cesarean delivery under spinal anesthesia.
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Test the ability of pre-anesthesia Pleth Variability Index (PVI) to predict hypotension after spinal anesthesia during cesarean section.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Estimate Receiver operating characteristic (ROC) curve, and sensitivity and specificity.
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
| Not applicable |
Gender
Female
Key inclusion criteria
Women who were to undergo elective cesarean delivery under spinal anesthesia.
Key exclusion criteria
Hypertension
Diabetes
Preanesthetic Cardiovascular events
Arrhythmia
Preeclampsia
Placenta previa
Multiple pregnancy
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masashi Yokose |
Organization
Yokohama city university school of medicine
Division name
Department of anesthesiology
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama, JAPAN
TEL
0810457872918
yokose_p12@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masashi Yokose |
Organization
Yokohama city university school of medicine
Division name
Department of anesthesiology
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama, JAPAN
TEL
0810457872918
Homepage URL
yokose_p12@yahoo.co.jp
Sponsor or person
Institute
Yokohama city university school of medicine department of anesthesiology
Institute
Department
Personal name
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
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
| 2013 | Year | 03 | Month | 15 | 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
| 2011 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | 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
The aim of this prospective observational study was to test the ability of pre-anesthesia PVI to predict hypotension after spinal anesthesia for caesarean section.
Management information
Registered date
| 2013 | Year | 03 | Month | 12 | Day |
Last modified on
| 2015 | Year | 03 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011859
