UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052821 |
|---|---|
| Receipt number | R000060285 |
| Scientific Title | Factors Affecting the Time from Spinal Subarachnoid Anesthesia to Fetal Delivery in Cesarean Section |
| Date of disclosure of the study information | 2023/11/25 |
| Last modified on | 2023/12/26 20:44:18 |
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Basic information
Public title
Factors Affecting the Time from Spinal Subarachnoid Anesthesia to Fetal Delivery in Cesarean Section
Acronym
Factors Affecting the Time from Spinal Subarachnoid Anesthesia to Fetal Delivery in Cesarean Section
Scientific Title
Factors Affecting the Time from Spinal Subarachnoid Anesthesia to Fetal Delivery in Cesarean Section
Scientific Title:Acronym
Factors Affecting the Time from Spinal Subarachnoid Anesthesia to Fetal Delivery in Cesarean Section
Region
| Japan |
Condition
Condition
Cesarean section for pregnancy
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The time from spinal subarachnoid anesthesia (SA) to delivery is associated with a decrease in umbilical artery blood pH during cesarean section.This study retrospectively examine the factors that influence the time from SA to delivery.
Basic objectives2
Others
Basic objectives -Others
Analysis of factors affecting the time from spinal subarachnoid anesthesia to delivery.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Time from spinal subarachnoid anesthesia to delivery
Key secondary outcomes
Umbilical Artery Blood Gas Analysis, Patient Background, Anesthesia Record
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
Cesarean section under spinal subarachnoid anesthesia in a singleton pregnancy after 37 weeks gestation
Key exclusion criteria
Emergency cases
General Anesthesia
multiple pregnancies
Patient's request for exclusion
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Michiko |
| Middle name | |
| Last name | Kinoshita |
Organization
Tokushima University Hospital
Division name
Anesthesiology
Zip code
770-8503
Address
2-50-1, Kuramoto-cho, Tokushima-shi, Tokushima
TEL
0880633-7181
michiko-kinoshita@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | Michiko |
| Middle name | |
| Last name | Kinoshita |
Organization
Tokushima University Hospital
Division name
Anesthesiology
Zip code
770-8503
Address
2-50-1, Kuramoto-cho, Tokushima-shi, Tokushima
TEL
-88-633-7181
Homepage URL
michiko-kinoshita@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima University
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
Tokushima University Hospital
Address
2-50-1, Kuramoto-cho, Tokushima-shi, Tokushima
Tel
088-633-7181
michiko-kinoshita@tokushima-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
| 2023 | Year | 11 | Month | 25 | 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
| 2023 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 20 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 20 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective cohort study
Management information
Registered date
| 2023 | Year | 11 | Month | 17 | Day |
Last modified on
| 2023 | Year | 12 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060285
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| Registered date | File name |
| Research case data | |
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