UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047519 |
|---|---|
| Receipt number | R000054193 |
| Scientific Title | Exploring the definition of hypotension in cesarean delivery under spinal anesthesia |
| Date of disclosure of the study information | 2023/04/19 |
| Last modified on | 2023/04/19 12:21:43 |
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Basic information
Public title
Exploring the definition of hypotension in cesarean delivery under spinal anesthesia
Acronym
Exploring the definition of hypotension in cesarean delivery under spinal anesthesia
Scientific Title
Exploring the definition of hypotension in cesarean delivery under spinal anesthesia
Scientific Title:Acronym
Exploring the definition of hypotension in cesarean delivery under spinal anesthesia
Region
| Japan |
Condition
Condition
Patients undergoing cesarean delivery under spinal anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore the definition of hypotension during cesarean delivery by assessing the incidence of intraoperative maternal nausea, pH levels of umbilical blood and Apgar score.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Intraoperative blood pressure
Key secondary outcomes
incidence of intraoperative maternal nausea, pH levels of umbilical blood, Apgar score.
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
Patients undergoing cesarean delivery under spinal anesthesia
Key exclusion criteria
Emergency cases
Patients undergoing general anesthesia
Target sample size
270
Research contact person
Name of lead principal investigator
| 1st name | Koichi |
| Middle name | |
| Last name | Suehiro |
Organization
Osaka Metropolitan University Graduate School of Medicine
Division name
Department of Anesthesiology
Zip code
5458586
Address
1-5-7 Asahimachi, Abeno-ku, Osaka 545-8586, Japan
TEL
0666452186
suehirokoichi@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Koichi |
| Middle name | |
| Last name | Suehiro |
Organization
Osaka Metropolitan University Graduate School of Medicine
Division name
Department of Anesthesiology
Zip code
5458586
Address
1-5-7 Asahimachi, Abeno-ku, Osaka 545-8586, Japan
TEL
0666452186
Homepage URL
suehirokoichi@yahoo.co.jp
Sponsor or person
Institute
Department of Anesthesiology, Osaka Metropolitan University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Anesthesiology, Osaka Metropolitan University Graduate School of Medicine
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
Ethics Committee of Osaka Metropolitan University Graduate School of Medicine
Address
1-5-7, Asahimachi, Abeno-ku, Osaka 545-8586 Japan
Tel
06-6646-6125
ethics@med.osaka-cu.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 | 04 | Month | 19 | 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
| 2023 | Year | 01 | Month | 18 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 14 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 24 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The various thresholds of intraoperative hypotension will be determined. The associations between these thresholds and the intraoperative adverse outcomes (maternal nausea, low Apgar score and acidosis of umbilical blood) will be investigated.
Management information
Registered date
| 2022 | Year | 04 | Month | 18 | Day |
Last modified on
| 2023 | Year | 04 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054193
