UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051772 |
|---|---|
| Receipt number | R000058787 |
| Scientific Title | The effects of general anesthesia on fetal outcomes in hybrid cesarean delivery: a retrospective observational study |
| Date of disclosure of the study information | 2023/08/01 |
| Last modified on | 2026/02/03 14:52:20 |
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Basic information
Public title
The effects of general anesthesia on fetal outcomes in hybrid cesarean delivery: a retrospective observational study
Acronym
The effects of general anesthesia on fetal outcomes in hybrid cesarean delivery: a retrospective observational study
Scientific Title
The effects of general anesthesia on fetal outcomes in hybrid cesarean delivery: a retrospective observational study
Scientific Title:Acronym
The effects of general anesthesia on fetal outcomes in hybrid cesarean delivery: a retrospective observational study
Region
| Japan |
Condition
Condition
placenta accreta spectum
Classification by specialty
| Obstetrics and Gynecology | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effects of general anesthesia on fetal outcomes in hybrid delivery
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Apgar scores of the newborn
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
| 100 | years-old | > |
Gender
Female
Key inclusion criteria
Patients who underwent cesarean section under general anesthesia at Osaka Metropolitan University from May 2007 to March 2023
Key exclusion criteria
1. emergent cases
2. cases where the reasons for cesarean section were non-reassuring fetal status
Target sample size
76
Research contact person
Name of lead principal investigator
| 1st name | Hino |
| Middle name | |
| Last name | Hideki |
Organization
Osaka Metropolitan University Graduate School of Medicine
Division name
Department of Anesthesilogy
Zip code
545-8586
Address
1-5-7 Asahimachi, Abeno-ku, Osaka city, Osaka, Japan
TEL
+81666452186
HinoH@omu.ac.jp
Public contact
Name of contact person
| 1st name | Hino |
| Middle name | |
| Last name | Hideki |
Organization
Osaka Metropolitan University Graduate School of Medicine
Division name
Department of Anesthesiology
Zip code
545-8586
Address
1-5-7 Asahimachi, Abeno-ku, Osaka city, Osaka, Japan
TEL
+81666452186
Homepage URL
HinoH@omu.ac.jp
Sponsor or person
Institute
Osaka Metropolitan University Graduate School of Medicine
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
Ethical Committee of Osaka Metropolitan University Graduate School of Medicine
Address
1-5-7 Asahimachi, Abeno-ku, Osaka city, Osaka, Japan
Tel
+81666453456
gr-a-knky-ethics@omu.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 | 08 | Month | 01 | 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
| 2023 | Year | 07 | Month | 10 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 05 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
retrospective observational study
Management information
Registered date
| 2023 | Year | 08 | Month | 01 | Day |
Last modified on
| 2026 | Year | 02 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058787
