UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057758 |
|---|---|
| Receipt number | R000062367 |
| Scientific Title | Impact of cesarean section on the endothelial glycocalyx |
| Date of disclosure of the study information | 2025/05/02 |
| Last modified on | 2025/05/05 13:32:41 |
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Basic information
Public title
Impact of cesarean section on the endothelial glycocalyx
Acronym
Impact of cesarean section on the endothelial glycocalyx
Scientific Title
Impact of cesarean section on the endothelial glycocalyx
Scientific Title:Acronym
Impact of cesarean section on the endothelial glycocalyx
Region
| Japan |
Condition
Condition
Cesarean Section under spinal anesthesia
Classification by specialty
| Obstetrics and Gynecology | Anesthesiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of our study is to investigate the impact of cesarean section on the endothelial glycocalyx.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The thickness of the sublingual glycocalyx layer in pregnant women measured by GlycoCheck
Key secondary outcomes
Changes in Plasma Syndecan-1 Levels
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Patients undergoing elective cesarean delivery
Key exclusion criteria
Patients who did not consent to this study
Patients who underwent a change to general anesthesia
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Juri |
Organization
Osaka Metropolitan University Graduate School of Medicine
Division name
Department of Anesthesiology
Zip code
5458586
Address
1-5-7 Asahimachi, Abenoku, Osaka City, Osaka, Japan
TEL
0666452186
takataka0061@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Juri |
Organization
Osaka Metropolitan University Graduate School of Medicine
Division name
Department of Anesthesiology
Zip code
5458586
Address
1-5-7 Asahimachi, Abenoku, Osaka City, Osaka, Japan
TEL
0666452186
Homepage URL
takataka0061@yahoo.co.jp
Sponsor or person
Institute
Osaka Metropolitan University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
JSPS
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka Metropolitan University Graduate School of Medicine Ethics committee
Address
1-2-7Asahimachi, Abenoku, Osaka City, Osaka, Japan
Tel
0666453456
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
| 2025 | Year | 05 | Month | 02 | 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
| 2024 | Year | 06 | Month | 30 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 05 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Evaluate the thickness of the glycocalyx layer under the pregnant woman's tongue before and after cesarean section as measured by GlycoCheck.
Management information
Registered date
| 2025 | Year | 05 | Month | 02 | Day |
Last modified on
| 2025 | Year | 05 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062367
