UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058504 |
|---|---|
| Receipt number | R000066888 |
| Scientific Title | Prospective Evaluation of a Noninvasive Finger-Cuff Device for the Prevention of Hypotension During Cesarean Delivery Under Spinal Anesthesia |
| Date of disclosure of the study information | 2025/07/22 |
| Last modified on | 2025/07/22 16:00:36 |
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Basic information
Public title
Prospective Comparison Study of a Noninvasive Finger-Cuff Device for the Prevention of Hypotension During Cesarean Delivery Under Spinal Anesthesia
Acronym
Prospective Evaluation of a Noninvasive Finger-Cuff Device for the Prevention of Hypotension During Cesarean Delivery Under Spinal Anesthesia
Scientific Title
Prospective Evaluation of a Noninvasive Finger-Cuff Device for the Prevention of Hypotension During Cesarean Delivery Under Spinal Anesthesia
Scientific Title:Acronym
Prospective Evaluation of a Noninvasive Finger-Cuff Device for the Prevention of Hypotension During Cesarean Delivery Under Spinal Anesthesia
Region
| Japan |
Condition
Condition
Pregnancy
Classification by specialty
| Obstetrics and Gynecology | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To Evaluation of the Utility of Noninvasive Finger-Cuff Monitoring for the Prevention of Hypotension During Cesarean Delivery Under Spinal Anesthesia
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Hypotension
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Evolution of blood pressure with a non-invasive finger cuff in operation room
Interventions/Control_2
none
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
Pregnancy female over 35 weeks gestation
Key exclusion criteria
No agreement
Target sample size
110
Research contact person
Name of lead principal investigator
| 1st name | Atsuhiro |
| Middle name | |
| Last name | Kitaura |
Organization
Kindai Univ. Faculty of Medicine
Division name
Anesthesiology
Zip code
5898511
Address
377-2 Ono-Higashi Osakasayama
TEL
0723650221
kitaura@med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | Atsuhiro |
| Middle name | |
| Last name | Kitaura |
Organization
Kindai Univ. Faculty of Medicine
Division name
Anesthesiology
Zip code
589-8511
Address
377-2 Ono Higashi Osakasayama
TEL
0723650221
Homepage URL
kitaura@med.kindai.ac.jp
Sponsor or person
Institute
Kindai 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
IRB of Kindai Hospital
Address
377-2 Oohigashi Osakasayama
Tel
0723650221
zizen@med.kindai.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 | 07 | Month | 22 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 07 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 07 | Month | 17 | Day |
Last modified on
| 2025 | Year | 07 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066888
