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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000040142
Receipt No. R000045740
Scientific Title Cerebrospinal fluid diagnosis under spinal anesthesia after epidural labor analgesia for intrapartum cesarean section
Date of disclosure of the study information 2020/05/05
Last modified on 2020/04/13

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Basic information
Public title Cerebrospinal fluid diagnosis under spinal anesthesia after epidural labor analgesia for intrapartum cesarean section
Acronym Cerebrospinal fluid diagnosis after epidural labor analgesia
Scientific Title Cerebrospinal fluid diagnosis under spinal anesthesia after epidural labor analgesia for intrapartum cesarean section
Scientific Title:Acronym Cerebrospinal fluid diagnosis after epidural labor analgesia
Region
Japan

Condition
Condition Patients undergoing intrapartum cesarean section after epidural labor analgesia
Classification by specialty
Obsterics and gynecology Anesthesiology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to determine whether cerebrospinal fluid in patients undergoing spinal anesthesia for intrapartum cesarean section after epidural labor analgesia can be diagnosed by a pH test
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Successful spinal anesthesia when cerebrospinal fluid is diagnosed by a pH test
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

Not applicable
Gender Female
Key inclusion criteria Patients undergoing spinal anesthesia and a pH test during intrapartum cesarean section after epidural labor analgesia

Key exclusion criteria Patients who did not undergo spinal anesthesia during intrapartum cesarean section after epidural labor analgesia


Patients undergoing spinal anesthesia during intrapartum cesarean section after epidural labor analgesia but have not been pH tested
Target sample size 10

Research contact person
Name of lead principal investigator
1st name Yoshie
Middle name
Last name Toba
Organization Seirei Hamamatsu General Hospital
Division name Anesthesiology
Zip code 430-8558
Address Sumiyoshi 2-12-12 Naka-ku, Hamamatsu City,Shizuoka prefecture
TEL 053-474-2222
Email yoshtoba@sis.seirei.or.jp

Public contact
Name of contact person
1st name Hiromi
Middle name
Last name Ikegami
Organization Seirei Hamamatsu General Hospital
Division name Anesthesiology
Zip code 430-8558
Address Sumiyoshi 2-12-12 Naka-ku, Hamamatsu City Shizuoka prefecture
TEL 053-474-2222
Homepage URL
Email hi-ikegami@sis.seirei.or.jp

Sponsor
Institute Seirei Hamamatsu General Hospital
Institute
Department

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 Seirei Hamamatsu General Hospital
Address Sumiyoshi 2-12-12 Naka-ku, Hamamatsu City Shizuoka prefecture
Tel 053-474-2222
Email m-kimata@sis.seirei.or.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
2020 Year 05 Month 05 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 11
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 No longer recruiting
Date of protocol fixation
2020 Year 04 Month 15 Day
Date of IRB
2020 Year 04 Month 15 Day
Anticipated trial start date
2020 Year 04 Month 15 Day
Last follow-up date
2021 Year 03 Month 31 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
2020 Year 04 Month 13 Day
Last modified on
2020 Year 04 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045740

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name

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