UMIN-CTR Clinical Trial

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	https://center6.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000045740
Publication of results	Unpublished

Result
URL related to results and publications	https://anesth-branch2022.org/
Number of participants that the trial has enrolled	13
Results	14 pH tests were performed on 13 patients, 13 positive and 1 negative. All those who tested positive were diagnosed with CSF. SA was also administered to those who judged negative, but anesthesia was ineffective. The pH test accuracy was 100% sensitivity, 100% specificity, and 1.0 diagnostic accuracy (95% confidence interval 0.70-1.0).
Results date posted	2022 Year 10 Month 18 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Thirteen patients were included, with an average age of 33.4 years and an average gestational age of 39.8 weeks.
Participant flow	Those who underwent spinal anesthesia during emergency caesarean section after epidural analgesia
Adverse events	non
Outcome measures	pH test results and effects of spinal anesthesia
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
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	2022 Year 10 Month 18 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000045740